My reasoning is based on the MHRA CHM Referral Process guidance. The guidance specifies that a CHM letter is issued only when the CHM provides a provisional opinion that the marketing authorisation should not be granted. There is no mention of a CHM letter being generated if the opinion is positive, which implies that a positive provisional opinion does not trigger this formal correspondence.
In addition, the new National Assessment Procedure, which introduces formal timelines such as the 28-day representations period and the CHM letter mechanism, applies only to applications submitted on or after April 3, 2025. The DCVax-L MAA review began on April 1, 2024, so it falls under the previous procedure, in which there was no formal requirement for a CHM letter or a 28-day representations period. Therefore, even under the previous framework, a positive CHM opinion would not result in a CHM letter, IMO. Regarding next steps after a positive CHM opinion, I would expect the MHRA to proceed with the standard process for granting the marketing authorisation under the applicable (pre-April 2025) procedure. https://www.gov.uk/guidance/national-assessment-procedure-for-medicines#chm-letter-and-representations
Market Data 
Markets 
AI
