NorthWest Biotherapeutics Inc (NWBO)

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We publish a UK Public Assessment Report (PAR) for all new MAs including
conditional MAs and MAs under exceptional circumstances. This is based
on the MHRA assessment reports with any commercially confidential
information or personal protected data removed. A lay summary is included.
We will consult with you on the text of the final PAR before publication on
the MHRA Products (https://products.mhra.gov.uk/) webpage. Following
authorisation of a NAS, we will publish a press release within one week and
a PAR within 30 days. For all other MA types, we will publish a PAR within
60 days.
We will only refuse an MA application after receiving the final advice of the
CHM (see section 2.6), except when you have not responded to a RFI
within the required timeframe.

This section of the MHRA guidance outlines what happens after a medicine receives internal approval. Once the MHRA decides to grant a Marketing Authorisation (MA), it prepares a Public Assessment Report (PAR) to summarize the approval decision and underlying data. Before the PAR is published, the MHRA consults with the company to finalize the language, particularly to remove any confidential or personal information. This collaboration happens after approval is granted, but before any public announcement is made. If the product is a New Active Substance (NAS), the MHRA commits to issuing a press release within one week of authorisation and publishing the PAR within 30 days; for other approvals, the PAR is published within 60 days.


The guidance also makes clear that MHRA will only refuse an MA if the company fails to respond to a regulatory request within the set timeframe, or if the advisory committee (CHM) issues a final negative recommendation. This means that silence from the regulator does not indicate rejection. On the contrary, if the company is in a document review phase and no refusal has been announced, it likely means the MHRA has already issued internal approval and the parties are finalizing materials for publication. In this light, the delay is not a red flag, it’s procedural. It fits the standard post-decision window, during which the company prepares for formal disclosure and downstream handoff to NICE.

https://www.gov.uk/guidance/national-assessment-procedure-for-medicines