Biotech Values

[ThomasS]

MNTA: Your question may be more difficult to answer than you think. "Parallel guidance" from the FDA implies parallel input from Teva/Amphastar, in the context of what MNTA stated today:
"...Momenta and Sandoz submitted a proposal to FDA for addressing the potential immunogenicity of M-Enoxaparin, in response to FDA's letter of November, 2007. On April 28, 2008, FDA responded to the proposal and provided additional guidance which indicated their general concurrence with the Company's approach and proposal. FDA also requested additional data from in vitro and in vivo animal tests, the testing of additional samples for tests previously proposed, and additional information regarding certain of the methods proposed."