Thanks for your insights! This was the response I was hoping for with my question. We're not out of the woods yet. Far from it. I'm pretty sure PW has these on his radar as well, so probably autorities / paperwork / competition are the main cause of the timing I assume. I don't have the impression the board is sitting on their behinds while watching the sun rise and set.I have absolutely zero doubt that afamelanotide works in all three areas ... photoprotection, DNA repair, and inflammation control. Why? Because I've used it and I know what my normal body response would be without it. If you can prevent a bad to horrific sunburn from occurring, then you know afamelanotide is doing these things. Will it work in stroke victims? I say absolutely ... the damage from stroke is death of brain cells due to lack of blood supply and the resulting inflammation that occurs from the blockage. I believe that Prenumbra will control the inflammation because it will moderate the the cell signalling that causes the inflammation at its root. The XP trials put the spotlight on how well Scenesse will perform in the area of DNA repair, so I am very keen to get those results.
But to me, the most significant effect out of all of the wonderful things this synthetic peptide does has always been inflammation control. So many big diseases could be made less harmful or potentially manageable with a healthy dose of inflammation control. We have seen this recently with COVID-19. The virus is most destructive due to its inflammatory after-effects. Control that and you control its lethality.
As far as breaking through the skin barrier ... really you need only the amino-acid sequence (His-Phe-Arg-Trp) which is the minimal sequence required for selectivity and activation of the MCRs (except for MC2R). The trick is how long it will stay activated. For improved staying power, you need additional post-translational modifications on the end(s) of the peptide. This is (actually one of 3 things) that distinguish synthetic Scenesse vs. our natural a-MSH.
The biggest risk in my mind is not the efficacy of the drug at all ... it is management's ability to execute and get the drug to market for a wide variety of indications big and small in a timely manner before either patent expirations or the bigger threat, competition in the form of a competing drug candidate. All it would take is for somebody to discover just one amino-acid difference or one different post-translational modification to create a legally recognizable NEW drug that performs just as good or better than what Clinuvel has in its portfolio and the future financial situation of the company would have to be refactored.
And really, it doesn't even have to be the same or similar set of amino-acids as we have seen. Its shape could be cyclic vs. linear as what Palatin has in its portfolio with Bremelanotide. All this new peptide or even molecule would have to do is fit in the 7-transmembrane GCPR pocket of the MCRs and keep them activated.
This is what keeps me up at night ... until Clinuvel management can execute as promised. They have money to spend on R&D. Why aren't they making sure there are no other potential peptide configurations out there that might compete? MT-7117 is nothing like Scenesse structurally, yet if it can stimulate the MCR pocket effectively, it could potentially be a rival drug. This is why time is the only risk factor to me.