MSB 0.76% $1.31 mesoblast limited

Ann: Trading Halt, page-546

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  1. 5,492 Posts.
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    I love the imagination on this forum, but the last time I checked the FDA is looking to approve Ryoncil for SR-aGVHD. That review team have no remit to look at any other indications for the BLA. And even if it were true, the implications for MSB could only be bad. The FDA may put increased scrutiny on manufacturing and product quality. Not something you'd be able to resolve in a few days.

    Any unscheduled FDA meeting takes weeks to set up, you can't just pick up the phone and call the review team. You request a meeting formally, and the FDA have weeks to respond with a proposed meeting date.
 
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