All, please actually read the information provided, specifically "the FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD."
I find this a little unusual following the ODAC process, however it is not a rejection by the FDA. This is a critical treatment with no other product in market so I think Meso wil make this work.
Finally, remember when everyone panicked before ODAC and Meso went back to $3? People will panic again now and those that have faith and patience will accumulate (I will be part of the latter group) and be rewarded later IMO.
GLTAH, DYOR.
Ann: Update on BLA for Graft Versus Host Disease, page-155
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