Humanigen Inc (HGENQ)

[cowtown jay]

Management should not have to run a new covid trial. It would be too expensive, and there is no reason that requires it.

The FDA claims they wanted to see additional safety and efficacy data for lenz.

I think the PANAMO trial (NCT04333420) of Gohibic may have provided some context for Regulatory consideration of lenz, based on what the government-sponsored ACTIV-5 trial determined.

https://www.fda.gov/media/166823/download?attachment

I think Gohibic may have shown slightly better efficacy in treating late-stage patients than lenz did. But I think lenz showed a better safety profile. These patients are too progressed to have been included in LIVE-AIR, but ACTIV-5 may have inadvertently provided a secondary choice for doctors treating these late-stage patients.

In addition, the PREACH-M trial demonstrated game-changing safety and efficacy of lenz in treating CMML cancer.

And a major question regards the trial Novavax conducted for their prototype covid vaccine. I am eagerly awaiting that trial data, to see if lenz was used in the manner we patented as a vaccine adjuvant.

But aside from additional safety and efficacy data for lenz, the true safety and efficacy of Pfizer's vaccine is showing significantly less efficacy than reported in their trial, and the public, as well as the medical community, is rejecting the continued use of their covid vaccine , as well as Paxlovid.

Necessity, as it has always been, will force the regulatory approval of a re-submitted EUA application for lenz.