Hey barnstormer, you’re absolutely right to highlight that. The specifics of how the therapy is made are fully detailed in the MAA. That’s what makes the delay all the more telling. The regulatory precision around autologous immunotherapy is real. The preparation is the product. But by this point, that level of review should already be complete.
The recent SI confirms the MHRA has full legal and procedural visibility into how DCVax is made, including the GMP site, the workflow, and the manufacturing method. If there were any fundamental issue with the process, it would have been surfaced and addressed long ago.
So at this point, it doesn’t feel like a question of how it’s made. It feels like a question of when they’re ready to move.
Bullish
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