Replies to post #673971 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

it’s very hard to imagine that the application has not been ready

The application is ready.

It's all about manufacturing.

[RobotDroid]

Nwbo will not explain anything. They will not own up to submission errors.

[iclight]

The FDA doesn't care what happens with the MHRA. DCVax wouldn't make it through an FDA Adcom if it is ever submitted.

If the goal was to get it approved worldwide, submitting to MHRA first makes no sense, regardless of them trying to get it approved via the "swift approval process".

If they thought the FDA would approve it based on the P3 the company would have submitted to the FDA first and then approval from MHRA would be near automatic:

From 2024, [the MHRA] will move to a different [regulatory] model, which will allow rapid, often near-automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world such as the United States, Europe and Japan.

From the UK horse's mouth

[Smitty5150]

I personally believe it’s ready. Femikes comment about having flask works in place is an interesting theory. But why wait? Approval by the MHRA will happen before the FDA at this point. If UK approves the fda hand is forced. Happens all the time. My hope is they submit BLA sometime in the next 2 months, but hope never got anyone anything when it comes to biotech investments;)