Replies to post #558447 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

The P3 results are great. Thanks so much, HyGro.

[biosectinvestor]

I did not say that the 2018 interim paper said they were revising the SAP. Accusing me of telling a falsehood not in my post is an interesting tactic. But since I did not touch on the subject, all I can say is “There you go again.”

The 2018 paper was an academic interim analysis and just like the JAMA paper it is not particularly about regulatory matters. However they did discuss that it was in fact still blinded, that they were looking at OS not PFS, and they discussed some issues about the trial to some degree. But your assertion that I said otherwise, or that either paper would be the appropriate place to give future plans for the company, is honestly, another absurdity.

The company communicated its plans in other forums, like the annual meeting, referenced obliquely in PR’s and other communications and commented on the FDA proposed plan for loosening external control arm requirements, including officially to the FDA in written form. This was discussed for quite some time long before the end of the trial and a lot of energy on this forum was expended in the question of how long it would take because the company assured us, including at the last ASM before they unlocked, that they would not unlock until it was finalized with all 4 regulatory authorities. And that is exactly what they did. Not after, before. And again, numerous onlbjective third party doctors, and the documentation, as well as assurances from the company have indicated that they did as they said they would. Only people who have dismissed every communication from every source, say otherwise. Such dismissals presume a massive conspiracy that is highly, highly improbable.

From the front page of this forum, annual shareholder meeting notes by IKE from 2019, also addressed in 2020 ASM, but this is clear enough, and you can find the link on the main page:

Question #10: Is there ongoing dialog with the FDA regarding formation of the SAP and will you wait to unblind until after the SAP is approved?

Answer (LP): "Definitely 'yes' we won't unblind until the Statistical Analysis Plan has been approved by all regulators. FDA and other, four regulators. We intend publicly as a company policy, which is pretty standard for companies, we don't talk about our communications that are ongoing with FDA or other regulators. We only say results, so I can't comment on interim communication type things, but in case there is any [lack of] clarity about remarks earlier about the SAP, it is an actual submission to the regulators. Like when you apply for an IND, that's Initial New Drug, application to get a clinical trial approved or when you apply to get a new product approved. You make an actual submission to get your SAP reviewed and approved."

Of course investors were anticipating the revised SAP long before that ASM in 2019, and I had argued with people that doing it with 4 different regulators so that it would be exactly the same, would take a long time and be extremely complicated, despite beliefs otherwise by numerous other well regarded posters, who thought it would happen within months, maybe half of a year. From experience with cross-border regulatory hurdles, I knew it would be challenging to ensure it was the same result and consistent. They often are quite independent and it takes a lot of back and forth by their lawyers before finalizing, typically, with multiple country circumstances like that where regulations are often not ExW tly the same and the applications may need to be simultaneous and in different languages even perhaps.

[SkyLimit2022]

The trial had changed over time because patients lived long and it spanned many years. The SAP was approved by the regulators. Ashkan is a careful and precise brain surgeon—listen to his words:

Dr. Ashkan said this in June 2022. Skip to timestamp 14:55 of the ASCO video.

Dr. Ashkan was the chief investigator of the murcidencel trial for patients in Europe. At King’s College in London, Ashkan is the lead clinician for neuro-oncology and the chair of the King’s Neurosciences Clinical Trial Unit. He is a world-renowned cancer trial expert. A few years ago, Professor Ashkan was named the UK Clinician of the Year by The Brain Tumour Charity. Additionally, Ashkan serves as an advisor to the U.K. government.

https://www.kcl.ac.uk/people/keyoumars-ashkan

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

[kabunushi]

As previously reported, the Company has been moving forward with the several stages of work that are needed to reach data lock and unblinding of the data from this Phase III trial. These stages include completing the draft Statistical Analysis Plan, conducting the final data collection and data validation, then data lock and unblinding and analyzing the data. Each of these stages involves teams of outside experts as well as Company personnel.