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Friday, January 13, 2023 11:10:12 PM
You presume that because they did not discuss “partial hold”, it means they did not discuss the issue with peer review or in the article. Assuming you’re a better peer reviewer than JAMA is not supported by the evidence.
I expect, as I have explained many times, that the placebo arm was determined not to be fit for purpose, and we note that it appears that when they did not enroll more patients, the patients that were enrolled appeared to be “randomized” all to the treatment arm.
Hence the inclusion of an external control arm, and the discussion of the issues they faced likely was, in fact, a direct address to the issues that resulted in the partial, not full halt and nothing about that halt ever suggested there was a DCVax-L reason for it. In fact, we know there are virtually no side effects from the treatment beyond what would be normal for patients receiving the standard of care and or dealing with a brain tumor.
I’d suggest that your presumption that it was not explained is merely a result of your wish that they would have used certain terms and there was no such requirement by peer review. The issues were explained and addressed and that was all that was required.
If there had been a safety issue or other practical issue with DCVax-L, I am sure it would have had to have been explained. But apparently, there was no such issue. That may disappoint some observers who heavily bet there was some hidden factor that upon its being revealed would cause the trial to be an unmitigated failure. But that turned out not to be the case, IMHO.
I expect, as I have explained many times, that the placebo arm was determined not to be fit for purpose, and we note that it appears that when they did not enroll more patients, the patients that were enrolled appeared to be “randomized” all to the treatment arm.
Hence the inclusion of an external control arm, and the discussion of the issues they faced likely was, in fact, a direct address to the issues that resulted in the partial, not full halt and nothing about that halt ever suggested there was a DCVax-L reason for it. In fact, we know there are virtually no side effects from the treatment beyond what would be normal for patients receiving the standard of care and or dealing with a brain tumor.
I’d suggest that your presumption that it was not explained is merely a result of your wish that they would have used certain terms and there was no such requirement by peer review. The issues were explained and addressed and that was all that was required.
If there had been a safety issue or other practical issue with DCVax-L, I am sure it would have had to have been explained. But apparently, there was no such issue. That may disappoint some observers who heavily bet there was some hidden factor that upon its being revealed would cause the trial to be an unmitigated failure. But that turned out not to be the case, IMHO.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
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