Replies to post #528615 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

MHRA approval will be the start of the obsolescence of the helmet.

[NotSure2]

I would prefer NWBO to not apply to the FDA before the other RA are done and aproved. Like this if FDA refuse they will already have been aproved on other RA and it will look bad on FDA. (if other RA aproved obviously).

[biosectinvestor]

Not unusual for microcap biotech companies with cutting edge cell therapy technologies that needs to be manufactured commercially for approval.

I believe they will edge it in globally through the UK, where their manufacturing is currently based and then be introduced via the ILAP program in the UK to Project Orbis. The process can be done in the UK on a more confidential basis, I believe. We shall see, but there is a lot new on that side and, as I have said before, name a cell therapy product that any major, well-regarded regulator allows to be sold for full price and manufactured domestically prior to marketing authorization.

I can’t name any. Seems a pretty special circumstance.