InvestorsHub Logo

jour_trader

04/05/24 12:27 PM

#398826 RE: sharkey1 #398821

They haven’t been filing them separately since SequestOx. They have been putting them in the Q’s and K’s. We may not see the CRL wording until 10K in June.

imanjen13

04/05/24 12:31 PM

#398827 RE: sharkey1 #398821

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.