Humanigen Inc (HGENQ)

[DonDonDonDon]

You can call it a conspiracy all you want

It is not hyperbole when I call it a conspiracy. It is your belief that the FDA knows that the data are good enough for an EUA but that they are conspiring against lenz. Notice the word "conspiring"? I am not using it inaccurately.

Most conspiracy theories start with a faulty premise. In this case, the faulty premise is that lenz's trial had mind-blowingly good data and only a conspiracy could explain it not getting the EUA, yet. Lenz had a small trial that barely achieved stat sig on its primary endpoint and didn't achieve stat sig on mortality. We have no idea what were the results of the ACTIV-5 trial. Since the LIVE-AIR trial barely had stat sig on the primary endpoint, it is conceivable that stat sig is lost when the data from the ACTIV-5 trial is added in. While we can only speculate about the ACTIV-5 data, the FDA knows the data.

Another problem with the 520 patient LIVE-AIR trial is that the data isn't uniform across the whole trial. The subgroup of patients with CRP<150mg/L and under 85yo had excellent data. The other half of the trial had bad data. So they certainly couldn't give an EUA to the entire patient population contained in the trial. The FDA doesn't like to give EUAs to subgroups of a trial. No conspiracy needed. So they changed the patient population in the ACTIV-5 trial to give lenz the opportunity the reconfirm the excellent data shown in that CRP<150mg/L and under 85 subgroup.