NorthWest Biotherapeutics Inc (NWBO)

[thermo]

Not much has changed post the Stupp opinion. The Stupp article said things we all knew or should have known. Not trying to sound like a know-it-all but everything he mentions I have thought about for years.

The therapy shows a bigger benefit in MGMT methylated. This was apparent in the blinded data and is the strongest counter argument to the time-bias concern. If time bias explains the survival benefit, why is it not better distributed across both groups?

An externally controlled trial was never going to be as compelling as a placebo-controlled trial. Stupp points this out with his “it remains to be demonstrated” line. But non-placebo-controlled trials get approved when the need it great.

Regulators must weigh risk of approving of an ineffective therapy vs that of denying an effective one. Stupp also points this out with his “being too stringent carries risk” line.

Safety and unmet need hold the key.