ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Regarding the FDA review timelines, I found this report to Congress regarding FDA Drug Approvals dated March 2020, which states the following as FDA goal:

Four key features of new drug applications (NDA) are linked to the time the Food and Drug Administration (FDA) takes to complete initial reviews of NDAs. Three key NDA features determine the time frames for initial review that would meet FDA’s goals under the Prescription Drug User Fee Act (PDUFA) and its reauthorizations, which authorize FDA to collect user fees from drug sponsors:

• Whether or not the NDA qualifies for the priority review program, which is
generally an expedited program for drugs that provide significant therapeutic improvements in the prevention, diagnosis, or treatment of a serious condition when compared to available drugs. The PDUFA goal for review of a priority NDA is 4 months less than for an otherwise similar standard NDA, for which the goal is to complete the review in 10 months.
• Whether or not the NDA involves a new molecular entity (an active ingredient that has not been previously marketed or approved in the United States). The PDUFA goal for review of an NDA with a new molecular entity is 2 months longer than for an NDA without one.
• Whether or not the applicant submits a major amendment (additional or new information, such as a major new clinical study) while the NDA is under
review. The PDUFA goal for a review of an NDA may be extended by 3
months if the applicant submits a major amendment.

The fourth key NDA feature is whether or not it qualified for one or more of three other expedited programs for drugs intended to treat serious or life-threatening conditions.

US Government of Accountability Report

As I understand it, female testosterone would be considered as a new molecular entity which could of resulted in an additional two months being added to the PDUFA date. Assuming the filing was made September 30, 2023 and the FDA took the full 60 days to accept the submission for review and the FDA gave themselves an extra two months for the review and they requested additional info to qualify as a major amendment, you could be looking at a revised PDUFA date as late as February 28, 2025. Obviously, transparency from ANIP would resolve this question. But we know that it is not in their DNA.

GLTA