ANI Pharmaceuticals (ANIP)

[LordDarley]

JTFM and everyone else,

I think it's a safe bet they have reproduced the molecule, the critical first step. If they had failed in that, I doubt they could have resubmitted the sNDA so fast. If they had had to reengineer their version of the molecule, they would not have been able to assemble the proof of capacity to manufacture stable quantities in such a short period of time.

So, I'm concluding the RTF letter was simply due to a concern about documentation that they could manufacture in stable quantities, and that there is little risk to what I originally thought would be the hardest part: reproducing the molecule.