dennisdave, this is a common misconception, and a very popular recent Bear narrative. NWBio has said many times, that they will also be submitting applications for DCVax regulatory approvals to the FDA, Health Canada and to the EMA. NWBio started the DCVax-L regulatory approval process with the MHRA in the UK because:
(1) NWBio believed that the MHRA would review the application and approve DCVax-L faster than the other regulatory authorities.
(2) NWBio owns and controls Sawston Facility, and they are working directly with their CDMO, Advent Bioservices to improve the formuations for DCVax-L and DCVax Direct.
(3) NWBio is working directly with Advent to conduct the comparability studies, and to perfect and improve the EDEN devices, to get those ready for scale-up and worldwide commercialization of DCVax.
(4) The MHRA has already approved a DCVax Compassionate Use / Specials program, and the data from that program can also be used to further support DCVax approvals.
The FDA primarily requires patient-level data when the Sponsor uses Real World Data (RWD) in support of its NDA or BLA application for commercial approval. Examples of RWD include the following: electronic health records (EHRs), claims, registries and patient-generated data. Here is the relevant excerpt from the FDA guidance related to patient-level data and RWD:
When a Sponsor's External Control Arm (ECA) is from other contemporaneous or concurrent FDA regulated clinical trials, and the INDs and clinical trials protocols have been reviewed and approved by the FDA, and these clinical trial are randomized controlled trials (RCTs), and the Inclusion and Exclusion criteria are similar to the Sponsor's clinical trial, then the FDA will automatically have access to patient-level data from these ECAs from these RCTs. FDA regulations require that all Sponsors with approved FDA INDs, must provide FDA with access to all patient-level data. NWBio does not have access to this patient-level data, but the FDA already has direct access to this data:
ECA that is from other RCTs are not considered to be RWD. I asked this question directly to the FDA in September 2023:
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