Published in Medical Letter on the CDC and FDA, February 6th, 2005
The NDA for Dacogen injection was submitted to the FDA on November 1, 2004. The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a substantive review.
The phase III trial achieved the coprimary endpoint of overall response rate. Patients in the Dacogen arm had a response rate of 17% as determined by intent to treat analysis, compared to a 0% response rate for...
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