Is the FDA going to delay approval till the beginning of the next US Administration? Then the newly sworn in President can claim all the credit for approval of the first Stem Cell treatment. Maybe all this is part of some back room deal; "you'll get your approval as long as it's a bit delayed".
There is so much bigger fish to fry than this indication. Has taken so much management attention, it's like we're taking the hardest path to market.
Ann: Mesoblast to File BLA for Ryoncil FDA Approval Next Week, page-92
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