MSB 2.70% 95.0¢ mesoblast limited

"overwhelming efficacy =Clinical study has shown that the...

  1. 3,924 Posts.
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    "overwhelming efficacy =Clinical study has shown that the predefined stopping boundary has been crossed and the candidates primary endpoint met."

    We don't know what the predefined stopping boundaries are. For the first annalases I would think that FDA MSB would have agreed that the bench mark would need to be set very high giving that there would only be very limited 60 day data that is needed for the most important secondary outcome. I feel that these predefined endpoints will get easier to reach at each annalases.

    For efficacy on survival above control we might have a target something like
    30% - 90%, 45% - 75% , 60% - 50%, 100% - 25%

    Because of the importance of time on ventilation this secondary outcome will some how be combined. Thinking about this we may reduce the time on ventilation by 50%. FDA will take this into consideration and further reduce the required survival benefit remember though the annalases just completed, very few patients would have reached 60days post enrollment indeed the data by the time we reach the second annalases of 45% could be multiplies stronger.

    Survival above control with 50% reduced time on ventilation.
    30% - 80%, 45% - 60%, 60% - 30%, 100% - 10%

    Shorters should be very happy with the markets reaction however their celebration could be short lived.

    1: The 45% annalases will be a lot easier to pass for efficacy.

    2: FDA approval pending triggering ongoing revenue.

    3: 2 × Phase 3 trial read outs.

    I have positioned my self as a buyer and I think short term returns will be huge in the next few weeks.

    Good luck all.
 
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