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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: David Howe who wrote (1943)	3/5/1999 2:57:00 PM
From: Don Miller	Read Replies (1) \| Respond to of 10280

I too would be unhappy, is it possible that what they were repeating is Gruntal's most recent projection and not actually a take over? I'm still asking the rumor sources on the other board. I want a lot more than $155 for my holdings.

To: David Howe who wrote (1943)	3/5/1999 3:40:00 PM
From: Don Miller	Read Replies (1) \| Respond to of 10280

Thanks

To: David Howe who wrote (1943)	3/23/1999 10:48:00 AM
From: Don Miller	Read Replies (1) \| Respond to of 10280

David, and Peter You two seem to be best ones to address this question, but other replies would be appreciated. It has been proven the original racemet drug, let us use Prozac as a example, had more than one isomer in the drug that was run through the three phases of FDA required test some years ago. We now know each isomer contributes different affects. That original isomer mixture can probably be defined by analyzing the original drug, or by producing the drug by the exact same process. Now the patent runs out and company B wants to produce a generic version of the tested drug. Patent owner probably will not released the process, nor the relative composition of the isomers tested. Let us say the FDA can and would make public the tested isomer mixture. Even knowing that company B's process will not produce that exact isomer mix. The FDA should have to make sure the generic drug is always identically the same as the originally tested drug. Company B should have to add or subtract isomers to get back to the tested composition. Given what is now known about the isomers, does this seem logical and would it be reasonable to expect it to be watched this closely? If so, it seems to me the burden of proof should always be on Company B.