NorthWest Biotherapeutics Inc (NWBO)

[IkeEsq]

Voting Thread for pre-ASM Question for Management

The following are all of the final versions of questions submitted on this board that people wished to ask management. I laid out the basic procedures in this post, solicited questions in this post, and requested edits in this post.

Voting will be open for two days, until market close on Wednesday January 23, 2019 (4:00 p.m. EST). All accounts opened prior to January 1, 2019 can vote on their ten (10) top choices by replying to this post. If you vote for more than ten, I will count only the first ten.

When voting is complete, I will tally the votes and send at least 7 and up to 10 questions to management via email and Priority Mail with Signature Confirmation. The number of questions will be based on any natural break in the votes for each question. The objective is to get management to file a responsive 8-k as they did on November 28, 2018.

List of changes:
Merged 4 and 26
Replaced 26 with sentiment_stocks's other question to avoid renumbering.
Edited 12 (added ", including whether or not there is a specific minimum length to the hoped-for long tail?")
Edited 15 (finalized instead of developed)
Edited 28 (IA=Interim Ananlysis)
Edited 09 (added 'detailed')
Rewrote 27
Edited 35 (added "liability or is the contaminated land part of NWBO's remaining 17 acres?")
Edited 36 (added "NWBO still anticipating a suit against those who manipulated its stock and")

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01 On August 21, 2015, NWBO announced a temporary suspension to the screening of new patients in the DC Vax-L Phase III trial. Please provide an explanation for this hold or an explanation for why you can’t communicate the reason, given that the FDA lifted the hold on February 3, 2017.

02 On December 5, 2018, NWBO entered into an agreement with regards to its property near Cambridge, UK. Why would the buyer pay so much for land that for the most part cannot be developed?

03 Did any of the 331 patients in the DC Vax-L Phase III trial benefit from any process improvements during the trial period (such as an improvement made in Germany)?

04 Will finalizing of the Statistical Analysis Plan (SAP) for the DC Vax-L Phase III trial incorporate the impact of favorable long-tail results on trial approval (as opposed to merely considering the results of the Primary and Secondary Endpoints)? If so, will this consideration of long-tail results require the FDA and/or other Regulatory Agency to support such a deviation from the trial Protocol? If so, how long might it take to obtain such support from regulatory agency or agencies?

05 On November 15, 2018, NWBO filed a Notification of Late Filing (nt 10-q) in which NWBO stated that “it is in late stage parallel negotiations with different unrelated third parties in regard to substantial alternative potential financings.” Please provide a clear explanation for what this means.

06 What strategic partnerships are being pursued for the Asian market for both treatment centers and manufacturing?

07 Why have trials for DC Vax-Direct, DC Vax-Prostate, and combination trials for DC Vax-L been delayed and when do you expect them to start?

08 Is the DC Vax-L Phase III trial well passed the Primary and Secondary endpoints and if so, is this due to the trial size being reduced from 348 patients to 331 patients (of which approximately 300 were randomized)?

09 On November 19, 2018, NWBO issued a press release providing data presented at the Society for Neuro-Oncology (SNO) conference in which NWBO stated that they would be moving forward with the stages needed in order to complete the DC Vax-L Phase III trial and that those stages included “finalizing the Statistical Analysis Plan, conducting the final data collection, data validation and data lock, and then unblinding and analyzing the data.” Please provide a detailed timeline for this process, including when each phase is expected to (or did) start and end, how long each phase is expected to take, and if some or all of the phases can be completed simultaneously.

10 How many DC Vax-L Phase III patients are still alive, how many control patients have crossed over, and how many patients are lost to follow-up?

11 Was ‘Method B’ or a variation of it ever used in the DC Vax-L Phase III trial?

12 What specific data are NWBO looking to capture that has caused the Scientific Advisory Board to keep the DC Vax-L Phase III trial blinded for so long, including whether or not there is a specific minimum length to the hoped-for long tail?

13 What were the Net Sales Proceeds, after mortgage payoff, sales commission, and other sales costs relating to the December 5, 2018 transaction regarding NWBO’s property near Cambridge, UK?

