So, has Teva attempted to meet the criteria with a different process (drug) since then? Or is it simply going to pretend, amid growing skepticism as the months roll by, that their application will be approved any day, which would make them look like idiots? In the end, does Teva lose more credibility in this fashion, or by publicly admitting they cannot do it? Teva filed their drug about seven years ago. Let us say that they now the technology to characterise the product as well as momenta. they would have to go to the batches that they used in their filing seven years ago. What are the chances that those batches, after being characterised would fall into the ranges of the Sanofi product?
For that to happen they would have to be very lucky. That is why Momenta feels confident. If Teva does have the road map on what they need, they will probably have to reformulate the drug based on the criteria ranges of the Sanofi product, so the new batches would have to be manufactured, go through stability before the fda two year ANDA review process could even begin
