MSB 3.33% $1.40 mesoblast limited

Ann: Mesoblast Completes Resubmission of BLA to FDA for SR-aGVHD, page-79

  1. 2,170 Posts.
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    Reg that line is so weird that I'm just about ready to call up Paul Hughes and ask him if its a typo that could have slipped through without Silviu seeing it. I'll chew it over today.

    Assuming it is a typo and should read "in vitro" - it wouldn't really change the substance of the release - in the rest of the text. Its kind of just like an opening headline after all.

    What makes this price sensitive in my opinion is that it puts the ball in the FDA court. Within 14 days after filing MSB will be advised if has been accepted for review (I expect it will be) - provided some attempt to answer the questions and points in the CRL is made it will be passed on for proper review.

    I think your chances of getting a successful outcome would have been better if you'd waited for IND file update feedback that was specifically positive or negative because even negative could have used constructively perhaps for another IND file update.

 
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