Replies to post #4411 on NorthWest Biotherapeutics Inc (NWBO)

[FatCat_Banker]

That was amazing.

[ou71764]

I agree with FCB, that's amazing! Thanks, Flipper! Not only do you have knowledge on what's going on, you lay it out in a logical, easy to understand format. But there's so much info, I'll still have to print it and study in detail at home.

Question: how much of this is new to you? I guess what I'm asking is if this is what lead you to your optimism a couple of months ago about an early halt, or is there anything here that has recently added to your thoughts about an early halt?

Also, might the DMC recommend a halt with a label requirement that it only be for the sub-types where the vaccine is the most likely to be effective?

[TheRedBaron888]

I'll need to go through that once more, but still....terrific stuff, Flipper !

[ou71764]

Flipper,

This is one part that you highlighted:

"All patients that generated a systemic CTL response showed no MRI evidence of progressive disease at the time of vaccination [initiation]. Conversely, no patient with actively progressive disease developed statistically significant 'cytotoxicity. (which means being toxic to cancer cells)." This is really really important.

I get the first part: the vaccine is more effective if the cancer is stable at the time the vaccine is administered.

But then it says that if a patient has progressive disease, that there is no cytotoxicity. And cytotoxicity means being toxic to cancer cells. So cytotoxicity is good, in that it's bad for cancer cells.

If that's the case then I guess I'm glad the trial excludes the patients with progressive disease. But I'd rather that the vaccine could at least "slow down" progressive cancer.

[ou71764]

Another thought as I read your post: enrollment is taking longer because not everyone qualifies. And it takes weeks before they know if a patient will qualify.

[longusa]

flip, thanks for the analysis and the leg work on this. Your logic seems sound to me IF the subgroups show PFS differences within the 4 week period following SoC. I could not find any charts on PFS that compares the subgroups. Did you come across subgroup-comparative PFS charts in any of your research?

Thanks again!

[john26632]

Flipper, back in February 2014 you had an amazing post (4411) titled "Pseudoprogression, True Progression and Four Subtypes" Toward the end you listed the subtypes and the possibility that each subtype could respond differently to DCVAX-L. If this indeed proves true, could the composition of sub-types currently enrolled in the DCVAX-L phase 3 trial skew the outcome? thanks