Replies to post #101070 on Biotech Values

[ThomasS]

MNTA/TEVA: More holes in the story from TEVA themselves:

Teva maintains the approval for an ANDA for generic Lovenox is appropriate because:
- The active ingredient in enoxaparin is significantly better characterized than the active ingredients of significantly more complex molecules

{1. The FDA isn't considering an aNDA for a "significantly more complex molecule," they are considering Lovenox, specifically.
2. "The active ingredient in enoxaparin is significantly better characterized..." "Significantly better characterized" is not the same as "completely characterized."}

- Pharmacologically active portions of enoxaparin can be identified and replicated, and

{Are they speaking irt ALL pharmacologically active portions, or just some? Does Teva decide what is active, or does the FDA?
Wonderful, but, what about the other portions of enoxaparin, active or inactive?}

- In vitro and in vivo PD tests are rapidly indicative of drug efficacy and safety.

{Those particular tests are not as comprehensive as Teva would have the FDA believe. In any case, this statement circumnavigates the larger issue of full characterization}