Tuesday, September 12, 2017 3:28:13 PM
SPA's
Accelerated Approvals
Fast Track Designations
Break Through Therapy Designations
Orphan Drug Designations to niche unmet disease states
Interim Analysis via possible expedited approvals based on safety/efficacy
Others
SRPT got approval for DMD based on N=12. That was unprecedented and controversial..but ended up getting approval
We need more of this with many more therapies. All of these designations do not mean squat unless utilized and implemented!!!
Sorry for the vent.....Pearsby
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