Replies to post #16732 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

Does this delay mean that Mylan could get approval of 40 mg first?

It's conceivable but not likely, IMO, insofar as MYL does not yet have approval for the 20mg product.

I am not sure if that means Mylan gets 180 day exclusivity?

According to FDA regs, nobody should be entitled 180-day marketing exclusivity since no one was able to launch within 30 months of the ANDA acceptance for FDA review.