Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-265

I very much agree that unprofessional submissions would be counterproductive. My personal view is that one or two very high quality submissions from HC people might be useful. However, I think large numbers that add nothing could have a quite negative effect.

I think anyone considering lodging a submission should seriously consider some questions first:
* Can you add anything useful, or will any important decision makers feel like they have wasted their valuable time by reading your submission?
* What about you means your view is relevant to AdComm/FDA decision processes? Eg. Have you or a loved one suffered from GVHD? Are you a doctor who treats GVHD? Are you part of a patient advocacy group? Are you a research scientist or a stem cell expert? Are you an American resident or citizen (AdComm/FDA are answerable to the American public, not random Aussies)?