News Focus
News Focus
icon url

linhdtu

06/09/11 6:08 PM

#121380 RE: investorgold2002 #121378

Amen. You are absolutely correct on this . eom
icon url

sodrock

06/09/11 6:43 PM

#121382 RE: investorgold2002 #121378

Here is my irrational explanation of the importance of TEVA and their communications. ;)

For me as a MNTA investor I will never know where TEVA is with Tenox and may never know where Mcopax in regards to approval. Until eventually they are approved or receive a "deficiency" letter..

However, when Teva attempts these types of shenanigans, be it Mistranslation, silly rumor etc. it leads me to believe that their posturing is about over for both enoxaparin (no longer talking about it) and copaxone. Because if what was posted in the Globes piece is true, TEVA essentially admitted that the CP would be accepted and generics must have clinical trials done. This third CP submitted by TEVA was specifically focused on the 5 criteria for sameness and clinical trials. The FDA basically said "we continue to get compelling data that refutes your claim" or as Dew simply put it "In your face, mothrfcker.”

My theory is that TEVA really felt strongly about the issues raised in the CP and more than likely weren't expecting a response from the FDA until September. This makes it an even more compelling speculative argument that MNTA is capable of characterizing Copaxone for "equivalence" and that is what TEVA is afraid of (overnight plummeting of sales).. At least SNY had the hospital market to salvage.

IMO MNTA has a slam dunk for a "similar" Copaxone product but that's not their business model; they are looking for "sameness"..

So although bullet points 1-3 are unknown; these types of blurbs help put the pieces together.