MSB 2.03% $1.45 mesoblast limited

Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-445

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  1. 17,116 Posts.
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    That's a completely nutty interpretation. The FDA has an accelerated approval pathway which is part of their approval structure. So of course they "support" it, they WROTE it. So to say that that was what Mesoblast was referring to is nonsensical.

    What is wrong is to suggest or imply that "the FDA supports accelerated approval for Rexlemestrocel for patients with LVADs" when the feedback from the FDA was actually conditional. The trial results MAY support accelerated approval. But I really think that's doubtful.
 
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