Thursday, November 12, 2020 10:00:20 AM
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 is still showing as 348, not 331.
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.
Here is the FDA’s guidance for primary endpoint for a multi-regional or international clinical trial that is being conducted in several countries:
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:
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.
Here is the FDA’s guidance for primary endpoint for a multi-regional or international clinical trial that is being conducted in several countries:
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:
