Cell Therapy News/Articles, page-275

Are you looking for results in scientific publications or are results as described in ASX announcements sufficient for what you are looking for?

In my opinion in a Phase 3 trial in the US what matters to the company paying for the trial is what the FDA is looking for and exceeding those requirements well enough to proceed to the Biologic Licensing Agreement phase.  There are a number of other things that are considered in the BLA phase.  Of course things like figuring out dose rates are important but in the end it is what the FDA wants that matters.

If you look through the Mesoblast 2018 ASX announcements you should find some info on the 36 month followup of those patients who responded in the CLBP P2 trial.  In ClinicalTrials.gov you can compare the various treatment arms in P2 and P3 trials.

Then there is one product that has begun the BLA phase, with one final meeting (hopefully) in April prior to BLA submission shortly after that.  Remestemcel-l met the primary endpoint of its' P3 trial and the primary endpoint of the 180 day follow up, a separate trial in ClinicalTrials.gov.