NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

I will say. If you study what the MHRA says about the request for information...
I now firmly believe that did receive the RFI, answered the questions and from that it derived that they are now waiting to be inspected. In case of NWBO it so happened that the RFI is taking longer than 60 days due to the busy schedule of the inspectors just as we saw with MIA.

Details. The applicant should prepare the responses to the MHRA questions as they have been introduced in the Request for Further Information ( RFI ) or the Commission on Human Medicines ( CHM ) Letter, by compiling them verbatim into this response template.
The goal of using an RFI is to gather information on a market in a formal, structured way. The document should identify the requirements an organization has while requesting specific answers to how the vendor will meet them.

MHRA Inspectors may visit a particular organisation to look at one trial (for example, a participating site as part of a broader inspection of a
multi-site trial’s co-ordinating organisation). They may also visit to do a ‘whole system’ inspection, when they will review an organisation’s facilities,
staff competency and training and assess its ability to conduct CTIMPs to appropriate standards. Most inspections will include a combination of staff
interviews, document reviews and facilities visits. An inspection of the organisation’s whole system may include any part of the organisation and any aspect of its operations having a bearing on CTIMP work. Example processes that may come under scrutiny include regulatory submissions, laboratories, investigational medicinal product (IMP) management, contract management, project management, trial-file management, quality assurance, training, computer systems, monitoring, pharmacovigilance, medical advisors, data management, statistical analysis, report writing, archives and the management of investigator teams