NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

You must have hard time reading :

“ 2.6 CHM letter and representations

You may receive a letter from CHM instead of a second RFI by Day 150. This happens if during the responses assessment phase, the MHRA consults the CHM under Paragraph 5 of Schedule 11 to the HMRs and the CHM is of the provisional opinion that it may be unable to advise the MHRA to grant the authorisation or orphan designation. The reasons for the provisional opinion will be set out in the CHM letter. The clock will be switched off when the CHM letter is sent.

You will be given the opportunity to make written or oral representations to the CHM in relation to the grounds set out in the CHM letter. You will be asked to confirm to the CHM Secretariat within 28 days of receiving the letter the type of representations (written or oral) you wish to make, if any. You must make representations within a further 6 months, unless you have requested and obtained a written confirmation of the extension of the time limit from the CHM Secretariat. However, we encourage you to submit your representations as soon as possible. We will restart the clock when you make your representations. Further details and instructions will be provided in the CHM letter and attached guidance notes.

You should submit your complete responses as an eCTD sequence. You should prepare your response document using our RFI response template. The response document should be provided both in PDF format in Module 1 and in Word (.docx) format in the working documents folder.

Orphan drug designation will be determined at the time of MA grant. If you decide to make representations in relation to orphan designation, we will defer our decision on the MA application until the representation process is complete.

We will consider the final advice of the CHM and proceed to grant or refuse your MA application (and orphan designation application where relevant). If we decide that your application is approvable, we may implement a third RFI round (as described in section 2.5) before we conduct final compliance checks and grant your application. “



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