The Exelogen suit appears to be baseless on all publicly available information. Exelogen seems to be a one man show - judging by their ineptitude to commercialise exenatide the first time, I have little faith in them pursuing the university's legal team.
What it does show is that there are interested parties for Invex's Intellectual Property before it's even commercialised. For those that have long memories, they will remember the Retrophin surprise takeover offer for Clinuvel in 2014. It was unsuccessful but clearly demonstrated interest in Clinuvel IP several years before they gained approval with the FDA.
It is now 'several weeks' since the initial FDA advice regarding the proposed Phase 3. I would hope the BoD would find it prudent to make a determination on the direction of the Phase 3 study(s).
The formulation has been selected - so the contract manufacturer appointment should be soon. The words used by the BoD was 'imminent' several months ago, so they need to hit the milestones they set for themselves.
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