It is possible that the DSMC informed the company

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Posted On: 10/16/2020 3:27:11 PM

Posted By: blafarm

Re: CDiddy #61626

Quote:
It is possible that the DSMC informed the company of their recommendation, and the company set the call to let some things transpire between now and then.

What those things could be: (feel free to add to my list)

1. DSMC recommendation sent to FDA to halt trial. 5 days gives a small window for FDA to decide.
2. DSMC recommendation to continue trial.
a. Company is taking this time to decide if they want to unblind the data
b. Company is prepping to submit the data to UK and others.
c. Company is sending the data/recommendation to potential partners.

Im sure there are more possibilities here. And, admittedly I am trying to shift my focus from being irritated in the 5 day wait period to find out what occured.

It is important to pay close attention to the headline of the PR:

Quote:
CytoDyn to Hold Webcast on October 20 to Discuss DSMC’s Recommendations from the Interim Analysis of the Phase 2b/3 Clinical Trial for Severe-to-Critical COVID-19 Patients

... and the body text of the PR:

Quote:
Management will discuss the recommendations of the Data Safety Monitoring Committee (DSMC) following their review of the interim analysis of the first 195 patients enrolled in the Company’s Phase 2b/3 clinical trial for patients with severe-to-critical COVID-19 indications, including a potential regulatory path forward.

We can spend hours discussing what those recommendations were -- but the point is that there are a plurality of them. So, it won't be as one-dimensional as, say, continue the trial to full enrollment. Maybe it's some combination of continue the trial to full enrollment, change the PE, or something to do with the FDA. It is currently impossible to know.

Quote:
1. DSMC recommendation sent to FDA to halt trial. 5 days gives a small window for FDA to decide.

I don't believe the FDA halts trials.

Quote:
7.2.1. DMC Recommendations to Terminate the Study
In almost all cases, a DMC is advisory to the sponsor; the sponsor decides whether to accept recommendations to discontinue a trial. The FDA will rarely, if ever, tell a sponsor which decision to make.

My understanding is that recommendation to halt trials due to substantial benefit are announced and enacted immediately, so as to not allow any more placebo patients to suffer or perish.