NorthWest Biotherapeutics Inc (NWBO)

[Umibe5690]

Senti, what you aver is possible but not confirmed fact as far as I know. Of course, I could be mistaken. It has happened before.

Firstly, a 2:1 ratio for Tx/control on the original 348 would yield 232 Tx and 116 control, not 110. So under your assumption of first filling all Tx(232), they would be short 17 patients in control, not 11, based upon 99 patients allocated to control. A 2:1 ratio of Tx to control on 331 would be 220Tx/110 control(+1 to either arm).

Anyway, overall, they were short 48 upon an enrollment of 300 patients. They enrolled 31 more patients and were short 17 of the 348 total. Instead of enrolling all 31 in Tx, they could have chosen to proportionately enrol the remaining 31 patients among the Tx and control arms. The reason why they would have chosen to enrol only in the Tx arm is obviously important. And it would have been done only with agreement with the FDA; or enrolment in the Tx arm may have been mandated by the FDA for possible ethical reasons. This is all supposition and not fact. In keeping with the trial protocol, they could have allocated 220 to Tx and 110 to control(+1 to either arm). The crossover arm was created in order to facilitate enrolment.

In any event, is it a fact that 232 patients are enrolled in the Tx arm(and 99 in control)? If, in fact, the remaining 31 were all allocated to Tx, this is possibly suggestive of efficacy one would think.

Best regards,
U