It sure seems an approval would be in order with allllllllll the data that's been shared ...We have seen MASTERS1 etc. achieved meaningful excellent outcomes in a one-year period with very low P-values. M1 saw over 15% improvement in EO with P=.02 for the full population of 60 plus patients, with a 20% improvement in EO with P<0.01 for the 31 patients in early treatment group. EO is a very high bar and P<0.01 means that these results almost certainly did not happen by chance. In Treasure the EO counts were not nearly as good, but the combined results were quite good and significant. The combined E0 rate for the placebo group was 9.8%, and the combined EO rate for the two treatment groups is 18.5%. That represents an 8.7% difference in EO which combined would have a P value of about .02 and note tPA provided ONLY a 10% improvement which is a GREAT Outcome for patients treated within 3 hrs. and a 5% improvement for patients treated at 3-4.5 hrs. This puts MS considering the combination of MASTERS1 and TREASURE better than the 3-4.5-hr tPA treatment and roughly equivalent to tPA under 3 hours. Everyone pretty much knows that MS will do better in MASTERS2 for many reasons, including the expected age differences, with possibility of the most significant noted of what we have learned from TREASURE ... Don't forget, we have been told that TREASURE MS did BETTER than the placebo in every major metric used to value stroke recovery, which makes MS safe, much safer than tPA.
So, the????????? is when will the PMDA give us at lease conditional approval??? There has certainly been STRONG evidence and meaningful benefit to ALLLLLL which a conditional approval WILL be a NO brainier ... Athersys has become a DREAM for ANY BIG PHARMA looking for a new innovative. We all'll know this has been a mismanaged company in the past with a GREAT product. Dan SHOULD and WILL get it done going forward ... GOOD LUCK LONGS
