It doesnt actually say that it was knocked back or declined.
it states:
The Phase 3 trial results showed that remestemcel-L provides a meaningful treatment for children with SR-aGVHD who have a very dismal prognosis. I look forward to having this much-needed therapy available to our patients.”
The last line outlines it in a very clear way.
I look forward to having this much-needed therapy available to our patients.”
All they need to demonstrate is the following:
The FDA also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the product’s biologic activity.
Which in effect comes down to dosage. egroduction
MSB to dispute FDA finding in Type A meeting, page-35
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