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Actually I also just noticed how prescient the CEO’s comment in...

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irenekwshiu

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31/08/23

22:36

Post #: 69675842
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Originally posted by dachopper: ↑

Dr Eric Rose - Chief Medical Officer Mesoblast June 30th webcast 2022

" Let me go back though to GvHD. To say we are not excited about this would be the understatement I think of the century. There are drugs approved recently for chronic GvHD with now two companies that have achieved more than a billion dollar valuation with that indication. We think we are going to be right in that range. This is a whole new class of theraputics, there is no off the shelf stem cell, or any cell product as far as I know aside from drug transfusions that is approved by FDA for theraputic use. The company stands at the precipice of a breakthrough in this regard for a class of therapeutics that I think will have wide use in multiple diseases, and we think it will be valued for that as well."

Dr Silviu Itescu - CEO Mesoblast Sep 30th webcast 2022

" In particular the only drug that has been approved to date for SrGvHD is Ruxolitinib. It was approved on the basis of a single open arm study, when it subsequently did a randomised control trial it was required to do in a post approval commitment, there was no survival benefit in Sr GvHD. Independent investigators more recently published a significant survival benefit with remestemcel in children with the highest risk of mortality where survival in the controls was in the order of 10%, and survival in remestemcel treated children was in the order of 64%. "

CHF FDA RMAT meeting - estimated end of Feb 2023

CLPB pivotal USA trial commence - expected April - June 2023

Remestemcel PDUFA date - estimated by June 2023

CHF partnership announcement - estimated after the RMAT meeting

ARDS trial announced - estimated H2 2023

Ryoncil phase 4 in adults - estimated H2 2023

2022 was the year of the popcorn, now it's main event time !

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Actually I also just noticed how prescient the CEO’s comment in the Sep 30 2022 webcast was as well, in light of what is now happening.

Thanks Dachopper for the post!

Last edited by irenekwshiu: 31/08/23

MSB Price at posting: 51.0¢ Sentiment: Hold Disclosure: Held
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