RE:RE:RE:RE:RE:RE:Here we go again It is obvious (read the last paragraph of the new release) that FDA asked for these changes after the pre BTD discussion. They do not ask for data beyond 450 days for BTD, but they do want all lab results confirmed by a central lab. These are very likely FDA required changes. We just had to get Health Canada to go along. There will be a delay. That's life for a Canadian biotech dealing with FDA. .