Reg,
just on that point you made the other day about Rex being the only current RMAT designee for back pain: good point.
Back at the end of the Feb 29 Earnings CC CEO Itescu said yeah, Rex has an RMAT designation for the back pain indication, but take note that this isn't an Orphan indication (implying in my brain that most or a significant number of of the RMAT designees are).
He said the lack of an ODD gave a real sense of the importance of the disease (to FDA), both in morbidity & its #1 reason for opioid usage in the Western world. Number he gave was 50% of opioid prescriptions being for patients with chronic low back pain. So, yeah sepsis and IL-6. MSB might be using IL-6 to do things like stratify trial participants for MPC-06-ID treatment. Sounds logical, as you said (also for COVID-19 - not sure if you were looking at that too) but I think CEO's saying he thinks FDA think the opioid sparing is a big deal too, maybe even bigger than sepsis in their (apparently readily politically-influenced) bureaucratic minds.
So, it could be a tight trifecta this year, but sadly my odds still seem to be shorter than ASXs at present i.e. on the 3 indications we're talking about as being there or thereabouts.
On IL-6, sepsis & COVID-19 for Revascor, you might check out this linked article: (J Pers Med. 2023 Feb; 13(2): 333) - worth reading in full, IMO.
Here's the extract I thought you'd be interested in:
You can see the connections being made to COVID-19, so the MOA 'raison' is getting clearer to me across indications, as I see it, which is fantastic.
I'm hoping MSB might have talked to FDA about data collection and measuring IL-6 levels as a new predictive biomarker in the confirmatory as well. I think FDA would find that very interesting.
All good stuff, I think.
Cheers
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