I am well aware that the IND is approved by the FD

I am well aware that the IND is approved by the FDA. so reread what I wrote; I think that you will understand what that means. I told you that I am a professional in the medical device industry. I am not saying anything else besides what I have already said. I am not an insider but if you look and research hard enough everything I am saying can be substantiated through serious due diligence.