Peter Lederman in Second Bout With COVID-19

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.

What's a recult? The drug has proven to be very safe thru all its uses and applications precovid. Most common complaint is skin sensitivity at the injection site. The  trial on the former president of the Philippines these last days as reported by his son is said be a life saver and after one shot, 3 more to go. The limited doses for the trial may include only government and political figures for the rest of this week. That sucks if true. If that works then they may bring the drug in for the general public, we hope. Then onto Brazil which is in Dire Straits..and not the band. Tom

theaudiotweak,

"What's a recult?"

Wrong finger on the wrong key. It was meant to be "results".

lewm explained the process very nicely and simply. We all hope that everything is the way you already see it, but there is not much ground for that optimism right now. It may be that the drug is safe, as in not having very bad side effects, but efficacy seems to be missing at this point in time. Even the fact that the president of Phillipines "got better" after one dose means virtually nothing for anyone but him. There are many more factors that may be at play so holding onto this particular straw is not much more than desperate wishful thinking. Relax, let the things settle and run their course. The company is trying to make money off of something they invested time and effort in. It just happens that it has not made a splash in any application quite yet, and maybe never will. It happens daily. It may be more common than success stories.