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Re: noelan_s09 post# 101196

Monday, 02/27/2017 10:22:22 AM

Monday, February 27, 2017 10:22:22 AM

Post# of 429205
Noelan -
The new SPA with the FDA includes the stop rules for stopping at the 80% interim, and the FDA has signed off on them. If the DMC recommends stop and the company agrees, the FDA is not going to have any problem with this. I am also sure, given their prior ADCOM experience, that the company in setting the stop rules made them convincing enough that any ADCOM would agree the drug works.
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