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Friday, August 30, 2019 12:55:28 PM
AF, et al who have written articles, posted negatives MB posts would love to hear we failed..
I do believe we failed what was the initial trial parameters. hence why we are resubmitting our homework with a NEW AND IMPROVED SAP.
SO YES, WE are redoing our homework and have plans to customize it to the new SAP, NEW SUBGROUPS, etc that we have determined to exist in the umpteen years the trial has existed..
our hopes are the FDA IS NOT SO CROOKED as to reject us when they look at the totality of the trial, long tail or survivors etc.
many drugs in the past has been approved with a mechanism of action of unknown origin.. it just works..
we are redoing our homework now, because we are figuring out that it does work, and its works fantastically in certain subgroups
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