Response from NWBO re: pre-ASM Questions
I got a call back from Les Goldman at 3:01 p.m. EST today in reference to the questions we had submitted and we chatted for about 20 minutes.
tl:dr - They are not going to issue a press release at this time. They are taking the advice of their counsel as to what they should discuss with investors and when. They do have a plan for going forward but do not want to impact its effectiveness by disclosing the details prematurely. He was willing to give straight answers to some of the questions.
1. (09 Timeline): They have been as forthcoming as they feel they can be at this time. They have laid out the sequence of steps, which is more than other companies do at this stage and each step is expected to take a couple of months. There may be some overlap but a lot of this is hard to predict in advance. If you start at November 19, 2018 and add a couple of months for each listed step, you should be able to figure out approximately when they expect to complete everything. They do not want to open themselves up to further litigation by making a prediction, as they did in 2015, only to find out that patients were living a lot longer than expected, which caused the trial to continue unexpectedly.
2. (10 Live patients): They do not want to be accused of cherry-picking the best data to disseminate at this point. They have tried to be consistent with the data they provide. These numbers will be provided when all of the data is revealed.
3. (01 Hold): The FDA was involved with the hold and discussing it right before applying for approval does not seem like a wise thing to do.
4. (18 Distribution of final 31 patients): All patients were randomized. You can't just put a group in one arm or the other. NWBO had nothing to do with which patients ended up in which arm. Because of the large number of sites, the final randomization may not have been exactly 2:1 but may have been off by a few people one way or the other.
5. (05 Financial negotiations): This statement referred to the real estate deal for the Sawston property. There were multiple bidders (3) at the time of the filing and they thought that things might close within the time to file the extension.
6. (20 Pathway to approval): No one has ever done this type of trial or seen these types of results with a crossover trial. They are blazing new trails and looking at a number of possible pathways, and may pursue different paths in different countries. Statements made by Gottlieb over the last 6 months have been very favorable to NWBO.
7. (36 Suit versus stock manipulators): They do not want to show their hand at this juncture and publicize how they plan to respond.
8. (03 Benefit from process improvements): No. They can't change things once they commence the trial.
I talked as well a bit about sentiment_stocks and Jack 2479's question (post 209491) regarding going after shorts, and getting the stock to a level more commensurate with where the company stands. His response was that they are continuing to be attacked by shorts but they are planning some big moves. However, they do not want to tip their hand in advance. They are adding some top-notch people to run parts of the organization and want their moves to have as much impact as possible rather than leaking some of the details now.
Ike
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