Replies to post #12969 on ANI Pharmaceuticals (ANIP)

[LordDarley]

The chemistry is way beyond my simple brain. In the last few years I have heard so much speculation (mainly from MNK investors jealous of the Acthar monopoly) that duplication is impossible, it has always seemed like a real risk to me.

When you think of it, none of us really knows the quality of the replication know-how that Merck sold to ANIP for $70M.

None of us knows what is in the freezer for a test sample and how perfect the ANIP molecules are.

If this is not a duplicate molecule, it's hard to think the FDA would issue an sNDA. ANIP must be convinced it has a perfect duplicate, and the teams of specialists who have checked and rechecked must think the same way. We will know by October 29.

[jadite]

RG- Thanks for the great explanation.

[Just the facts maam]

Thanks RG for helping understand the process.

[LordDarley]

RG, Thanks, but I'm not sure this discussion of how to create a generic relates to the ANIP application for an sNDA for an NDA that it owns. We are not creating a generic, which is the ANDA process.

We own the NDA. For $75M I have to assume we were not left with the task to reverse engineer the molecule from scratch (as if we were creating a generic) but we must have been given technical know-how. I also have to assume we obtained samples of the molecule as produced by Merck so that we could demonstrate to FDA we were replicating what it had approved.

Are these fair assumptions? If so, the task for our sNDA is two-fold. (1) Prove that we are producing the same molecule as Merck and (2) demonstrate we can do that on a consistent basis. I am assuming that ANIP has concluded it has satisfied #1 and that establishing #2 was the hang-up. Otherwise, the resubmission would not have been so quick. If #1 is a problem, i.e., we are not the same as the Merck molecule, we could face the spectre of required safety testing for a new NDA. That's hopefully not going to happen, but replicating that molecule is critical for an sNDA piggybacked on the ancient Merck NDA.