Replies to post #121927 on Biotech Values

[investorgold2002]

I was referring to the GIVE initiative where presumably certain ANDA applications are given "priority" review

to qualify

1) all patents should have expired or patent cases should be won or no orange book patents listed
2) significant need for that drug/treatment

presumably GIVE priority review would reduce ANDA approval time by half. Fondaparinux ANDA was filed in 2008, it is expected to get approval anytime now

[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.

[investorgold2002]

"Why do you believe FDA approval of mC is tied to the legal case between TEVA and MNTA? "

GIVE initiative (if they can actually use it..dew thinks it can be used only for simple molecules..i don't necessarily agree with that, since i have heard from other sources that fondaparinux is a pretty complex molecule and there is nobody in this world other than Glaxo that makes this API today) that expedites review of ANDA applications, is ONLY applicable for ANDA's that can launch immediately after approval. So the products should satisfy one of the following:
1. No OB patents listed
2. Patent litigation resolved
3. Patents expired