Replies to post #107488 on Biotech Values

[mouton29]

<<Not only don't they back it up, but the explanation is actually completely off topic - it isn't an explanation of why their generic enoxaparin is approvable, but just an explanation of why in their opinion a generic enoxaparin is possible but a generic Copaxone is not>>

It's their press release so they get to define the topic. Their stock had just fallen, perhaps based on the logic that generic Lovenox approval presages generic Copaxone approval, so its not surprising what the real purpose of the press release is, and there is nothing hidden about it -- the second paragraph following the language previously quoted is explicit:

Given the complexity of Teva's Copaxone® and the serious, degenerative nature of multiple sclerosis, it is Teva's belief that any potential generic version of Copaxone should be evaluated via pre-clinical and full-scale, placebo-controlled clinical trials with measured clinical endpoints in multiple sclerosis patients to establish safety, efficacy and immunogenicity in a real patient population.

Returning to their language on enoxaparin, I understand it is not addressing the five fda criteria, but is your interpretation that they are not even talking about their own generic enoxaparin, rather someone else's (presumably not Amphastar's so I guess that leaves one other possibility)? I suppose the language could be interpreted that way, but since it purports to be a statement about why their version should be approved, that seems a little strained.