Replies to post #99916 on Biotech Values

[RockRat]

One relatively simple little conundrum still bothers me:

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.

So, either Teva really has met these very measurable criteria and it really is a matter of timing that MNTA got approved first, so that approval for Teva's version really is imminent

OR

Teva is bald face lying about having met said criteria. If the FDA were to reject Teva's ANDA or didn't rule for a few months, can you imagine the shareholder lawsuits over that statement? Would they really chance that?

Regards, RockRat