Humanigen Inc (HGENQ)

[DonDonDonDon]

I suppose more data from Activ-5 is a possible reason for delay

I understand a fraction of what you do about all things pharma but the ACTIV-5 trial expansion is what made me think that lenz wasn't getting the EUA at least until the ACTIV-5 was fully enrolled. The trial expansion happened at exactly the time the EUA was expected. It would be impossible to enroll the trial in the US if the EUA was granted since they couldn't give someone a placebo if the drug is available through the EUA. Would they expand a trial if they knew it wouldn't be possible to enroll? I don't buy the argument that the FDA and NIH are separate entities where the right hand doesn't know what the left hand is doing. I guess the trial could enroll outside the US and they did add 2 sites in South Korea.

It seemed to me that they wanted more data. The trial had very good data but it is small and its kickbutt data came from the 256 patient subgroup of those with CRP<150mg/l and under 85yo. So it makes sense to trial that subgroup to reconfirm the data from the first 700 patients and possibly even attain stat sig on mortality. One reason the FDA may reassess their position is the seriousness of Delta. The Covid situation has changed dramatically since the ACTIV-5 trial was expanded. HGEN needs the EUA ASAP so that they can shift manufacturing into high gear.

antidotal

One of my favorite eggcorns. It is like deep-seated/deep-seeded or buck naked/butt naked where the eggcorn is kind of accurate.

Disclaimer: I sold all of my HGEN on Aug 10. People might accuse me of bashing a bit because I want HGEN's share price to fall back down but really not owning HGEN is allowing me to be more honest without any incentive to pump.