NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

Let me just clarify my current stance on this:

It seems clear they have "data" and will be presenting it, in the abstract or poster or both. Through two dose levels for all 36 patients (it appears all are enrolled, with the further 24 under enrollment by now), and through three dose levels by 5/19 (the data from which seems open for discussion at ASCO, and by PR to the public). This should clearly include efficacy data. She stated: "we have filled the first two dose levels with patients," (see my last post) meaning at least 36 patients have by the time of the abstract submission received two dose levels. Their site states:

We are currently conducting a 60-patient Phase I/II trial of DCVax-Direct for all types of inoperable solid tumors. The trial is under way at MD Anderson in Houston, TX and MD Anderson in Orlando, FL, with additional sites in varying stages of preparation. The eligibility criteria can be found in the profile of this trial on www.clinicaltrials.gov. The Phase I stage of the trial [comprised of 36 patients] involves dose escalation, testing 3 different dose levels of DCVax-Direct, and confirmation of the optimal dose. The Phase II stage of the trial will focus on efficacy. The primary measure of efficacy will be regression (i.e., shrinkage or elimination) of the patient’s existing inoperable tumors. Such regression is a rapid endpoint: if it is going to occur, is anticipated to occur within a couple months of treatment.

[brackets and emphasis mine]

Although the focus of the Phase II stage will be on efficacy, it does not mean they aren't viewing efficacy and tabulating results thus in the Ph I stage. How else can you find optimal dose finding without efficacy results?

And so, it seems to me they will have safety/tolerability, dose finding and initial efficacy (localized and it seems, systemic) data to share at ASCO, both in the abstract, and especially poster. Then, by PR (which should be even more complete/ current, and might possibly include other mentions such as Breakthrough Therapy designation, etc.), we will immediately after be informed of the complete, up-to-date picture of things, and that, combined with what they have displayed at ASCO, will be open to talks at their large booth space, on Monday, June 2nd and Tuesday, June 3rd (as longusa pointed out).