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To award fast track in August 2016 and to organise a patient meeting in October only to approve in February 2018 makes the entire fda look like a joke,

Whatever the procedure is they should make a new one while helping clinuvel to distribute to us patients this summer.


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Hopefully this is where Gottlieb will make an impact. There is a review of the PDUFA process where, though the goal timelines are still the same (review within 6 days of the 60 month filing date) the collection of monies shifts to a majority from approved drug income:


Restructuring the User Fee Programs


Under PDUFA VI, FDARA would change the historical structure where prescription drug user fees were derived one-third from facility fees, one-third from various application fees, and one-third from product fees. The new structure would collect 20% from application fees and 80% from fees for approved products, with fees for supplemental applications and facilities being eliminated.




btw, did Clinuvel ever apply for "Breakthrough Status" which appears to be the fastest of all the accelerated review designations?


Im hoping Farma's timeline for approval is being conservative and that fact that cGMP is proven in Europe along with existing packaging/marketing will mean a significant cut to the Feb 2018 approval date.

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