It seems to me that MNTA would have been better off to just go the improvement route and do an NDA/BLA with trials. By now they could have had a product on the market.
A hypothetical Lovenox knockoff approved via the NDA route would not have been automatically substitutable for branded Lovenox and would have needed to be actively marketed, greatly lowering the profit margin of such a product compared to the profit margin of generic Lovenox.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”