List of Proposed pre-ASM Questions for NWBO
OK, this is a bit of a beast. There were a total of 59 questions and a couple of non-questions (which I list at the end). I condensed those down to 39 to reduce duplicates and randomized them with a set of numbers from random.org. I have edited and condensed the questions, fixed typos, spelling and grammar, spelled out acronyms and abbreviations when I could figure out what they were, and specified exact dates, events, and communications. I list each proposed question in bold, followed by the original(s) with the sender in parenthesis. If anyone wishes to revise/rewrite any question or disagrees with my edits or combinations, reply with edits and the number of the question to this message.
I will gather all edits that are replies to this post on Monday January 21, 2019 at market close and post a final list for voting by end of the day, EST on Monday January, 21, 2019.
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.
a. Please explain the reason for the hold or why you can not tell us? (hankmanhub)
b. What was the reason for the clinical hold? (survivor1x)
c. DCVax-L: What was the reason for the screening halt? NWBO stated the reason for the screening halt would be provided once the matter was resolved. Why is the reason for the screening halt still not given despite the halt being lifted? (Evaluate)
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?
a. Sawston: why would the buyer pay so much for land that is largely undevelopable? (Evaluate)
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)?
a. DCVax-L: Did any of the 331 patients benefit from any process improvements during the trial period (such as an improvement made in Germany)? (Evaluate)
04 In revising the Statistical Analysis Plan (SAP) for the DC Vax-L Phase III trial, will NWBO be revising the endpoints?
a. DCVax-L: in revising the SAP, will NWBO be revising the endpoints? (Evaluate)
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.
a. NT-10Q: Provide more info on the vague statement "Northwest Biotherapeutics … is in late stage parallel negotiations with different unrelated third parties in regard to substantial alternative potential financings" (Evaluate)
06 What strategic partnerships are being pursued for the Asian market for both treatment centers and manufacturing?
a. what strategic partnerships are being pursued for the Asian market for both treatment centers and manufacturing. (Evaluate)
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?
a. New trials' start dates and why were they delayed (doingmybest)
b. Why hasn't any of the Direct P2 trials started yet? (IMHO any questions about Direct are lower priority as compared the P3 L trial, but may be we can fit one in) (aperture007)
c. When do you expect P2 for direct to start? (hankmanhub)
d. When do you expect the combo trials to start? (hankmanhub)
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)?
a. DCVax-L: Is the trial continuation well past Primary & Secondary endpoint thresholds in part due to the trial size being reduced from 348 patients to 331 patients? Of which perhaps only approx 300 patients randomized? Pls elaborate. (Evaluate)
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 timeline for this process, including when each phase is expect 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.
a. Your November PR about SNO detailed a set of stages you were undertaking to reach the completion of this trial program. These included finalizing the SAP, final data collection, data validation, data lock, and unblinding and analyzing the data. I would like a range of months that it will take to reach data lock, and when you do, approximately how long after data lock will you be able to provide us with top line data? (sentiment_stocks)
b. What is its status? Is it complete/nearly complete? (longfellow95)
c. How long (in months) to scrub (if not already begun), to lock, to top line, to release of stat anal, to FDA filing (if results are positive)? (hankmanhub)
d. DCVax-L: Timing for remaining stages of DCVax-L trial (The upcoming stages include finalizing the Statistical Analysis Plan, conducting the final data collection, data validation and data lock, and then unblinding and analyzing the data.)? Much of this multi-month process can be done in parallel, so could be faster than 4 x 2 months? (Evaluate)
e. Timeline to top line results (doingmybest)
f. Did they start any of the mentioned multi month processes and which one they started? It has been already multi months from the time that LP mentioned it. (PHYInvestor)
g. what is the timeline for completion of DCVax-L phase -3? (PHYInvestor)
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?
a. How many phase3 patients are still alive as we haven't received an update since 2017?
b. DCVax-L: How many patients remain alive? How many control patients remain alive that have or have not crossed over? (Evaluate) Ike Note: They would not know how many specifically control patients are alive unless they have unblinded and analyzed the data, right?
c. How many patients in the P3 L trial remain alive today and how many are LTFU? (hankmanhub)
d. DCVax-L: Does NWBO anticipate commencing any combo trials with DCVax-L? Which? When? (Evaluate)
11 Was ‘Method B’ or a variation of it ever used in the DC Vax-L Phase III trial?
a. Was Method B or a variation of it ever used in DC VAX L? (survivor1x)
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?
a. What specific data are they looking to capture that is the reason the board has suggested it was more prudent to remain blinded for this long? (survivor1x)
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?
a. Sawston: What were the Net Sales Proceeds, after mortgage payoff, sales commission and other sales costs? (Evaluate)
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?
a. 6/30/18 shares outstanding were 444.6m, plus 3.2m "A" Preferred and 7.5m "B" Preferred. During the third quarter, all outstanding Preferred were forced to convert. That should have added at least 107m shares to the total outstanding, plus some other issuance. Yet NWBO reported just 510.1m shares outstanding as of 9/30/18. Please explain how this is possible. (JerryCampbell)
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 developed at that time and if not, why not?
a. DCVax-L: Was a statistical analysis plan developed shortly after NWBO stated it was headed to final data lock in their PR from February 2017. If not, was NWBO not really serious about going to final data lock at that time? (Evaluate)
16 If the German Hospital Exemption (HE) is no longer under consideration, what are NWBO’s intentions in Germany?
a. If German HE is completely out of the picture, then clarify intentions. (Evaluate) Ike Note: Sorry, if this is way off, not sure what you are asking.
