NorthWest Biotherapeutics Inc (NWBO)

[hankmanhub]

More questions for the ASM:

From hankmanhub Tuesday, 01/09/18 05:40:28 PM
Post # 152591

These are two of the most immediate questions that I (probably we all) would like to have answered at the ASM if not already known by Jan 21, aside from the ultimate question of the success of PIII.

1) When and in what journal is the awaited paper to be published?

2) What will be the trigger for deciding when to unblind the PIII? (What are they waiting for now, given that both endpoints have been reached!)

questions for the ASM:


(Also in response to post 154372 and 154382)

Here is my attempt at accumulating all questions for the ASM in 1 post. I show the post number, and who posted the question (I took the liberty to shorten some of the questions), followed by some of my own questions at the end of this post.
154351. Vator. What was the past screening halt about and if they will not say, ask them what is the reason they cannot tell us.

154354. Virgilio . 1) Publication: first hinted on June '17 and still no news (8 months have passed!);
2) Interim blinded data: they said they will release them (with no specific timeline), and 4 months have passed, and nothing yet.
3) SEC investigation: I believe news about results (bad or good) are imminent.


154356. anders2211. Is NWBO management aware that a vote for the increase of authorized shares will most probably not reach a positive quorum if NWBO's communication on the update of the phase 3 trial stays silent and many question remain unanswered?

154359. doingmybest. 1) Why has FDA not assigned a designation such as fast track?
2) More importantly, what is the current regulatory pathway with FDA? Explain the status of the study and timing of what to expect.
If NWBO does not state that they are still blinded on Sunday that raises a couple of additional possibilities.
Is NWBO using OS for a full approval (not wanting a confirmatory period), and, is NWBO setting the stage for discussions with FDA for a broader platform of approvals across primary and secondary treatments across the solid tumor field because the science spans DCVax-L and Direct and because there are no safety concerns?
What is the current regulatory pathway strategy being pursued and why?


154361. doingmybest. 1) What is the current regulatory pathway being pursued with FDA and the timeline?
2) What level of engagement have you had with FDA about the pathway and their concerns?

154362. Marzan. If NWBO clings to 'the trial is still blinded' reasoning for keeping silent, then ask: has that 231 OS number hit or not?

154360. CherryTree1. since the trial has been going on so long is there any concern now about patients dying of old age?

154391. RootJim. (…since the trial has been going on so long) is there any concern that shareholders might die of old age?


Other questions:
Divulge something about NWBO’s share authorization vote strategy & timing (ie how soon after the ASM? Same day? Same week? Not for another month?)
See post 154399 … approx February 2018?

Has Overall Survival events threshold been crossed & when (July 2017?).
When can unblinding be expected? After all patients have died, or sooner? Target number of events or target timeframe for unblinding?

Publication of blinded results: which journal will this be published in? In days/weeks/months? NWBO on several occassions made it appear this was “Imminent” … shareholders deserve some update/indication.

Is any Buyout being considered in the near future (within a month or 2)? Any buyout discussions taking place currently with any Big Pharma?

Is Accelerated Approval being considered or pursued at this time? Is an alternate method of approval being pursued with FHA at this time? Has a Biologics License Application been submitted/filed, or is this in the works? Or: is NWBO strategy to only pursue Full Approval?

Update on attempts to obtain approvals from other countries: UK, Germany, Canada?

Have all the trial-site visits been completed? If not, when is that expected to complete?

Update on starting combination trials:
a. Phase II Clinical Trial Evaluating Combination Therapy Using DCVax-L and Nivolumab (https://clinicaltrials.gov/ct2/show/NCT03014804)
b. Phase II Clinical Trial Program Combining DCVax®-L and Pembrolizumab (Keytruda®) for Colorectal Cancer (www.nwbio.com/nw-bio-announces-phase-ii-clinical-trial-program-combining-dcvax-l-and-pembrolizumab-keytruda-for-colorectal-cancer)
Post 146682: which 10 centers in Germany? which "“liquid biopsy” measures?

Miami Conference: are 5 executives from NWBO attending? Why so many? Can important news/updates be expected? Will there be any live streaming of the event (if no, then why not?).

Have there been any facility inspections at Sawston by any of the regulatory agencies (from USA, UK, Germany, Canada)?

How many patients have been treated in Germany under the Hospital Exemption (self-paid or otherwise)? Results: How have they faired after treatment? (Update to this October 2014 PR: www.nwbio.com/dcvax-l-hospital-exemption-program-now-under-way-in-germany)

Is NWBO still hopeful that PFS endpoint will generate good results, despite the delay in unblinding and apparently awaiting OS endpoint reults?