2023 The Final Countdown, page-552

It's been a very interesting turn of events since Grossman departed as CMO and was replaced by Dr Rose ... and then the appointment of Krause as a non-exec Director and now a shareholder and advisor.

Dr Fred Grossman was brought on board in August 2019 who replaced Dr Skerret, largely due to his commercial experience and promise of leading Mesoblast's first BLA submission through the FDA.

However what played out was a Gross misjudgment on how the Ryoncil BLA was prepared.. which was laid bare at the ODAC where SIlviu shone as the CEO / real CMO .. whereas Grossman was sheepish at best.

I get the feeling that MSB may have known that the pathway they are now taking was always available ... but probably more onerous in terms of ongoing manufacturing compliance... but it appears that they were swayed to take an easier route, which was subsequently picked apart by the FDA.

The departure of Grossman, the swift availability of data that was 'in place' before and during the phase 3 trial and the swift appointment of Dr Rose and more importantly Krause was no doubt Silviu being keenly aware of what was on the line and that there would be no short cuts this time around and that the BLA re-submission will be done his way with people he knows can get the job done.

I still don't know how they managed to get Krause (ex Deputy Director in FDA CBER) as a NED, then shareholder & advisor, Rob Califf's (Head of the FDA) Duke university connection with our SR-aGVHD lead investigator Joanne Kurtzberg ... there are some powerful undercurrents at play...

watching the next few weeks very keenly...

goodluck all