Hi,
I would imagine theres parents out there watching their kid suffering
that are hoping for a positive decision.
For us guys worst case we get sent back to the drawing board.
SI has publicly stated that the FDA has been very helpful in working thru this submission .I cant see how we would get to this stage and not have Batches etc worked out.
Also the company has said they are endeavouring to produce 20,000 treatments for Covid . Thats tells me we can expect a successful outcome so if Ryoncil is knocked back where does that leave the FDA with ARDS.
Personally I cant see the FDA hanging all those unfortunate kids out to dry .
Aloha.
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-703
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