RE:RE:the protocol change notice from Health CanadaI'm thinking so Legit,
I'm betting the PR on the 16th was a trial balloon for whatever data changes the FDA wanted? The way the data was presented was different. Now they just contact the sites and re tally the data in the proper format, and re-submit if it is a no brained maybe the FDA beats the 60 day clock and we all get a nice Xmas gift. I guess it depends on who's desk it drops on.