Based on the latest statements from Teva, it seems it is hung up on immunogenicity issues, as opposed to failure to meet the 5 criteria. But some feel that Teva has left enough wiggle room in their statements about meeting the 5 criteria, that that may still be an issue. Failure to meet the immunogenicity standard might imply failure to meet one of the 5 criteria, as well. In spite of Teva's contentions and posturing, I think thy will not get approved, and that they will continue to posture and push out the timeline on a quarterly basis, while implicitly, if not overtly, blaming it on the intransigence of the FDA. Their 'tude suggests that they are not trying to advance development of t-enox, but are sticking with what they've got -- whatever it is -- and hoping for the regulatory best.
I wonder how much longer their credibility on this issue will last. I think the most pessimistic analysts (except Oppenheimer, which seems to be in the "not approved for a long time if ever" camp already) are expecting approval in the first half of next year. So if it doesn't happen, I would expect the overhang to finally start lifting.
Cheers, Tuck |
