Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

If I were a Hospira exec, and my company just demonstrated the ability to meet the FDA's sameness criteria, I would go after a slice of the much bigger pie [the Lovenox prefilled-syringe market]. Why could Hospira not file an sANDA, and why would it (or a new ANDA) not walk through the process easily, maybe even quickly?

That logic does not stand up to scrutiny, IMO.

No ANDAs are getting a quick review by the FDA these days; to the contrary, FDA reviews of even the simplest applications are taking two years or more. If HSP’s generic Lovenox were a serious program, why would HSP target 1% of the market (the vial formulation) and risk waiting another two years or longer for approval of a second ANDA for 99% of the market (the syringe formulation)? It doesn’t ring true.