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DewmBoom

10/29/18 12:03 PM

#156084 RE: chonrm #156082

Your understanding of my calendar is broken. My days are FDA days that exclude clock stoppage. This is really what count and not the absolute calendar days.

JustGoDeep

10/29/18 12:08 PM

#156088 RE: chonrm #156082

Clock was stopped for about 3 weeks.

Today is about day 88.

That assumes the clock has not been stopped more than once.

Fact is we don't know.

FDA seldom gets thing done on time. FACT!!

Biel!!

Monster!!

Simpsonly

10/29/18 12:15 PM

#156091 RE: chonrm #156082

OCD negativity is getting in the way of the truth.
109 days total elapsed days since submission to FDA.

LESS two factors - first, the two weeks at the beginning when the submission is reviewed for completeness, at which point the FDA clock starts and, second, any hiatus caused by FDA asking questions or for clarification, during which the FDA Day clock stops, then resumes when answers are received.

Therefor, there could be 14 plus 30 or 44 days added to what is perceived by many to be 90. In fact, ignore the days and any clock, it is a guideline only. Like flying, I would rather have a late successful landing than an early failure.

Go BIEL.

Blatcherone

10/29/18 1:22 PM

#156120 RE: chonrm #156082

You said you do email the company with questions. Apparently not. They already responded to those who asked that the FDA asked additional questions which changes the clock. Time would be better spent asking them, not us.