The reality is Day 168 results were a miss hence the market reaction, and PAR only have themselves to blame for that.
While the trial was 1) exploratory, 2) not powered to achieve statistical significance and 3) with no formal hypothesis being tested, PAR did includein their statistical analysis plan the following:
"For all primary, secondary and exploratory analyses, 95% CI will be presented unless stated otherwise."
So while 008 was not powered to achieve statistical significance PAR still included a 95% confidence interval. PAR also pre-specified all other endpoints, includingMRI results at day 168. So while we can question the sample size or whether the 12 month readout will be more applicable than the 6 month readout, the truth is the sample size is too small to draw conclusions either way, whether we obtained statistical significance or not. So maybe PAR should've excluded p-values if their intention was to only use 008 to inform 003, since there is no other reason to include them.
In saying that, the results do suggest that iPPS has DMOAD potential and that the totality of beneficial impacts on OA need to be considered alongside singlular endpoints. This would also be consistent with, in my opinion, the best statement in the entire announcement:
"All trends, results and signals in all tests and biomarkers indicated that iPPS is beneficialfor treating both the symptoms and diseases progression of knee OA."
My views only, dyor
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