Replies to post #807064 on NorthWest Biotherapeutics Inc (NWBO)

[underpar71]

Scientific Expertise: Referrals are made during the initial assessment phase (up to Day 90) for advice on quality, safety, or efficacy of innovative medicines, new active substances, or biosimilar products. ---- LIKELY WHAT HAPPENED WITH FORST MEETING

Major Variations: The CHM is often consulted on major changes to existing licenses, such as entirely new therapeutic indications or changes with significant public health implications. ----LIKELY WHAT IS GOING ONE NOW. Entirely new therapeutic indication.

[SkyLimit2022]

seekazy,

“CHM is where apps go to die”

You’re recycling the same nonsensical rumors.😶

Reaching CHM review is a significant milestone. Suggesting that CHM’s advisory role is negative reflects a misunderstanding of how the MHRA process works.




Review the CHM annual reports published by MHRA. There are many new pharma products that CHM advised MHRA about before they were granted full or conditional approvals…

For example, CHM advised MHRA on the MAA for Casgevy before its approval made headline news around the world…


MHRA Approves Casgevy


Imperial College London


Worldwide Clinical Trials



In CHM’s own annual report, they highlighted their advisory role in the review of Casgevy, along with other noteworthy approvals…
“CHM continued to carefully consider the data on quality, efficacy & safety of a number of new active substances and after detailed deliberations on diverse issues, advised the MHRA on the approvability of …

• Casgevy (exagamglogene autotemcel), a gene therapy product based on innovative gene-editing CRISPR tool for treatment of sickle-cell disease and
transfusion dependent ß-thalassemia, which was approved first in the UK before any other country in the world.”

CHM 2023 Annual Report

CHM 2024 Annual Report

Dr. Shirley Hopper, MHRA