Replies to post #119430 on Biotech Values

[dewophile]

the company has stated for a long time now that they think FOBs will require some clinical trials at first - nothing new there
with better characterization what mnta hopes to bring to the table is the need for smaller trials and therefore faster time to approval, higher likelihood of approval, higher probability for a label across indications, and higher probability for substitutability. Presumably once there is more experience with FOBs down the road the possibility for eliminating efficacy trial exists, and the law leaves this open to the FDA's discretion, but mnta has always stated that in the early going this is not likely

[Bio_pete]

MNTA - To heck with the 505j pathway. At least we would get a PDUFA date instead of a date sometime 3 or 4 yrs down the road. Limited clinical trials may not be a bad thing.

[DewDiligence]

That clinical trials will be required for FDA approval of FoB’s is old news—see, for instance, #msg-53728063 (referenced in the ReadMeFirst). Regards, Dew