dismissed EB-2 NIW Case: Biotechnology Finance

PUBLIC COpy 
DATE: DEC! 4 2011 
INRE: Petitioner: 
Beneficiary: 
u.s. Department of Homeland Security 
U.S. Citizenship and Innnigration Services 
Administrative Appeals Office (AAO) 
20 Massachusetts Ave., N.W., MS 2090 
Washington, DC 20529-2090 
U.S. Citizenship 
and Immigration 
Services 
OFFICE: TEXAS SERVICE CENTER 
PETITION: Immigrant Petition for Alien Worker as a Member of the Professions Holding an Advanced 
Degree or an Alien of Exceptional Ability Pursuant to Section 203(b)(2) of the Immigration 
and Nationality Act, 8 u.s.c. § 1153(b )(2) 
ON BEHALF OF PETITIONER: 
INSTRUCTIONS: 
Enclosed please find the decision of the Administrative Appeals Office in your case. All of the documents 
related to this matter have been returned to the office that originally decided your case. Please be advised that 
any further inquiry that you might have concerning your case must be made to that office. 
If you believe the law was inappropriately applied by us in reaching our decision, or you have additional 
information that you wish to have considered, you may file a motion to reconsider or a motion to reopen. The 
specific requirements for filing such a request can be found at 8 C.F.R. § 103.5. All motions must be 
submitted to the office that originally decided your case by filing a Form I-290B, Notice of Appeal or Motion, 
with a fee of $630. Please be aware that 8 C.F.R. § 103.5(a)(l)(i) requires that any motion must be filed 
within 30 days of the decision that the motion seeks to reconsider or reopen. 
Thank you, 
\~ Peny Rhew 
Chief, Administrative Appeals Office 
www.uscis.gov 
Page 2 
DISCUSSION: The Director, Texas Service Center, denied the employment-based immigrant visa 
petition. The matter is now before the Administrative Appeals Office (AAO) on appeal. The AAO will 
dismiss the appeal. 
The petitioner seeks classification pursuant to section 203(b)(2) of the Immigration and Nationality Act 
(the Act), 8 U.S.C. § 1153(b)(2), as a member of the professions an advanced The 
petitioner seeks employment as a 
company that the petitioner founded. The petitioner asserts an exemptIOn requmement 
job offer, and thus of a labor certification, is in the national interest of the United States. The director 
found that the petitioner qualifies for classification as a member of the professions holding an advanced 
degree, but that the petitioner has not established that an exemption from the requirement of a job offer 
would be in the national interest of the United States. 
On appeal, the petitioner submits a brief from counsel. 
Section 203(b) of the Act states, in pertinent part: 
(2) Aliens Who Are Members of the Professions Holding Advanced Degrees or Aliens of 
Exceptional Ability. -
(A) In General. - Visas shall be made available ... to qualified immigrants who are 
members of the professions holding advanced degrees or their equivalent or who 
because of their exceptional ability in the sciences, arts, or business, will substantially 
benefit prospectively the national economy, cultural or educational interests, or welfare 
of the United States, and whose services in the sciences, arts, professions, or business 
are sought by an employer in the United States. 
(B) Waiver of Job Offer-
(i) ... the Attorney General may, when the Attorney General deems it to be in 
the national interest, waive the requirements of subparagraph (A) that an alien's 
services in the sciences, arts, professions, or business be sought by an employer 
in the United States. 
The director did not dispute that the petitioner qualifies as a member of the professions holding an 
advanced degree. The sole issue in contention is whether the petitioner has established that a waiver of 
the job offer requirement, and thus a labor certification, is in the national interest. 
Neither the statute nor the pertinent regulations define the term "national interest." Additionally, 
Congress did not provide a specific definition of "in the national interest." The Committee on the 
Judiciary merely noted in its report to the Senate that the committee had "focused on national interest by 
increasing the number and proportion of visas for immigrants who would benefit the United States 
economically and otherwise .... " S. Rep. No. 55, WIst Cong., 1st Sess., 11 (1989). 
Page 3 
Supplementary information to regulations implementing the Immigration Act of 1990 (IMMACT), 
published at 56 Fed. Reg. 60897, 60900 (November 29, 1991), states: 
The Service [now U.S. Citizenship and Immigration Services (USCIS)] believes it 
appropriate to leave the application of this test as flexible as possible, although clearly 
an alien seeking to meet the [ national interest] standard must make a showing 
significantly above that necessary to prove the "prospective national benefit" 
[required of aliens seeking to qualify as "exceptional."] The burden will rest with the 
alien to establish that exemption from, or waiver of, the job offer will be in the 
national interest. Each case is to be judged on its own merits. 
