NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

I don’t believe the External Control Arm (ECA) is a problem with the FDA either. The FDA were the ones who mandated the crossover option for all of the patients in the DCVax-L Phase III clinical trial.

The crossover option was not mandated by the MHRA, Health Canada or the EMA.

The FDA knew and understood that the crossover option was going to take away NWBio’s ability to use the DCVax-L Phase III clinical trial internal control group. It would be unethical and immoral for the FDA to require NWBio to give all of the trial patients a crossover option, and then turn around and not allow NWBio to use an ECA.

The primary reason that NWBio opted to apply in the UK first, is because manufacturing was already set in place. NWBio owns and controls the GMP MHRA certified Sawston facility, and NWBio has an approved CDMO in Advent Bioservices, in place to operate the Sawston facility. The Sawston facility is strategically located in Europe, and is also capable of serving patients throughout the EU. I am expecting a DCVax-L regulatory application to be submitted to the EMA in the upcoming months.

According to the recent 10-K, NWBio has been talking with about 6 CDMOs, strategically located throughout the US, and now they are poised to submit regulatory applications to the FDA and Health Canada, in the upcoming months.