Dew,
Having just come across this January post on Teva's comments, this would seem to answer the questions we have if Teva has somehow submitted a new drug or revised their old drug using better characterization. Obviously, they have not.
What I also find bullish here is that Teva is stating in January that their full immunogenicity testing results were submitted no later than January of 2010. And yet you still have Teva speculating that since they submitted their data a month after MNTA, that perhaps the delay of obtaining approval is that the FDA has had one last month to review this data.
Come on, it is August for crying out loud!. It has been at least 8 months, and 9 months for MNTA. That seems to be about as fecetious of reasoning as any I can think of.
I believe the historic Premarin example set the stage, and the FDA monograph, both in summary and in detail, closed the curtain on Teva's theory that it only need to replicate the "active sequence". The active sequence in Premarin was also found by companies who spent tons of money to do it. But they never were able to reproduce the other contituent chains that altered the efficacy of the drug in ways that no one exactly knew how (as it was never tested) but they knew they did something.
MNTA gets around all this by reproducing these strands, so they don't have to argue that strand x or strand y or "inactive".
The Premarin example is very illustrative as the estrogen itself, thought of as the "active" component turned out to be regulated by all these other constituent chains. And that is exactly what the FDA is saying now, that the active heparin chains are great, but their characteristics in the way that they behave in the body is dependent upon these other component chains.
At least that is my interpretation of what the FDA has said, and this is in direct contradiction to what Teva has been claiming and lobbying to make the standard.
Tinker
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