Ann: Clinuvel completes first Phase II US study , page-2

re: Ann: Clinuvel completes first Phase II US... FDA needs to have a heart and allow those who were in the study to continue to have access to the drug in the Spring / Summer months. As the ann. indicated, Clinuvel is lobbying the FDA for that. If its granted, that would be big - it would be hard to imagine the FDA not approving the drug if they allowed some of those in the trial to continue to use it.

Unfortunately, I don't believe Clinuvel was / will be successful in trying to get the FDA to approve the drug for EPP without a Phase III trial. There was some mention back in late 2010 that Clinuvel hoped to submit for approval in the US about when they submitted for EMA approval.

FDA will almost assuredly make them do a Phase III trial IMO. I just hope it gets started this spring (in the Northern Hemisphere).

Wouldn't it be something if the US did what Italy did and allowed access of the drug for EPP patients without further trials. Unfortunately, the FDA is as anal as they come, so that would only happen in our dreams.