Biotech Values

[DewDiligence]

ITMN – I concur with the point made by Biomaven on SI: the FDA historically has not imposed a penalty for missed trials as long as a company can furnish two pivotal trials that succeeded. (Perhaps the FDA ought to figure out a way to impose such a penalty objectively, but they’ve never indicated any intention to do so.). Hence, I’m inclined to agree that ITMN’s chances for eventual approval are very good even if they come up short on the current review cycle.

As far as I know, the EMEA’s M.O. on this matter is similar to the FDA’s.