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RockRat

02/03/11 8:57 PM

#114018 RE: exwannabe #114017

>>the possibility that Teva resubmitted with an improved product in face of either a rejection or other bad feedback.

It is the only answer I see that avoids making either DD or RR come out as being very wrong.<<

That has an Occam's Razor flair for reconciling our positions. I think it has been discussed that the FDA does not publicize ANDA rejections, and the sponsor does not have to, either (unless it definitely hits the materiality threshold, which Teva could argue it did not). So that could well have happened, and we would not have heard about it. Further, ItalFarmaco and Lupin may have been able to take the improved product to market with the same name. That would address Dew's assertion that T-enox is still Lupenox. That improved product would have to be a little heavier. As I said earlier, I'd love to see an up to date measurement of Lupenox' molecular weight.

This could be a real annoyance in settling dinner bets . . .

Regards, RockRat
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ilpapa

02/03/11 9:16 PM

#114020 RE: exwannabe #114017

Back on the main point, I fail to understand why people ignore the possibility that Teva resubmitted with an improved product in face of either a rejection or other bad feedback.



That's the point. They'd be nuts to continue to charge blindly into windmills with the same old Lupenox. What they are presenting now must be an altered product. Otherwise they're incompetent boobs. And Teva are anything but incompetent boobs who tilt at windmills.