Biotech Values

[dewophile]

FDA climate

my overall impression is that until this recent spate of rulings the FDA's cautionary stance post-vioxx had actually ebbed somewhat. one thing to bear in mind is that all these drugs are for indications for which there are existing therapies - so the bar should be higher. as for MNTA specifically, if you think the FDA is getting more gunshy then it can cut both ways - on the one hand delay approval of any generic, and on the other set a higher bar that only MNTA can cross, leaving it as a sole generic