Biotech Values

[biomaven0]

considering approving Teva’s generic as a non-substitutable “branded” product

I personally consider the chances of that are close to zero. The FDA would be saying that while the drug is not actually "the same" as enox, they are nevertheless approving it without any clinical trials to prove safety and efficacy. That would be unprecedented to my knowledge.

In my calculus I see only three plausible outcomes - "yes", "no" and a prolonged "no decision." I consider the chances of an outright "no" as being fairly low, although there are certainly versions where Teva admits that they have to go back to the drawing board and we would know that there would be several years before any possible approval, so those would be tantamount to a "no."

Peter