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Biotech / Medical : Elan Corporation, plc (ELN) -- Ignore unavailable to you. Want to Upgrade?

To: biostruggle who wrote (5120)	11/17/2003 2:36:55 PM
From: Cacaito	Respond to of 10345

The entire trial meningo-encephalitis rate was 6%, no deads, but very troublesome. The Fda will never let it pass nearby, the whole trial was done in Europe, cause the Fda was worry with a crude vaccine. The lawyers at Wyeth (they change the name from American Home Products due to Redux legal debacle)will not let it go trough. The BIG question is why Wyeth/Elan did not go STRAIGHT to a conjugate vaccine that will almost completely bypass the stimulation of T cells (the cause of the meningo-encephalitis) or to the Mabs that fully bypass T cells. The answer is that the Europeans let them do it, and it was further advance than the other drugs, and the single dose scalating quantity study in 60 subjects did not show any problem. The Antigenics adjuvant could be a problem (it does not seem to be the problem), but they add Polysorbate (it seems to be THE problem) during a reformulation of the vaccine after most of the doses were given, and then they started to see the meningo-encephalitis. Now, not the Fda, neither the Europeans will let AZ-1792 be given again (remember that the French top health department officials ended up in jail with the hemophiliacs getting the Aids tainted products, everyone is on alesrt).