Thanks for the question, Atilla. I want to be clear up front that I do not speak for the company, and I am not affiliated with the MHRA. This is not a forecast or a guarantee. It is simply my interpretation based on what is already public and how these processes typically unfold in this setting.
The last significant regulatory development was the implementation of Statutory Instrument 2025 No. 87, which went into force on June 17, 2025. That regulation established the legal basis for the manufacturing, traceability, and oversight of patient-specific autologous therapies in the UK. Before SI 87, there was no defined statutory path for approving a product like DCVax-L. That gap has now been resolved. There is no remaining legal obstacle to licensing a decentralized autologous therapy under UK law.
The marketing authorisation application for DCVax-L was submitted in December 2023 and was validated by the MHRA in early 2024. Since then, there has been no indication of a scientific or manufacturing deficiency. The public presentation by Dr. Marnix Bosch on June 16, 2025, focused entirely on DCVax-Direct. It did not reference DCVax-L as still being under review. That shift in focus implies that the regulatory phase for L is complete and that the company has moved operationally to its next program.
It is also worth asking whether some of the data shown in the Bosch presentation may have represented early real-world data from patients treated under special access or named-patient conditions in the UK. Some of the booster-agent combination data shown could plausibly fall within that category, especially if treated under expanded access mechanisms. While it was not explicitly labeled as real-world data, it is reasonable to consider that some of what was presented may overlap with the kind of early-use evidence MHRA may already have reviewed internally.
MHRA is scheduled to release new guidance on real-world data on July 14, 2025. Because the DCVax-L application was submitted and validated before that date, the new guidance is unlikely to affect its current review. However, the implementation of real-world data collection infrastructure is still relevant for NHS access. Therapies accessed via Individual Funding Requests typically require a plan for real-world monitoring, especially when introduced through the IFR pathway in oncology. This involves coordination between the MHRA, NHS England, and possibly NIHR to ensure that early use is properly tracked across treatment sites. That structure likely needs to be in place before approval is announced, even if it is not formally part of the license.
In parallel, the labeling process still needs to be completed. That includes the Summary of Product Characteristics and the Patient Information Leaflet. For a therapy like DCVax-L, which is individualized and distributed across multiple sites, labeling is more complex than for conventional biologics. It needs to address delivery coordination, variability across patients, and site-specific readiness. Label finalization is typically the last step before license publication.
Taking all of that into account, I think the most reasonable window for approval is between the second half of July and the end of August. That gives enough time for the July 14 real-world data guidance to be issued, for labeling to be finalized, and for any remaining cross-agency coordination to conclude. If approval moves into September, it would likely reflect operational timing or rollout planning, not a scientific issue. If nothing is announced by early Q4, then the cause might relate to broader strategy or implementation alignment that has not yet been made public.
So to answer your question directly. Based strictly on procedure and pacing, I anticipate approval sometime between late July and August. That is not a prediction. It is just a practical interpretation of where the process appears to be, based on what is already visible.
Bullish
Market Data 
Markets 
