ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Breast Cancer Data is very telling. It explains why Abbvie hired Dr Snabes.

2011-06-07 According to the Clinical Trial history update, the trial was Active but no longer recruiting. (Patient # 3656 had been recruited some time prior to this date).

Clinical trial changes

According to the American Heart Journal Article

A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder

Breast and endometrial safety examinations

Breast examination and mammography will be performed at baseline and annually. Endometrial biopsy will be performed at baseline and at study years 1, 2, and 5. Participants with vaginal bleeding will undergo uterine evaluation that includes an endometrial biopsy. Study medication will be discontinued in participants with evidence of uterine cancer, complex or adenomatous hyperplasia, or atypia.

AJH article


2015-12-19 Patent prosecution for patent application #13/135224 added new claims stating that retoring T-level in addition to reducing the risk of a CV event also reduces the risk of Brest Cancer (See Claim # 29 & 30)


2016-01-11 Kerisha A. Bowen, Ph.D., Anip's patent agent filed for a refund request because on 2015-12-19 she filed as a Large Entity (Abbvie?) $1400 fee when she meant to file as a Small Entity (Anip) $700 fee. Seeing that 2015-12-19 was her first prosecution of this patent application, it appears to be an honest mistake, especially if, as I suspect, Abbvie had been helping by providing the data for the filing.

Something to ponder.