Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-150

I know, hence it will help formulate part of MSB's argument about why they cannot conduct a RCT, since it will be unethical. But if you remember, the FDA still recommended a RCT as part of the CRL in spite of what was argued as part of ODAC.

And as Lopez mentioned, the FDA also requested a lot of data, which will help MSB's attempt to bypass the need for a RCT. So in the end it will come down to whether the FDA will require a RCT or whether MSB have done enough to bypass this requirement.

Or are you saying that an RCT is irrelevant?