Have people been reading the PM FDA briefing document? The AM document is the one that just talks about manufacturing control and raises discussion questions about how they can ensure consistency in their product, while noting that they have no concerns about safety for the product.
The PM one goes into a lot more detail regarding the trials that they'll be looking at for effectiveness and invites discussion to see which markers/outcomes should be the most important to measure remestemcel-L against, and whether the panel thinks the trial was robust enough to warrant approval on its own vs needing another clinical trial.
Have people been reading the PM FDA briefing document? The AM...
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