Replies to post #84992 on Biotech Values

[DewDiligence]

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.

[wallstarb]

I think that unfortunately the FDA has become a politcal beast that is beholden to the people that they are out to regulate and that in instances like this there's big $$$ out there slowing down the approval path for generic biologics and other generics.

I can't say I blame companies for tryign to protect their investments and tehre is a tradeoff - cheap drugs vs real innovation. But so many of the recent drugs have been small tweaks on existing ideas and its very infrequent there's a true innovative and novel way to combat a disease.