banter and General Discussion, page-3414

You mean the ‘real life data’ like Ryoncil being used off label to treat those poor kids afflicted with GVHD in the absence of any SOC ? Their treatment has continued since the FDA decided to ignore the 9-1 ODAC vote in favour of a green light for Ryoncil. Approx 15 months has elapsed since then….and clearly Ryoncil has been efficacious & effective to the satisfaction of patients, parents, doctors & the FDA for that matter. Otherwise…given the degree of scrutiny applied to this new therapy, the FDA would not have wasted a nano second ordering a Clinical Hold or even a partial Clinical Hold on Ryoncil ???