Biotech Values

[tinkershaw]

According to Teva, the FDA said it is not completely clear how Copaxone works, so the agency cannot be certain the new version would be as effective.

I would much rather read what the FDA actually said. Funny how what the FDA said is exactly what Teva has said in its citizen petitions that the FDA has rejected on multiple occasions.

As with lovenox, in which it is not clear at all how all the supposed "junk" works (which is all that TEVA has stated it needs to work on) the FDA nevertheless allowed mlovenox on the market as identical without having to run a clincal trial. This is because what MNTA submitted was proven by MNTA, in a manner acceptable to the FDA, that it was identical, and therefore knowing the mechanism of action is irrelevant as identical is identical.

It is part of Teva's very tortuous web of spin however.

Tinker