Replies to post #101834 on Biotech Values

[DewDiligence]

What I don't get is why people here think that Teva's application which is an ANDA could possibly be approved as a "not-substitutable."

It is possible, albeit unlikely. As noted in a prior post, Teva could have run a small clinical trial without telling anybody. Even if Teva hasn’t run a clinical trial, it’s well within the FDA’s statutory authority to approve Teva’s drug and declare it non-substitutable for branded Lovenox (which would be an extremely bullish outcome for MNTA).

What I further didn't get is why you made a big deal over the fact that Sandoz' drug was approved as a "fully-substitutable." If I understand you and biomaven correctly, it couldn't have been approved any other way.

Incorrect—the FDA could have approved it as non-substitutable for branded Lovenox. This wasn’t a likely outcome, but it was possible.