Tuesday, July 05, 2016 7:38:46 PM
There is close to 0 chance that the FDA won't approve Scenesse once we reach PDUFA.
If they submit the NDA after the patient meeting - perhaps sometime EOY or in January / February, then we will see a PDUFA date sometime next summer. Perhaps June / July, 2017.
Just in time for EPP patients to at least enjoy a part of the summer without pain.
This news ought to add at least 50 % to the share price once the ASX opens this evening. I bet it won't, though, but eventually this is extremely valuable.
First and foremost, this is a day of celebration for those who suffer from EPP. I am extremely happy on their behalf.
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