Excellent analysis
@Phaedrus. May I offer an additonal insight for your consideration . It is my understanding from anecdotal conversations, that many severe grade patients treated by Ryoncil in the EAP and GVHD001 achieved complete remission and that the subsequent levels of Chronic GVHD (which are usually up to half the acute patient population) were more than halved to around 15% of the survivors treated with MSCs for acute sr GVHD.
This would be very persuasive “real world evidence” if Mesoblast can prove this to the FDAs satisfaction. Ruxolitinib has already been approved for CGVHD so they could take a double whammy if the blaster files a supplemental BLA in a year or so for this indication, once it has had time to collate this data. CGVHD requires long term treatment and I think I read somewhere , with Ruxolitinib lifetime treatment costs can be in excess of $1m per complete response (will have to find notes). This has obviously not escaped the MSB management but they have plenty on their hands right now. Chronic is more a B cell mediated pathway which is a further demonstration of Ryoncil’s myriad of immune pathways accesssed which provide paracrine activity. Silviu has recently filled his patent for treatment of this indication , so his intentions are on record . Together with Crohn’s Colitis , potentially Ulcerative Colitis , and other GI related auto immune diseases, there is plenty of label extensions representing “low hanging fruit” for this therapy. Analysts will be reluctant to talk about “off label sales” but i note that Edison included revenue in forecasts in a very comprehensive note published online in 2019. I think “off label” has enormous potential..but much of the above is for the medium term or partnership as the Company has even bigger fish to fry ! What an opportunity. OP
https://www.patentguru.com/inventor/itescu-silviu
Please do not rely on the accuracy on any facts or opinions expressed in the above post when making any investment decisions.
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