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Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation
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To: scaram(o)uche who wrote (272)9/17/2002 1:19:05 PM
From: aknahow  Read Replies (1) of 631
 
"Did anyone else understand that the trial was going to be that large? Did I simply miss something? Seems a bit of overkill."

Yes, this was understood, once DNA failed to reach the agreed upon number of subjects treated with its' own product and the last ditch effort to prove the two drugs were identical failed.

This last P III was ongoing even as the P.K. results were being determined and has now concluded.

There is a possible relationship between the large number of subjects required for DNA and the delay for BGEN. Amevive was used in a combined total of 1,300 subjects but some were I.V. and others were I.M. The "standard" of 1500 subjects was not reached even for the combined methods of use, but seemed not to matter to anyone.

The Amevive delay does not seem to be related to the concept of a P IV after approval as the link you provided indicates that P IV responses are included in Class I responses.
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