Replies to post #11041 on ANI Pharmaceuticals (ANIP)

[pcinsurto]

I found this rescission. There are many. Google “fda reverses rtf”

Alkermes on Monday announced that the US Food and Drug Administration (FDA) has reversed an earlier decision to issue a refuse to file (RTF) letter and accepted for review a new drug application (NDA) for the company’s experimental treatment for major depressive disorder.

“FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued March 30, 2018 follows productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission. No additional data or analyses were submitted by Alkermes to FDA,” the company said in a statement Monday.