PAR 0.00% 26.5¢ paradigm biopharmaceuticals limited..

Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-27

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  1. 4 Posts.
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    To quote from the quarterly outlook statement 30/4/24 "Once agreement is reached with the US FDA, Paradigm anticipates providing an overview
    of the next stage of the phase 3 OA program including an overview of the clinical trial
    design, dose justification and proposed participant numbers for the trial."

    Get the feeling the next ASX announcement regarding the US FDA will be huge.IMO

    PAR needs 3 big ticks on Design, Dose Justification and proposed participant numbers.
    The proposed participant numbers will be interesting as this will be a key factor on how much money is needed to finish the programme. IMO

    An old PAR R&D preso back in 2020 indicated the next stage the participant N=700 mixed with a quick search of the FDA website indicating the median cost per participant is $41117 US per participant and I get rough calc of $43M AUD to finish the next stage of the program.IMO This is acheivable.

    Another quick search of the FDA website. the range of participants for a confirmatory P3 study is between 300- 3000. The cost could also blow out if unfavourable.

    If the next ASX announcement is favourable, will this mean unspohiscated investors will finally have some clarity on how much it will cost to finish the program? Unlikely, but I thought I would throw in my 2 bucks to keep the PAR heart beat going.

    DYOR

 
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