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misiu143

05/25/21 10:32 PM

#167837 RE: 3X Charm #167835

3X , mostly yes , company design but then FDA not agreeing with this or that and may change some things before approval ..
This I know for sure ,

As here we heard from Dr Harish , Dr Lalezari , Dr Yang
“ we wanted 4 doses but FDA pushed back “

They can’t all be lying .,

Just imo
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that_little_voice

05/26/21 10:52 AM

#167872 RE: 3X Charm #167835

100% I live in that world. Hence why you have meetings and discussions with FDA BEFORE THE TRIAL. FDA is not here to run the trials, they are here to give clues as to what they will need to see to approve it. The more NDA the more money goes to FDA so they want more drugs on the market.

Also, if Nader submitted and started with 2 doses, then he has to finish with two. You can not change dosing in the middle because you don't like it. Need to run a new trial. Nader with his endless pumping and PR plowed ahead,