Replies to post #685053 on NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

If according to Senti and Hyperopia, the submission of the MAA was
delayed so that the MAA approval was delayed to occur a number
of months prior to the approval of the Flaskworks process, why was the
MAA submission not even further delayed so that it would coincide with
the flaskworks process approval?

What is the point of having a gap of few months between those two
approvals if that time gap ( a number of months) would not be sufficient
for NICE and NWBO to agree on a reimbursement sum for the artisan
treatment and for said treatment to be utilized before it is replaced
by the Flaskworks methodology?

Seems to me that kind of delay in the MAA submission would have simply
harmed patients who could have benefited from the artisan manufactured
vaccine but due to the delay could potentially miss the lifesaving boat.

[flipper44]

This part I have and still agree is possible, except for the Flaskworks process occurring within that time frame. Reimbursement might require some time (two to three months) after approval. Imo.

There are three independent timelines; one for commercial approval of DCVax, one for NICE reimbursement, and one for Flaskworks process approval. They will likely occur in that order, and potentially reasonably close together, so it’s not necessarily inconsistent with a 150-day approval process for DCVax. — hyperopia

I don’t agree with Senti that marketing approval for DCVax-l is now awaiting Eden approval. That would be a bait and switch. Placing delays back into the hands of NWBO from the hands of regulators. IMO.

Your alternative opinion they will wait to use Eden instead of artisan following initial approval is also pie in the sky. To suggest the NICE reimbursement process is not currently running parallel is patronizing. To suggest validation of Eden can occur in a short period of time to avoid commercial artisan production would be inconsiderate to patients, imo. To suggest more brain surgeons can’t switch from paraffin tumor preservation to frozen preservation and transport quickly, is an insult. IMO

I know some here can’t wait for technologies like Eden, but the artisan process is happening as we speak, can be ramped after approval, and displaced after validation of Eden occurs down the road. Imo.

Moreover, there are interim reimbursement sources if the reimbursement process from NICE were to need more than three months after approval to decide. Imo.

[beartrap12]

hyperopia, NWBO is in the unique position of already having approval from MHRA to treat patients under the specials, compassionate program where patients pay for their treatment. So, on the day MHRA approves DCVax-L, which longs expect, how can they deny treatment to UK patients who rush to Sawston for the treatment, even if that means adding their names to a backlog of patients? I think UK will be forced to pay for their treatment from day one, and I believe they have a program to guarantee that payment for patients between approval date and NICE setting payment amount. I can't help but think commercialization begins immediately for UK patients, with MHRA paying something to NWBO until NICE confirms the actual amount, then reembursing them the difference, if there is any.
Meanwhile, the specials program has allowed NWBO to ramp up manufacturing which is on the brink of bringing on automated manufacturing. If the Eden unit lags behind manufacturing approval, I believe they will use the manual method. I can see the compassionate program closing to foreigners and other cancer types until Eden is in place so that they can handle the UK patients.