Thread by @eastvillagetwt

DCVax-L Phase 3 Trial Results

Final Top Line Results, Phase 3.

Delivered 5/10/22 to the New York Academy of Sciences by

Dr. Paul Mulholland, MBBS, MSc, PhD, FRCP, University College Hospital, UK

#DCVaxL $NWBO #TLD

via @YouTube

If you watch this by idea closely, you’ll note that the trial coins not proceed ethically UNLESS it was a crossover style. But all the patients lived longer including the recurrent ones who got access to #DCVaxL late. THAT was their placebo arm originally. There is no way in hell

, in my opinion, that a regulator is going to push a drug company into a crossover trial ethically, and then say, oh, man, your drug is so successful in making everyone live longer, but there is nothing that can be done. You fail! That’s not how regulation works.

Regulators are not irrational, as much as that suits Wall Street to play that game and pretend it is so. The regulators 1) gave allowance for an external placebo, as they have in other cases, though this case had some unique circumstances addressed by procedures clearly; and

2) the company had pseudoprogression, which shows the mechanism of action is working, again, regulators are RATIONAL, and this was an adaptive trial, which the FDA actually likes and for which it has guidance, so the went with the preferred measure for efficacy, not it’s proxy,

They went with ongoing survival (which PFS or recurrence is supposed to be a shorthand measure but often is not). Survival is the gold standard. For not initial and recurrent Glioblastoma, they got outstanding survival results and clearly increased survival numbers by a lot.

The drug also has minimal side effects, effectively they are reinjecting the patient’s own blood product. The company has extensive patents and has other things the do to enhance the immune reaction, they have process and mass manufacturing patents pending shortly.

For these reasons, the ridiculous column of a known antagonizer of this company should basically not be read as very insightful. This is all my opinion and I continue to own shares in $NWBO. #DCVaxL this plus #DCVaxDirect will be an incredible platform for combination therapies.

See also the #DCVaxLComboTrial and the #DCVax Combination Patent which is pending … more to come…