<<<Teva in its citizen petition wants the FDA to define sameness as the same degree of inhibition of Factor Xa and Factor IIa as in branded Lovenox.
On the other hand, SNY argues—and MNTA agrees—that the FDA should define sameness as the same degree of all of the constituents in branded Lovenox , not just FXa and FIIa.
Sure if you get Xa and IIa right it should work on those targets. But there is no way without studies to know what other effects that are different may have been introduced. MNTA is right about sameness. It either is the same and should be substitutable or it is not and you need studies
MNTA's position of requiring sameness suggests MNTA has the ability to exactly replicate Lovenox, while Teva's position reveals possible weakness.>>>
Up until this morning this was the general feeling about a possible Teva approval. This is a summary from others, consistent with the Citizen Response Letter to Aventis, Teva's response thereto, and the monograph provided by the FDA, as well as Craig Wheeler's comment about requiring 100%, not 80% characterization to obtain approval under the standards the FDA created.
One analyst note, contrary to the opinion of multiple other analysts, contrary to our opinion, with the note taken directly from public statements that many of us heard last week from Teva's CEO and CFO, who have no more idea than Wheeler did as to when, or if, ever, the FDA will approve their drug, and suddenly everyone appears to assume that a Teva approval is imminent and inevitable.
Well, it may be. But nothing has changed other than boy can that brokerage work over the independent investor with anxiety, worry, doubt, fear, and uncertainty.
What I write here won't change whether or not approval is ever granted, but has anything actually really changed? Does anyone here have a changed opinion as to Teva's chances of approval given all that we know?
As I've stated earlier today, I don't think Teva can be approved without some flexibility on the part of the FDA. Teva simply has not characterized the drug. They have recreated core aspects of the drug, but they have not characterized the drug down to the detail necessary to meet the requirements the FDA laid down.
Now perhaps, since Teva is a fine company, they have put something together that may otherwise impress the FDA. As the FDA did not say that full characterization was necessary.
But given Teva's argument, of to define sameness as the same degree of inhibition of Factor Xa and Factor IIa as in branded Lovenox. DOES ANYONE HERE THINK THAT IF THIS IS WHAT TEVA HAS THAT THE FDA WILL BEND AND BE FLEXIBLE ENOUGH TO APPROVE IT?
I'm not an expert, I don't work for the FDA or anything close, but can Teva somehow meet the exacting standards the FDA set down if what they have is what they say they have?
Just curious if anyone's opinions on this have changed due to the statements of Teva's top 2 managers and the reiteration of those statements by a brokerage.
Thanks.
Tinker
