VB submission is basic on a reasssesment and legal case against...

VB submission is basic on a reasssesment and legal case against the FDA via other companies, base on devices seen as meds, (TGA?)
that case was about 2.5 years ago.
iin turn the FDA had to reasess non approval re devices. I believe that legal case is what those comments are about in presentation.

i did quickly read somewhere that the FDA is 'working by their agenda "try to chnage the goal posts" to suit them. re device med or whatever

maybe that the path for VB won't be as smooth but otherwise i believe given those precidence mentioned (not actuall quoted) it will get FDA approval.