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Re: dennisdave post# 730146

Monday, 11/04/2024 8:40:16 AM

Monday, November 04, 2024 8:40:16 AM

Post# of 818554
Nothing unreasonable about having a legitimate control arm. Especially considering mOS was better in the interim data release when patients who did not receive DCVax at all were included in the data. The precedent for an ECA in GBM was set by Medicenna who actually met with the FDA after their P2 to request using an ECA. The FDA was clear that they needed patient level data AND a hybrid control arm with both ECA and internal control patients. The FDAs stance on ECA is well documented and well reported here by non-Koolaid drinkers.
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