Matter of New York State Dept. of Transportation (NYSDOT), 22 I&N Dec. 215 (Act. Assoc. Comm'r 
1998), has set forth several factors which must be considered when evaluating a request for a national 
interest waiver. First, the petitioner must show that the alien seeks employment in an area of substantial 
intrinsic merit. Next, the petitioner must show that the proposed benefit will be national in scope. 
Finally, the petitioner seeking the waiver must establish that the alien will serve the national interest to a 
substantially greater degree than would an available U.S. worker having the same minimum 
qualifications. 
While the national interest waiver hinges on prospective national benefit, the petitioner must establish 
that the alien's past record justifies projections of future benefit to the national interest. The petitioner's 
subjective assurance that the alien will, in the future, serve the national interest cannot suffice to 
establish prospective national benefit. The intention behind the term "prospective" is to require future 
contributions by the alien, rather than to facilitate the entry of an alien with no demonstrable prior 
achievements, and whose benefit to the national interest would thus be entirely speCUlative. 
The AAO also notes that the regulation at 8 C.F.R. § 204.5(k)(2) defines "exceptional ability" as "a 
degree of expertise significantly above that ordinarily encountered" in a given area of endeavor. By 
statute, aliens of exceptional ability are generally subject to the job offer/labor certification 
requirement; they are not exempt by virtue of their exceptional ability. Therefore, whether a given 
alien seeks classification as an alien of exceptional ability, or as a member of the professions holding 
an advanced degree, that alien cannot qualify for a waiver just by demonstrating a degree of 
expertise significantly above that ordinarily encountered in his or her field of expertise. 
The petitioner filed the Form 1-140 petition on May 27, 2009. In an accompanying statement, 
counsel stated that the petitioner's "past, ongoing and prospective leadership role as a financial 
sponsor of biotechnology and pharmaceutical development unquestionably serves the U.S. national 
interest. " 
earned a Bachelor of Arts degree in physiological sciences 
1991, and a Bachelor of Medicine and Surgery degree from 
acqUIred various medical credentials through 1998, but there is no LU,",.U,",,", that the 
administration degree 
the petitioner has any 
Counsel stated that the petitioner is responsible for "[m]ajor equity investments ... [that] have 
supported the successful development and FDA [Food and Drug Administration] approval of 
numerous high-impact drugs," such as the cancer drugs Erbitux, Tarceva and Nexavar, Vidaza (used 
in myelodysplastic syndrome), Soliris (to treat some cases of paroxysmal nocturnal hemoglobinuria) 
and Recothrom (which controls bleeding during surgery). Counsel also stated that the petitioner 
steered investors away from products later found to be ineffective. 
The petitioner's initial submission contained no documentary evidence of his investment activities. The 
unsupported assertions of counsel do not constitute evidence. See Matter of Obaigbena, 19 I&N Dec. 
533, 534 n.2 (BIA 1988); Matter of Laureano, 19 I&N Dec. 1, 3 n.2 (BIA 1983); Matter of Ramirez­
Sanchez, 17 I&N Dec. 503, 506 (BIA 1980). This principle is highly relevant, because there is at least 
one instance in which the evidence does not match counsel's claims about that evidence. 
A former surgeon and 
school, has won its 
-being products on a web site for 
[The ...,"'uuv","', 
Euros 
the plan, with a further 
company is created within three 
The record does not support the claim that the petitioner won a Entrepreneurship award." 
The record shows only that the petitioner won an award with total value. The record 
contains no evidence that the beneficiary created DrViva.com within the required three months, and 
no evidence that he received the~vestment as a result. Indeed, the record contains 
no evidence that DrViva.com ev~etitioner's own curriculum vitae does not mention 
DrViva.com. (The domain name http://drviva.com currently belongs to a private nursing practice.) 
Counsel states that the petitioner is a 
have difficulty obtaining a labor certification. 
and as such he would 
leagelnelllt that 
there are certain occupations wherein individuals are essentially self-employed, and 
thus would have no U.S. employer to apply for a labor certification. While this fact 
Page 5 
will be given due consideration in appropriate cases, the inapplicability or 
unavailability of a labor certification cannot be viewed as sufficient cause for a 
national interest waiver; the petitioner still must demonstrate that the self-employed 
alien will serve the national interest to a substantially greater degree than do others in 
the same field. 
