Replies to post #322184 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I have a great deal of respect for AVII as well, but I believe he had a personal involvement in this case and advised someone with the disease to take a different course. It's hard to admit you may have been wrong when someone's life was on the line.

I believe after he's seen the data he'll become a fan, but time will tell.

If prostate surgery would give adequate material, is it the opinion of those here that DCVax-L would be at least as effective as Provenge.

Prostate is often one of the slowest growing cancers, often surgery isn't performed, especially in senior patients as they could often die of other causes before prostate would be a problem. I had an uncle who was treated in that way. That said, I would think that DCVax-Direct would be ideal in this application, even if it were operable, but the choice was made not to. It's said that if most men live long enough, they'll get prostate cancer.

The problem with running a DCVax-Direct trial in prostate is that it's so slow moving, the trial would need to be very large and could take decades to gain meaningful results. I suspect that if DCVax-Direct is approved for a number of more aggressive cancers it will be applied to prostate without further proof. If in fact DCVax-Direct was proved to halt the growth of prostate cancer with essentially no negative side effects, I believe that many men would opt to give it a try before using other forms of therapy because of the side effects.

Out of curiosity, how long does it take to go from leukapheresis to having DCVax-Direct ready to dose. We all take cancer very seriously, but experience has shown me that once discovered, surgery often takes one to two months to schedule and execute. I know in both my, and my wife's case, it was over a month. If DCVax-Direct can be made in days, or weeks, it might very well be used prior to surgery as the SOC. DCVax-L could be made from the tumor and used in treatment, and should tumors reoccur, new DCVax-Direct might very well be applied.

I'm uncertain, but believe leukapheresis only takes a matter of hours, or a couple days at most. I know when stem cells are donated they are gathered in 1 to 3 days in a similar manner unless the donor wishes to have the cells removed from the marrow, which is much more painful, but quicker.

Out of curiosity, does anyone know if the time to produce the vaccine is faster with the new devices the company just acquired, or is it primarily lowering the cost of doing so.

Gary

[Doc logic]

froggmister,

AVII77 believes that his numbers point to selection process and not treatment effect. The problem is that mOS does not demonstrate late term separation which I believe actual data can and will. The other issue is that some effect, like for example up to 2 months added to OS from crossover plus salvage therapy will now be accounted for. The real victory here ,though, is that methylated mesenchymal, a very aggressive subtype not specifically tested for, might actually demonstrate a high cure rate and that others are receiving various degrees of benefit beyond that. Then there is the ancillary evidence from outside this trial that benefit can be increased by combos with ICLC and others and potential evidence that an “optimized” vaccine in the second half is producing improved results even though played down by some key folks. When a key clinician says he wants this treatment for all of his patients and AVII77 ignores this I wonder if his learning has biased him against the impact of patient advocates and the totality of evidence. I do not doubt that he feels he has good reasons to believe his position is based on a solid understanding of the patient selection process. I do believe, though, that late separation, adjudication of PFS, biomarker correlations to treatment benefit and patient advocate support at a minimum will make this approvable. I also believe the evidence will be better than this but that is gravy. Best wishes.