Peter Lederman in Second Bout With COVID-19

The FDA calls this “data dredging”. If the drug or vaccine doesn’t meet the stated criteria for success, you find another way to make it sound good by sifting the data. It is a regulatory no-no, but may work for the lay press. Maybe it helps the stock price. 

Theaudiotweak, why do you assume the paranoid view? Maybe the truth is that this drug is not effective in severe covid, and the FDA would be doing the right thing based on real data not to grant it an EUA, much less a bona fide  license. Seems to me like the sponsor is just grasping at straws, trying to find some use for this drug that was originally developed to treat HIV, and apparently didn’t make much of a mark in that area either. Their idea is only to make money.

The real number was to be 4 doses specified by the drug maker not the 2 the FDA used for the Original Trial. Sure that would skew the final numbers.

More disclosure to come out this week from the use of this drug on critical care patients in the Philippines including a former ex president.  Not paranoid just alert and optimistic. Tom

You are operating under a false assumption. The FDA doesn’t design the clinical trial. The sponsor is responsible for that. Then the sponsor submits the proposal to FDA for approval of the study plan before the trial can commence. In the phase 3 trial the dose and the number of doses and the amount of drug per dose would have already been established based on phase 1 and 2 results. The algorithm for making those decisions is also work done by sponsor, usually starting with animal studies before phase 1. Sounds to me like the sponsor simply wants to take another shot at showing an effect, using 4 doses instead of 2. If 2 doses was at least “safe” for the participants, FDA might allow it, but it requires a whole new proposal. And some new evidence to suggest 4 doses would be both safe and any better than 2. With a view to protecting the safety of participants, doesn’t that make sense? That’s the job of FDA.

I would not hold my breath for those recults. So far, it appears very unpromising.