Id. at 218 n.5. 
Simply listing some of the petitioner's specific portfolio management activities does not establish 
their significance relative to the work of others in the same specialty. Rather than provide 
documentary evidence in this regard, counsel asserted: "The magnitude of [the petitioner's] impact 
on US-based biotechnology and pharmaceutical companies is widely acknowledged by leaders in his 
field and related fields." To support this claim, the petitioner submitted nine witness letters. 
stated: 
chairman and chief executive officer stated: 
[The petitioner's] relationship with began shortly after he started working as 
an investment analyst at a' investment fund, •••••••• 
Group, in _ He embarked on a comprehensive process of due diligence on 
_in an exemplary effort to become extensively acquainted with our company 
and drug pipeline .... In early 2005 he initiated a substantial investment in_ 
on behalf of _ Later that year,_ announced that . . . our then 
investigational agent Revlimid® (lenalidomide) . . . [was found] to have 
overwhelmin~y in multiple myeloma, an incurable type of blood cell cancer 
affecting over_ people in the United States. This . a 
period of steady share price appreciation from approximately $16 share 
in March 2005 to a peak of $76 per share in August 2009. 09 is 
expected to generate net product sales of approximately $1.7 billion .... 
[The petitioner's] investment in our company is illustrative of his professional modus 
operandi and the contribution of institutional investors to the drug development 
industry. 
manager of investor relations at the Biotechnology Industry Organization (BIO), 
a primary research firm providing investors 
with on-demand access to a network of industry experts. At the time, [the 
petitioner] was working with . His 
reputation preceded him as a mdividual, extremely capable 
of making substantial investments for well-deserved companies .... 
Page 6 
Most recently ... I asked [the petitioner] to participate on the Advisory Board for 
[BIO's] largest investor conference put on by the organization. 
I offered [the petitioner] in our group in 
2007 .... The combination of his qualifications ... , professional pedigree ... and 
strong track record of performance renders him highly suited as an institutional 
investor specialized in the biopharmaceutical sector and is most unusual in the 
financial services industry .... 
I am pleased our group was able to attract an individual of [the petitioner's] caliber. 
. . . [The petitioner] has demonstrated a capacity for discerning critical nodes in the 
drug development process that represent opportunities for institutional investors to 
profitably support bringing the next generation of therapeutics to patients, and 
simultaneously protect investors against deploying capital toward unpromising 
projects. 
praised the petitioner's "record of professional accomplishment," but cited only one 
eXllffiple of the petitioner's work: 
One of the earliest investments m 
November 2007, was' .. [ a novel 
agent for treatment-failure gout, a rare indication large~ted by other investors, 
even healthcare specialists. On December 13, 2007 _announced significant 
positive results in a late-stage clinical study with its agent, producing an investment 
gain for _. FDA recently assigned Savient's application for approval to 
license the drug priority review status, a designation reserved for drugs deemed to 
potentially provide an important new advancement in treatment or provide a 
treatment for which there is no adequate therapy available. If approved, Savient's 
agent may significantly improve the quality of life for people living with gout, one of 
the most common rheumatic illnesses. 
appeared to make contradictory assertions, saying "rare" 
occurrences of "treatment-failure gout," but then broadening the drug's most 
common rheumatic illnesses." If the drug is only for a small fraction of gout patients who do not 
respond to other therapies, then references to the wider incidence of gout are irrelevant. 
The record contains no documentary evidence from 
petitioner's specific role in advancing the unnamed 
to show the 
Page 7 
does not claim that the beneficiary played any part in discovering, developing or 
stated: 
In my numerous interactions with him over the years, [the petitioner] has impressed 
me as an astute investor, whose ability to integrate diverse bodies of clinical, 
biostatistical, financial and regulatory knowledge with clear judgment distinguishes 
him even among other investors specialized in biomedical companies .... 
I specifically recall a series of conversations with [the petitioner] in 2004 about the 
experimental agent Genasense™ (oblimersen sodium) for malignant melanoma, the 
most lethal form of skin cancer. . . . Genasense was being developed by Genta Inc . 
