NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Hi Retiredinlovinglight,

Here is something I wrote recently, which kind of jives with your numbers.

Various potential scenarios in DCVax-Direct multiple injection (phase 2) trial starting this fall.

Let's imagine:

1. 24 pancreatic 100% response no recurrences. 24 lung 100% response no recurrences. 24 colorectal 100% response no recurrences. No major adverse side effects. I'd say they would approve it. (100%)

2. Change those numbers to 90%. Expand each indication to 60. I'd say they'd still approve it. (100%)

3. Change those numbers to 87%. Expand each indication to 120, I'd say they'd still approve it. (100%) IMHO

Keytruda had nothing close to these numbers in their 173 phase 1 trial, and their safety record was abysmal in comparison to DCVax-Direct, but they were approved at phase I based upon an unblinded trial. (The safety trial was over 400, but it had major issues and was not used by the FDA for an efficacy determination).

It would be my hope that the phase II Direct multi-injection trial will expand each indication to much larger numbers per indication. Even 180 per indication in the common cancers (lung, colorectal) seems financially reasonable if the phase I results are stellar. Perhaps 60 in the less common cancers (pancreatic, others). The enrollment would be quite rapid.

There is a statistical rule that basically states if you have several different subgroups, let's say 10, and only one does well, it may be that this one subgroup is simply a statistical anomaly as opposed to true efficacy. In those situations, the statistical burden of proof increases for that one subgroup. On the other hand, if you have, let's say 3-6 cancer types, and all respond extremely well to the same therapy, you should be able to say this is higher statistical proof of efficacy than each group might prove individually.

If the results are stellar in several cancers, and the FDA treats DCVax-Direct at least as well as it treated Keytruda in the approval process, then I think this will be an abbreviated unblinded phase 2 multi-injection trial that will be modestly/moderately enrolled and halted early to allow access to everyone who needs it! IMHO.