What angers me most is that there is a chance that paediatric SR-aGVHD sufferers could possibly get shafted even if we get accelerated approval.
If the COVID - ARDs trials is successful... and there is a huge supply shortage of Remestemcel-l... who do you think are going to miss out?
If the FDA approved it this time around, MSB could start supplying and have inventory held specifically for them.
But all this built inventory for Ryoncil launch... it could very well be lost to a much larger unmet need.
It potentially puts MSB in a very difficult situation.
MSB to dispute FDA finding in Type A meeting, page-393
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