Replies to post #772463 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

ilovetech,

Been saying something similar for years. This is why I focus on manufacturing because a platform that is foundational to all else with regard to treatment needs manufacturing that makes it accessible at scale. Regulators can find all the time in the world by playing games with the intent of the rules. They can bounce back and forth between each other to buy time for what they want amongst other avenues of approach. NWBO surely knows this but all they can do is work towards what the regulators want which keeps the ball rolling even if in a direction that looks like circles; ). Just hope MHRA isn’t trying to keep NWBO 40 years in the desert like Moses, Caleb and Joshua had to put up with because of the lack of faith by the people; ). Best wishes.

[skitahoe]

ILT, I really believe that NWBO's price for DCVax-L will be the same regardless of the manufacturing method. It could be profitable if manufacturing is manual, but clearly they want it automated as quickly as possible.

I suspect that patients using all the vaccine made from their tumors will pay well into triple figures over a few years. It's not out of line with other less effective treatment they could be using.

Gary

[VMLG17]

To add, it’s been mentioned on this board before that DCVax treatments will eventually offset government expenditures on inpatient hospitalizations, chemo/radiation, and other related costs possibly resulting in net savings.

[Chiugray]

Ilovetech, Good points. Country budget constraints are legitimate realities.

Say the DCVax gross margin % is 70% and Eden (automation) saves $15K in manufacturing cost. That translates into a $50K lower selling price or a savings to the UK's NHS, while NWBO gets to maintain its profit % and maybe faster expansion into markets, a win-win.

It is a matter of when, ie the UK being nimble to expedite approvals and expansions, but if it can, I see these trade-offs:

- more DCVax-L (better, cheaper) means less other more expensive drugs
- expedite Eden approval means earlier cost savings for NICE/NHS
- e.g. label expansion to stage agnostic (same biological mechanism, include grade 3 gliomas)
- e.g. label across tumor types (DCs are agnostic)

Interests are aligned. The UK will want DCVax-L, a breakthrough cancer therapy, to succeed big time even though it is a USA company. Sawston's expansion and success in the UK creates high skill jobs and continued investment. A profitable UK operations means UK taxable income grows and positions the UK as a global leader in life sciences and will attract more biotech investment, partnerships, and talent to their shores. Financial gain and soft power gain.

[meirluc]

I agree that the UK fiscal crisis could be a strong incentive for the MHRA to
approve the MAA once the capabilities of Flaskworks to cheaply produce an
adequate product have been established. Then, while the artisan method may be
used for a limited time after approval, switching over to Flaskworks should not
take that long.

Furthermore, if the current trial pertaining to the treatment of accessible recurrent
GBM (NCT04201873) shows that treatment with ATL-DC (DCVax-L+polyICLC)
with/without keytruda has great efficacy, the cost of the treatments for new GBM
patients could possibly be substantially reduced because those accessible rGBM trial
patients were not treated with chemoradiation and still greatly benefitted from their
treatment. In fact, chemoradiation, especially temodar, is immunosuppressive and
could lower the benefits of the DCVax-L/poly ICLC treatment and therefore, nGBM
patients could be better off without chemoradiation and the treatment costs will also
be lower.

The major difference between nGBM and rGBM patients is that the recurrent tumors
usually display a stronger mesenchymal signature and those tumors are therefore
likely to be more aggressive but OTOH such tumors are also more immunogenic and
therefore are probably more likely to be outmatched by the vaccines produced from those
same recurrent tumors.

Of course, if the addition of keytruda is added to the mix because it has demonstrated
to further increase the potency of the vaccine, the cost of the treatment could be
substantially higher. We therefore just have to wait and see how all this plays out.