It's very interesting stuff.
There is no way they get away with not doing further studies, unfortunately.
This was all due to a direct intracardiac injection. But it looks like it is causing systemic benefit?
They'll need to do studies to see if a systemic infusion has the same effect. There's no way that they'll grant approval for this sort of injection without exploring potentially safer routes of administration if those make more sense from the proposed mechanism of action. Once they come up with a proposed mechanism of action, that is.
Overall quite neat. Let's hope the next study meets the primary endpoints this time!
Ann: Rexlemestrocel Reduces Heart Attacks/Strokes/CV Death in CHF, page-96
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