ANI Pharmaceuticals (ANIP)

[LordDarley]

Friends, I did check in today after this disappointing news, mainly to give you a little comfort and perspective, from having been on both sides of the federal regulatory process (not with the FDA).

This is a pretty standard technique by bureaucrats to push out deadlines to take final action. You just say something is lacking, and that tolls the decision period and keeps the matter from being delinquent on your case list. Your progression through Grades and Step Levels depends, in part, on timeliness, so your rejections of filings keeps you from getting black marks.

I really doubt there is anything here that can't be addressed successfully, but the four month deadline for action has been pushed further away.

Except for this little gut punch, for which we are all old hands, I hope all are well and safe.