Look, just because the FDA went public with the 5 criteria 3 months ago does not mean the applicants weren't aware of these criteria till then. In fact, I'd say it is highly likely that all the applicants were aware of these criteria several years ago.
Amphastar and HSP also have dissimilar drugs. They may be way off on molecular weight or they may not. No applicant has offered any public comment about that. But Dew is offering a public assertion that Teva is still using a drug that is dissimilar in a very basic way. And I am just saying it is likely that the FDA told Teva several years ago that it was not approvable.
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?
I think it is more plausible that they never started with a process (drug:Lupenox) that was so far off in molecular weight. genisi's digging to date also points that way.
All 3 applicants are behaving similarly, but if we take Dew's assertion at face value, Teva is behaving much more stupidly than I am willing to believe, much as I'd like to.
Regards, RockRat
AI
