You’re right that the 18 to 24 month timeline Linda Powers gave in 2011 didn’t play out. Calling that out is fair. Fourteen years is a long time, and a delay of that scale deserves scrutiny. But the full picture is more complex than just a missed projection.
This was not simply delay. It was a strategic shift. The original goal was to bring a novel immunotherapy to market through a conventional pathway. But as the trial evolved, so did the scientific and regulatory environment. What began as a single trial became a transformation of how personalized cell therapies could be manufactured, scaled, and approved. That meant building GMP facilities in the UK and the US, acquiring and integrating Flaskworks to automate the process, and advancing through a regulatory system that had no legal category for what was being built.
Pharma companies were not interested in that model a decade ago. Autologous therapies did not fit their existing infrastructure. They could not be bottled, shipped, and sold in bulk. There were no CDMOs ready to support it. There were no clear reimbursement pathways. And there were no regulatory precedents. Without milestone partners or institutional backing, the only way to fund the program was through dilution. That is a legitimate point of frustration for investors. But it was also the only lever available to stay alive while the science and the system matured.
What looks like a painfully long journey was, in fact, the shortest possible route. The company could not fast track a therapy that required regulators to write the rulebook in real time. The FDA did not have a framework for decentralized point of care immunotherapy. The MHRA did not either until June 2025, when it formally created the legal classification for Personally Individualised Cancer Vaccines. The trial could not be unblinded early because the survival benefit created ethical obligations to maintain the blind. Flaskworks could not be skipped because no commercial path existed without scalable automation. Every step that took time was a step that could not be avoided if the goal was a real and lasting approval.
Today the trial is done. The data is peer reviewed. The application is submitted. The manufacturing is built and audited. From the company’s side, everything is complete. If there is a delay now, it is no longer operational. It is regulatory. The MHRA has what it needs. The science is in their hands.
The frustration is understandable. So is the impatience. But the delay is no longer internal. And what feels like a long wait was actually the fastest path through a system that had to be built along the way.
Bullish
AI
Market Data 
Markets 
