Biotech Values

[RockRat]

With all due respect . . . Are you kidding me?

>>After reviewing the FDA's response to the citizen petition, which outlines 5 criteria to demonstrate "sameness", Teva believes that it has demonstrated to the FDA that its version of generic Lovenox meets their criteria and that Teva's pending ANDA is approvable. <<

This sentence sure reads to me that Teva believes it has met the 5 criteria. Yet you say:

"However, nothing in that statement is indicative of meeting the standards that the FDA laid out. NOTHING." Why does that seem to me to contradict your assertion that "Reading it in context of this Indian drug, yes, Teva was exactly accurate?"

In my opinion there is no way Teva can accurately say that Luponex meets the 5 criteria. I'm not a lawyer, but if they are really talking about unmodified Luponex when they refer to their version of generic Lovenox, this is close enough to a flat out lie to be actionable.

Regards, RockRat