NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

To guess, all I can do is try to work out the timeline, and see what dates that leads to.

The company had indicated a couple of weeks for the stat people to work through the data before presenting it to the company; thereby unblinding management et. al.

When Data Lock is reached, the independent statisticians will be given access to the unblinded dataset. The Company will remain blinded while the statisticians make the computations, converting the mass of raw data from the trial into formal tables and listings, and survival and progression measures, to report the trial results.
As previously reported, the statisticians’ work is estimated to take a couple of weeks. When their computations are completed, the Company will receive the results of those computations and thereby become unblinded. It is anticipated that the Company’s Scientific Advisory Board, the Steering Committee of the Trial and other key medical expert advisors will likewise receive the results, and thereby become unblinded as well.

https://nwbio.com/nw-bio-announces-completion-of-further-data-gathering-for-phase-iii-trial/

So let’s make that couple of weeks 4 weeks, taking us to November 4. However, Linda Liau spoke on November 6 and indicated to listeners that she was still blinded. It’s possible that management kept her blinded for a few more days, given that she was giving a public presentation; however when she next spoke at the Boston GBM conference (costing $2k to attend virtually), and she was probably not still blinded then. So let’s be really generous and make a couple of weeks equal five weeks, pushing the general unblinding of management and their advisors to November 11. I will note, here, however, that management had begun pointing to the 10/5 press release citing that passage about the public announcement and scientific publication around 11/05. Which argues that they had already arrived at the decision to go the direction of a journal by then. And it was sometime soon after that Linda Liau pulled her presentation from the SNO website.

The company would then need to provide the unblinded data to their SAB, Steering committee, and the appropriate principal investigators, and then we’d want to allow time for their detailed discussions as to how to best present the data. To my mind, that would take two weeks. But with Covid ever-present, and the sheer number of people needed to coordinate with, 4 weeks seems perhaps more adequate, taking us to December 9th. During that time, it’s entirely possible that those who were tasked with writing a journal article had already begun that work upon unblinding, especially if that was the conclusion all the advisors were quickly arriving at. If it took an additional month to complete the first draft, that would take us to January 6. At that time, I’d think they’d want to run it by all the investigators to be named as authors to receive their input, suggestions, etc. I’ll note, that VuBru had earlier likened this process to “herding cats.” Herding cats might take two weeks if they were super speedy. I’d also think that they might have approached their first journal of choice during those past several weeks to alert the journal of their intention to submit and to get a read for their reception. If we give that process of allowing the back and forth with the article authors (the PIs) three weeks, that takes us to January 27, at which time, I’m hoping the article was ready for its formal submission. If we want to give it four weeks (which frankly, seems more realistic), we would be at February 3rd. VuBru had suggested that the herding cats step might take two weeks, but if some of those authors had questions or better, yet, suggestions, that might have added more time to the process, which is why I think four weeks may be more likely. There have been some rumblings about enhancing the topic of recurrent GBM with regards to the paper, so perhaps they found they wanted to dig deeper into that subject, but I don’t know that. I'm simply musing.

Below is VuBru’s suggested timeline:

I further assume that LL will be first author (as in the blinded/blended paper) and that she would be the one drafting the paper, possibly with the primary statistician simultaneously working on the statistical methods and results sections. LL always seems to be quite busy, but given that she knows this literature quite well without having to do an extensive literature search, I can see her finishing an initial draft in as short as 2-3 weeks (beginning of December). Next, she would have to send the draft out to 68 or so co-authors for comments and edits. If I were in her shoes, I would give the co-authors a two week deadline (which is a realistic minimum for busy physicians) to send back comments. Every time I have written a paper with a lot of authors, it has been like herding cats, and there are always a couple of people who don't respond until they have been reminded multiple times. LL will be limited in her ability to finalize and submit the paper until every author responds, because all authors will be required at the time of submission to click a link saying they did indeed contribute to and agree with what is presented in the submitted paper and they all will also have to fill out online copyright assignment and conflict of interest forms. The article will not be sent out for review until all authors do this. Someone will always be slow to take care of these requirements, and with 60+ co-authors, I can see this taking up to a couple of weeks between submission and actually being sent out for review. So my guess is that they by today (note: December 19th) would have gotten to the point of having an article submitted.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=160341086

Next up is the actual journal submission and full review and time line for this process. As I mentioned at previous times, it's been rumored that Linda Liau and Dr. Ashkan are said to have very good working relationships with some of the major journals. Perhaps they, too, have had to peer review other papers for them, but whatever the case may be, my hope is that the journal of choice was prepped for the article to arrive ahead of time, and had expressed adequate to intense interest in publishing it.

VuBru, who has been through this journal process on numerous occasions, suggested that if the article were to receive a rapid review, it should have been within about two weeks. However, you’ll note that he states that no paper is ever accepted without revisions, so he suggested it would take AT LEAST another two weeks to revise the paper (remember, they have to get the doctors to sign off AGAIN on the revised version).

VuBru:

If NEJM or Lancet did send it out for full review, I think it would be on a rapid timeline, where the authors would get reviews back within 2 weeks. No paper is ever accepted without revisions, so there would be a process of another approximately 2 weeks (if they are trying to rush it) to revise the paper and get everyone to ok the changes, followed by another 2 week review process (and hopefully acceptance).

Four weeks later would take us to February 24 for a possible acceptance, assuming that the original journal accepts it and is the final journal. If the first journal rejected the paper, the submission process would start over again (VuBru said the journals usually refuse the article within two weeks), so we’d be adding two weeks if the time line if they were to go to a second journal and be accepted there.

So to my thinking, between February 24 to March 10 (padding it all by two weeks in case the review process takes longer than four weeks - which I could pretty easily see happening), I’m hoping that they receive that “formal acceptance” by the journal, at which point, I’m thinking the company would be given the permission (by the journal) to make some sort of agreed to top line data announcement.

To my thinking, if it takes longer than March 10th, the delay could be due to any number of things. With Northwest, Murphy’s Law is ever looming to “wreak some havoc”; however, I do have deep confidence of this management team’s ability to unwind any problems and still come out on top (or even in a better place). But that’s me. I’ve seen them fall into enough holes that they’ve been able to dig themselves out of and trudge forward, that I’m sure they can weather getting this pivotal phase 3 GBM trial data into a decent to great journal.

In conclusion, I’ve beefed up every step, because it’s Northwest, and they have never failed to add more time to their time lines. Still, if they were all quicker (motivated by glory, by the need to raise funds, by the desire to get DCVax to patients quicker, to get angry shareholders with pitch forks off their backs… there are many reasons to speed this process along), any time from now on could yield a top line announcement, but I’m mentally preparing myself for it to be between 2/24 and 3/10. And I think after 3/10, I think the wait becomes even more intense as it still could just be a case of letting the perfect be the enemy of the good, and perfection will be achieved eventually, and hopefully in short order after that point.