MSB Trading 2020 - a new dawn, page-8306

Reading the CRL and listening to Drs Itescu and Grossman carefully in the webinar I think points to what is going on here.

The reason for the delay is that FDA doesn’t want to approve groundbreaking and controversial therapy ON CHILDREN AND WITHOUT A DOUBLE ARMED PLACEBO TRIAL......when they can wait 4 weeks and approve the exact same product FOR ADULTS AND WITH WITH A DOUNLE ARMED TRIAL ....They are going to stop the covid trial at and approve along with GVHD..

DrItescu was hinting at this in code in the webinar, bringing up covid ards trial a lot and talking about November a lot when the subject of the call was an entirely different trial......I don’t think he brought up covid to help the share price and say “but don’t worry we still have covid trial” I think he was suggesting covid trial was the reason for the delayNotice he didn’t mention heart failure or back pain ....because they weren’t related to the subject but Covid was mention because it was related to the topic of the conference call as it is the reason for the delayCovid and GVHD both drop early to mid November on same day.

this way they approve and start treating GVHD which has an unmet need without needing to cut corners without a double armed trial...

approving for gvhd, while correct and needed would open the FDA to criticism as it will be first stem cell approval and without placebo trial and it is on children under 12............wait a month and those Criticisms do not occur, everyone wins and the process has more credibility and less scepticism. IMO