Ann: Phase III Clinical Trial Update and New IIH Market Analysis, page-25

Ok news not the greatest but I dont think its as bad as people gonna re-act (mainly retailers)

Primary endpoint remains unchanged
Protocol changes focus on reordering secondary endpoints - replacing PMD with the more ROBUST Quality of Life Short from 36 (SF-36). This has already been evidenced in several major IIH trials
EMA rates quality of life measure HIGHLY

Sample size reduces to 130 patients
Incentive to patients - 6 month open label extension on Presendin
Changes are CASH NEUTRAL
Recruiting to materially accelerate

It might take a further 6 months to go back to the EMA to revise protocol? How long does this usually take?

Watch the over-reaction