Replies to post #14499 on ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Possibly Silvr, If ANIP is going it alone in the US, Dr. Reddy seems like the logical choice. Yet, I also would not be surprised if they made a deal with Aspen as an API supplier. Aspen has USDMF and CEP/COS designation for Testosterone API, whereas Dr. Reddy only has the USDMF designation. If they have a partner such as AbbVie and/or Merck they will want be marketing in the Europe, especially the UK which has become more receptive to the need for am=n approved female testosterone drug.

I remember Art forging a partnership with Aspen during his tenure.

Testosterone suppliers

On a side note: I found this interesting Clinical Trials Results Information Submission: Good Cause Extension Request Process and Criteria

Pending FDA or other regulatory/health agency review: A study must report clinical trial results information even if the data are under FDA or other
regulatory/health agency review, consistent with any certification of delay submission, as applicable.

Looks like they have to submit results by October 27th even if they have submitted an NDA. I don't know how long to will take to post it once submitted.

GLTA