Replies to post #710475 on NorthWest Biotherapeutics Inc (NWBO)

[barnstormer]

Gary, if that's the case, then why would the last paragraph of today's 8-K include preparations for inspections scheduled in both the US and UK
Meanwhile, we are continuing to focus on working with our teams of consultants on activities related to the review by the Medicines and Healthcare Products Regulatory Agency (MHRA) of our Marketing Authorization Application (MAA) in the UK, including preparations for inspections by the MHRA that are scheduled to take place in both the US and UK. Is the company being deceptive or is there something we're simply not aware of? (Silly question, with this company it seems there are always things we're not privy to).
When the NWBO Cognate litigation settled, Cognate had a contract for manufacture of Direct. I suspect that that contract probably transferred to Charles River when they purchased Cognate a couple of years later. If it didn't, I don't recall seeing anything on it. I believe Charles River is likely capable of putting together adequate manufacturing ability to meet FDA requirements.

[Steady_T]

I must disagree with your logic.

Sawston is a commercial production facility. I am unaware of any requirement for FDA approval that discusses the amount of commercial production volume required for approval.

Sure Sawston is not adding the tiny high purity clean rooms. I agree that the company is focused on the EDEN production method. It looks like the UK demand will consume all of the existing Sawston production capacity.

Maybe NWBO will not file with the FDA until the EDEN technology is ready for inspection. That seems to be an avoidable delay in the FDA approval process.
The company can file with the FDA based on the SAWSTON facility and get the approval timeline started. If the FDA NDA is approved prior EDEN being ready that is not a problem. The company doesn't have to accept requests for treatment, but will have approval in hand. When Sawston has EDEN ready the company can file for approval of the EDEN process with the UK and the FDA simultaniously. At that point it can begin to service the US demand.

I agree that making the treatment available in the US will most likely require the EDEN process to be able to service the demand.