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Re: Om Mani Padme Hum post# 3934

Monday, 01/26/2009 12:49:30 PM

Monday, January 26, 2009 12:49:30 PM

Post# of 58465
Enrollment in the AGENDA Phase III trial.

However, an FDA decision can come sooner than the enrollment being filled.

Based upon the "need for additional data" the FDA requested from Genta leadership with respect to the last NDA submitted, and the results of the interim AGENDA trial, it very well could get approved prior to the end of the quarter. It may not, but the trial data looks outstanding and that's what the FDA requested.

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