Our covid 16-17 trials interim look is so important this time around…it may only offer us information a week or two early depending on how quick the trials fill. This early look is what can make or break our primary endpoint and we need the success of this interim look might provide. This is last weeks news at the bottom of the post for Humanigen and what they have done to modify their primary end point. Lesson learned for us?

I hope we have learned our lesson to change our interim primary end point if needed. I hope we hit our original primary end point but if not… we can’t skip our analysis at this interim time to be able to change our primary endpoint so we achieve a much needed primary end point with success. Let us be this smart in our future direction and lesson learned from the lack of the DSMB not helping us last time around. It’s the DSMB that I blame the most for our lack of direction of success last trials. They had the opportunity to help us change and did not. Their lack of helping us gave us false security of going forward we would meet our primary endpoint. Amazing screwing we got from that group leading us astray with false hope.



02:42 PM EDT, 07/30/2021 (MT Newswires) -- Humanigen (HGEN) said Friday that the National Institutes of Health progressed lenzilumab to a phase 2/3 trial from a mid-stage phase and revised the primary endpoint to survival without ventilation in hospitalized COVID-19 patients.

The modified study now has 400 patients across 60 US sites, the clinical-stage drugmaker said. It is supplying the drug candidate for the study funded by the agency.

Lenzilumab achieved the primary endpoint in another late-stage study with a 1.54-fold improvement in the likelihood of survival without ventilation compared with placebo.

The stock was down more than 4% in late trading amid a broadly weaker market.