Not if it's reproducible and consistent with all other results. This is the second randomised, double blinded trial that has succeeded, so the chances the result is due to random chance is less than 0.25%. While it can be argued that P&F was a secondary endpoint in this trial, it was actually a key secondary endpoint top line result i.e. has similar status to a primary endpoint.
In other words, if PAR can demonstrate a reliable surrogate endpoint at the 6 month readout then they will have enough data to apply for accelerated approval through the FDA.
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Not if it's reproducible and consistent with all other results....
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