Replies to post #99937 on Biotech Values

[alertmeipp]

So, in theory, all companies sending in applications for approval "think" or "told investors that they think" they have met all FDA requirements.

[tinkershaw]

RockRat,

There is no black and white when it comes to rules. Even thou shall not kill, except in self-defense, to avert a worse disaster, or to kill infidels...

I think what Teva is doing is arguing with the FDA as to what the rules really mean, and why their results really do "functionally" and "practically" meet these criteria.

As we all know "equivalent" does not mean what it says, anymore then does the Clayton Act that states "there shall be no restraint of trade" (paraphrased but pretty close). Really, that would make all contracts an anti-trust violation because each contract restrains trade, and excludes others.

So Teva can make this argument based upon how they want the FDA to interpret their rules in relations to Teva's submission, and the FDA may never agree with them.

I think actually that it is in Teva's best interest for the FDA to remain as rigid as possible, and keep the barriers to approval as high as possible, in order to protect Copaxone which is also seeking approval through the ANDA process. But, as we've seen, they will argue for more flexibility on Lovenox and less on the impossible to characterize Copaxone (according to Teva).

Was Sanofi "lying" when they said it was impossible to characterize Lovenox? Given their patent application on Lovenox, perhaps, but probably not.

Tinker

[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