. . . In September 2003, Genta's management announced results from a late stage 
clinical study of Genasense, characterizing them as "positive." [The petitioner's] 
willingness to take a critical look at the data and discern this characterization as 
unsubstantiated led him to the high-conviction, counter-consensus view in advance of 
an April 2004 advisory committee meeting of FDA's oncology division, at which 
Genasense's safety and efficacy data were to be publicly discussed, that an 
investment in Genta should be avoided. On April 3rd, 2004, the committee members 
voted that the data presented failed to provide substantial evidence of effectiveness, 
and in the five years since, Genasense ... has not been recommended for FDA 
approval for melanoma or any other indication. 
i . . •• 
asserted that the petitioner's reluctance to invest in was "counter-consensus," 
contains no documentary evidence to establish the claimed pro-Genta consensus prior 
to the April 2004 FDA meeting. Such gaps in the record serve to illustrate USeIS's strong 
preference for objective documentation over witness letters. 
continued: 
Investors like [the petitioner] enhance the efficiency of the convoluted financing 
process for drugs in development by discerning the critical nodes in the drug 
development process that represent opportunities for institutional investors to 
profitably support bringing the next generation of therapeutics to patients, and 
simultaneously protect investors against deploying capital toward unpromising 
projects. 
The last sentence quoted above closely matches a sentence in 
clear who is the original author of this passage. Nearly· in a letter 
from 
Page 8 
[The petitioner] has worked for some of our leading competitors of the highest 
quality. The stature of these firms in our industry, and the scope of [the petitioner's] 
investment management activity on their behalf, establishes his status as a leading 
investor in biopharmaceutical companies . 
. . . [The petitioner] and I have never been colleagues, but on multiple occasions we 
have discussed our respective investment theses on biopharma companies. I have 
come to understand [the petitioner's] extensive research process, and have been 
impressed with his ability to discern the critical nodes in the drug development 
process that represent opportunities for institutional investors to profitably support 
bringing the next generation of therapeutics to patients, and simultaneously protect 
investors against deploying capital toward unpromising projects. 
Another phrase seen (with minor variations) in several letters is the assertion that investors like the 
petitioner "direct precious and limited financial resources to . s that create value by 
developing safe and effe~icines." A letter from chief executive officer 
and principal founder of_Pharmaceuticals, contains that phrase. _ asserted: "Since 
the time of [the petitioner's] first investment in -. our companY'~price has gained 
approximately 60%, while the general market has declined by about 40%." 
Biopharmaceutical financiers preferentially direct investment capital to companies 
that create value by developing safe and effective medicines to meet significant 
patient needs, and the investments made by institutional investors like [the petitioner] 
on behalf of their employers support the successful development benefiting patients 
in the US and elsewhere suffering from a range of medical conditions .... 
Based on my frequent interactions with [the petitioner] over the years, I regard him as 
belonging to a very small corpus with the appropriate educational qualifications and 
expertise to synthesize biomedical data of a highly complex and specific nature with 
equally technically demanding financial information .... 
Even among members of this small group, my fellow senior ImClone executives ... 
and I view [the petitioner] as astute and distinguished. 
stated that the petitioner "judiciously instigated" a "recent major equity investment" in 
before the company made a major announcement about clinical trials for a new 
drug. Shortly afterward, the price ofa share of_climbed from 
Page 9 
In January 2006 ... I interviewed [ 
manager. SAC's New York affiliate, 
extended [the petitioner] an m 
at one of our competitors and his academic credentials .... 
portfolio 
subsequently 
pnor track record 
Talented biotechnology investors such as [the petitioner] direct capital to companies 
that create value by developing safe and effective medicines to meet significant 
unmet patient needs. Consequently, such companies may gain more efficient access 
to essential resources, including capital, human talent, vendors, suppliers and 
contractors. Sophisticated investors characteristically also show an expertise, as [the 
petitioner] does in his sector, for avoiding investments in companies with dubious 
prospects. 
At Sigma, [the petitioner] demonstrated an ability to capitalize on biotech investment 
opportunities, occasionally neglected by other investors, where drug development 
catalysts present potential for significant value inflection. 
"' .... ,uu ... ' ... no expertise in finance or biopharmaceuticals. Instead, he described himself as 
specialized in stress management, and organizational 
psychology." He collaborated with on a book based on his "Trading to Win training 
programs for dealing with trading stress, portfolio management, risk control and leadership as they 
relate to peak performance in the trading arena." Some language from letter also 
[The petitioner] has consistently demonstrated an ability to capitalize on biotech 
investment opportunities sourced by identifying catalysts in the development of drugs 
with potential for significant value inflection, and leveraging his skill set as a surgeon 
and M.B.A. to develop an information advantage. . . . Only a small cadre of 
healthcare investors pursues this laborious process with the discipline [the petitioner] 
does .... 
