FDA Prediction, page-26

Not a problem mate. I am not an insider and don’t have to be one to say experien group are confident with the approval. For someone have 99% clearance do you think they will take on a case they are not confident at all?

Looking back US trail result released late last year most of the figures were good enough but not pneumonia and bronchitis even after extra adjudication, couple of months were then spent in consultation and preparation before case lodged April this year.

Our management has learned great lessons about risk management from previous failures. If they did not exclude both illnesses FDA may still approve the case but they rather compromise them to have extra guarantees of approval.
Experien group is not somebody that is convinced to manage the case from day 1, it was a relief to see that Ann the final lodgment was done through them, the odd for not getting approval is less than 1% but the doubt people have in this forum is a far more than that for some reason.