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Re: genisi post# 71301

Monday, 01/12/2009 11:51:30 PM

Monday, January 12, 2009 11:51:30 PM

Post# of 257253

VRUS – I guess that this kind of conditioned enrollment reflects the FDA's worry over safety and will slow the trial.

Agreed. A two-stage enrollment schedule would seem to be overkill at this stage in the development program. I presume that the kidney tox in monkeys played a role in the FDA’s mandate.


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