Let me ask you this: what exactly are you looking for? Do you...

Let me ask you this: what exactly are you looking for? Do you want Mesoblast to make the entire detailed trial database public, complete with every TNFR1 and IL2Ralpha reading in picograms per mole? Should they livestream the data analysis? You seem to be seeking a level of specificity that most companies wouldn’t disclose for proprietary and competitive reasons. There’s a balance between providing transparency to investors and guarding the competitive edge, which is why many companies, Mesoblast included, stick to broader updates.

Yes, they didn’t provide every tiny detail about how the potency assay is being measured in their September 2023 update, but that doesn’t mean they’re being intentionally vague. They’re following the standard practice of communicating what’s required and what steps they’re taking to meet FDA expectations. Mesoblast specifically stated that they were working on generating new potency assay data to link the product from the Phase 3 trial to future commercial batches.That’s pretty standard biotech communication.

Also, let’s be clear: FDA approval is based on a rigorous process that involves both the submission of new data and reanalysis of existing data, depending on what’s required. Mesoblast doesn’t need to reinvent the wheel by retesting everything when they already have a substantial data pool. It’s not just about dumping new patients into the mix for the sake of it—it’s about satisfying the FDA with scientifically sound, reliable results that demonstrate consistency.

So, what specifics would actually satisfy you? I doubt any company would be expected to make every little technical detail public when they’re already working with the FDA to resolve these issues.