The investment expertise [the petitioner] has established lies in analyzing drug 
development strategy, a detailed knowledge of biostatistics, and of FDA policies, 
guidelines for industry and precedents; financial valuation methodology; trading 
around positions; and managing portfolio risk. 
On February 2, 2010, the director advised the petitioner of the director's intent to deny the petition. 
The director informed the petitioner that the initial submission did not include sufficient evidence to 
show the intrinsic merit or national scope of the petitioner's occupation, or to establish "the 
significance of the beneficiary's efforts in the field." 
Page 10 
In response, counsel stated that the intrinsic merit of the petitioner's work is evident from the record. 
The director has since acknowledged as much, and there is no need to discuss the issue further. 
Counsel asserted that the national reach of the pharmaceutical industry demonstrates the national 
scope of the petitioner's work, and that the petitioner played "no small part" in bringing new drugs 
to market. Counsel further claimed that "the evidence submitted to date unambiguously proclaims 
[the petitioner] to have had a substantial impact on funding for the development of critical 
pharmaceuticals that significantly exceeds that necessary to satisfactorily perform the task." 
In a personal statement, the petitioner acknowledged that some witnesses have referred to him as an 
"investor," but asserted that such a general term fails to account for "the demanding skill of 
simultaneously analyzing complex biomedical and financial data." 
With regard to his record of achievements, the petitioner stated that: 
I have had management discretion over investment funds in excess of $100 million in 
gross market value, and in the course of my career to date achieved financial gains of 
approximately $200 million for my employers, and in tum their clients and investors. 
More importantly, I feel privileged to have been able to playa critical role in the 
development of medicines that proceeded to gain FDA approval and benefit millions 
of patients in this country and abroad .... 
I have, in addition, financially supported many companies ... developing promising 
earlier-stage therapeutics yet to advance to FDA approval and commercial success. 
A less obvious, though arguably no less beneficial aspect of my efforts historically, is 
the active commitment of capital against investment opportunities I strongly regard 
as unpromising .... The eventual outcome of these drug development projects has 
validated my decisions . . . , saving the industry from further wasting valuable 
resources, and patients from potential harm. 
(Emphasis in original.) Like the petitioner's initial submission, the response to the director's notice 
consists largely of witness letters. Three of the six letters are from prior witnesses. The petitioner 
asserted that these witnesses "comprise an elite group." 
the director to review her earlier letter, and stated: 
Pharmaceutical and biotechnology companies need major infusions of financial 
support to conduct the research and development that lead to new and successful 
drugs which save lives and improve the quality of life for patients with serious illness . 
. . . As an investment manager at three renowned investment funds, between 2003 and 
2009, [the petitioner] proved himself to be an extraordinarily talented investment 
manager who recognized and supported promising products in development, and 
steered investors away from products less likely to yield valuable biopharmaceuticals. 
urged the director to review his previous letter, and stated that the petitioner's 
"record of accomplishment in his field is eminent, and his history of serving the national interest 
substantially greater than his colleagues." 
also asked the director to re-read his previous letter, 
view on [an investment prospect with] 
Atherogenics set him a cut above other investment professionals focused on the same opportunity." 
The first of three new witnesses is 
Cancer Research, who stated: 
In my erstwhile capacity as I met [the 
petitioner] numerous times in the investment research on our company, 
starting in 2003. OS!' s lead product, was then in advanced clinical studies 
for treatment-resistant metastatic , a truly desperate diagnosis. Despite 
inconclusive results from earlier stage trials ... , [the petitioner] developed a highly 
sophisticated, contrarian perspective ... that _ would demonstrate significant 
efficacy in an additional pivotal study in lung cancer, known as BR21, ongoing at the 
time. This was an anti-consensus view developed through months of meticulous 
investment research. . . . The significant equity investment he subsequently 
'-'lU;UUI-'1\.111'-'U turned his then the renowned alternative investment firm 
In April 2004, the results of BR21 demonstrated that significantly prolonged 
survival in lung cancer patients whose malignancy to other organs, and 
progressed despite prior chemotherapy. Just how controversial [the petitioner's] thus 
validated view had hitherto been, is aptly demonstrated by the 159% increase in 
OS!' s share price the day the trial results were announced. 
