Australian newspaper article, page-57

The timeline of the Australian article is out of whack a bit. It says Meso went back in Jan 2024 to the FDA and were told they had enough for approval. Meeting minutes from the Jan meeting and subsequent announcement were not released until 26/03/2024. Immediately upon that announcement our American major shareholder bought massively on market. Our new chair bought on 12/04/2024 and then our Chief Medical Officer did not buy on market until 30/04/2024.

Why did the CMO wait? If kids aGvHD was a slam dunk why not buy then?

The quarterly released on the same day the CMO bought on market contained this:

FDA informed the Company in formal minutes following the Type B meeting held in February under
Mesoblast’s existing Regenerative Medicine Advanced Therapy (RMAT) designation, that it supports
an accelerated approval pathway for Revascor® (rexlemestrocel-L), Mesoblast’s allogeneic
mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with
reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD).

yes - I have mentioned all this before- but in the Australian article supposedly all about kids aGvHD strong likelihood of approval there was a little snippet from Si on the heart indication



Prof Itescu said the company would then seek to do a confirmatory study to demonstrate the efficacy of the drug in other patients, and a wider market.


Why is he pointing to demonstrating efficacy in other patients? Is LVAD accelerated approval a slam dunk with efficacy not in question? The CMO appears to think so


Interesting that Si has also said
Product 1
Product 2
Product 3

Anticipating order of market approval? aGvHD, LVAD,CLBP


Looking forward to an announcement this morning


Reg