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Andy2018

09/11/20 2:10 PM

#20074 RE: nelskof #20072

It’s not about javitt you probably don’t know how “unmet medical need” and clinical trials works. again this is the only covid “therapy” company had Fast Track, priority review and expanded access all 3.
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aGuyUS

09/11/20 2:10 PM

#20075 RE: nelskof #20072

YOu have discounted the fact that the FDA in this case isn't looking at Safety as RLF-100 has 20 years of testing proving safety. Hence the trial data statistically was narrowed to eliminate this because this is a treatment with a proven track record for safety.

The only concern here is if the drug treatment works better than Placebo and to what statistical % benefit does it work. So a smaller trial group is all that is needed.