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nelskof

10/01/20 3:54 PM

#24509 RE: Here Today #24507

That's where I'm confused and admittedly not an expert on biopharmas/trials, etc.

My understanding with the placebo trials is that no once can see the data except the DMC. The doctors don't know who is getting the drug. The patients don't know. Dr. Javitt doesn't know.

There is speculation the DMC may have looked at some of the data but Dr Javitt made it sound like they wouldn't know top-line results until the study was over, hence 28 days.

My counter then is that the DMC may be waiting to analyze all of the results once they get to the 102 patient interim analysis. I haven't seen anything that states anyone has looked at results since the first interim review at 30 patients. And only the DMC can halt the trial based on results.

Am I making sense? lol
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elllk

10/01/20 4:17 PM

#24522 RE: Here Today #24507

I agree, they could have a very good idea on how things are going. For instance, even if it is not at all official they might see that the % of patients doing very well is very close to the % of patients on RLF-100 and the % doing poorly is close to the % on placebo. Even if it is 50% on each that could provide a tell. Also, particular minor effects of RLF-100 might very often indicate who is on RLF-100 and who isn't. Nothing, of course, is official until the blind is pulled but they might be quite confident going into that in any case.

Again, of course, they are not going to say anything definitive until the complete unblinding is done.
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djhfsu

10/01/20 4:28 PM

#24525 RE: Here Today #24507

Two videos within the last week or so from Rep. Andy Harris who is ON the review board. Call me blind and deaf but could have sworn he sounded optimistic on RLF-100.

Was I blind and didn't see with my own eyes. Was I deaf and didn't hear with my own ears.

No guarantees in life but as of today, I'm holding and remaining positive.

Dave
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djhfsu

10/01/20 4:29 PM

#24528 RE: Here Today #24507

Also....lots of politics in play these days with the FDA and who is pushing what. Wish I could read Javitt and Co. brain but have to think they are dotting their "i"s and crossing their "t"s.

Who knows.....very strange times.

Dave
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Tiger Money

10/01/20 5:16 PM

#24536 RE: Here Today #24507

Here Today. What you are saying makes sense but it is flawed. That is not how FDA studies work. From a realistic standpoint, if the med is working and saving all the ones getting it and while the placebo folks are suffering, they can't simply stop the trial. If that was the case, they would have never needed Phase II/III because the 21 person study showed how great the drug worked. Hence, your argument would be why go to phase II/III. you wouldn't but unfortunately and immorally, that is not how it works.