ANI Pharmaceuticals (ANIP)

[Just the facts maam]

The Libigel Safety Trial was set up under an SPA with the FDA to follow up each patient for 5 years. If patient follow up had continued as per protocol, the 3656 patients would be subject to yearly Breast Exams and Mammograms. The 18,280 patient years of data collected might have produced Breast Cancer reduction claimed in the patent applications.

More interestingly, the last follow up date for the trial was anticipated to be August 2016. Between August 2016 and October 2016 :
• Dentons on behalf of ANI has filed 3 new patent applications (all presently pending) claiming benefits of the three patent applications filed by Biosante in 2011.
• Dentons also allowed the Libigel trademark to expire without submitting a new name to replace it on behalf of ANI. And,
• Libigel which had been marketed as a licensing opportunity on the Deals.bio website, has since been removed. At no time did it ever advertise the cardiovascular or breast cancer event reduction.

In addition, Ani's 2016 Annual report does not even mention Libigel as it did in all the previous 10-k filings.

Certainly looks like a deal is in place.