Replies to post #769824 on NorthWest Biotherapeutics Inc (NWBO)

[underpar71]

I agree with your assessment and timelines. However, the CHM letter is usually a precursor to denial, pending appeal? Someone here suggested that scenario. If that were the case, it would be a material event, do you agree?

"A CHM letter from the MHRA (Medicines and Healthcare products Regulatory Agency) in the UK is a formal notification that the Commission on Human Medicines (CHM) is advising against approval of a marketing authorization application for a medicine, potentially leading to denial. While not a direct denial, it signals a strong likelihood of refusal. "

[Doc logic]

exwannabe,

MHRA has plenty of leeway with regard to how they handle an application and you admit this. This puts them in position to string things out to the point they see as necessary so a company can prove that they can take care of initial demand that MHRA wants to meet. No one knows what that level is because there is no set number ever shared publicly but clues can come from intervening company or affiliate actions.
Advent increased space that likely is in support of meeting a need for apheresis centers because of a shortage in capacity that has been a known issue for several years. There is also the change in plans from expansion of Class B clean room suites to Class C conversion from Class B set aside space designated for Class B clean rooms. This strongly suggests that future space development will be only for Flaskworks as this smaller conversion space is expected to double the manufacturing capacity which obviously is needed to be part of the plan after inspections took place since this announcement came after the inspections were done.
Bottom line is that MHRA appears to have wanted increased dedicated apheresis space and Flaskworks ready for expansion of capacity sooner rather than later. Though you dismiss the requirement of Edens, the readiness for Flaskworks expansion sure looks to be an MHRA priority. There would otherwise have been no need to push forward the expansion of capacity planning with converted Class B development space to Class C for the sake of saving time, cost and space for future use. Best wishes.

[froggmister]

3) NWBO received the CHM notice that means major issues exist and NWBO must hash out with them

Maybe I'm wrong and someone will correct me, but I think the question of whether or not this is material is moot; this scenario seems extremely improbable.

1. In March the application was accepted by the MHRA

2. In June it was referred to the CHM, which from all of my digging acts very similarly to AdCom in the US - a scientific advisory board. If there were issues with, for example, trial design or the validiity of the controls used in the trial, they might stop the application right here. They didn't.

3. Instead, extensive inspections were conducted after the CHM. So yes, there may have been many issues raised by the inspections regarding quality controls and such, which would constitute many "pop quizzes" to borrow Senti's term, and the company would need to address any issues there, but if the trial passed muster on the scientific end in June and what followed were site inspections, what would come up that would send it back to CHM with a "major" scientific issue that would cause a denial/appeal?

I don't pretend to be an expert in this area so maybe I'm missing something.