<<<Teva's problem is more than just the ability to fully characterize the components of Lovenox. They would also need to identically manufacture. This must also be part of MNTA's proprietary toolset: the ability to reverse engineer Lovenox.>>>
I agree, and we know when they filed their ANDA they had not characterized the molecule sufficiently to meet the criteria the FDA put out.
This being the case, I don't believe that Teva could just rejigger the drug over time with the same ANDA as they came to understand more of it. Instead, all they can do is take their originally submitted drug, go through it, and more carefully characterize their drug in comparison to Lovenox, and convince the FDA that it is good enough.
As we have discussed, a new ANDA filing after mid 2008 would be confidential. I think only by filing a new drug that is fully characterized can Teva meet the standard. Their original drug just cannot match Lovenox due to the lack of characterization and the astronomical odds of accurately reproducing and reverse engineering the drug without substantial characterization of the drug to begin with.
That is my line, and I'm sticking to it. I just don't see anyway around it if Teva is sticking with its original drug, and its original drug cannot be reformulated in the same ANDA filing. Which rules out most everything except for some double secret subsequent ANDA filing - which would be possible I guess, but would seem incredulous if true. I would think TEVA would want the world to know that they to have MNTA type powers. Would add more value to the company.
Given that analysts have stuck with the same Teva line, and they get the line from Teva, it would seem the conclusion from all the information given us that Teva has not submitted some double secret new ANDA on a more fully characterized candidate T-enoxparin II.
Tinker
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