MSB 4.07% $1.15 mesoblast limited

Ann: P3 Trial of MSB's Cell Therapy in CHF Completes Recruitment, page-37

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    It all depends where you place the emphasis, here as you do

    "This second, confirmatory study will be conducted in parallel with a patient population that has an identical clinical profile; approximately 600 of them using the same primary endpoint"


    Or here as I would

    "This second, confirmatory study will be conducted in parallel with a patient population that has an identical clinical profile; approximately 600 of them using the same primary endpoint"


    Either way there is no mention as to what phase the trial is, 3 or 4.


    I've looked for FDA guidances on parallel trials in the past and again today and can only find a parallel trial in relation to medical devices not drug trials.  However I do find the phrase confirmatory trial and the word studies in the FDA document Accelerated Approval, second last para, 


     "These studies are known as phase 4 confirmatory trials."


    This is the ASX announcement where the trial change was published.

    PHASE 3 HEART FAILURE TRIAL SIZE TO BE SUBSTANTIALLY REDUCED FOLLOWING FDA DISCUSSIONS


    Perhaps this will be clarified in the morning. smile.png


 
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