NorthWest Biotherapeutics Inc (NWBO)

[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