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theorysuit

03/14/24 6:35 AM

#678457 RE: hyperopia #678445

I’ve thought that Northwest Bio may bring manufacturing in house (i.e. buy Advent) at some point, to lower the cost of production even further, possibly when automated commercial production begins, or when production numbers reach the point of limiting coverage. This way, the profit that Advent would have charged, could be passed along as cost savings to governments, in order to keep the number of patients covered, as high as possible.



Why would NWBO buy ADVENT? NWBO funded ADVENT, but LP/TOUCAN owns it. That is a crime and that conflict of interest/related party transactions is why NWBO voluntarily left to the OTC. NWBO should have this internal manufacturing capability already, but the CEO decided NWBO should fund it, but she and her fund should own it. Nice Scam she got going on there. You ever wonder why it took so long, look no further than she needed to fund her own CDMO. Maybe she ain't as dumb and slow at execution as some think.
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attilathehunt

03/14/24 9:14 AM

#678476 RE: hyperopia #678445

When NICE ascertains price, is a drug/treatment allowed to be priced higher and NICE only pays what they state?

Meaning if NICE says DCVax is only reimbursed for 150k, can the ultimate charge be 200k and the difference is considered out of pocket or what NICe states is the max it can be charged?
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ATLnsider

03/14/24 1:03 PM

#678527 RE: hyperopia #678445

Thanks for your feedback hyperopia. I do have a few comments and questions related to your feedback.

You stated the following quote below, which suggests that each DCVax-L production batch would be limited to only 3 years of doses, which as you correctly stated would be about 10 doses:

studies have confirmed product stability for 3 years, or ~10 doses per batch.


I do agree that in the Phase III trial, NWBio wanted at least enough tumor tissue to produce 3 years of doses. But in a few cases less than 10 doses were produced, and in some cases more than 10 doses were produced.

What I have seen from my research is that the total number of DCVax-L doses produced in a batch for each patient, is dependent on how much of the tumor can be safely resected, and then how much DCVax-L vaccine can be produced from the resected tumor tissue.

If you take a look at this Compassionate Use case that was presented by Dr. Bosch at ASCO on 6/3/2023, you can see that the first batch of DCVax-L doses were produced for this patient (Sarah), and administered to this patient in 2013. There were enough DCVax-L doses produced in this first batch to give to this patient from 2013 to 2019. That is almost 6 years:



This patient was scanned and monitored every 6 months. There was no tumor recurrence or disease progression since 2013.

Also, apparently, some of her original resected tumor tissue was cryopreserved / frozen, and was saved and not used to make the first batch of doses. Apparently, there was enough tumor tissue leftover to make a second batch of DCVax-L doses, so that this patient has been able to receive more doses through 2022. That was about 9 years of doses total, without a second tumor resection surgery.

She is alive 11 years after her original tumor resection surgery in 2012, with no tumor recurrence or disease progression. You can listen to Dr. Bosch’s remarks about Sarah’s case beginning at about the 44:10 minute mark:

Bullish
Bullish
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ATLnsider

03/14/24 2:33 PM

#678539 RE: hyperopia #678445

hyperopia, my other post was getting too long, so I decided to continue in a separate post. You also stated the following:

you notice though, all these ATMP’s are for rare conditions, so the patient number are not large, which is a very big consideration for these countries with national insurance coverage. When you start talking about patient numbers in the tens of thousands per year or more, it could be a real budget breaker. With just the DCVax pricing numbers discussed, in the UK for example, at 3K GBM patients per year, that is close to $750M for that one product alone, and doesn’t even consider the other treatment therapies. (removing Temo will help)



Unfortunately, in my opinion, I believe that some on this board are grooming, conditioning, and programming NWBO investors to believe that a total price of $250,000 for 3 to 10 years of DCVax-L doses is very expensive, and it is over-priced. But, I strongly disagree with that. In my opinion, NWBio is a small company that has spent $billions developing DCVax-L, and NWBio deserves to charge a fair price for DCVax-L.

When DCVax-L is approved by the MHRA, that will be NWBio only approved commercial product. In order to fully develop the DCVax vaccine platform, and make it available for all or most solid tumor cancer patients, on a tumor / tissue agnostic basis, it will be imperative for NWBio to be able to charge a fair and competitive price for DCVax-L.

You mentioned the addressable market size for GBM patients in the UK of about 3,200 patients annually. However, there was a recent approval of an ATMP in the UK for a CRiSPR therapy to treat sickle cell anemia. The treatment is named Casgevy. It was developed by Vertex Pharmaceutical and CRISPR Therapeutics. It is estimated to cost about £1,500,000 in the UK, and about $2,200,000 per patient in the US. The addressable market size in the UK is estimated to be about 2,000 patients per year. That is an estimated cost of $4.4 billion in annual sales just in the UK alone:

https://medcitynews.com/2023/11/u-k-is-first-to-approve-a-crispr-based-therapy-covering-two-blood-disorders/

https://www.genomicseducation.hee.nhs.uk/blog/casgevy-the-first-crispr-therapy/

https://www.cnbc.com/2023/12/08/casgevy-first-crispr-gene-editing-treatment-approved-in-us.html

Vertex Pharmaceutical and CRISPR Therapeutics both have more capital, money and other resources that NWBio has. Plus, they have other approved treatments in their pipelines. I do not believe that only much larger pharmaceutical companies, with more money and other resources, should be able to charge a fair price for their treatments, but a small company like NWBio will be beat down by the regulators.

However, I do believe that even if the cost of DCVax-L is initially priced at $250,000, when the Flaskworks devices are approved to be incorporated into the manufacturing process, the cost to produce and the cost to patients will go down significantly. In addition, when DCVax-L is receives tumor / tissue agnostic approvals in the future, NWBio will realize significant economies of scale, and the cost of DCVax-L will decrease even further. As a reminder, in my future NWBO stock price valuation projections, I am predicting that the cost of DCVax-L will go all the way down to $75,000 per patient over the next several years:

Bullish
Bullish