NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

dennisdave, as I stated, the ECA guidance is relevant, but I do not believe NWBio is waiting for this guidance to be finalized before they submit the DCVax-L BLA to the FDA.

As a result, the updated FDA guidance regarding RWD and RWE is not relevant to the DCVax-L Phase III trial. However, the guidance that is relevant, is the FDA guidance regarding the use of ECAs. Hopefully, the FDA will finalize the ECAs guidance soon:

https://www.fda.gov/media/164960/download

I believe that NWBio and the FDA have had frequent and ongoing conversations about the ECAs that were used. I believe these conversations go all the way back to before the the clinical trial data was unblinded.

As you may remember, NWBio did not unblind the DCVax-L data until they got SAP buy-in from all of the regulatory authorities, including the FDA.