Replies to post #773153 on NorthWest Biotherapeutics Inc (NWBO)

[Red_Right_Hand]

CHM meetings are part of the MHRA process. CHM consists of subject matter experts (i.e., scientists/doctors) who advise the MHRA. There is not an extra step, or a need for MHRA to refer MAAs to CHM to be denied or approved, because the CHM is integrated into the MAA review process, where their role is to provide their opinion about approval/refusal of the MAA. The CHM does not approve or refuse. The CHM provides their opinion to MHRA about whether to approve or refuse, and why. The CHM advises but the MHRA decides.

https://www.gov.uk/government/organisations/commission-on-human-medicines/about

We’re responsible for:

-advising on applications for both national and European marketing authorisations
-considering further representation against our provisional advice in respect of national applications
-advising on the need for, and content of, risk management plans for new medicines
-advising on the impact of new safety issues on the balance of risks and benefits of licensed medicines - eg adding warnings, restricting or suspending use of a medicine
-advising the licensing authority on changes to legal status of marketing authorisations

[meirluc]

" Perhaps, it was referred to the CHM to consider all solid tumors...That is what I believe and I will certainly get ridiculed for it"

Not ridiculous at all but more likely that we will first be approved only for GBM and glioma III.
Thereafter we will need many flaskworks units because without them, the demand coming from
the huge number of patients with various types of solid tumors, cannot be met. Since installation,
testing and certification of the many flaskworks units will take a long time, my hunch is that
approval may be first limited to GBM and glioma III patients and sometime thereafter many other
solid tumors will come into play.