@col69 Ask your self, would it be wise to start a trial, any trial when the FDA has not shown commitment in approving a off the shelf product like the GVHD treatment?
?? .... so based on your comments the purpose of the CR was all just a ruse then because we are (supposedly) not going to start any trials until Remestemcel-L is approved by the FDA .... whenever (IF ever) that might be ?
Sorry but I cant agree with this logic ..... can you enlighten me then on what happens if the FDA don't approve Remestemcel-L for treating sr-GVHD on this 3rd submission and want to wait until the adult trial is concluded (say) 18 months away because they aren't happy with the potency assays .... you can't seriously believe that Mesoblast is going to just sit around and wait and put all trials in hold in the interim ?
banter and General Discussion, page-8327
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