Today, the EME Programme published the minutes of their board meeting held on 25 and 26 October.

The board of the EME Programme has made an "in principle" decision to fund the study (the application entitled "A randomised double-blind placebo controlled Phase 2B clinical trial of repeated application in gene therapy in patients in cystic fibrosis") subject to a number of changes being made.

The final decision will be made when the changes to the project are agreed with the GTC. The time this takes will depend on the scale and complexity of the changes. The EME programme conducts a comprehensive scientific peer review to ensure the study is further strengthened and this is all part of the standard process for EME Programme funded studies.

Matthew Reed, Chief Executive of the Cystic Fibrosis Trust said;
"We are delighted to hear that the EME Programme is keen to fund this clinical study. This is subject to some changes being made to the gene therapy application which could take some time. This is very much part of the usual process once a funding decision has been made. This is very encouraging news and we hope the changes can be agreed as soon as possible. We are in close communication with the GTC and will keep our website up to date as more information becomes available."

"In the meantime, donations to the Gene Therapy Appeal are still coming in and we continue to accept donations to the appeal online"

Questions and Answers

1. Did the GTC receive the whole grant?
The EME programme has decided to fund this clinical study in principle, subject to some changes being made in the application, as a result of the scientific peer review. The GTC and EME Programme will now go into a period of discussion to determine the details of the study and the size of the grant. Applications are managed through a robust, peer-reviewed process, which ensures scientific rigour and value to the public purse; this is all part of the standard process for EME Programme funded studies. There is no doubt that this peer review will add value and will further strengthen the study going forward.

2. How long is it likely to be before any clarifications or changes are agreed between the GTC and the EME Programme?
It is difficult to put a clear time line to this, the project team will need to discuss and implement the required changes. Once this has been done, a contract has to be drawn up and agreed between the funder and those responsible for the research. Once this contract has been signed the GTC can start the research, subject to the necessary research governance being in place.

3. If all the changes requested are made, will the trial then go ahead?
The trial has the biggest chance of going ahead once the necessary research governance has been put been in place and a contract has been signed between relevant parties. We will update our website as more information becomes available.

4. How much has the Gene Therapy Appeal (exclusive of the EME Programme grant) raised to date? And how will these funds be used?
As of 8 November 2011, the Appeal has raised more than £1.5m. We are very grateful to the CF community and all their amazing efforts to ensure this appeal is successful. We continue to fundraise for the full cost of the Gene Therapy Programme this year and the trial preparations.