banter and General Discussion, page-11415

"As for the idea that Eric Rose only acknowledged the potency assay issues in 2023, that’s not accurate. The concerns about batch consistency and potency assays were central to the FDA’s 2020 CRL, and Mesoblast has been actively addressing this since that time. In their official communications, Mesoblast has frequently outlined the steps they’ve been taking to improve their potency assay, long before the 2023 statement."

JB is right. Again. In all of what he is stating.

Wrt Rose acknowledging the assays issue was due to Mesoblast, JB is correct. I assume he is correct that it was in 2023 - from memory, that feels about right.

The ONLY indication prior to Rose's statements was that Fred Grossman got punted (and kept on as a consultant). That was a long time after ODAC in 2020. I'm thinking at least a year. BUT, there was no statement that mentioned the assays that went with it!

MSB's first response, from no other than the great SI, no less, was pointing the finger at the FDA (for which there was some merit, IMO). But that merit did not include the assays.

MSB has spent US$80-100M worth of heavily diluted (CR) shareholder funds and they haven't told the market exactly what the problems are with the assays and exactly what they have done to rectify.

The market has to just believe they know what they are doing with their 3rd BLA attempt. That's why the SP struggles to make $1.50. JB didn't do that.