NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Firstly, they already have approval and licensing for specials. So it is unlikely there is a problem with production per se.

Most likely the regulator is taking their time because they are in fact approving a facility for a drug that will be precedent setting and very unique. This will be a first time for this kind of personalization if a drug. Other regulators will be reviewing their work.

I do not believe necessarily they need CRL for regulatory purposes. That was to be told to them by the regulator, but it’s not a fixed issue. However, if indeed it is required it would not likely hold up the UK approval. On the other hand, if ILAP is being used to enroll in Project Orbis, and IF the FDA wants to see a contract with CRL and a realistic planned scale up, that kind of negotiation might take a little extra time.

But I really just think the MHRA is just very carefully sitting all i’s and crossing all T’s and working very hard not to screw up with some oversight that another regulator might point out. And of course supply lines for inputs or spare parts can be an issue in this era, as we were told, and that too can be a very vexing issue.