As I have previously said, there is a huge unmet need for...

As I have previously said, there is a huge unmet need for Diabetics and Ischemic’s with Inflammatory biomarkers in the CHF Indication. The company has previously received feedback from the FDA to focus on the patients at highest risk for death or other major adverse cardiac events (MACE). I believe the upcoming meeting with the FDA under the existing Regenerative Medicine Advanced Therapy (RMAT) designation shall discuss the potential marketing approval pathway for rexlemestrocel-L in high-risk patients with HFrEF (Heart failure with reduced ejection fraction) and recorded inflammation.
Diabetics are the focus in my opinion for a potential Accelerated Approval (AA) and thankfully Mesoblast has a multi center Phase 3 completed because this meets FDA guidelines for the AA.
Confirmatory trial with surrogate endpoints would take 2-years instead of 5-years. There is no reason why the trial does not continue in order to record the Gold Standard MACE and Mortality endpoints. This just requires patient follow up for a few more years.Repeating what I have said before, the HUGE indication is the ischemic class II/III HFrEF2 patients (with high inflammation levels). The upcoming DREAM "TWO" HF trial should have a goal to get earlier approval based on a surrogate endpoint. The FDA and Mesoblast must first be aligned on the surrogate endpoint.LVEF improvement at 12 months should be an appropriate early surrogate endpoint. Targeting the key mechanism of HFrEF which is inflammation must be a major priority. Understanding mechanisms that drive HFrEF is a key objective of the FDA, and Mesoblast has now provided the FDA with results from three randomized controlled trials in class II/III HFrEF and in end-stage HFrEF with left ventricular assist devices (LVADs), which ALL support the idea of a common mechanism of action (MOA) by which rexlemestrocel-L reverses inflammation-related endothelial dysfunction and reduces adverse clinical outcomes across the spectrum of HFrEF patients. Remember that Mesoblast reported that effects on LVEF and MACE outcomes were even more pronounced in 301 HFrEF patients with high baseline levels of inflammation as measured by hsCRP. This should be the Data that pushes the FDA to approve the trial with the surrogate endpoint and recruitment criteria of high baseline levels of inflammation, as the data showed that increased LVEF preceded long-term reduction in major adverse cardiovascular events (MACE) and associated recurrent hospitalizations for non-fatal heart attack or stroke.