Ann: Mesoblast Maintains Momentum with FDA, page-32

  1. 17 Posts.
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    This was a positive update and the only individuals who are saying it’sa puff piece or being negative towards the announcement are individuals whom arebearish on MSB.

    I like what I am seeing with MSB as communications have improved.

    It’s great to see the Type B meeting with FDA under its RegenerativeMedicines Advanced Therapy (RMAT) designation for REVASCOR happened last weekand we will receive the final minutes from FDA in order to provide detailedfeedback and timelines for potential filing in early July. This will happenwithin 30 days, so early July or even sooner.

    I also like that MSB have announced that in early July, Mesoblast hasan upcoming meeting with FDA to discuss a pivotal trial of Ryoncil® in adults with SR-aGvHD.

    It’s great to see that MSB are encouraged by the strength of the ofthe Ryoncil® commercial launch, the rate of hospital on-boarding, physicianadoption, and payor coverage exceedingly their expectations in the ten weeks sincecommercial launch.

    This is stating that sales are increasing beyond MSB’s expectations soShorter’s be aware!

    Time is ticking for the shorters! I would normally never say this butI think over the next 4-7 weeks they have to start to exit.
    We all know shorters aresmart and know how to play the game. I’m sure they will have thought offmultiple exit strategies but time is now against them.
    Wouldn’t it be nice tohave multiple media outlets put out more awareness of MSB and have good newsstories about this battle-hardened little Aussies/US company whom is making hugepositive inroads into the medical world.
    Just a great announcement and very positive.

 
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