Replies to post #33297 on Humanigen Inc (fka HGENQ)

[DonDonDonDon]

You know, when the NIH Covid Treatment Guidelines were published, I was concerned that they cited our primary endpoint of SWOV as a Key Limitation of our trial design.

I think you are confused. Management has said that the trial was not powered enough to show stat sig on mortality. 9.6% of lenz patients passed away whereas 13.9% of placebo passed away for a p value of 0.2287. So the key limitation was that the trial wasn't big enough to demonstrate stat sig on mortality but would easily attain stat sig on mortality in a bigger trial if those percentages remained consistent. I don't think the primary endpoint of SWOV has ever been said to be a key limitation. They attained stat sig on it. So I googled "key limitation" and lenzilumab and a post of yours from July 30th popped up. In it you say that "Then the NIH finds that because we were not powered to detect a survival benefit, that that constituted a Key Limitation in our trial." Getting confused between SWOV and mortality is a common theme in your posts. They are not the same. They aren't even similar endpoints. Below is your post from July 30th and a post of mine where I explain the SWOV endpoint.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165787803&txt2find=swov

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

[ohm20]

and the DSMB is evidently getting real-time data on the patients.

If that were the case they would be violating the rules of a blinded study. At that point the data is considered tainted and the entire trial will be rejected by the FDA. The DSMB are allowed to see data at pre-specified interim analysis points, that's it.

[jjson]

Thanks cowtown jay for a welcoming kind reply.
I see where you are going with this.

Do you think Humanigen is submitting their Activ-5 interim data to UK as well?
I tried to find any companies that were rejected after the rolling review by MHRA, but I couldn't find one.