Quote:The Honorable Paula Xinis U.S. District Judge
District of Maryland 6500
Cherrywood Lane Suite 255 Greenbelt, MD 20770
April 8, 2024
Re: United States v. Nader Pourhassan,
No. 8:22-cr-00440-PX
Dear Judge Xinis:
On behalf of Dr. Nader Pourhassan, we write in further support of Dr. Kazem Kazempour’s letter dated April 5, 2024, see ECF No. 113 (the “Letter”), and to further request that this Court order the disclosure of additional FDA communications regarding CytoDyn’s Covid-19-related patient and clinical trial data. In the Letter, Dr. Kazempour properly requested that the Government conduct a full Brady review given our preliminary review of the March 29 Production. See ECF No. 113 at 1-2, 9. As is the case for Dr. Kazempour, such discovery is material to Dr. Pourhassan’s defenses and is exculpatory.
In the Government’s response, filed today – April 8, 2024 – the Government accuses Dr. Kazempour of “mischaracteriz[ing] the internal FDA communications he has received to date as exculpatory” and disputes that the FDA was acting out of “animus.” ECF No. 114 at 1, 5. The FDA communications, however, speak for themselves. For example, on March 27, 2020, when CytoDyn shared results from the first instances of leronlimab treatment on critically ill Covid-19 patients in Intensive Care Units in New York—long before there was any clinical data that might provide a basis on which to question the drug’s potential to achieve authorization—an FDA employee commented to colleagues internally “Approval is OUT OF THE QUESTION!!!” and “I HATE THEM[,]” referring to CytoDyn. See Exhibit 1 (DOJ-PROD-0003615641) (emphasis – but not all caps – added).
Any reasonable juror would agree that this amounts to animus, and by the FDA’s own admission, such “hate” made approval “out of the question.” As this document further demonstrates, the March 29 Production raises concerns extending beyond the BLA allegations, but also to the Covid-19 allegations. The Government has charged Dr. Pourhassan with securities fraud and wire fraud in connection with CytoDyn’s and Dr. Pourhassan’s statements regarding clinical data and the potential of leronlimab as a treatment for Covid-19.
See Indictment at Counts 9 and 10 (ECF No. 1). Critically, the Government’s allegations in connection with these charges are predicated on the FDA having Case 8:22-cr-00440-PX Document 118 Filed 04/08/24 undertaken an allegedly careful review of data emanating from CytoDyn’s clinical trials, and adopted an interpretation of the significance of such data that differed from that of CytoDyn’s and Dr. Pourhassan’s public statements, and that made the likelihood of CytoDyn securing relevant FDA drug authorizations lower than CytoDyn and Dr. Pourhassan allegedly represented to the public.
Documents like those above contained in the March 29 Production, however, demonstrate that the FDA did not conduct any such careful review. Instead, the FDA’s so-called review appears to have been a sham, with the FDA deciding that it was going to block meaningful consideration of CytoDyn’s drug leronlimab before clinical data was even available for its review and interpretation.
1 When Dr. Pourhassan raised these serious concerns with the Government in a letter dated April 3, 2024, and requested that the Government implement search parameters designed to capture potentially relevant and exculpatory materials in connection with the Covid-19 allegations
2—as is its duty—the Government refused Dr. Pourhassan’s requests outright. See ECF No. 113-3. Given the proximity of trial, the critical nature of these belatedly disclosed exculpatory documents, and the additional potentially exculpatory and impeachment material the Government retains in its possession—in contravention of its constitutional and statutory discovery duties—Dr. Pourhassan joins Dr. Kazempour’s Letter, and looks forward to answering any questions the Court may have at the conference scheduled for April 15, 2024.
Sincerely,
/s/ Adam Lurie _______________________ Adam Lurie Linklaters LLP Counsel for Dr. Nader Pourhassan
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