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Message: DAPA HF

The good news is ... if BoM succeeds, and 208 actually achieves "proven safe and effective" by the FDA, we could get a significant amount of "off label" utilization while awaiting additional sanctioned and studied indcations? So that those indications may be marketed.

Dependig on the final safety profile, risk versus benefit profile, and likelihood of helping desperate souls based on post hoc evalutions in addition to the primary and secondary identified endpoints.

I mean ... if RVX-208 becomes FDA approved for CVD, and also shows glowing promise for CKD, what is to stop some doctors from going off label while P2/P3 CKD studies are underway (given a stellar safety profile for low risk of course!!).

Cognitive?

Heart failure?

Obviously the closer to approved indications the better, but a safe profile plus positive data, and /or serious promise for some desperate people brings some interesting questions into play? Getting it paid for pre-approval could be a limiting factor as well though, for off label ... but severe enough cases could find ways to pay for the therapy, and would likely be willing to take on off label risk.

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