You may be surprised to know that P1 trials will not be needed and PAR can gain approval for HFpEF by just performing one single phase 2b trial, for all the reasons you specified i.e. unmet need, high mortality rate etc. Whether or not PAR needs to perform a phase 2a trial will depend on how sizeable their safety database is and whether it already contains information on individuals with pre-existing forms of heart disease, which I imagine it will. If the P2b results are remarkable, PAR will be able to apply for approval through the accelerated approval pathway prior to performing any P3 trials.
We will obviously know more once the other pre-clinical studies have been performed (my estimation is within the next 12 months) and after PAR meets with the FDA (my estimation is Q1 2023). This could also probably be the catalyst for the next capital raise if management moves quickly.
I think the mooted market response is because the market has lost faith in management being able to deliver. While they have a good product and strategy, their delivery to date is sub-PAR.
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You may be surprised to know that P1 trials will not be needed...
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