Biotech Values

[10nisman]

<< Teva has publicly stated that it thinks it has also met the 5 criteria for approvability. As stated in the 45 page response to the CP, those criteria are pretty detailed and specific; not much wiggle room, IMO, you either meet them or you don't. The FDA has latitude, but once it decides what the rules are, it's got be black & white, and to my eyes the FDA has done that. >>

TEVA can think all it wants... However, its the FDA that makes the final decision whether they have met the criteria or not. Its kind of like looking in the mirror and thinking you're hot stuff before you get opinions of people that can actually determine whether your hot or completely not.

As of right now, MNTA has received approval and had TEVA been close the FDA would have waited to approve both at the same time.

10nis