ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Jeff, I agree with Biotech's being high risk, high reward. Libigel with 3656 patient population and 7300 patient years of data. Has greatly de-risked this venture.

I strongly believe that since the study was under an SPA, the meetings with the FDA, post-results from the two efficacy studies, led to the path BPAX and Libigel took. I believe that the FDA came back with their support if they continued to monitor and assess and prove the 5 year safety of the patients.

Since these were women at risk of experiencing CV Events the differentiation from placebo came rather early. Breast Cancer differentiation took longer materialize.

I can foresee future trials with women with a family history of breast cancer. This could be a significant break through as well.