4C as expected, but notes that the Company has worked closely...

4C as expected, but notes that the Company has worked closely with FDA during the course of the review period and remains in ongoing dialogue with FDA.That is a big hint as far as I'm concerned. Why emphasize they are in ongoing dialogue unless to give us a hint that things are progressing, but that there are no problems that they think will kill the approval.It tells me there are no major problems that Meso is aware of, or they would have to make an announcement under continuing disclosure rules, or at least suspend the shares from trading.They remain in ongoing dialogue, so that is right up to date. If the FDA discovers a fatal problem Meso has not yet been informed. FDA is unlikely to leave the final decision until the last moment - it has probably been already written up and sent to peter marks for final approval.Having said all of that, Meso and the market were blindsided in 2020 by the CRL, so you can't say approval is guaranteed, but I do take this as an indication of how they think it is going.Cash balance at the end of the quarter was US$71.3 million, with up to an additional US$40 million available to be drawn down from existing financing facilities subject to certain milestones - those milestones could be met on Tuesday. That's plenty of cash, and the operating cash burn was $16.3m, in line with the quarterly average of the past year. US$7.2 million (44.2%) was for manufacturing activities ahead of potential product launch - so the other operations cost $9.1m.


From a friend of MSB, read before it’s gone!