Replies to post #15382 on ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Roddy4, it is hard to say exactly when. I estimate that they had a PDUFA date which the FDA could not meet, due to the massive amount of data to be reviewed. So we are just waiting for them to complete the review. Sometime the FDA automatically extends the PDUFA to give them additional time to complete a review. Since the NDA submission was between July 1, 2023 and September 30, 2023, we could see a decision soon. If approved, I expect a major announcement to be made prior to the approval being added to the FDA website. Since ANIP has not provided the PDUFA date, it is impossible to estimate exactly when we should hear.