Ann: Update on US FDA De Novo Classification Request, page-211

"at this time"are the operative words chosen by these people SAnofi. IMHO they should have nought to do with them ever again...if RAP and Experion turn around the FDA decision then Sanofi will come knocking again just watch.
As far as FDA goes it is they who have to say what the dangers of using RAP tech are...they have to spell out what they see as potentialmdangers oter wise RAP and Experion will have nothing to work on or with. As far as RAP and Exerion are concerened there are no possible dangers from the use of the rap app. So when they are told in writing bt FDA then they can answer these reasons and we can get back on track. WE will have to be told the FDA danger fears once they are explained to RAP...surely! That would be keeping shareholders and the market informed so our chances of success can be weighed roperly...not listening to TK's opinions he is leading himself astray with half baked hope and half baked applications and half baked leadership. Obviously he is overworked...he needs help and several more experienced people around him.