very interesting indeed. I moved to Australia 5 years ago and it seems they are on top of a lot of new treatments here but are slow to roll them out seems they go through our FDA there so its slow. Treatment in the gov health care here is slow also...Ive been waiting 2 years now to start TX and Im getting close now. I guess I have some minor dental work to be done to ensure the best results so Im currently getting that done. Nice meeting you and all the best in your treatments also.
The trial first has to be approved by the FDA which is likely to accept the recommendation of the Recombinant DNA Advisory Committee (RAC). The next meeting of the RAC is in June, when this proposed trial is likely to be discussed. Details of their decision will be available on http://oba.od.nih.gov/rdna_rac/rac_meetings.html#RAC2013
If recommended, Benitec will then apply to the FDA for an IND. When the FDA grants approval (could be as soon as Sep/Oct this year) the details of the trial, including enrolment requirements will be available on the www.clinicaltrial.gov website.
This trial will be phase I/II first human test. Usually small 14 subjects group in phase I for safety.
Thanks John keep watching. Interesting isn't it?