In September 2004, proceeded to demonstrate a ~ survival benefit 
in a second desperate , pancreatic cancer. ... ~rofound clinical 
impact is reflected commercially by its blockbuster status, with 2009 global sales 
revenue exceeding $1.2 billion. The successful development of constitutes a 
high point of my career, and [the petitioner's] support of OS I at a critical time surely 
provides a compelling example of his professional accomplishments. 
asserted that the "first and foremost" indicator of the petitioner's "professional impact ... 
[is] the clinical and commercial success of biopharmaceuticals he has supported and the fate of those 
he has urged against." 
Page 12 
\..LeUj"",,,,,,,, asserted that the petitioner proved himself to among 
ority of capital allocation to 
"Industry sources recognize 
the prospects for success of 
"less than 50 individuals . . . [who] control the . 
developmental stage [biopharmaceutical] companies." 
that [the petitioner] has played a leading role in the expert 
pharmaceutical pipeline products." 
closely mirrors one from the petitioner's own statement, continuing 
In witness statements: 
A less obvious though no less beneficial aspect of [the petitioner's] efforts historically 
is the active commitment of capital against investment opportunities he regarded as 
unpromising. The eventual narrative of these drug development projects validates 
[the petitioner's] investment management decisions, saving the industry from further 
wasting valuable resources, and patients from potential harm. 
To explain the lack of documentary evidence to support the petitioner's claims, 
strictly proprietary nature of [the petitioner's] work, and the protective 
create to defend the financially sensitive information he routinely assimilates." 
While on a personal level [the petitioner] and I are only peripherally acquainted, and I 
have no self-interest in his application's success, I am well aware - as a business 
journalist writing since 2001 exclusively about biotechnology, healthcare and drugs­
of [the petitioner's] outstanding professional reputation as a distinguished investment 
manager in the biopharmaceutical industry. 
. . . My experience in 2005 and 2006 as a healthcare analyst for an investment 
management firm augments my perspective on [the petitioner's] work. 
At the intersection of institutional finance and biopharmaceutical science, few have 
the expertise to make investment management decisions and evaluate drug 
development companies with the same sophistication as [the petitioner]. ... He has 
not merely prospects for success, as your aforementioned letter seems to imply, but 
an established record of investment management success at his field's premier firms. 
The petitioner submitted copies of nondisclosure agreements that he executed with his employers, 
along with Securities and Exchange Commission filings showing that his employers hold ownership 
interests in various pharmaceutical companies as a result of the petitioner's investments. 
The director denied the petition on June 22, 2010. The director acknowledged the intrinsic merit of 
the petitioner's occupation, but found that the petitioner had not established its national scope or 
Page 13 
shown that his record of achievement warranted approval of the national interest waiver. The 
director stated: 
The petitioner[']s work has given financial support to conduct research and 
development of new drugs through investment by investors. His successful 
investment in biotechnology and pharmaceutical history has produced significant 
financial gain for his employers/clients and investors but the goal of [a] Financial 
Analyst is to manage portfolio involved in capital allocation for the investors, which 
could be performed by other Financial Investors also. Therefore the record does not 
clearly establish that no other Financial Investor can perform this job as [well as the] 
beneficiary, and will directly or indirectly, impart a national-level benefit to the 
United States . 
. . . There are numerous Financial Analyst [sic] and Financial Investors seeking 
employment in the United States .... 
Testimonial letters did not establish that the self-petitioner has accomplished anything 
more significant than other capable members of his profession holding similar 
credentials and investing capabilities. The record does not establish that the work 
being performed by the beneficiary could not be accomplished by a U.S. worker 
possessing the same minimum qualifications. 
On appeal, counsel asserts that "the manifestly non-local geographic distribution of [the petitioner's] 
endeavors" establishes the national scope of his occupation. When compared with the beneficiary in 
_ whose work derived national scope through integral connection to the national 
transportation infrastructure, the petitioner meets the national scope requirement. The petitioner's 
work is not entirely local, and its national reach is not so minimal or trivial as to be negligible. The 
petitioner's occupation is an integral link between a national pool of investors and a national pool of 
potential candidates for investment. 
Counsel repeats that ~oner is a principal of the company where he seeks to work. Counsel 
again observes that _ as quoted earlier, permits USCIS to take the unavailability of labor 
certification into account as a minor factor, provided that other circumstances exist to warrant 
exemption from the job offer requirement. The question, then, is whether those other circumstances 
exist here. 
