Replies to post #516335 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

no2koolaid,

Just my 2 cents but this has all been painstakingly dealt with by investors and NWBO alike over the last 7 years. I know some chemo patients have accrued costs for treatment of over $1,000,000,000 and that is truly unsustainable. Manual production of L gets up to 3 years of treatments done for about $185,000 and that price will drop with the more automated, more closed system commercial scale manufacturing. Linda brought a key component producer in house and other component products are available more as commodities now. Bottom line is the cost to produce is significantly less than what was originally the case even with the very significant and unsustainable inflationary pressure on medical costs. The other favorable factor is that this treatment is designed to lead to a cure rate perhaps with as few as 3 treatments ie rGBM combo trial and 8 week immune response correlating to longevity in Direct Phase 1. Beyond the potential of L, Direct will bring costs down for other cancers substantially as well when validated. National health systems and insurance companies need this answer for the long term solution to out of control healthcare costs. They will embrace this long term solution. Best wishes.

[hyperopia]

no2koolaid, are you aware that DCVax has “orphan drug designation” in the US? It will be exempt from the negotiation process under The Inflation Reduction Act, so this should not be an immediate concern for Northwest Bio or their shareholders.

The Inflation Reduction Act’s Drug Pricing Provisions: Considerations for the Cancer Community

Under the IRA, negotiation-eligible drugs include brand-name and biologic drugs without generic or biosimilar equivalents covered under Medicare Part D or Part B that are among the highest-spending Medicare-covered drugs and are nine or more years (small-molecule drugs) or 13 or more years (biologics) from FDA approval. Excluded from negotiation are:

* Drugs that have received an “orphan drug” designation for only one rare disease or condition and the only approved indication(s) is for such disease or condition

https://www.cardinalhealth.com/en/services/specialty-physician-practice/resources/healthcare-policy/the-inflation-reduction-acts-drug-pricing-provisions.html

[Maverick0408]

Also, as you know, there are a series of issues with pricing in the EU, as each country effectively negotiates its own deal, irrespective of a broad EMA approval.

—- This is correct. This is why I continue to believe that they must go after FDA immediately and not EU, in parallel with MHRA. Individual country reimbursements within EU will take a while to resolve for a relatively small percentage of addressable revenue.