Biotech Values

[DewDiligence]

The pending FDA approval of mC (ANDA) is a separate issue from the legal patent case.

That’s exactly right, IMO.

Investorgold is significantly overstating the relevance of the FDA’s GIVE initiative to NVS/MNTA’s Copaxone ANDA. The main point of the GIVE initiative was to ensure that the first ANDA for a simple small-molecule drug can be reviewed fairly quickly, allowing at least one generic to reach the market expeditiously. For complex drugs such as Copaxone, where the review stresses the FDA’s scientific capabilities, the concept of a “priority” review is all but meaningless.