am i the only one who thinks "overwhelming efficacy" was NEVER going to be shown at the first read out?
imo, even if there was "overwhelming efficacy" it would remain in the best interest of all parties involved (FDA, NIH, MSB) to continue the trial.
the more data there is to present to the FDA the better.
the fact is we dont know if there was overwhelming efficacy or not - the results weren't published.
the DSMB is under a lot of pressure in approving this drug for millions or even billions of potential users, taking 'shortcuts' would not benefit anyone in the long run, and im sure the FDA is tired of companies claiming they have a cure or treatment just to waste time and money on bogus claims.
Overwhelming efficacy - the stats required, page-325
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