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


To: Extra Pale who wrote (4580)10/19/2000 11:55:30 AM
From: jayhawk969  Read Replies (1) | Respond to of 10280
 
Thanks,

I expected something like this. Eight times a normal dosage causes problems!

Based on a review of the available clinical data, (R)-fluoxetine, at the highest dose tested,
demonstrated a small but statistically significant increase in QTc prolongation. While we believe that
this is a clinically insignificant effect, development of a lower dose would delay the New Drug
Application submission by at least two years.


Something still doesn't smell right. IF they were to "develop a lower dose" the effect would not go away at the 8 times current dosage level, Is there something significant in FDA testing about "8x dosage" as an upper limit. Obviously they have tested dosages at a variety of levels. What am I missing?

I believe that there is something we do not know about the efficacy of new developmental drug (by Lilly) or the cost/profit ration of introducing Prozac II.