FDA ODAC Meeting Material discussion analysis, page-181

In context from your original post. The relevant points I believe.


Statement made under title 1.2 Topics for discussion. Not Resolution to be voted on.

So FDA looking for input from expert panel.

Without a demonstrated ( not that it doesn't exist but how do we measure/demonstrate it) relationship with clinical effectiveness and or vivo potency/activity, controlling these CQAs may not be sufficient to ensure manufacturing process consistency .

So FDA is looking for input from the expert panel on how to regulate consistent manufacture from batch to batch. Not whether remestemcel works as this is covered in the FDA conclusion. The FDA is convenced it works as that is their conclusion.

To me this reads as FDA is looking for any way to ensure number and potency of factors released from MSCs at site of infamation.

Not number of MSCs per dose per batch.

This is my unprofessional opinion however I'm consoled by the FDAs own conclusion on safety and efficiency.

So in summary it works and is safe, however experts any ideas on the best way to ensure consistency per batch or dose or per MSCs/ factors released there of? Please discuss.