Awesome DD Thanks No fault of yours, but of course it's missing the one thing I'm looking for... A link to the submitted Orphan Drug Fast Track Approval applications! I've spent hours on that site and everything is many months old. They don't post anything till the drug is on the shelves. Just like this one but at least it says the phase II was completed last month. https://clinicaltrials.gov/show/NCT01009931