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02/19/08 12:22 AM

#3324 RE: exwannabe #3314

<I thought that an IND always specified the P1 safety trial to be done. Comments? >

The Phase One trials are already done - in fact the Phase One trials do not have to be in patients with the particular indication - or have any disease or condition at all (they can be "healthy" volunteers).

So - they're done years ago.