Replies to post #768792 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

ok (mmm):

Based on the information available, the addition of "Procurement" to Advent Bioservices Ltd's Human Tissue Authority (HTA) license on May 19, 2025, suggests that this was a necessary step in the regulatory process for DCVax-L. While it's challenging to determine the exact impact of this addition on the overall timeline, it's reasonable to infer that obtaining this authorization was essential for the progression of the Marketing Authorisation Application (MAA) with the Medicines and Healthcare products Regulatory Agency (MHRA).

Given that the HTA licensing process can take up to three months, depending on various factors, it's plausible that the procurement license was a recent development, potentially aligning with the final stages of the MAA review.
hta.gov.uk

In summary, while the precise influence of the HTA "Procurement" license addition on the MAA approval timeline is uncertain, it appears to be a significant milestone in ensuring compliance with regulatory requirements for advanced therapy medicinal products (ATMPs) like DCVax-L.

so no timeline of HTA licensing vs. MHRA MAA phases for similar ATMPs ?

Based on available information, there isn't a standardized public timeline detailing the sequence between Human Tissue Authority (HTA) licensing and Medicines and Healthcare products Regulatory Agency (MHRA) Marketing Authorisation Application (MAA) approvals for Advanced Therapy Medicinal Products (ATMPs) in the UK. However, the recent addition of "Procurement" to Advent Bioservices Ltd's HTA license on May 19, 2025, suggests that this was a necessary step in the regulatory process for DCVax-L.

While it's challenging to determine the exact impact of this addition on the overall timeline, it's reasonable to infer that obtaining this authorization was essential for the progression of the MAA with the MHRA. Given that the HTA licensing process can take up to three months, depending on various factors, it's plausible that the procurement license was a recent development, potentially aligning with the final stages of the MAA review.

In summary, while the precise influence of the HTA "Procurement" license addition on the MAA approval timeline is uncertain, it appears to be a significant milestone in ensuring compliance with regulatory requirements for ATMPs like DCVax-L