re: Ann: FDA Investigational New Drug Applica... G?day...

re: Ann: FDA Investigational New Drug Applica... G?day Shellbell,

Can only hope we get the go-ahead by May 22. To be honest though, my understanding is the FDA can ask questions as long as they like. From memory, I believe they can simply advise within the 30 days that there are more questions to come. Not necessarily because VLA submission is unsatisfactory as much as scientific answers are quite likely to raise other questions. Burlay, I also have faith in Management. They have always answered questions I have asked, and BD has always been very approachable. Would not be too hung-up on time frames and would definitely not bet the house on a May 22 positive result.. Sooner or later I believe (hope) we will get the much awaited ?YES? though. Hopefully not being a dreamer. Each reply must be one step closer to answering all possible FDA questions.