Athersys Inc (ATHXQ)

[edwick709]

29% of stroke patients got an EXCELLENT outcome,ATHX may go for A.A. to FDA NOW.
1)using GOLD standard methodology, a STAT,Sig.(p=0.02) IMPROVEMENT over PRESENT standard of care (window of therapy EXTENDED from 3 hours to 36 hours) is PROVEN.
2) Potential IMPACT, on 15 MILLION patients WORLDWIDE.
3) Hence in terms of FDA CRITERIA for ACCELERATED APPROVAL(large IMPROVEMENT over SOC and the MAGNITUDE of EFFICACY) this GOLD standard study may qualify for ACCELERATED APPROVAL.
4) ATHX could be in negotiations with FDA right now.