RockRat ... TEVA has made many assertions over the last 3+ months that are extremely suspect. Bill Marth has been spinning facts for years -- remember the crazy FDA/TEVA tL "labeling" discussions he referenced in 2009? Other examples:
(1) In July 2010, after MNTA received approval, TEVA mgmt. came out in a CC and explicitly asserted their belief that they would be approved in August (because they submitted their immunogenecity data late -- crazy assertion for a senior executive to make, since it was complete speculation)
(2) TEVA released PR hours after MNTA received approval arguing that they have met all the criteria and expect approval soon -- very strange (some definite PR/marketing strategy at play there).
(3) TEVA management is now asserting that the FDA verbally confirmed they (TEVA) have achieved bioequivalence with their tL generic -- sounds fishy to me.
(4) TEVA's application has been sitting out there for a long time (far longer than MNTA's) ... if TEVA were close to obtaining approval (w/in 12 months), i suspect that the FDA would have consolidated approvals.
There are so many other bizarre statements, when i have more energy, i will post them. TEVA is good, but they are not saints.
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