Humanigen Inc (fka HGENQ)

[cowtown jay]

You referenced the concluding paragraphs of the FDA's "Decline" letter for the use of hydroxychloroquine sulfate (HCQ). And I would not be surprised if the FDA's "Decline" letter sent to Humanigen concluded in that exact same language in regards to lenzilumab.

However, the second paragraph of that HCQ letter states the following (segmented for distinction of the points made):

"...based on the totality of the scientific information
available,

it is unlikely that hydroxychloroquine sulfate may be effective in disease prevention or treatment of early COVID-19 infections.

Further, in light of ongoing reports of serious cardiac adverse events and other adverse drug effects,

we conclude

that the known and potential benefits of hydroxychloroquine sulfate in disease prevention or treatment of early COVID-19 infections do not outweigh the known and potential risks for these proposed uses."

Based on those comments, I'm surprised that HCQ's EUA request was declined, rather than being flatly denied.

In terms of lenzilumab (segmented to match the above)...

the scientific information we provided was our Phase III clinical trial results...

which demonstrated improvement of 54-90% over standard of care...

the safety results were in-line with the placebo arm, reflecting no marginal detriment attributable to lenzilumab...

and, we're told, the FDA could NOT determine that risks outweigh benefit.

So...

if our FDA Decline letter does, in fact, conclude with the boilerplate language such as used in the Decline letter they issued for HCQ, the basis for the lenzilumab Decline must be entirely different. I think the issue has to be regarding verifiability.

https://aapsonline.org/FDA-EUA-HF-rejection-letter.pdf

And this was interesting

https://www.fda.gov/media/138945/download