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dloggold

01/18/25 11:15 AM

#43674 RE: cowtown jay #43673

Haha i figured that would pull a trigger. Jay while i doubt you i would not have a problem if you were right.. 
if you were not a lawyer you missed a calling.
You make good arguments. 
Where the heck are cam and dale hiding at
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cowtown jay

01/18/25 1:38 PM

#43675 RE: cowtown jay #43673

Thanks, dlog. To me, it is self-evident that management can not be held criminally liable, just because the FDA raised questions, and then Declined to review the evidence in the EUA application. That's all it took for criminal charges to be brought in this case. That would mean the FDA could act with impunity by hiding behind a Decline determination, which doesn't need to be justified, as a Denial would require.

Wife and daughter went to law school, but I was the only one who filed Motions or Objections, subpoenaed evidence, and argued a case which the judge thought I had, but I couldn't convince him of the damage Naked Shorting had on a company's equity financing capability. I found what I thought I was meant to do when I became a Special Investigator for the US Government for awhile after 9-11. But after some time, I knew I was ultimately interested in getting on the other side of investigations concerning the US Government. I'm still proud of the federal credentials I held, and I'd be happy to retake them as a contracted investigator, if our new Administration gets serious about things.
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cowtown jay

01/20/25 1:42 PM

#43677 RE: cowtown jay #43673

"... 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:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175678449