Ann: Invex Receives Written Response from FDA on Type C Meeting, page-12

FDA require 2 trials no matter what. If the EU trial doesn't suit FDA then there will be 3 trials.

IXC could change design for EU trial to suit FDA so overall they only need 2, but personally I think stuff them. EU is a big market. Start there then do the larger (most likely single at that point) US trial for FDA.

FDA obviously think the trial design is too subjective and believe there is a correlation between vision function (which can be tested) and Intercranial Pressure. This is why they want this as an endpoint. EMA obviously don't care as much.

The previous ph2 had devices inserted, however IXC can't do that this time as it would be unethical to do the surgery on so many people on placebo.

My view is go EU, stuff US, and hopefully will get to pick up some cheaper shares.

if this drops even just a little we could be looking at negative EV.