Replies to post #664091 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

I’m starting to think NWBO might be a pilot participant for the proposed SWIFT program which might be able to review in 60 days (SWIFT is not formal yet, but is supposed to be ready in 2024)

I’ve given some other reasons why this is possible, including but not limited to LP’s new program proclivities, strange behavior by some better publicly informed longs, MHRA’s tendency to pilot before full implementation, the express reference to cancer vaccine applicability, etc. The list is quite long.

I think it’s possible nwbo was assigned a “special” veteran team (which is a tool SWIFT wants to incorporate), perhaps some previously worked on the CRSPR process.

I think it’s possible MHRA had an Oncology Expert Working Group advising NWBO prior to submission.

I really didn't and don't think MHRA wants DCVax-l to hit bumps once NWBO submitted their maa. Therefore setbacks, if any, were to occur before submission.

I think SWIFT, motivated by cancer vaccine type technology (“high impact”), oncology working groups and veteran special teams assigned upon submission will get this done at lightening speed.

MHRA still has some of the best and most qualified regulator professionals on the planet. Their restructuring post Brexit wasn’t going to slow the UK down for long. Now, imo, patients will soon reap the benefits.

[skitahoe]

Meirluc,

When Sawston was approved for commercial production originally, it was a different submission that did it. I'm uncertain if they wanted a change to that approval that it would be done in the MAA, or if they'd submit an amendment to the original submission. In my mind I'm guessing that before asking to use the EDEN, it would need to go through some sort of certification program, hopefully acceptable to all regulators. Once certified, converting existing facilities to it shouldn't be a major issue as the device is already certified. I have no knowledge of precisely how this would be done, but I would hope such certification is underway.

I believe that when the FDA receives a BLA and establishes a PDUFA date the FDA will send inspectors to the commercial production facility specified in the BLA at a date they'll established. By that time, if production will be done with the EDEN unit, it should already be certified so that the inspectors are checking the total production facility, not certifying the EDEN at that time. Of course this is JMHO.

Gary