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Re: Phoenix300 post# 140863

Friday, 02/26/2016 8:28:02 AM

Friday, February 26, 2016 8:28:02 AM

Post# of 403773
"Could the trial start mid-May the week the Prurisol Phase 2 top line results are released?"


No:

"CDER and CBER generally recommend that a sponsor submit a protocol intended for special protocol assessment to the Agency at least 90 days prior to the anticipated start of the study. The protocol should be complete, and enough time should be allowed to discuss and resolve any issues before the study begins. Special protocol assessment will not be provided after a study has begun."

http://www.fda.gov/downloads/Drugs/Guidances/ucm080571.pdf

Assuming the SPA is accepted unchanged (or at all) it would still need some work-up before it could commence properly.

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