Replies to post #33314 on Humanigen Inc (HGENQ)

[ohm20]

I see where they mention CRP < 150. Since it's not an inclusion/exclusion criteria all ordinal scale 7 patients are thrown out of primary endpoint consideration which makes the patient population smaller. Then consider the number at ordinal scale 5 and especially ordinal scale 6 that are over CRP > 150 that might leave a small enough population that there's no way it hits a statistically significant p value.

Bur as the NIH says -

The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies.

So when do you expect HGEN to start it's own new phase 3?

[cowtown jay]

When I first saw the inclusion of patients that entered Ordinal Sale 7 near the time of randomization, I also worried about the effect this group could have on the trial.

""Illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO)." We did not do that in our internal trial. Our Hazard Ratio for mortality could be negatively impacted by this inclusion."

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165187073&txt2find=inclusion

https://clinicaltrials.gov/ct2/history/NCT04583969?A=1&B=41&C=Side-by-Side#StudyPageTop

I don't trust either the FDA or the NIH, and I seriously would like to see the HHS Inspector General get involved overseeing a retrospective analysis of the available NIH trial date, as our as the one we did on our internal trial. We have got to remove any questions of trial data integrity, and determine why the FDA came to their decision to decline our EUA.