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Biotech / Medical : Duramed (DRMD) Synthetic Estrogen Product -- Ignore unavailable to you. Want to Upgrade?

To: Doug Bean who wrote (907)	2/13/1999 9:08:00 PM
From: tommysdad	Read Replies (1) \| Respond to of 1837

There are several products we are talking about here and that's where (I think) the confusion lies. For Cenestin, DRMD has done "double-blind placebo-controlled studies". Well, that's the definition of Phase III studies, though I have not heard the company refer to a "Cenestin Phase III study". That's just semantics. However, FDA can certainly come back and say <<"well we like the look of the NDA so far but would like to see further studies">>. They could ask for more safety tests, an additional "Phase III study", or just another PK study. Heck, they could ask to talk to the people harvesting the yams. That very frequently happens. [the additional studies, not the yam thing!! ;o) ] I'm betting it won't happen here. When Cenestin was "generic Premarin", FDA didn't say the drug didn't work (it did, of course), but that it was "not equivalent" to Premarin. The Phase III study planned for 1999 mentioned in the December press release was for the Cenestin/MPA combo for post-menopausal women with a uterus (the MPA is added to, theoretically, counteract the estrogen's uterotrophic effects). The press release was not written well, IMHO. I am sure a lot of people were confused by this press release. <<I understand AHP is developing their own conjugated estrogen . . .>> "developing" is an understatement. It's called "Premarin" and it's been on the market for 40 years. All informed Duramed shareholders are certainly aware of that . . . Are you perhaps thinking of AHP's next-generation estrogen? They have one of those, too, called "TSE424". But unlike Cenestin and Premarin, it's a pure single compound, not a mixture of "conjugated estrogens".