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iwasadiver

04/01/21 1:22 AM

#366195 RE: HappyLibrarian #366161

They already did not reject the end point changes. The wording was that it was uncertain whether the Regulators would approve the treatment based upon the new end points and the comparison between DCVax and historic placebo patients. That was it. If the Regulators did not dismiss the end point change or the comparison to historic norms, and based upon the way the company planned on performing the data analysis, there is reason to expect that the next step would only entail the examination of the data, not a controversy about end point changes.