MSB to dispute FDA finding in Type A meeting, page-209

@stockrock - thanks for responding to me so quickly

I have listened and relistened to the webcast, read FDA website and articles on CRLs and Accelerated Approvals as well as gone back over the ODAC docs

My interpretation of where we are at now is that FDA has (based on what MESO say they have requested in the CRL) moved past most of the issues it threw up at the ODAC - aGVHD Trial Null Point set by MESO at 45%, Lot Quality to name what I think were two big ones. Not sure if they have completely parked prior (previous owner) fails though.

Perhaps what I should be asking you, is assuming it is a Class 2 CRL (is the class stated on the CRL issued by FDA?) and rereading on the ODAC FDA presentation to the afternoon session that they accept that Rem-L showing 70% aGVHD ORR at 28 Days is “statistically significant” - if the MESO approach of taking the 28 Day ORR to the FDA as a surrogate Accelerated Approval proposition (on the basis that there is no approved treatment, high unmet need etc.) is what would turn the CRL into a Class 1 - ie accelerated approval granted and trial to follow?

On the Webcast SI although understandably frustrated says he is confident of an accelerated approval - appreciate he would say that of course.