Replies to post #548332 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

The JAMA independent peer review looked at the trial design and validated the conclusions of the statistical analysis.

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

[SkyLimit2022]

It is important to note and remember that murcidencel approval does not depend solely on one trial. The P3 was brilliantly executed, but the applications for approval will require paper clips and plenty of staples for all the extra pages that will be included—there is a voluminous catalog of supportive data that has been collected, analyzed, and validated.

Data collected from the P3 and ECA comparison only comprise a fraction of the clinical efficacy data that exist for murcidencel today. Murcidencel has been studied in three trials—only one of those three relied on an ECA, and that ECA included over a thousand well-matched contemporaneous patients.

All clinical data are relevant to a regulatory application including those data gathered from other studies, interim analyses, and compassionate use. All three trials have produced substantial safety and efficacy data, and two of the three clinical trials ran for over a decade with survivors alive today.

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

https://virtualtrials.org/video2022.cfm?video=202207

[Dr Bala]

The data is excellent. Thanks, HyGro.