Ann: Phase III Clinical Trial Update and New IIH Market Analysis, page-149

Appreciate your input Dr T.

With regard to costs, I'm encouraged by this statement in the release:

Overall, the changes are expected to be cash neutral with respect to the original IIH EVOLVE trial costing, with recruitment anticipated to materially accelerate due to an expected significant reduction in pre-screen and screen failures.

Dropping the requirement down from 240 to 130 patients should certainly mitigate the costs associated with any delays in gaining approval.

Regarding the impact of drugs like Ozempic, it should be noted that the worry isn't that obesity and therefore IIH are about to be cured. Obesity is a complex condition and reducing appetite isn't going to eliminate obesity or IIH entirely. The only problem is that it may limit the number of trial participants.

...increasing availability of these drugs may impact the execution of the IIH EVOLVE Phase III clinical trial as patients potentially elect to not participate in the study due to a 50% chance of receiving placebo initially for 24 weeks.

My view is that it is pessimistic to assume that we won't be able to find 130 patients in the world who would be willing to go without Ozempic for 24 weeks so that they can participate in our trial.