NorthWest Biotherapeutics Inc (NWBO)

[Nick119]

I've been using my time over the last few weeks to build up some personal knowledge on the clinical trial process, the average time to deliver and came across some great research papers on the subject. I hope to enlighten some others on this board as well, but in summary I do believe that NWBO is not out of the jurisdiction of reasonable timeline here, even not considering COVID. Still without considering COVID, there are facts that also need to be considered:

-The trial spans 15 years: Think of all of that has changed that makes the analysis more complex; IDH mutation status, pseudo progression, to name a few.

-86 sites across 4 countries: Consider all of the clinical staff involved, communications across time zones, supply chain difficulties, etc.

-NWBO's company size: They are 18 or so staff, with the help out of outside consultants trying to put this all together and do it in a way that will result in definitive success. Within a lot of the clinical trial timeline research papers I've read, I've noticed that the data samples of average time to data release are only taken from the large enterprise biopharmaceutical companies that would have almost unlimited resources & much more concise/efficient processes & experience on the matter; so I do think some consideration has to be applied here.

Now once you can consider the challenges above, let's factor in COVID on top of that. I believe @iwasadiver's post from this morning is incredible perspective of the chaotic downstream impact that COVID has caused in ways that we all can't comprehend because we're not on the inside. Personally I can comment on this too as I run a 100+ IT team for major healthcare organization in the midwest. We have missed deadlines on just about every project in flight because of various issues with supply chain. For example, we cannot get new hardware; I am literally cobbling together whatever we have to continue the organization's operation.

Now for the education piece; I've read numerous research papers & publications over the last few nights and one of the most informative in my opinion was this piece released by the National Academy of Sciences: 'The Clinical Trial Lifecycle and When to Share Data' https://www.ncbi.nlm.nih.gov/books/NBK286004/" rel="nofollow" target="_blank" >https://www.ncbi.nlm.nih.gov/books/NBK286004/

In this piece, their recommended timeframe for data release is within 12 months and publication within 18 months. We know that NWBO is working on releasing both the publication & data together, and we are only on day 409. While I am one of the investors impatiently waiting, I think we need to give NWBO leadership some room to breathe here.

To further this point, and this is where I know I am injecting a bit of speculation, but I do believe that NWBO is likely involved in the Real Time Oncology Review (RTOR) program, which will greatly accelerate the approval process: https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review

Let's look at the requirements for a second:

1.

Drugs likely to demonstrate substantial improvements over available therapy, which may include drugs previously granted breakthrough therapy designation for the same or other indications.

- Check. I think this is an obvious one.

2.

Straightforward study designs, as determined by the review Division and the OCE.

- I do think this may be a point of contention for some, but I do believe NWBO has a re-approved SAP that meets these requirements. I believe the draft documentation we've been seeing from the FDA regarding the normalization of using outside controls as a measurement helps meet this requirement.

3.

Endpoints that can be easily interpreted (e.g. overall survival, progression free survival, etc.).

- Check.

4.

Submissions with greater complexity will be considered for RTOR on a case by case basis. Additionally, FDA generally prefers the Assessment Aid (AAid) be used with RTOR.

- Even if requirement #2 is a bit blurry, I believe they would be approved on that case by case basis because of the significance of the results.

Additionally, there have been many great posts on this board that cover the justification on the likelihood that NWBO is using this RTOR program, but I also believe that it is a possible contributing factor on why we haven't heard anything yet.

As a visual aid, I edited one of the images as a quick reference:



This is just my humble and attempt at an educated 2 cents that I'm sharing in hopes to relief some panic that this wait is causing some of the long investors here. Appreciate you all.