I understand that there can be different synergies, but I don't believe it will be necessary for MSB to actually show a synergistic MoA effect for FDA marketing approval. I feel this because Revascor won't be a first-line or even a second-line therapy. As a quasi-salvage therapy, it's quite enough IMO if it doesn't do any harm (tick that box), and then (for AA) has a reasonable prospect of providing positive mortaility-related benefits not available from other treatments.
Obviously, the LVAD patient population will already have had the LVAD treatment itself and precursor drug cascade, and even in DREAM-HF it was an inclusion requirement that participants have had optimal medical therapies with the best possible coronary revascularization (See link here).
But what a what a way to get the post-approval attention of any & all potential licensing partners in LVAD treatment market, say. And also for Bigpharma with an existing on-market small-molecule HFrEF product that is now accepted as first-line (or foundational) therapy, i.e. the sponsors of SGLT2 inhibitors (See link here) or even - dare I say it - Entresto (See link here), but which just don't work as well as might be hoped by the patients concerned. These Bigpharma entities would want Revascor for less truly synergistic benefits in effect - more IMO to deflect from concerns about ongoing treatment costs with existing products without real QALY benefit for those refractory to the treatment.
Consider this extract from CEO Itescu's last earnings call:
" ...We focused our program on these 2 patient populations because they continue to be the -- despite all drugs that are currently being used, including SGLT2 inhibitors, including the sacubitril / valsartan combination, despite all of those drugs, patients progressively and inexorably proceed to Class 3, 4, and end-stage.." .
If the sponsors of those products could really be kept honest & accountable in terms of their 'best efforts' obligations to promote Revascor, that''s the kind of economic 'synergy' for MSB products that I'd like to see.
Cheers
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