AI
Sunday, January 03, 2021 9:18:53 PM
I agree flipper44, in fact I believe that the FDA was the first regulatory authority (RA) to buy-into the revised SAP & endpoints. I believe that the EU (UK & Germany) was the last to approve the revised SAP & endpoints. I believe waiting on the UK & Germany buy-in is what held up the DCVax-L trial data lock until 10/5/2020.
In fact, Linda Powers mentioned getting buy-in from the FDA first, then the other RAs in her response during the annual stockholders meeting. Here is the quote again:
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"
The EU clinical trial registry is updated by the EMA. I found the updated EU clinical trial registry, with the 6 revised endpoints on 10/8/2020, and I posted it to this message board. The data lock was announced by NWBio on 10/5/2020, just 3 days earlier.
I believe that after NWBio received a verbal or written confirmation of their SAP buy-in from the MHRA & PEI around the 1st of October. This was the last RA buy-in that NWBio was waiting for before that did the data lock. A couple of days later, NWBio issued their data lock PR on 10/5/2020. It only took the EMA clerical staff 3 calendar days or less to update the EU clinical trial registry.
The DCVax-L Phase III trial started in the US in 2007. The FDA had to approve the original trial protocol, and the original endpoints. The DCVax-L trial only started with about 50 trial sites, all in the US. The EU trial sites in the UK and Germany were not added until starting around 2012:
https://nwbio.com/dcvax-l/
The FDA is the lead / governing RA. The FDA approved the first trial protocol and SAP, and it should be the first RA to approve the revised SAP.
Since 2018, the FDA has been the leading RA in the world that is actively promoting & advising clinical trial sponsors to include Real World Evidence (RWE) and Real World Data (RWD) in their analysis of safety & efficacy for approvals of new drugs or biologics. Here is some guidance directly from the FDA about using external contemporaneous external control groups in clinical trial data analysis:
In fact, Linda Powers mentioned getting buy-in from the FDA first, then the other RAs in her response during the annual stockholders meeting. Here is the quote again:
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"
The EU clinical trial registry is updated by the EMA. I found the updated EU clinical trial registry, with the 6 revised endpoints on 10/8/2020, and I posted it to this message board. The data lock was announced by NWBio on 10/5/2020, just 3 days earlier.
I believe that after NWBio received a verbal or written confirmation of their SAP buy-in from the MHRA & PEI around the 1st of October. This was the last RA buy-in that NWBio was waiting for before that did the data lock. A couple of days later, NWBio issued their data lock PR on 10/5/2020. It only took the EMA clerical staff 3 calendar days or less to update the EU clinical trial registry.
The DCVax-L Phase III trial started in the US in 2007. The FDA had to approve the original trial protocol, and the original endpoints. The DCVax-L trial only started with about 50 trial sites, all in the US. The EU trial sites in the UK and Germany were not added until starting around 2012:
https://nwbio.com/dcvax-l/
The FDA is the lead / governing RA. The FDA approved the first trial protocol and SAP, and it should be the first RA to approve the revised SAP.
Since 2018, the FDA has been the leading RA in the world that is actively promoting & advising clinical trial sponsors to include Real World Evidence (RWE) and Real World Data (RWD) in their analysis of safety & efficacy for approvals of new drugs or biologics. Here is some guidance directly from the FDA about using external contemporaneous external control groups in clinical trial data analysis:
