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Re: rafunrafun post# 198579

Wednesday, 06/26/2019 12:05:45 PM

Wednesday, June 26, 2019 12:05:45 PM

Post# of 425931
Raf respectfully I think you are focused on the wrong thing. Whether it is chronological or not is not as important as the calendar itself.

There is an Adcom on August 7th this year from CDER. Again, historically post August 7th CDER does not schedule Adcoms for the remaining weeks in August. Why? Most likely because August tends to be a popular vacation month. Scheduling is a nightmare.

So that leaves September. What do we know about September. Two things: 1) Adcoms for CDER tend to resume around the second week of September (Sept. 11th / 13th). Why? People are back from vacation / scheduling is easier. September signals back to business on Wall Street and with the federal government.

2) Our PDUFA date is September 28th.

Do you really think the FDA will schedule an ADCOM for us in September. And do you really think if we were going to have an ADCOM the first or second week of August we wouldn't know by now?

Relax. There will be no Adcom. I believe we are in for an early approval. How soon? I don't know but before September 28th.

PS: I'm sure CDER saw that front page article on heart attacks in the WSJ. CDER is gravely aware of what is at stake.

Clock is ticking. All is well.
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