14 In its 2018 10-q filings, NWBO lists 444.6 million shares of common stock, 3.2 million shares of Preferred Series A, and 7.5 million shares of Preferred Series B as of June 30, 2018 and 510.1 million shares of common stock as of September 30, 2018 after the mandatory conversion of Preferred shares on September 7, 2018. If preferred shares converted at a rate of 1:10, the total common stock as of September 30, 2018 should have been over 550 million shares. Can you explain this discrepancy?

15 On February 6, 2017, NWBO issued a press release stating that “[t]he external parties managing the Trial are now moving forward with the process to reach data lock.” Was a statistical analysis plan finalized at that time and if not, why not?

16 If the German Hospital Exemption (HE) is no longer under consideration, what are NWBO’s intentions in Germany?

17 Are there plans to get NWBO relisted on a major exchange and if so, is a reverse split one of the options under consideration for increasing share price?

18 Were the final 31 of 331 patients in the DC Vax-L Phase III trial randomized between treatment and control or were they all in the treatment arm? If they were all placed in the treatment arm, why?

19 What if any support or input has the FDA provided for the DC Vax-L Phase III trial?

20 On November 19, 2018, NWBO issued a press release providing data presented at the Society for Neuro-Oncology (SNO) conference in which NWBO referred to “no well established pathway.” Can you explain what is meant by this and if it is regarding the approval process, please describe what pathways NWBO considers open to DC Vax-L?

21 Has NWBO received any buyout or partnership offers and if so how many of each?

22 Were the doses for the final 31 DC Vax-L Phase III trial patients manufactured in Memphis, TN?

23 Is completion of the DC Vax-L Phase III trial necessary prior to unblinding?

24 Approximately how long does NWBO expect the FDA to take to make a decision on approval once topline results are released?

25 Was the December 5, 2018 agreement relating to NWBO’s property near Cambridge, UK a simple real-estate deal between NWBO and Huawei or is it part of a larger collaboration between the two companies?

26 Why did NWBO stop enrollment of the pseudo progression arm at 32 instead of continuing to enroll patients to equal 48?

27 Does NWBO have any evidence to suggest that Neil Woodford had access to insider or non-public information that could call into question the legality of his trading NWBO shares, including but not limited to having access to notes taken by Ms. Katherine Wolf during a meeting in 2015 with NWBO management?

28 In the DC Vax-L Phase III trial, how many efficacy Interim Analyses (IAs) were conducted and what type of information did NWBO receive concerning the efficacy IAs, including but not limited to whether or not the endpoints were statistically significant?

29 When did or will the latest data collection on the DC Vax-L Phase III trial begin and if it has been delayed, why?

30 What preparations are being made in Germany for manufacturing DC Vax-L in anticipation of the German Hospital Exemption (HE) or ‘medical tourism?’

31 How will shareholders be notified upon the completion of the SEC investigation mentioned in the 10-q dated November 16, 2018?

32 When and in which jurisdiction does NWBO expect to first seek approval (e.g. FDA, NICE, etc.), and which approval track does NWBO expect to move the fastest?

33 How many naked-shorted shares of NWBO common stock does NWBO believe to be currently in circulation?

34 Why hasn’t the SEC investigation mentioned in the November 16, 2018 10-q been completed yet?

35 On December 5, 2018, NWBO entered into an agreement with regards to its property near Cambridge, UK. Did this result in the sale and/or transfer of the contaminated land and its associated liability or is the contaminated land part of NWBO's remaining 17 acres?

36 Is NWBO still anticipating a suit against those who manipulated its stock and when will Cofer Black’s report on the manipulation of NWBO’s stock be released?

37 Is NWBO reanalyzing the flagged pseudo-progressions in the DC Vax-L Phase III trial and if so when will that be completed?

38 How many patients have been treated with DC Vax-L outside of the Phase I-III trials, through self-pay or other avenues, where does the revenue/income from those patients appear on the financial reports, and how have those patients fared?

39 Has NWBO recently re-evaluated whether or not Cognate is still a reliable supplier, and if so, does NWBO consider them to still be reliable?