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?
a. Is a R/S on the table to get to a major exchange? (Umibe5690)
b. Plan to migrate back to a major exchange(doingmybest)
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?
a. DCVax-L: Were the last approx 31 of 331 patients not randomized between TX and Control, but rather all in Treatment group? Why? (Evaluate)
b. If the trail is supposed to be randomized 2:1. Why are there only 99-100 placebo? Were the last 30-40 patients all given treatment, if so why? (survivor1x)
c. DCVax-L: Were all of the last 31 enrolled patients placed on DCVax-L? If there are only 300 truly randomized patients randomized out of an originally intended 348, did that slow down the trial? If so, who/what/why was that done? (Evaluate)
19 What if any support or input has the FDA provided for the DC Vax-L Phase III trial?
a. What support or input has the FDA provided for the P3 trial? (aperture007)
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?
a. Regulatory pathway(s) being pursued (doingmybest)
b. You mentioned in your November PR that there is "no well established pathways". Could you explain to us further what you mean by that? And if it involves how you intend to approach the FDA in terms of an approval process, could you tell us what pathways you are considering as open to you? (sentiment_stocks)
21 Has NWBO received any buyout or partnership offers and if so how many of each?
a. Have you turned down any actual buy outs from BP? How many? (hankmanhub)
b. Have you turned down any actual partnering deals with BP? How many? (hankmanhub)
22 Were the doses for the final 31 DC Vax-L Phase III trial patients manufactured in Memphis, TN?
a. DCVax-L: Were the final 31 patient doses made in Memphis? (Evaluate)
23 Is completion of the DC Vax-L Phase III trial necessary prior to unblinding?
a. Will it require completion prior to trial unblind? (longfellow95)
24 Approximately how long does NWBO expect the FDA to take to make a decision on approval once topline results are released?
a. Once topline is release for the P3 trial (assuming encouraging results) what's the estimate timing on approval? (aperture007)
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?
a. Why did they work with Huawei for the real estate deal. Is it only a simple real estate deal, or is there more into it: i.e, a collaboration, or a DCVax related deal with a Chineese company? (PHYInvestor)
26 Will revising the Statistical Plan for the DC Vax-L Phase II trial require Agency buy-in, and if so, what is the minimum amount of time this will take?
a. DCVax-L: Will revising the Statistical Plan need Agency buy-in, and if so, what is the minimum amount of time this will take? (Evaluate)
27 Is Neil Woodford under any moratorium or can he freely trade his shares?
a. Is Woodford under any moratorium; can Woodford freely trade his shares? (Evaluate)
28 In the DC Vax-L Phase III trial, how many efficacy 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?
a. How many efficacy IAs were previously conducted on the phase III trial and what type of information was NWBO provided regarding the efficacy IA(s)? For instance, including but not limited to, were you provided whether the endpoints were statistically significant? (flipper44) Ike Note: Not sure what IAs are.
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?
a. DCVax-L: When did/will data collection start on this go around. If it keeps getting pushed off, why is that? (Evaluate)
30 What preparations are being made in Germany for manufacturing DC Vax-L in anticipation of the German Hospital Exemption (HE) or ‘medical tourism?’
a. What is happening in Germany with preparations for manufacturing there, in anticipation of demand for L treatment from medical tourism or HE. (Evaluate)
31 How will shareholders be notified upon the completion of the SEC investigation mentioned in the 10-q dated November 16, 2018?
a. When the investigation is completed how will the sharesholders be notified? (aperture007)
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?
a. when are they going to apply for approval in any of the jurisdictions (FDA, NICE...)? Which jurisdiction will they apply for approval first? (we need date and agency) (PHYInvestor)
b. Do you expect the US or UK approval track to move more quickly to approval? (hankmanhub)
33 How many naked-shorted shares of NWBO common stock does NWBO believe to be currently in circulation?
a. How many naked shorted shares does NWBO believe are out there? (Evaluate)
34 Why hasn’t the SEC investigation mentioned in the November 16, 2018 10-q been completed yet?
a. Why hasn't the SEC investigation been completed yet? (aperture007)
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?
a. Sawston: did the sale also convey the contaminated land (and liability)? (Evaluate)
36 When will Cofer Black’s report on the manipulation of NWBO’s stock be released?
a. When will the Black report be ready for release? (hankmanhub)
37 Is NWBO reanalyzing the flagged pseudo-progressions in the DC Vax-L Phase III trial and if so when will that be completed?
a. Are you re-analysing the pseudo-progressions and when will that be completely done? (hankmanhub)
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?
a. DCVax-L: How many patients have been treated with DCVax-L under self-pay? Where does this revenue/income show on the financial statements? How have these patients fared? (Evaluate)
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?
a. Have you considered whether Cognate is still a reliable supplier and are you satisfied that the answer is still YES? (hankmanhub)
Eliminated questions:
None of the following are actually questions . . .
1, Maserati now (Hbpainter)
2, on completion of P3 for all board members. (Hbpainter)
5- I think we should also tell them that the rewarding of board members with shares, should be tied to successes related to approval and commercialization of the product. Why would we vote for them to get more shares without any of these successes realized. We did not benefit from any of the developments in the company so far, in fact we lost significant of our dollar value wealth. (PHYInvestor)
