Athersys Inc (ATHXQ)

[pearsby09]

Supposedly they are transforming their process in the direction of a more efficient method to bring therapies to the USA unmet disease state patients by:
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