No, not really. This is a cell therapy with complex manufacturing, that has had difficulty with supply chain and product release issues that have been overcome but also is facing openly shared safety concerns (not issues) by regulators because of open processes that they prefer to be fully closed. Time helps address those concerns. In my opinion the question is whether or not both MHRA and NWBO have had enough time with no issues created by artisan or a closed system plan moving forward to adequately address their concerns. Best wishes.
It’s highly misleading to characterize CHM’s review as negative. The committee’s advice to the MHRA about DCVax-L has not been published.
Review the CHM annual reports published by MHRA. There are many new pharma products that CHM advised MHRA about before they were granted full or conditional approvals…
For example, CHM advised MHRA on the MAA for Casgevy before its approval made headline news around the world…
Consider the Oct 2023 CHM minutes referencing Casgevy during the month before MHRA’s approval announcement was published in Nov 2023…
In CHM’s own annual report, they highlighted their advisory role in the review of Casgevy, along with other noteworthy approvals… “CHM continued to carefully consider the data on quality, efficacy & safety of a number of new active substances and after detailed deliberations on diverse issues, advised the MHRA on the approvability of …
• Casgevy (exagamglogene autotemcel), a gene therapy product based on innovative gene-editing CRISPR tool for treatment of sickle-cell disease and transfusion dependent ß-thalassemia,which was approved first in the UK before any other country in the world.”
Market Data 
Markets 
AI
