Ann: Mesoblast Partners with BMT CTN on Adult SR-aGVHD Trial, page-269

https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/otp-town-hall-cell-therapy-chemistry-manufacturing-and-controls-june-2023-06082023

@Stellowe, I notice I left the above link out from my post which you replied to. It’s part of a “townhall” series put out by the FD A to educate industry on their requirements. There’s a link on the page to a recorded Q and A session in August last year (the session might have taken place in Jun). Matthew Klinker, the CMC reviewer who is in charge of branch 2 of the CMC Office for Cellular and Human Tissue Therapies and likely behind the FDA request for more data from MSB, answered a number of very specific questions from around the 24 minute mark.

The other staffers present also answered some slightly more general CMC questions, so all in all the recording provides very good insights.

They might still be too general though, for @JB1975 who wants to teach the company how to do things.