Replies to post #610150 on NorthWest Biotherapeutics Inc (NWBO)

[supersteve13]

Please prove that a futility recommendation occurred. :)

[skitahoe]

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

[Doc logic]

iclight,

Do you understand the process of a futility recommendation?; ). It’s a back and forth after given if given and if you recall NWBO submitted documents to the regulators who then decided not to enroll anymore SOC/placebo patients but continued to allow treatment patients to do so to their full prescribed number. The trial can be allowed to continue if it does no harm. The problem was that positive treatment effect was received by those who took L but not being received by those unwilling or unable to crossover so guess what they did?; ). Low and behold they allowed no more SOC/placebo patients into the trial because anyone not starting in the treatment arm or not crossing over was being harmed compared to the treatment first arm or crossover. That’s a big no, no in Germany. This action actually reduced the powering of this trial too. Now why would a regulator deliberately reduce the powering of a trial that they also only allow treatment arm patients to continue to enroll in?; )))). Hint, it’s not only because SOC is no longer fit for purpose which is the safe claim. Maybe the answer lies more in Fraunhofer’s claim that enrollment was only done to the point statistically necessary and that being backed up by JAMA Oncolgy publishing the Phase 3 DCVax-L (Murcidencel) results 7 years later. Hmmm. Best wishes.

PS. Just a friendly reminder. If you want to see this better step outside tomorrow morning into the daylight of a cloudless sky, open up your eyes and you will see it’s a new day.