Replies to post #101703 on Biotech Values

[bladerunner1717]

Peter,

Did the FDA require trials on clopidogrel? If they didn't, then why do you think it's so unrealistic in the case of Teva's drug?


Bladerunner

[DewDiligence]

I personally don't believe the possibility of Teva getting approval as a non-substitutable [Lovenox] generic is realistic. The FDA would essentially be saying it's not the same drug, but is nevertheless safe and effective, and I just don't see them doing that without requiring trials.

For all we know, Teva may already have completed a small trial in support of a non-substitutable FDA approval. I’m not saying this is likely, but it can’t be ruled out.