ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Did anyone pick up that ANIP filed two NDA 505(b)(2) application in their Q3 earnings release?

Company’s strong R&D organization delivered five new product launches and filed three new ANDAs and two new 505(b)(2) applications in the quarter; retained number two ranking in Competitive Generic Therapy (CGT) approvals

Q3 Press release

Combined with the NDA filed in Q1 that makes all three NDA's currently under review.

According to the R&D expenses only one of the two NDA 505(b)(2) submissions fee were paid for by ANIP in Q3 . It makes me wonder if the other one has ANIP filing for testosterone but paid for by AbbVie or another company. If so they can drag out posting results until it is approved.

ANIP paid for the Q1 NDA filing.

We must be getting close to a decision on the first two.

Should be a fun ride.