Clinuvel had the PD ethics sorted quite some time ago. It was the patent they had not secured delaying the 6th indication. Announcing must mean they have either now got the patent through the patents office or are certain this will be secured.
There are a host of papers written on afam and CNS, including on MS. Clinuvel could probably have gone for a few CNS disorders but have chosen PD and I expect like with EPP, PD must have the best chance of success.
My poor understanding of PD is that the outcome in patients is a loss of dopamine in the brain. Something must cause this loss and it looks like there is a focus with BP etc on the rise of alpha synuclein in the brain with PD sufferers as dopamine is lost and MCR1 reading is weak. While afam does not cross the BBB as far as I know, afam boosting MCR1 action does make it through, lowers the alpha synuclein and slows/ceases? the loss of dopamine.
The amount of real world evidence from all the EPP patients monitored over the years has given Clinuvel a massive base of information. If this works on a trial of 6 patients with EOPD and achieves study endpoints this will be ???? greater than $14.96.
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