Replies to post #678335 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

ATLnsider,

The big consideration isn’t the cost of the treatment per se, I believe it’s the additive up front cost to SOC that needs to be addressed by those who know this will quickly be ramping up into other indications. The need to control costs when it does will likely impact the perceived relative importance for chemo and radiation in all of these indications. Temodar will likely not be SOC for unmethylated GBM and other indications where it provides no benefit and in older patients where lower dose or elimination of it led to better results with DCVax-L. NICE will want MHRA to adjust SOC according to actual benefit as soon as possible once L usage ramp up begins in earnest. Patients will also experience a better quality of life with these adjustments so I expect a balancing act begin to play out between the old SOC and new SOC being established once L is approved as this will help mitigate the impact of additional up front costs created by treatment with L. Best wishes.

[flipper44]

Thanks for comparison costs ATL.
Very helpful DD.

You made your case. DCVax-l is very competitive price wise, and when you take into consideration the drugs other therapies must administer after treatment to deal with toxicity, DCVax-l is a bargain.

[exwannabe]

when Advent, Charles River Laboratories (CRL), or any other CDMO working with NWBio to manufacture DCVax-L, all the patients’ dosages (up to 8 to 10 years of doses) are made upfront in 1 batch process.

Wow.

Reality check. They make at most 3 years worth of doses. They may not even be able to manufacture any but currently still charge the patient.

But who cares about reality when it is better to keep head in the sand.

[CaptainObvious]

I think it would be possible for the CDMO making the batch to participate in the effectiveness of the vaccine by, after covering their costs + a fixed fee, getting a commission for each dose actually administered. This would lower the upfront cost.

Of course the CDMO would take on sharing the risk of no further income should the patient not survive to receive all of the treatments.

[CrashOverride]

💣 🔥 💸

[erik007tc]

ATL, we have the breakthrough medicine and we have the manufacturing but we don't have the expertise to fully commercialize our product in full scale.

LP' s words in 10K:


"We do not have a marketing or sales force and have no experience in marketing or sales"

"These factors may result in significant difficulties in commercializing our product candidates."

"We may be unable to recruit and train effective sales and marketing forces or our own, or of a partner or a services firm, and/or doing so may be more costly and difficult than anticipated."

"we may be unable to generate significant revenues."

First time LP said these in a 10k, with all the barriers on marketing and sales, we are stuck in OTC and heavily manipulated by 7 evil shorters. The Mgm't ages are at the point of retirement and we are very low on cash. I believe we get bought out after approval, what is the point of regulatory approval if we can't fully commercialize our products?! management knows and still not hiring ($).

We already have collaborations with big pharma, it's time for them to take over. Right?

[Sir Pumpernickel]

Bwahahahahaha!!!!! Bullshit, bullshit….and more bullshit……ALL BULLSHIT AND PIE IN THE SKY AND NOT AN OUNCE OF FACTS TO BACK IT UP…….Period…
Pumpernickel YuYU….. LaLAAAAA……….. YuLAYuLAYuuuuuuuuuuuuuuuuuu………AAAAAAAAAAAAWWHHOOOOOOOOOOOOOOOOOOOOooooooooooooooooeeeeeeeeeeeeeee!!!!!!!!

[hyperopia]

Some excellent points ATLnsider, and I’m quite certain that NICE and Northwest Bio will negotiate an acceptable pricing model, (likely spreading payments over years) and DCVax will be covered by the NHS. No doubt about this.

A couple minor points of difference; studies have confirmed product stability for 3 years, or ~10 doses per batch. This will be extended obviously for another 3 years, if a new batch is made for a recurrent patient. Also on your second point, I personally don’t think patients are used for the Flaskworks development work. I thought they could have gone that route years ago, if they requested approval for the Flaskworks process for investigational use, but they didn’t. I think they are probably using a commercially available blood product like Leukopaks, for the comparability studies. Although these products are from healthy volunteers, it’s acceptable to regulators, as long as it’s used for both sides of the comparison.

The ATMP Pricing is really great information, and I hadn’t seen all that in one document. If 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)

This is why it’s necessary to bring the cost of production down as low as possible, in order to have the lowest price, or the coverage will be limited. 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.