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declaes

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declaes

Re: Extremist223 post# 1138

Thursday, 11/30/2017 4:18:41 PM

Thursday, November 30, 2017 4:18:41 PM

Post# of 1990
Following the IDMC’s interim analysis, the Company met with the FDA to discuss the ADAPT trial and the future direction of the Rocapuldencel-T program in April 2017. The FDA agreed with the Company's decision to continue the ADAPT trial, and further agreed to review a protocol amendment to extend the trial beyond the originally targeted 290 events and a revised statistical analysis plan that the Company plans to submit.

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