It wasn't a hold. It was only a partial hold. They actually completed the enrollment of patients with fewer placebo patients than anticipated. The partial hold was ultimately lifted.
They were likely not told why, as it was suggested. You can conclude whatever you want, but it seems inconsistent with the facts. More likely, looking at the crossover percentage, there was no placebo arm that was adequate to serve the purpose of a placebo arm. Delaying the treatment of newly enrolled patients would therefore be detrimental to their care if you know you're causing patients to live longer. Remember, the DSMB is able to see the results, and so is the regulator, NOT the company, as the 2017 court decision outlined in discussing this very matter.
So rather, I have explained and think it makes much clearer sense given the number of treatment arm patients they ended up with, and the fewer placebo patients than they should have had at the end of the trial they had planned, that rather, it was found, as I said the other day, that the placebo arm was no longer ethical if you were not going to have a true placebo arm anyway. Delaying their treatment just shortened their lives, and a DSMB and regulator likely could clearly see that. I don't think it had to do with PFS, because PFS was 1) not a useful measure given pseudoprogression, but also 2) there was a statistically inadequate placebo arm to use to determine PFS against the treatment arm. Regulators are not arbitrary, like shorts would like them to be.
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.
