Replies to post #448676 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I think they all basically allow for the local regulator to approve and for that to be sufficient. If the UK approved, it will basically be pushing paper at the others most likely.

[exwannabe]

I'm curious whether the FlaskWorks unit would be certified by all 4 regulators simultaneously, or if they're going after one at a time. In that it's the U.K. where DCVax-L is available under compassionate use, it would figure that the trials of the FlaskWork unit is being conducted there. Hopefully all regulators will respect the work being done, but I don't know that it is certain.

There are two very different concepts in play when you talk certification.

For Specials (and IND use) the manufacturing process needs to be GMP. That is a quality control concept. It says nothing about Flaskworks manking the "same" DCVax-L as being trialed.

This should be fairly easy. AFAIK, it can be done either at the compnent level (NWBO having a manufacturing cert on the device) or at the user level (Advent getting their cert to include use of the device).

The GMP certs are accepted across many RA's, including the ones in play here.

For commercial production, it is far different. When/If a BLA is approved it will have extensive documentation of the manufacturing process. To change the process requires a BLA/MAA change that is approved by the regulators. For major changes (and this is) it can require equivalence testing that can be clinical trials (though they would likely use various markers and not have to wait on OS).

In theory they can change the BLA/MAA to include Flaskworks now, but that is not rational. It would add significant regulatory risk and potential delays. Better to get the approval, then the Flaskworks modifictaion.