Replies to post #511895 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Yes, that is correct. The FDA did in fact approve the trial to resume and it was successfully completed.

[Dr Bala]

Irrelevant.

[Hspooner]

That’s a complete fallacy Ex, here is the PR!!
On February 3, the FDA lifted the partial clinical hold which had been in place on the Trial. As previously reported, the Company has been in an ongoing dialog with regulators. The dialog culminated in the FDA lifting the partial hold. As previously announced by the Company, and as the Company also informed the FDA, the Company has closed enrollment and is not going to enroll the last 17 of the planned 348 patients.
https://nwbio.com/nw-bio-announces-lifting-clinical-hold-dcvax-l-phase-iii-trial-fda-progression-free-survival-events-reached-overall-survival-events-not-yet-reached/

[vator]

Wrong. The company could have resumed screening and enrolling more patients. The company chose not to do this because it would have extended the trial even more based on the time missed from the screening halt. The company felt they had enough enrolled in the trial to get proper results. Your assertions have been wrong on this matter for years on end.

[Doc logic]

exwannabe,

No it’s not false. The hold was lifted which means that technically NWBO was free to begin screening again but since NWBO had already informed FDA that they would voluntarily not seek to enroll any more patients, they would need to notify FDA of their intentions to do so if they wanted to begin screening again. In such a case, as some of us have figured out by now, the hold would have been reinstated without any reason given. The games people play to hide what’s going on are pretty contrived sometimes right?; ). Best wishes.