Ann: Invex Receives Written Response from FDA on Type C Meeting, page-22

I've followed Invex since IPO and the FDA advice is disappointing.

The key piece of information to me is that the primary outcome requested by the FDA Neurology - The Perimetric Mean Deviation did not have a significant result in the Phase II by Invex.

The FDA Opthalmology said that if they gave a vision based endpoint, they would need two trials. My interpretation of the reason why was because the Phase II did not have a significant result as noted below. For this reason, if Invex needs FDA approval, they will need to run two well controlled trials, looking at PMD.

In my mind, the equation has changed, the FDA is a dead end, and Invex with the cash it has, needs to move squarely to one trial to gain EMA approval and then look to sell to the highest pharma bidder in 2024.

See excerpt from the Phase 2 result announcement below - https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02236887-6A979554?access_token=83ff96335c2d45a094df02a206a39ff4