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Sunday, February 24, 2019 4:47:31 PM
The federal standards can be broken down to just about 3 words ie "do no harm". So somehow, in order to "do no harm", 17 SOC patients were left out of this trial when NWBO agreed not to enroll anymore patients even though they were "technically allowed" to do so. I will side with exwannabe's position on this. NWBO had to agree not to enroll any more patients after the 331 even though they were "technically" allowed to. The fact that this discrepancy occurred was not validated until after a lengthy time period had elapsed past final enrollment. I would suggest this period of time might have correlated to PFS eventing by SOC being monitored by the CRO and FDA via shipping records and I have a feeling that German SOC patients were crossed over before a PFS event at the time of the halt. Whether or not all SOC patients might have been crossed over or not I have no idea but I would expect that they were at some point. If so, this is another possible explanation for last patients enrolled approaching the 36 month mark not eventing as quickly and creating an upturn in projected 36 month survival. Best wishes.
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