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BooDog

10/15/18 1:18 PM

#244902 RE: PlentyParanoid #244896

Good stuff PP. Let's not forget the hundreds of hours it takes putting all this stuff together to move an indication forward.


Message in reply to:

"It took 10 months to ask for a meeting?"

Dear TIAB. If you had read FDA guidelines you might have been able to hazard a guess by yourself.

A test of advanced reading comprehension and logic:
https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm

Hint: the last paragraph sort of gives FDA's preferences away.



Don't think we'll be waiting much longer.

$IPIX