Replies to post #730132 on NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

With respect to the "patient level matched control data" of the ECAs, requested
by the FDA to be included in the BLA, it should be pointed out that the fact
that the mOS of the unmethylated GBM treatment group of the DCVax-L trial
was not statistically different from the mOS of the unmethylated GBM patients
of the ECAs, should have greatly diminished the need for patient level matched control
data. The similarity between the mOS of the treatment group to the mOS of the
comparable population in the ECAs, shows that the inclusion/exclusion methodologies
of the DCVax-L trial was a good match for the inclusion/exclusion policies of the
ECAs.

IMHO, there was therefore no reason for the FDA not to accept NWBO's BLA.