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Re: sharkey1 post# 398821

Friday, 04/05/2024 12:31:12 PM

Friday, April 05, 2024 12:31:12 PM

Post# of 400571
Strangely a CRL is not considered a material event to my surprise. Apparently since it not a rejection of the filing but rather a notice that the anda application will not be accepted in its present form, companies can rely on that technicality and not disclose until it files the 10Q.
Nasrat alluded to the fact that when he talked about continuing talks with the fda. The drugs in question are not that big and even when approved will not be a big mover of the bottom line.
The three needle movers which will be very important have not reached their pdufa date which will occur later in the year.
I do agree that receipt of a CRL should be considered a material event.
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