NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

Adam Feuerstein: "Oh, and your mesenchymal subgroup conjecture is pure fantasy because it's a retrospectively defined subgroup of patients."

I understand why defining a subgroup after the fact is not generally allowed. But if there is new flexibility at the FDA to ensure good drugs do not get rejected out of excessively rigid rules, then this might be an area worth debating.

Defining a subgroup after the fact could allow approval of a subgroup purely out of random variance for that subgroup. But the amount of variance is not infinite. So, while I admit I do not fully understand these issues, it seems to me that an alpha hit makes mores sense than simply denying any possibility of consideration for approval.

Maybe an alpha hit is not the right term. I don't mean using up some freebie margin that does not effect the required efficacy for approval, but rather, a raising of the bar to account for / offset a reasonable level of statistical advantage from defining a subgroup late in the game.

In the end, if it is blatantly obvious to a human that the methylated mesenchymals (15% to 22% of all patients) will nearly all gain a complete response if DCVax-L is administered, yet consideration of approval is not allowed based on the rules, then the rules should be looked at closely.

Here, for you Adam Feuerstein to point only at a rule, with no statement about claimed efficacy for that very large subgroup, larger than the actual subgroup that Celldex trialed for and failed, shows your hand. A hand that has always been about trying to snuff out NWBO because your buddies in Big Pharma all agreed among themselves, in negotiations with the Insurance companies, that they would not pursue autologous cancer vaccines due to the estimated manufacturing expense, making Northwest Biotherapeutics a renegade that must be eliminated.