https://hotcopper.com.au/threads/msb-a-new-dawn.8377341/page-1905...

https://hotcopper.com.au/threads/msb-a-new-dawn.8377341/page-1905?post_id=79363780

A chatGPT summary of @Phaedrus' post:

The commenter agrees that Accelerated Approval (AA) for Revascor in end-stage (class IV) congestive heart failure (CHF) patients is plausible and supported by FDA’s willingness to accept the DREAM-HF trial (which enrolled class II/III patients) as a confirmatory study. This is unusual since FDA typically requires two large phase 3 trials in the same patient class, but they appear to accept DREAM-HF due to biomarker overlap—namely elevated inflammation—in both LVAD (class IV) and class II/III patients.

However, while approval in class IV patients may proceed, approval for broader class II/III ischemic heart failure patients will still require a new confirmatory trial, per the company’s April 30 statement. That’s a significant distinction.

There’s a paradox: DREAM-HF (class II/III) can support class IV approval, but not vice versa. The likely reason: new standards of care (e.g., SGLT2 inhibitors) emerged after DREAM-HF began, and those meds now affect expected outcomes in class II/III trials.

The commenter clarifies that DREAM-HF did show reductions in MACE hospitalizations, but not in decompensated CHF hospitalizations, which are frequent but less severe events often treated with diuretics and not counted as "major" events.

They emphasize the promise of regenerative medicine but note that actual tissue regeneration remains difficult. However, Revascor's inflammation-reducing effect is promising, and results like increased ejection fraction suggest potential efficacy.

Overall, the tone is cautiously optimistic: Revascor may be close to approval for the highest-risk patients, but broader use will require more data and likely trial redesigns considering new standards of care.