At the same time, the AAO must also note that the petitioner has not shown that labor certification is 
out of the question for his occupation. Indeed, the petitioner has, for several years prior to filing the 
present petition, worked as an H-IB nonimmigrant for various United States e~any one of 
whom could have sought labor certification on his behalf. The provision of _ permitting 
USCIS to take self-employment into question should not be construed to say that an alien can create 
favorable conditions on his own behalf merely by leaving the employ of a United States employer 
and becoming self-employed. 
Counsel protests that the director "misperceives [the petitioner] as, alternatively, an 'investor,' or a 
'financial analyst'" rather than a biopharmaceutical portfolio manager. Counsel states: 
To thus equate [the petitioner] with the 'numerous Financial Analyst and Financial 
Investors seeking employment in the United States' is entirely to miss the point that it 
is precisely [the petitioner's] ability to operate at the junction of biopharmaceutical 
science and institutional finance that distinguishes him, and that his clearly evidenced 
record of accomplishment places him in the highest ranks of the elite community of 
biopharmaceutical investment specialists. 
A point of clarification is necessary here. It may be that the petitioner's "ability to operate at the 
junction of biopharmaceutical science and institutional finance ... distinguishes him" from financial 
analysts in other areas of specialization, but by itself it does not distinguish him from other 
biopharmaceutical portfolio managers. Specialization is not an inherent basis for granting the 
national interest waiver; there is no blanket waiver for qualified workers in the petitioner's 
occupation. 
Counsel states: 
It should be manifestly obvious, in light of the trade secrecy agreements, and expert 
testimony specifically addressing this issue ... that such items as patents, research, 
publications, etc., would be grotesquely inappropriate and conspicuously unavailable 
as evidence of [the petitioner's] achievements in facilitating the financing of 
medically and publicly critical pharmaceuticals, and conversely, of deterring and 
arresting the development of publicly deleterious products, such as to name 
but one prominent example. 
Counsel cites an unpublished AAO decision from 2003, in which the AAO approved a national 
interest waiver for a senior mechanical engineer at an aerospace company, based largely on witness 
letters from high-ranking figures in industry and academia. Counsel has furnished no evidence to 
establish that the facts of the instant petition are analogous to those in the unpublished decision. 
While the USCIS regulation at 8 C.F.R. § 103.3(c) establishes that AAO precedent decisions are 
binding on all USCIS employees in the administration of the Act, unpublished decisions are not 
similarly binding. 
In the present proceeding, the petitioner has relied almost exclusively on witness letters. Such letters 
can shed light on documentary evidence in the record, but cannot take the place of that evidence. 
Going on record without supporting documentary evidence is not sufficient for purposes of meeting 
the burden of proof in these proceedings. Matter of Soffici, 22 I&N Dec. 158, 165 (Comm'r 1998) 
(citing Matter of Treasure Craft of California, 14 I&N Dec. 190 (Reg'l Comm'r 1972)). 
The opinions of experts in the field are not without weight and the AAO has considered them above. 
USCIS may, in its discretion, use as advisory opinions statements submitted as expert testimony. 
See Matter of Caron International, 19 I&N Dec. 791, 795 (Comm'r 1988). USCIS is, however, 
ultimately responsible for making the final determination regarding an alien's eligibility for the 
benefit sought. Id The submission of letters from experts supporting the petition is not presumptive 
evidence of eligibility; USCIS may, as we have done above, evaluate the content of those letters as 
to whether they support the alien's eligibility. See id at 795; see also Matter of V-K-, 24 I&N Dec. 
500, n.2 (BIA 2008) (noting that expert opinion testimony does not purport to be evidence as to 
"fact"). USCIS may even give less weight to an opinion that is not corroborated, in accord with 
other information or is in any way questionable. Id at 795; see also Matter of Soffici, 22 I&N Dec. 
158, 165 (Comm'r 1998) (citing Matter of Treasure Craft of California, 14 I&N Dec. 190 (Reg'l 
Comm'r 1972)). 
The AAO does not dispute that the individuals who signed the letters endorse the views expressed in 
those letters. Nevertheless, the AAO cannot ascribe the precise wording of the letters to those 
individuals, given the numerous demonstrable use of shared language that an unidentified party 
appears to have furnished to the witnesses. The witnesses signed the letters, but it is not clear to 
what extent they wrote them. 
Many of the witnesses' claims appear to be amenable to documentation. For instance, 
asserted that "less than 50 individuals ... control the ·ty of capital 
developmental stage [biopharmaceutical] companies." Either seen evidence to that 
effect, or the figure is little better than a guess. Such a statistic to be the subject of a 
non-disclosure agreement (someone supposedly disclosed it to who does not work in the 
industry). 
