...and here's an on-demand video from August last which I...

...and here's an on-demand video from August last which I continue to find very interesting & hope all MSB holders will find interesting:




You'll need to register to view it. Register here.

I particularly commend to MSB holders the presentation by Ms Zheng, especially around the 29:58 mark, where she sets out Lonza's business successes in 2023. Here's the slide which Ms Zheng uses:




No prizes for guessing which sponsor's product was the subject of an FDA audit at Lonza Singapore in May 2023. Lonza were clearly very excited about it as well - it's not every day that the FDA is able to verify the validation of a cell therapy's manufacturing processes to their satisfaction in a new facility, much less to do so with zero 483s.

IMO this is clear and unequivocal validation of the statements made by CEO Itescu and Mesoblast management to ASX regarding validation of MSB's potency assays. Analysts and brokers should be giving Mesoblast credit for having done exactly what it said it had done.

Some non-holders have screamed that Mesoblast processes - especially assays - are 'not being validated'. Some holders will (no doubt) whine and complain that management 'could do so much better' & that we should 'trash them all'.

Clearly, FDA inspectorate were able to verify the validation of all manufacturing processes (including all release and in-process assays) to their satisfaction. What more could we take to the FDA now, and what more could we have taken to the FDA on the last BLA resubmission? The more I read, the more I understand how poorly Mesoblast has been served by the FDA's processes to date.

I think Mesoblast management are now right on track to deliver scaleable success to their shareholders (including me). Despite the whinging and moaning. What's more, I think Dr George knows that too.

Cheers
GLTA(LT)H