Replies to post #23704 on Humanigen Inc (fka HGENQ)

[cowtown jay]

If I understand what CYDY is saying, they only needed 390 patients to complete their Phase III enrollment, which they have done. HGEN is saying we needed 390 patients to complete 75% enrollment, which we have done.

"CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021."

https://ih.advfn.com/stock-market/USOTC/cytodyn-qb-CYDY/stock-news/83961665/biotech-companies-recent-milestones-and-potential

"The next interim analysis for efficacy is planned when the study reaches 75 percent events (302 events) which will require approximately 390 patients to be enrolled in the trial."

5th paragraph

https://www.humanigen.com/press/Humanigen-Announces-Positive-Interim-Phase-3-Data-of-Lenzilumab%E2%84%A2-in-Patients-Hospitalized-with-COVID-19

So is the discrepancy due strictly to the opinions of the members of the companies' DSMB's? Is it because leronlimab was shown to be more effective at the 75% interim review than lenzilumab? Did either HGEN or CYDY misinterpret the guidance their DSMB's provided? Is it because we are accumulating additional data to be used in our BLA, whereas CYDY may be using their HIV trial data for their BLA?

I don't know.

But, if CYDY has, in fact, completed enrollment; and, if we have enough data to be awarded an EUA before completing enrollment, then maybe we should ask for it before CYDY announces trial results in about two weeks. So, yes, the race is on.