NorthWest Biotherapeutics Inc (NWBO)

[Whitewater55]

Final Questions to be sent to Management

The votes are in and the top eight questions are below. I am going with top 8 because there was a three-way tie for 9th, which would have brought the total questions to 11, which seems a bit much. I will make another post shortly with a copy of the letter and tracking number.

1. 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.
2. 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?
3. 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.
4. 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?
5. 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.
6. 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?
7. 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?
8. 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)?