PAR 6.67% 24.0¢ paradigm biopharmaceuticals limited..

Ann: 2023 Annual Report and Appendix 4E, page-15

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    Maybe I misunderstood what you were saying, but the way I understand it is that one of the four doses being tested as part of PARA 002 Stage 1 will be put forward by the DSMB as the dose to move forward to Stage 2. The criteria the DSMB use will be spelled out in the SAP, but I understand it to be the minimum effective dose, that is the lowest possible dose that can achieve a statistically significant clinically meaningful improvement in pain and function. So the DSMB will decide on what the minimum effective dose is and then PAR will have to use that specific dose.

    In order to determine the minimum effective dose the DSMB have to unblind the study. PAR won't be allowed to look at the results because if they do then they will have to pay a Type I penalty since the trial is blinded, so we won't get a readout for 002 stage 1. We will just be told that the dosage will be.
 
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