NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Thus far there have been 55% patients with a pattern of tumor infiltration and 62% with pattern of necrosis. I think that was as of December of last year. Tumor infiltration is highly correlated with overall survival and progression free survival. Moreover, immunotherapy takes longer than other types of treatment like chemo, but, on average, the effects last longer and the side effects are much less frequent with DCVax. Response rates in Yervoy were literally in the single digits when it was approved (and those that achieved a complete response averaged 30 months to get to that point)-- and response rates per Recist do not always correlate with overall survival or even durable responses. Opdivo and Keytruda had response rates from about 13% and I believe in one indication almost made it to 30% -- with more side effects than DCVax. I think the question no one knows the answer to is whether DCVax-Direct will try to go for approval based upon response rates or some other measure. Phase II of the current phase 1/2 trial was able to transition patients after their sixth dose to more frequent dosing, multiple doses, correct dose and correct maturation. This is what we've all been waiting for. LP stated in December, they were able to do that "now" -- again "now" meaning when she spoke back in December.

Ready will just have to wait like the rest of us for the remaining preliminary Direct data from phase I when it is provided. Unlike chemo, immunotherapy data typically gets better as results mature. So even when the data from base I is fully revealed, do not assume those results will not mature and improve even further. That is the nature of immunotherapy.

My guess is the first indication we move forward on will be one with a high response rate.

Ready for Blue sky is wrong about the reduction in desire to move forward on Direct independent trials.

On May 21, 2015, Dr. Bosch provided this in his conclusion.

Based on the encouraging data gathered to date, including survival data, we are planning to move forward with at least 2 Phase II trials in different cancers, in parallel

Ready was simply wrong that this view has changed. Instead, it was reaffirmed 5 days ago.

Remember, we are not getting the whole story (only a few case examples) sooner because of the Budzar/AF kerfuffle.