NorthWest Biotherapeutics Inc (NWBO)

[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.