News Focus
News Focus
icon url

10baggerz

11/22/25 6:29 PM

#799366 RE: Baxers #799347

Great post. This discussion is so much more meaningful than arguing about success vs failure till our heads explode.

I lean towards your interpretation but I also think DD's theory answers a lot of questions too. 

The main unanswered question I have is if the MHRA is still processing the original MAA 2 years after submission, why do they keep going out of the way to emphatically state that the MAA is NOT part of their backlog?
Just of the top of my head the MHRA stated this at least 3 times in writing. Once when they announced the backlog was cleared on 3/31/25, once a month later when Lyriki emailed them, and again last week in the answer to the UK parliament. 
They've also implied on more that than one occasion that the application was "with the company" and we should contact the company for further information. 
For a regulator consider the MAA click to be stopped for a long period of time and to state something like that there has to be something going on. I think it was probably related to a major RFI that all parties knew would take a longer time than normal.
Other possibilities include a major's revision to the MAA or the company working through major issues with the CHM. Or maybe the MHRA basically placed the MAA on hold until they cleared their backlog for some other reason? IDK
Any of these theories do explain with GZ's email to Lefty49 that the MHRA  communicated infrequently with NWBO until after the announced that their backlog had been cleared ONLY 7.5 MONTHS AGO and since then have been in frequent contact. 
Bullish
Bullish
icon url

sentiment_stocks

11/22/25 6:36 PM

#799369 RE: Baxers #799347

I think minimally that the company will be willing to breakup what they would charge for the entire set the vaccines. They are likely looking at charging for the first six vaccines (perhaps even as each is administered), and then charging for each additional vaccine when given.

Treatments were administered as follows: days 0, 10, 20, and at weeks 8, 16, 32, 48, 72, 96 and 120.

So the first three treatments would be given within the first month, and then at the 2 month mark, then the fourth month, then at the end of the year - thus in the first year, the patient would receive a total of six vaccines.

This type of fee arrangement does put the burden of initial cost onto the company (making profits likely somewhat small), but should the patient survive into the next year, then the cost of the vaccine is almost purely profit.

NICE may find some variation of this payment arrangement fits better with what they’re willing to pay.
icon url

LK-Yako

11/22/25 8:12 PM

#799383 RE: Baxers #799347

Baxers,

I am of the same opinion as you are, to obtain the initial approval of DCVax-L using the artisan method.
If NICE doesn’t approve the higher cost of manual manufacturing, then the patients would have to pay for it until such time when FW receives approval? How does that sit with their method of paying for medical costs? It would seem rather strange to give approval for treatment and choose not to pay for it because the cost is too high.
Given this line of thinking, NICE would start paying for the cost of DCVax-L treatment when FW receives approval? Just thinking out loud.