ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Catty, I agree that it does not make sense. If Libigel has not been handed off to a partner to continue with, ANIP should, at a minimum, spend the $6 million, maybe less, to complete the analysis. Have the results peer reviewed and publish the findings. Then they can openly seek a partner.

Given the 70% CV reduction with 4000 patient years of data, and a breast cancer reduction of unknown number of patients it has a high probability of consistent finding after 7300 patient years.

The Libigel Patents expire December 29, 2028 and which would most likely be extended the maximum 5 years (up to 50% of development time) by the FDA to December 29, 3033, if approved.

Though there has been no indication that AbbVie is working on it.Dr Snabes is still at AbbVie and AbbVie still has not used their Priority Review Voucher (PRV) acquired August 19h, 2015 for $350 million. All the predicted uses for the PRV have been launched or an NDA has been filed, including AbbVie's JAK1 selective inhibitor, Upadacitinib without using it.

If, Libigel is still alive, and the PVR was intended to be used on it, AbbVie will want to submit the notice of intention to use the the PRV by March 29th, 2019 (minimum 90 days notice). AbbVie does not need to identify what drug they intend to use it on at this time. AbbVie would then have to file an NDA using the PRV (identifying the drug) by June 29th, 2019 in order to ensure an FDA decision by December 19, 2019. Giving them the maximum FDA patent protection of 14 years combined (including FDA extention).

2019 is shaping up to be a big year for ANIP. If Libigel is in play, this should be a very big year for ANIP.

Good Luck to All.