Replies to post #240007 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Umibe5690,

Now that was a solid well thought out balanced post Umibe. One of the points I would like you to consider about PFS and immune response in particular is that the immuno score developed by a member of NWBO's SAB is being put into wide use and I expect it will be part of the SAP being put together as a prognostic indicator for potential benefit for all patients. This in turn will potentially guide doctors in their choice of treatment schedule and combos for all patients in the future.

Management will score big brownie points at this stage if they demonstrate that they understand the impact of investor angst with regard to time lines and dilution. They need to be a little more proactive in their approach about announcing how they plan to move forward to get ahead of the bear arguments even if they don't share much info. On the other hand, and I don't like that hand much, if a trap is being laid then a portrayal of extreme weakness right before expected top line might stir up some brazen behavior.
Again, let me just say thank you for this post of yours. For me it clears up some doubts about the intent of a previous post you wrote which appeared to express more angst than balance. However, after I posted this comment I happened to read more subsequent posts of yours and hence this afendum. Now I am back to questioning your intent because questioning seems justified. Best wishes.

[iwasadiver]

Umibe;

I have been working a lot clinically and simply haven’t had the time to delve deeply into your question previously. However, it appears you’ve pretty much answered the big questions with this post of yours. Every issue you’ve put forth here, the PFS significance, the OS significance, the Methylated group vs. Non, the mesenchymal, etc., etc., etc. are precisely the points I believe the revised SAP are addressing, most likely only in a new way (I believe there were some forms of these various items to begin with).

I believe the nuance is in these different types of tumor markers and going forward are precisely what the progressing science of Immune Therapy will require for every new treatment trying to be brought to market. I put up the BMY supported paper published recently in Lancet Oncology showing the OS at 4 years from a group of trials conducted in NSCLC using Opdivo. In another post I showed a link to EMA’s review and ultimate approval for extending the indication of Opdivo to squamous cell head and neck cancers and how that review used BMY’s revised SAP to include which patients had other treatments, which patients showed greater than 1% PD-1 expression, which did not, etc. and how these patients all faired. In conclusion the two papers showed how large improvements in certain markers, smalller improvements with lesser markers, etc. all led to approval for expanding the indications and how an immune therapy’s data must be judged.

I won’t comment on the management issues, I think you’ve given your position and me mine.