NorthWest Biotherapeutics Inc (NWBO)

[DocLee]

Hank, you are right to be dubious about the FDA adopting or being influenced by any decision made by the MHRA (and any other Regulator) on DCVax-L but I think that there may be reason for hoping that this could be about to change.
There has been a Mutual Recognition Agreement ("MRA") between the MHRA and the FDA since 2021 which has initially only encompassed "Pharmaceutical Good Manufacturing Practices" (GMP) in the field of 1] Vaccines for human use; 2] Plasma derived pharmaceuticals; 3] Investigational products (clinical trial material).
On the FDA's website it is stated that the FDA and the MHRA have been considering expanding the scope of the MRA to include vaccines and plasma-derived pharmaceuticals for human use which will be considered again in July 2025 based on further assessment. This must entail collection of relevant current information so that if the FDA does not actually have a watching brief on the MHRA (and vice versa), it must soon put one into place if it is to have sufficient information on which to decide whether or not to "extend the scope" of the MRA.
It follows that, if not already, the FDA will most probably soon be party to the MHRA's assessments on all the necessary aspects of DCVax-L for its licencing and this can only at the very least shorten the time which it will take the FDA to decide on licencing DCVax-L