Isotechnika Pharma Inc IPHAF

RE: RE: RE: RE: Rolling submission for approval

[macbethorfaust]

'Of course, my personal opinion is that LUX doesn't have sufficient data to file for a fast track application."

And this personal opinion of yours is based on what exactly and is worth how much?

Look, the drug has long had fast track and there would have been ongoing contact with FDA as a result. When they say they are entering into discussions at this stage obviously they are talking about NDA discussions. There is incidentally no guarantee that fast track will get you priority NDA consideration just that one usually follows the other and if not we are still well within our survival time lines. And posterior or anterior, both are serious, both cause blindness if left untreated.

And by the way getting NDA for posterior uvietis will almost certainly mean off label use for the anterior uvietis as well.