Replies to post #758710 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

You guys are working overtime here to drive this one home when it’s not true.

“While the inspections are completed,”

[beartrap12]

Antihima, I think we agree on inspections completed and Sawston certified. I can't help thinking that MHRA pushed for NWBO to search for C-labs in the UK and other work-arounds to the clean room shortage, to come closer to covering all patients. UK has about 3,200 new GBM patients a year and probably the same number of recurrent GBM patients. Management never mentioned reaching out to other companies to use their clean rooms until this current report. While it does sound like something Linda would come up with to fill the void, I would not be surprised if MHRA pressed her for a better solution while EDEN was waiting. And they came up with 3 ways to increase productivity:

10K:

The Company’s contract manufacturer, Advent BioServices, has prepared plans for how the manufacturing of DCVax-L products could be ramped up in the event of potential commercialization using just the existing two manufacturing suites and facilities, and could potentially reach a significant portion of the Glioblastoma patients in the UK. The plans include a transition from a single daily shift of operations to two shifts daily, supply chain considerations and determination of the personnel that would be required. The plans also include potential arrangements for a simplified initial Grade C lab, as described below. Advent estimates that this simplified initial Grade C lab could enable doubling of the production that would be feasible with the existing two manufacturing suites. Arrangements with private clinics have also been developed, as described below, which could potentially assist with initial commercialization.

These three items alone could have taken much of what feels like a lot of extra time.
Of course, ours was a huge application on a new and complex personal vaccine treatment for GBM, that may be applicable to all cancers, that has never been done before with a new manufacturing plant to boot.

[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.