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Replies to #71301 on Biotech Values
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DewDiligence

01/12/09 11:51 PM

#71394 RE: genisi #71301

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.