John Hester, right on ball. Exact question I wanted to ask: CMC...

John Hester, right on ball. Exact question I wanted to ask: CMC issue and/or new RCT needed? Looks like they may not need the RCT, just CQA data which MSB have created additional data for and will present to FDA in a couple of months. 'General agreement' on approach with FDA, according to SI. Promising.

I thought they had solid data at ODAC on the correlation of their CQA with outcomes and potency. It was different to the what FDA wanted and it wasn't as clean cut as one would have liked, so they weren't prepared to give them any leeway. FDA asked the ODAC panel to come up with alternative CQA's which is a bit like asking your lawyer how to conduct a skin graft operation. It's now being worked through with a specialist department at FDA. It's a process but good to not hear any more complaints on efficacy data from FDA.