Other claims about the financial performance of various companies appear to be equally amenable to 
verification, particularly with regard to publicly held corporations whose stock prices and other 
financial information are available to the public. The AAO is under no obligation to seek out this 
information and add it to the record on the petitioner's behalf. 
Witness accounts of good drugs the petitioner supported, and bad ones he opposed, are anecdotal 
and do not establish his overall track record. The record offers no way to tell whether the petitioner 
and the witnesses have selected these accounts to present the petition in the most favorable possible 
light. Another consequence of the lack of primary documentary evidence is that the record offers no 
objective way to distinguish between the petitioner's track record and that of others in the specialty. 
The only comparisons offered come from witnesses whom the petitioner has selected, and the 
petitioner has a demonstrable interest in submitting the most favorable letters. 
Throughout this proceeding, the waiver claim has rested on the assertion that the United States 
benefits from the availability of effective new drugs, and from avoiding ineffective ones. Credit for 
drug development, however, belongs to the researchers developing the drugs. USCIS will not 
transfer a significant part of that credit to investors or other intermediaries who play no part in the 
actual discovery or development of the drugs. 
Page 16 
The petitioner has not shown that his withholding of investment funds has stopped dangerous or 
ineffective products that would otherwise have reached the market. Counsel, on appeal, names 
.' a pain reliever pulled from the market amid concerns of serious health risks. The record, 
however, contains no evidence to show that the petitioner (or any portfolio manager) played any role 
in the withdrawal of Counsel appears to have named the drug as an example of a dangerous 
drug, rather than as pIe ofthe petitioner's work. 
observed that the petitioner opposed investment in the maker of 
an committee determined "that the data presented failed to provide substantial evidence 
of effectiveness." The record does not show that the petitioner's opinion influenced the FDA's 
decision, or that it was the petitioner, rather than the FDA, who the drug off the market. _ 
_ acknowledged that the petitioner's opposition to was "counter-consensus," 
implying that other investors were supporting the drug's also does not 
indicate that the petitioner's actions ceased all efforts to promote the 
that "several additional studies" have taken place following the FDA's 2004 decision. 
Even if the record showed that the petitioner played an active role in stopping the development of 
some drugs, the AAO will not find that a portfolio manager serves the national interest by refusing to 
invest in products he or she does not find worthy. One might construe such a finding as usurping the 
authority of the FDA, and is subject to abuse if an investor opposes the development of a particular 
drug for non-medical reasons (such as a vested financial interest in a competing pharmaceutical 
company). It is certainly each investor's prerogative to choose which projects are worthy of 
investment, but the AAO is not willing to conclude that the petitioner would serve the national 
interest (not to be confused with the interests of his clients) by impeding the development of drugs 
that he does not consider promising. 
As shown above, the petitioner is not directly responsible for the development of new drugs, or for 
stopping drugs that do not belong on the market. Instead, any direct benefit that arises from the 
petitioner's work would corne in the form of financial return from his investment acumen. The 
petitioner has not, however, advanced financial considerations as a basis for the national interest 
waiver. The petitioner having made no claim in this regard, the AAO will not speculate as to the 
substance or merits of any arguments the petitioner might have made with regard to such a claim. 
The petitioner has established that he is a successful biopharmaceutical portfolio manager, and that 
some figures in the field and related fields consider him to be especially skilled in that occupation. 
Exceptional ability in one's field, however, is not an automatic basis for a national interest waiver. 
The petitioner has not provided objective evidence that his work as a biopharmaceutical portfolio 
manager has influenced his field as a whole and benefited the United States to a greater extent than 
others in the specialty. The record, therefore, does not support the assertion that the petitioner will 
prospectively benefit the United States to an extent that would warrant a national interest waiver. 
As is clear from a plain reading of the statute, it was not the intent of Congress that every person 
qualified to engage in a profession in the United States should be exempt from the requirement of a job 
offer based on national interest. Likewise, it does not appear to have been the intent of Congress to 
grant national interest waivers on the basis of the overall importance of a given profession, rather than 
on the merits of the individual alien. On the basis of the evidence submitted, the petitioner has not 
established that a waiver of the requirement of an approved labor certification will be in the national 
interest of the United States. 
The burden of proof in these proceedings rests solely with the petitioner. Section 291 of the Act, 
8 U.S.C. § 1361. The petitioner has not sustained that burden. 
ORDER: The appeal is dismissed.