Hmm, is anyone else a bit circumspect on Scott's prediction that...

Hmm, is anyone else a bit circumspect on Scott's prediction that it's a 65% chance that the FDA will allow a single pivotal registration trial? Where did he pull that stat from?

From an FDA Opthalmology office perspective, they'll need to see the significance in a PMD endpoint. But after 12 weeks, there was no significance in their Phase 2 data when they release it. There was significance in the LOGMAR, but for some reason the FDA Opthalmology division isn't interested in this, so they're stuck to prove PMD over 6 months, an endpoint that exenatide has not shown significance in.

Liaising with FDA Neurology is a new ball game, but then again, the FDA could easily say they want 2 well-controlled trials, and Invex is forced to capital raise to run 2 simultaneous trials or wait for success in the EU trial before running a second trial which would extend the timeline for buyout to post 2023+++.

The idea of a lumbar puncture EMA endpoint isn't as simple as everyone lets on. The ethics of doing a lumbar puncture on a patient who you're giving a placebo medication to for 6 months needs to be questioned.

I feel the SP may hover lower as sophisticated investors exit unless the company brings back confidence with success in their regulatory interactions.