ANI Pharmaceuticals (ANIP)

[Just the facts maam]

QYQ, if eventually, as Biosante's Board claimed, this merger was in our best interest and we eventually capitalize on the Biosante pipeline then there is nothing to go after. An argument can be made for the questionable tactics and maybe some misrepresentation in the filings. But there would be little to gain.

On the other hand if Libigel is off loaded cheaply and becomes the blockbuster we believe it will be, then the fraud has been confirmed. I still don't think that is the case and at some point it will all make sense.

But, I also not blind to the possibility that they could be greedy enough to think they could pull it off. That is why I am researching when the statutes of limitations would kick in.

We have suspicions that a fraud may be occurring or have occurred. In reality this won't be able to confirmed this until we see what ANI has up their sleeve for Libigel.

I am still looking at the statutes of limitations. To my understanding it is 2 years from the discovery of 5 years from the actual fraud. Technically since the ball is still in play there is no definitive way of proving if a fraud has occurred.

There are many changes that could be triggering what we are seeing.
- The increased value of Generics, Specialty Branded Pharmaceuticals
- The shortened lifespan of novel drug exclusivity
- The possibility of the FDA allowing phase IV post marketing trials to prove efficacy for large trials that would normally be too cost prohibitive to entertain. Take a look at the following,

In an op-ed in The Wall Street Journal, former FDA commish Andy von Eschenbach proposes that the "FDA should approve drugs based on safety and leave efficacy testing for post-market studies." How would this work? Well, Andy suggests creating pilot programs in which patients would be entered in registries, and the FDA and drugmakers would later determine whether a medicine is effective.

Andy Says: Test Efficacy During Post-Marketing

Wouldn't Libigel for CV Benefits, HSDD and Cognitive Function improvement be a good candidate for Andy von Eschenbach vision? It would be the perfect pilot to test his vision.

We already know that one of Biosante's employees Courtney Caskey is working at Registrat Mapi which specializes in post marketing studies.

We really have to see how it all plays out. If at the end we are not satisfied, then I suggest we have a conference call to see how we should move forward.