Ann: Meeting Requested with FDA on Revascor Accelerated Approval, page-28

ROFL ... how long have you been invested in MSB for ? Everything announced by SI in CCs / AGMs / ASX announcements etc takes twice as long (and then some) to play out ..... I gave a classic SI example yesterday in Post #: 78498660 in relation to the CLBP sites claimed that would be open in "the coming 4 weeks"


You're going to see a ramp-up of enrollment in short order. We've invested substantially in sites. The number of centers that are coming on board that are onboard now is approximately 15. We expect over the coming four weeks to get up to about 40.


https://clinicaltrials.gov/study/NCT06325566?intr=Rexlemestrocel-L&rank=3


5 weeks on and the number of sites sits at 18 .... nowhere near 40 and not even half way to 40 (20) 5 weeks later .... and yet people defend SI repeatedly on here !


All he needs to do is say "you're going to see a ramp up of enrollment in the coming weeks" and leave it at that but no he always goes into specifics and makes what 'appears' now to be exaggerated claims or unrealistic predictions of what is going to happen and wonders why the market doesn't believe a word he says when none of it comes to fruition weeks on from said specific statements .... throwing the word "expect' into the equation doesn't cut the mustard no matter how many on here make reference to these types of terms in his comments - he really needs to start under promising and over delivering .... it's not that hard - just sayin'

IMO that said, the announcement today is a positive and what I take away from it is that the next Type B meeting for the AA pathway (they have already had one) will see a CHF partner at the table because apart from finalising the BLA submission guidance they are also finalising the proposed design and primary endpoint for the confirmatory trial, CMCs etc etc - I cannot see a big pharma group not wanting to be present for same if you're throwing hundreds of millions of dollars at this indication and perhaps even being involved in the manufacturing process ?


GLTAH