If this turns out to be true, IMO it's unconscionable for the FDA to make EPP patients wait another year just for a Phase III trial. Italy has already allowed EPP sufferers to have the drug. And given the excellent safety profile of the drug, this is the FDA being the same old FDA.
The FDA needs a massive overhaul (again).
I've always been confident the EMA would approve the drug for EPP. I can't express the same level of confidence with the FDA.
us epp trials - this is getting serious, page-2
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