It was the best investors in Momenta Pharmaceuticals
"The agency has not requested human clinical trials at this time."
That sentence was in a press release about Momenta's generic version of Sanofi-Aventis'
If the FDA had requested clinical trials to prove that the drug worked, the duo might have just scrapped the project. The generic drug isn't expected to fetch as high a price as its branded counterpart, so the return on investment in a clinical trial might have been extremely low.
Lovenox is a pretty complex molecule. It's not as complex as protein-based biologics, but certainly more complex than your average small-molecule drug that's typically approved through the ANDA process. The fact that the FDA is requiring Genzyme
No word yet from Teva Pharmaceutical
Momenta expects to submit the additional information to the FDA in the third quarter of this year. Generic-drug makers don't have a Prescription Drug User Fee Act (PDUFA) set up, so there's no way to know how long it could be until the drugmaker hears back from the agency. Last time, it took more than two years to hear that the FDA wanted additional information. It's hoped that Momenta, a Motley Fool Rule Breakers pick, hears back much more quickly this time.