Replies to post #803654 on NorthWest Biotherapeutics Inc (NWBO)

[jesster64]

Well dennisdave. The board is speechless. No doubt running to AI to dissect every word. LOL

[manibiotech]

You are mis interpreting as usual to your liking . In MAA , intended process is manual not Flasworks.  

[brooktrail1933]

"We generally require that the commercial manufacturing process intended for the MA be fully qualified, GMP- compliant, and reflected in the Manufacturers License before the MA is granted.
MHRA will typically assess the updated process as opposed to the original, especially if the applicant intends to commercialise the new route.
Timeline impacts are usually considered clock-stops, not backlog.
We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.
The MA must reflect the commercial manufacturing route."

The manual process IS "fully qualified, GMP-compliant and reflected in the Manufacturers License".
The manual process IS "the original", and the applicant INTENDS "to commercialize" it.
The manual process IS "the original process".
The MA DOES "reflect the commercial manufacturing route", which is the manual process.

You are taking their statement and twisting it around to correlate with your (false) insistence that you are right and the vast majority of the rest of us, including those who are familiar with the inner workings of the company, are wrong. You have a pathological need to always "win".

[Red_Right_Hand]

The third option, which is consistent with both MHRAs email and with NWs public statements, is that the initial application and initial license will be for manual production, because that is what NW still intends to still commercialize with initially, with a follow-up mod after eden is certified.

[martyDg]

So what’s the hold-up on the MA? Advent is already fully GMP-certified. And GZ already said they didn’t amend the MA for Flashworks, so the manual method should still stand.

[bas2020]

Your personal biases are causing you to misinterpret or misapply what the MHRA has said.

“The MA must reflect the commercial manufacturing route.”

The fact is that NWBO intends to use BOTH methods of commercial manufacturing... manual and automation. Therefore, approval will be granted for the manual method... and then the variation will be applied once the automated process is validated.

Seems rather clear to me... but you're free to believe what you want.

[FeMike]

Now here is the contradiction: GZ has explicitly confirmed to me that manual production is (in his view) the intended commercial route.
That statement is directly at odds with what the MHRA says — and with reality. If Flaskworks were not the intended commercial route, the entire closed automated system would be economically and strategically pointless. Everyone understands this. You don’t build Flaskworks for fun.

I do not know the answer to this, and I'm not saying you are wrong, but I do think you are failing to recognize the distinct possibility that both manufacturing methods are viable commercial production routes.

Capacity is much lower, but it still exists, with the Grade B room and artisan manufacturing method. It is a viable route to commercial production and, as such, the MA can be approved based on that. It doesn't matter that NWBO is hopeful to switch to another manufacturing process within possibly months of an approval decision.

MHRA's statement says:

We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.

I don't believe that is the case. NWBO has explicitly stated on numerous occasions that initial rollout and commercialization will be done with artisan method. Just because that initial period has decreased from a couple years to potentially 6-9 months, doesn't mean they don't still intend to use it to bridge the gap.

NWBO intends to use artisan until Flaskworks is ready, at which point they intend to switch. So if the MHRA's general guideline is that they can't grant the MA based on the original process if the applicant no longer intends to use it, I think it's safe to say that when they ask NWBO this question, the company's answer will be "Yes, we intend to use the artisan 'original' process to manufacture this commercially". Which is true, they do intend to use it, until a more economical and efficient method becomes available.

That's my opinion of the situation. I certainly see your angle, though, and don't discount it as a possibility. I'm just not sure the evidence you've given means 100%, beyond a shadow of a doubt, NWBO has to get Flaskworks validated before the MAA will be decided.

[AllSheWrote]

You are not right about anything. The email reply from MHRA is perfectly consistent with NWBO's application for manual commercial production. What you are failing to process is that, at least right now, there is no Flaskworks. A functioning Flaskworks device is so far from testing, approval, and practical application that it might as well not even exist.

[hankmanhub]

We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.

The key is in the phrase "if the applicant no longer intends to use it." Our situation is that the applicant DOES intend to use it! So it qualifies. It is also true that the applicant is also working on future developments to mass produce the treatment which when ready will later be presented to the regulator. This in no way places the current application in any jeopardy. It does not state that an applicant may not work on future developments while awaiting approval on the current application. It merely states that a treatment already abandoned will not be approved. This is what is meant by:

We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.
The MA must reflect the commercial manufacturing route.

[KRISGO]

dd, what was your question that prompted this response from the MHRA? Would you mind sharing it?

[NotSure2]

Without NICE approval, no need Flaskwork, there will be so little patient anyway, not enough to keep company afloat.

NICE approval (extremely low chance of approval) will take 2,3,4 years also.

GZ is right.