There was no data at the time to support more than
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"There was no data at the time to support more than 2 "
Is this the FDA's reasoning or yours? What kind of data was required to support more than two?
"AND the CD12 protocol that Dr. J assisted in developing had the primary endpoint as 14 day mortality, which proves CYDY didn’t completely believe more than 2 doses were needed."
Now I am confused. If originally CYDY planned for 14 day mortality then two doses (day 0 and day 7) made perfect sense. I don't see how this decision "proves" anything. And it would make perfect sense to add another two doses for days 14 and 21 when it was decided (by who?) to have 28 day mortality. No?
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Le-Ron-Li-Mab, and they have not.