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Re: None

Friday, 08/09/2019 5:54:33 AM

Friday, August 09, 2019 5:54:33 AM

Post# of 425623
Anybody consider the possibility this is no more than an actual schedule delay?

This is not like putting a date and the calendar and letting everybody know. The FDA has gigs of data to analyze and evaluate. Then they have to find a date that can align with a bunch of outside experts who have their own world to deal with.

I would guess highly likely that the reaction to this delay (both here and in the market) is very overblown.

BTW, the FDA has to put the priority review PDUFA data (which is a GOAL) if the submission deserves it even if they can not meet it.

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