"...the FDA had declined EUA approval..." the DOJ incorrectly claimed in their second Indictment. So, another example of conflated outcomes. It's an example of bias against management, even with a preponderance of evidence negating the FDA's expressed opinion as to the data, demonstrating a very favorable risk/benefit determination.
Even a rookie FBI agent should have had enough common sense to verify the validity of the FDA's stated concerns. This is especially true when the FDA's own actions demonstrate absolute support for lenzilumab, starting with granting Investigational New Drug (IND) authorization in April 2020, and continuing with FAST-TRACK designation for Novavax and Sanofi lenz-enhanced (?) vaccines, awarded as recently as two weeks before the DOJ's second Indictment.
Then, there is the issue of third party verification of lenzilumab's safety and efficacy, demonstrated in the LIVE-AIR trial, with results published in the Lancet and Thorax peer-review journals. And did the FBI challenge the trial design of the government-sponsored ACTIV-5 trial, excluding patients who showed the most benefit from their trial, and including patients who exceeded disease severity levels established by the company?
Additional questions should be asked about collusion between competitive pharmaceutical companies and government agencies who are largely funded by these commercial entities.
The FBI can't just act on boiler-plate language about FDA concerns, especially when ultimately, the FDA doesn't even Deny the EUA.
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