I wish I could Cheetah. I thought at first Prana had a couple of options to remove the hold, one being a safe trial design. Now it seems they need the safe trial design, AND some sort of proof/evidence that what happened in a dog brain will not happen in a human trial. I imagine that will be extremely difficult data to provide.
I am not aware of any SMON symptoms from any of PBT2's 8 clinical trials, at the highest dose in question. I can only cite problems seen in another drug, which was being massively overdosed at the time, CQ. Back then scientists were not able to prove why just some showed symptoms, and were not able to prove on a molecular level why the drug caused the symptoms. Now I guess Prana have to do that in dogs and people, with not one case of PBT2 induced SMON toxicity in humans to work with. I can't imagine that is a trivial exercise. Until the specialists give Prana the completed data, I don't think there is much to be said, but it would be nice if our CEO would give us some more indication that they have something completed. Maybe they do not want to disclose any ongoing work being discussed with the FDA.
I am not in contact with anyone at Prana and the above is just a guess.
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