Replies to post #570979 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Of course the prerequisite modules (which have been MHRA pre-assessed) for the (imminent) final MAA have been worked on for well over a year, moreover, what the MHRA recently shared (regarding the general process), is that the process validation of the same product batches used for part of the MIA approval are likewise to be (being/have been?) used as the process validation requirement for the MA. This is something the bears have been trying to cloak for sometime, by conflating the two independent licensing processes as otherwise completely non-duplicative processes. The latter could not be further from the truth. Instead, batch process validation overlaps utilizing the same exact batch documentation for purposes of both product validations, and you’ve heard from LP, two months ago, that this validation is complete for purposes of the MIA inspection, and is now finishing up during the very ripe post inspection process. In other words, “pre-digested” for the MAA.

In a nutshell, it means the two regulatory completions (MIA and MA), are being drawn closer in time by means of pre-MAA rolling review in addition to the redundant batch validation process — the latter identically used for parts of both MIA licensing and MA licensing.

Note: For some time, I’ve mostly been under the impression this will commercially ramp from manual to Flaskworks. I don’t see this in a negative light. With the 1B Advent expansion, the U.K. should be able to commercially ramp toward UK patient demands as Cognate thereafter meets North American demands, after which both highly qualified crews can smoothly transition toward closed automated as European and global demand create, by chance, an ever upward revenue trend. Then, thereafter, revenue can ramp further with combinations, Direct and Hyperactive DC technology. JMO.