Replies to post #173856 on Biotech Values

[DewDiligence]

…FDA trying to set some kind of record on MNTA mcopax review…

It might not be a record. Teva’s Lovenox ANDA has purportedly been under FDA review for 10 years and 8 months (although it was probably withdrawn some time ago).

…there really needs to be some kind pdufa like timeline for [ANDA reviews]…

There is for newly submitted ANDAs—see the GDUFA regs in #msg-70883351.