NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

I am re-posting this because some are trying to make a bear argument by saying NWBio has not gotten buy-in from the FDA. I have also included Lykiri post of IkeEsq's transcription of the NWBio Annual Meeting last year. I want to capture all of this information in 1 post so that NWBio investors & prospective investors can have access to it.

NWBio has SAP & endpoints buy-in from all 4 regulatory authorities (RAs). I do not understand the need to keep re-litigating this issue because of a slow clerical update. NWBio has not updated the US clinical trial site since 2016. The trial size on clinicaltrials.org is still showing as 348, but we all know the trial size was changed to 331 in 2017.

Here are some facts:

(1) There is only 1 DCVax-L clinical trial. It started in the US first & it was approved by the FDA first, before any of the other 3 RAs.

(2) The 1 clinical trial is based in the US, but it is being conducted in 4 different countries (US, UK, Germany & Canada)

(3) There is only 1 SAP for this clinical trial.

(4) The SAP is the same in all 4 countries, with all 4 regulatory authorities (RAs).

(5) NWBio said that they would not unblind the data & let the statisticians start the process of reviewing & analyzing the data until they got buy-in on the SAP from all 4 RAs.

(6) In the UK & Germany, the RAs (MHRA & PEI) are responsible for updating the revised endpoints in the clinical trial register. In the US, NWBio is responsible for updating the revised endpoints in clinical trial register.

(7) NWBio said they would not lock or unblind the data until they got buy-in from all 4 regulatory authorities, then on 10/5/2020, NWBio issued a PR saying they had locked the data.

(8) Then, 3 days later on 10/8/2020, I discovered that the EU updated the endpoints in the clinical trial registry for the UK. Here is my message post from 10/8/2020:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158783215

(9) A few days later, the clinical trial registry for Germany was updated with the new endpoints.

(10) Here is a quote from Linda Powers from the Annual Shareholders Meeting (ASM) held in 2019:

IkeEsq Sunday, 02/03/19 01:24:29 PM

NWBO 2018 Annual Shareholders Meeting
February 2, 2019 at 13:30 EST
1050 Connecticut Ave, NW, Washington D.C.

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."

Everything fits together like a glove.

Here is the FDA’s guidance for primary endpoint for a Multi-Regional Clinical Trial (MRCT), or international clinical trial, that is being conducted in several countries:

For MRCTs, the primary endpoint, whether efficacy or safety, should satisfy these criteria, as well as be acceptable to all concerned regulatory authorities, to ensure that interpretation of the success or failure of the MRCT is consistent across regions and among regulatory authorities. Agreement on the primary endpoint ensures that the overall sample size and power can be determined for a single (primary) endpoint based on the overall population and also agreed upon by the regulatory authorities.



Here is the link:

https://www.fda.gov/media/99974/download

NWBio’s SAP guidance is pretty clear. Here is NWBio’s SAP guidance and press release from June 2019:



Here is Webster’s dictionary’s definition of buy-in: