Replies to post #3147 on NorthWest Biotherapeutics Inc (NWBO)

[JTORENCE]

Flipper
200-400 dollars per share??

[ou71764]

Flipper, I had a long response that I just lost. I'll give the conclusion and work on restoring my rationale: while I'm sticking with my guesses, your estimates aren't crazy.

[ou71764]

re: DCVax-Direct. Is it possible for it to have a 80-100% response rate, with some patients having a complete response?

I looked at the Triozzi pilot study again. In their study a tumor had to have 50% shrinkage to be counted as having a response. 6 of 10 in the Triozzi study had at least 50% shrinkage. Another one had 25% shrinkage.

Further, one patient in the Triozzi study had a complete response - not just in the injected tumor, but with nearby tumors as well:

One patient (Patient 8) with melanoma manifested a complete response of the injected tumor and eight other 0.5–1.0 cm satellite lesions within a 6-cm radius of the injected tumor.

The current RECIST guidelines say that a tumor has to show 30% shrinkage for it to be considered a response. I am guessing that that's what the NWBO trial will use. Given that DCVax-Direct is an enhanced version of the vaccine used in the Triozzi study - and that the bar has been lowered to meet the threshold as having a response - then yes, it is possible that DCVax-Direct will hit a 80% response rate with some complete responses.

I won't go out on a limb to predict a 80% response rate. For me there are too many trial variables that I don't understand. Anyone (other than a research scientist) who looks at that write-up of the Triozzi pilot study has to admit that they don't fully understand everything that's in it. So the difference in the protocol between the pilot study and the NWBO trial isn't clear to me. Plus, I have no way of knowing how much better DCVax-Direct is than the vaccine used in the pilot study.

But yes, it is possible that there will be very big news from the DCVax-Direct trial.

[ou71764]

Flipper, another part of your triple digit price estimate for 2014 assumes that the phase III DCVax-L trial will be halted early.

I think your estimate of 24 months PFS for the treatment arm is possible, especially since that's what it was in phase I/II. The control arm will be under 1 year even if it ends up beating the historic norms for SOC. Anything around a PFS of 18 months for the DCVax-L arm should mean easy approval for DCVax-L. So I do think DCVax-L will be approved.

But having statistically significant data at the time of the interim review(s) is a whole other issue. If DCVax-L has less than 24 month PFS and the trial arm beats the historic norm, I still think DCVax-L will easily get approval - but that the trial will have to run its course. I am expecting unblinding after the trial has ended. My estimate for a PR on topline phase III results is that it will be in the first half of 2015.

But if you are correct on what will happen with DCVax-L and DCVax-Direct in 2014, then I agree that we'll see a triple digit stock price in 2014. I don't know how much over $100 we'd see. But the news you are predicting is huge.

But I'm sticking with a stock price far lower. I don't think your logic is flawed - it's more that I think it's less likely for all that to unfold like that in 2014 than you do. But I am hoping you are correct!!