NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

It’s exactly when I said, and they said only after August “the last 17”… does not say no more patients were enrolled after the hold.

You really did not say anything new you just linked to an earlier PR, than previously.

And it focuses on the events.

This confirms what I said and what I said was consistent with the final outcome. They had enough patients to complete the trial, and they were not told the final patients were either treatment or placebo, just the last x number would nir be needed, the end result was that they had their original trial number, no additional placebo patients. They effectively completed the trial, and they were then waiting for the final events.

“To date, the regulators have not agreed to remove the partial hold, but have allowed all of the patients in the Trial to continue being treated in accordance with the Protocol. The Company is pursuing ongoing dialog with regulators. However, at this point the Company believes that the potential benefits that could be obtained from enrolling the final 17 patients would not be worth the time it would take, as the process of re-starting and re-training the sites (including through Institutional Review Board renewals) for further enrollment would take months, followed by further months for the recruitment itself.”

No need to expand the number, no placebo, though they were not apparently told the arm was not fit for purpose they likely knew enough to know that they had a lot of crossover patients, a hallmark of a successful drug that virtually all patients desperately wanted to take even upon recurrence. And they had known about the problem with pseudoprogression, so also likely that there would be a challenge with patients being diagnosed as recurred under the old standard measure for recurrence for that part of the trial, but the secondary measure was mOS. So before being unblinded they did adjust the trial and they had extended the time out for OS anyway, for the long tail survival arm anyway, so that made the most sense, and of course they would also know then to discuss with the regulator the need for the external control arm to have a statistically vigorous measure for OS.

Contracting that out to a truly blinded, highly respected third party statistical and epidemiological team was a very clear effort to address any concerns about bias, to inoculate any final result for purposes of regulatory discussion and review and further have a result that regulators could reasonably consider as valid, though other drugs approved for gbm had far less clean statistical and other issues. They bent over backwards given what they knew up to that point.

You really did not say anything new. They made an incredible effort to get this to where it is and to get approval to be providing it through the specials program even now, is amazing in my book and speaks to the respect the regulator in the UK holds them in.