Humanigen Inc (HGENQ)

[cowtown jay]

The data from the LIVE-AIR patient population would be of sufficient volume for the FDA to make a regulatory decision. Trial size was established in consultation between the FDA and management.

The NIH ACTIV-5 trial tested late stage patients, including patients who had, or were on, IMV. The FDA even included patients on ECMO, whose outcomes were not to be factored into the trial results.

No new trial is required for an EUA. We should be able to extract ACTIV-5 results for their patients who were in ordinal scale 5, and use those results as an adjunct to the LIVE-AIR trial results, if necessary. The ACTIV-5 patients in ordinal scales 6 and 7 were too progressed in disease severity, and were not included in LIVE-AIR. We also have safety and efficacy data from lenz on the PREACH-M study, which may soon win approval in Australia, and all of this data could be included in a resubmission of our EUA application. I think our OS is already higher than management wants, and I doubt they will reverse split, even at 1:5. There will be no need to do so, anyway, after the loaned shares are recalled, and we could even see a forward split, which I hope we don't, even f it would be temporary.