Replies to post #727777 on NorthWest Biotherapeutics Inc (NWBO)

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Yes, NICE tries to align its decision with MHRA. Notably, MAA approval will likely lead to FDA BLA submission through BP partner(s). This will give us great revenue potential which will be reflected in the stock price. Markets are forward looking with investors paying a lot now for future earnings.

NICE issued its assessment for exa-cel (Casgevy) relatively quickly after the MHRA granted marketing authorization. The MHRA approved exa-cel in November 2023, and by March 2024, NICE had already issued a draft decision regarding its use for sickle cell disease, initially not recommending it for NHS funding due to cost-effectiveness concerns. However, discussions with stakeholders, including Vertex, NHS England, and patient groups, continued through public consultations. By August 2024, NICE issued a final draft guidance recommending exa-cel for beta-thalassemia under the Innovative Medicines Fund, allowing for additional data collection on its cost-effectiveness.

This timeline shows an effort to align appraisal with regulatory approval, ensuring patients can access new treatments swiftly, though the process includes critical reviews of economic and clinical data.