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Re: philsdaddy post# 46100

Monday, 02/21/2011 3:41:29 PM

Monday, February 21, 2011 3:41:29 PM

Post# of 146240
Hard to say. That would come out of FDA guidance. But, there is no delay due to load times during phases. There would be no waiting for data in phase 2 and 3 trials.

Under orphan drug and accelerated program:
6 months to 1 year for phase 1
I season phase 2
1 season phase 3
Approval 6 months following NDA with a high priority review

In the meantime, ministries of health in regions hard hit by dengue would have the ability to approve use first as compassionate use and then as a treatment after the tox package is done.

A particularly vicious strain...

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