banter and General Discussion, page-11385

You bring up valid points, particularly about the FDA’s role in ensuring that the potency assay was addressed, and yes, Mesoblast’s initial approach during the 2020 ODAC meeting didn’t meet the FDA’s expectations. However, it’s important to note that Mesoblast has not been hiding the issue of potency assay concerns. The FDA’s CRL in 2020 explicitly mentioned the need for more evidence on the consistency and effectiveness of the potency assay, which was already communicated back then.

As for the idea that Eric Rose only acknowledged the potency assay issues in 2023, that’s not accurate. The concerns about batch consistency and potency assays were central to the FDA’s 2020 CRL, and Mesoblast has been actively addressing this since that time. In their official communications, Mesoblast has frequently outlined the steps they’ve been taking to improve their potency assay, long before the 2023 statement.

Regarding the FDA’s rejection of the Biologics License Application (BLA) in 2020, it’s not unusual in biotech for companies to go through several rounds of feedback and adjustments. Mesoblast has been clear about the need to ensure the product’s consistency and efficacy before moving forward with approval. Their response has included creating a new trial plan to meet the FDA’s requirements, focusing on developing a validated potency assay.

The idea that Mesoblast would have shipped product with an unresolved potency assay issue if they’d been granted approval in 2020 is speculative. FDA oversight is designed to prevent this kind of situation, and Mesoblast has demonstrated a commitment to ensuring their products meet the highest standards of safety and efficacy.

I agree with your broader point that the MSC treatments need to ensure potency across different donors and batches, and this has been a core focus for Mesoblast as they work with the FDA to resolve these issues. The company is doing precisely what is needed—ensuring the potency assay is corrected and validated before seeking further approvals.

while some of your concerns are valid, Mesoblast has not been withholding information or delaying action. They’ve been transparent about their efforts to fix the potency assay issue since the 2020 CRL, and they’re actively working to meet the FDA’s stringent requirements.