InvestorsHub Logo
Followers 27
Posts 2484
Boards Moderated 0
Alias Born 04/02/2014

Re: nelskof post# 21593

Wednesday, 11/11/2020 12:06:27 PM

Wednesday, November 11, 2020 12:06:27 PM

Post# of 42820
“The next interim analysis will happen after 302 events, which Humanigen calculated will require around 390 patients.”

“The monitoring board looked at the data for the interim analysis and recommended raising the target number of recoveries from 257 to 402.”




390-257= 133 patients left to be enrolled





I’m not sure what the enrollment capacity is per site for the P3 trial. I don’t think they will be able to enroll more than 6 people at a time per site. Again I don’t know but I am going off of the Big Effect Trial since they mentioned they will generally have no more than 6 enrolled at a time.

BIG EFFECT TRIAL—

“Approximately 100 subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once.”

I believe intervention means the experimental drug so since it’s random and we don’t know what patient is given the drug, I would assume at least 2 people per intervention. That’s how I came up with the number 6. 3 interventions = 6 patients enrolled

We theoretically at this rate, should have about 90 (347 total) patients (15 sites) enrolled within the next 5-7 days or so. I am assuming a 11 day window of recovery so starting at nov 6 when the article came out puts us a 5-7 days until the 11 day window completes. Which means the following 11 days after that we should be able to enroll an additional 90 to easily hit the 390 (437 total at this point) mark by around November 28th. And finally after Nov 28th, another 5-11 days later, 302 patients will have recovered by then


We need someone to sticky the link below-

https://www.fiercebiotech.com/biotech/humanigen-links-drug-to-improvements-severe-covid-19-patients