I agree with you that halt's are indicative of a problem, but they're also an opportunity to resolve it. While I wasn't a shareholder back then, the picture I get of the stop was the realization that PFS wasn't a valid goal as people were judged to have progressed, but were living longer. Pseudoprogression was recognized as the cause, and it was dealt with. In addition the German's didn't want any more patients not to get the vaccine up front, it clearly had benefits and they shouldn't be denied, even temporarily. All this was resolved during the halt, when the trial resumed to enroll patients no more control patients entered, all received the vaccine and all prior control patients who hadn't yet crossed over were crossed over. Whether the halt was futility, base of PFS, or was caused by the German unwillingness to continue with controls included, I don't know. What's clear is all the Regulators agreed to the change and it was to be documented with a SAP prior to the trial completing. The SAP may have taken longer than anticipated, because getting all four regulators to agree on specific language must have been difficult, but it was done. Because OS became the primary goal, I believe they determined that the trial should run till the last to enter had 5 year survival, that dictated when the trial could data lock.
Gary
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