Replies to post #2570 on UniCycive Therapeutics Inc (UNCY)

[Stumblebum]

Let’s just get it approved this time 🤞….no more crl please….if Uncy management can’t correct what was wrong with the third party manufacturer after being told by the fda….they are truly dumb s#&$@%ts

[Whalatane]

Please stop making sense ...its messing with my plan ( disclosed previously )..:--)
You're right again
sigh
Yes theres are several reasons why the FDA may approve in the last week before June 29th .
1) its only a manufacturing issue ...no dispute about efficacy , safety data etc
2) Co was notified months ago what the manufacturing issue was ...and FDA probably won't inspect facility for another 3 mths anyway .
So no excuse for not getting it fixed ...whatever it was .
3) Once they clear the manufacturing issue FDA will concentrate on labeling and if Co has enough finished product on hand should they approve . If approved on or by the 29th ...Co can start selling ...or at least handing out free samples ...ala the launch of Lipitor ( some personal experience with that ) .
So if they clear the labelling and available supply of OLC ...then no reason for the FDA to delay to the last day .

Kiwi

[Denisk]

Here is the answer I got from Google Ai as to the Target date for the PDUFA:
"Note: The FDA accepted the NDA resubmission, with a PDUFA target date of June 27, 2026. "