NorthWest Biotherapeutics Inc (NWBO)

[hankmanhub]

I am no expert, but in my lay opinion, only one trial should be needed to gain approval for all solid tumors of any type.

Can we not ignore the differences between the cancer's location and focus on the similarities and design the trial such that say a minimum number of persons will be treated for each named cancer and above that minimum they could enroll any cancer type as may wish treatment to fill the trial. This could simply be thought of as a trial for treatment of "solid cancer," without any further adjectives or sub-categories.

So for example perhaps the trial could name say 20 (not rare) solid cancers, and perhaps have trial size of say 1000. Then they would have to enroll at least say 25 of each of these types of cancer in the trial. That would be 500 patients, and the remaining 500 could be of ANY solid cancer without respect to cancer type.

I would suggest that a good response to this sort of trial should merit a global approval for all solid cancers (even beyond the 20 named cancers) without taking years of trials, and huge expense, for many lengthy trials in every solid cancer type.

I am sure many will say this is not the way of the FDA. And I say why the heck not. If in fact certain cancers will not succumb to the DCVAX treatment that will be seen by following the treatment for the first several years to see if there is no effect on certain cancers. In any case even then at least the DCVAX is safe and does not cause any harm.