MSB to dispute FDA finding in Type A meeting, page-76

@otherperspective you make some excellent points in your message, the main one being that "FDA are out of their depth".

On a relative basis I think that they are.
That is why I think they have asked for this extra trial, which may ultimately be completed post approval depending on how well SI et al go when meeting them.

They are in the difficult position of passing judgement on a therapy which far surpasses their understanding.

In some ways it could well be stage management to appease significant 'external interests' who can / do place them under pressure.

One thing that is not an effective assessment tool is retrospective evaluation of other drugs or therapies.

Some are rubbish and downright dangerous. These are not good examples of why our product 'should' be approved but rather a reference to why the FDA sometimes need to do more before they approve drugs.