Humanigen Inc (fka HGENQ)

[cowtown jay]

"... it is just as possible to conclude that the FDA Declined our Denial..."

I can hear the DOJ's excuse now. 'We didn't consider the Decline's affect on the status of a Denial of the company's EUA application. We acted upon the FDA's information provided to us, which focused on their discussions with management over various concerns,' the most serious, to me, being unable to make a risk/benefit determination.

There will never be another case of this magnitude for any of the government personnel involved. Millions of lives are in the balance.

Has the SEC and the DOJ even challenged the FDA's expressed concerns? It's not outside of your purview in this case. You cannot reconcile the FDA's concerns with the facts. The FDA themselves quickly IND-Authorized lenzilumab in April of 2020 to treat covid, nearly five years ago. I also suspect there are recently two FAST-TRACK designations the FDA made to expedite the use of lenz in other applications.

There are no risk/benefit concerns expressed in Mayo Clinic's case cohort study, which, with lenzilumab's efficacy, led to them working with Humanigen's doctors/executives in the highly successful company-sponsored LIVE-AIR trial. A key take-away from the trial investigators was lenzilumab's safety profile. See the presentation of the Investigators' Meeting here:

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