A Short Update
The team has been awaiting news on the outcome of a meeting with the MHRA licensing team and the FMT facility in order to give you some clearer timelines.
COVID has had an impact on being able to carry out any recommendations suggested by the MHRA in updating the facility (regarding building work) which is being set up specifically for this research into ME and for this clinical trial.
The Trial Team have been working on preparing the Trial Documents (protocol, patient facing documentation, quality management documents etc) and Ethics/MHRA submission and are awaiting for further information from parties involved in order to progress the submission.
Also in preparation is the organisation of the RESTORE-ME Trial Management kick off meeting which will be scheduled soon – after confirmation of committee membership.
A PPI representative to sit on this committee has been nominated.
The Trial Management meeting will be a suitable opportunity to provide more of an update with progress and timelines in these difficult times
As soon as we haveore information from the kick-off meeting we will provide it here.
