NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

First of all, you, as I have said, posted a falsehood when you said this:

Besides, the guidance, like others, specifically states that OS is compared to ECAs is not a valid endpoint.

That is not what the FDA Guideline says, the FDA Guideline says

Data derived from externally controlled trials are seldom reliable for time-to-event endpoints, including overall survival

You turned seldom into never.

More important the Guideline also says this
A. Survival is considered the most reliable cancer endpoint, and when studies can be conducted to adequately assess survival, it is usually the preferred endpoint.
B.

Data derived from externally controlled trials are seldom reliable for time-to-event endpoints, including overall survival.

But NWBO did not compare its data to externally controlled trials. NWBO compared its data to present Standard Of Care SOC.

Third C. "Demonstration of a statistically significant improvement in overall survival can be considered to be clinically significant if the toxicity profile is acceptable <which in the case of DCVAXL is, being zero> and has often supported new drug approval and as The Danish Dude pointed out ."

45 approvals id'ed where FDA accepted ext. control data in benefit/risk assessment; doing so for many reasons incl. rare nature of the disease, ethical concerns wrt use ofplacebo or no-treatment arm, seriousness of condition, and unmet medical need