COmplicated topic so a long reply. I was extolling the virtues of this study early. I sold some stock in the $1.70's and was buying it unchanged to my surprise the same day and more at $1.19 two days later. My posts here:
https://hotcopper.com.au/posts/67127885/single
https://hotcopper.com.au/posts/67142330/single
and this by another excellent poster on the subject:
https://hotcopper.com.au/posts/67148410/single
They were not stellar in the sense the 168 day results did not match the impressiveness of the 56 days results. That's presumably what the market got caught up in, suddenly unsure whether once a week or twice a week injections preferable, given the results, and some perhaps even questioning efficacy.
For the market that was undeniably dire - look at the price reaction.
I think the market is mistaken which is why I have been buying in to the falls. I think the market got tied up on the failure to show statistical significance in WOMAC, cartilage loss and pain at 168 days.
As PAR says itself in its release "Cartilage loss is generally considered to be the most important disease feature of OA". It headlines with the improvement, of once a week patients, but then with a P-value of 0.065 and even worse, no real change in twice a week (the the market doubts the integrity. Hence I have said before PAR did not present this well. Its almost a footnote:
"This phase 2 clinical trial is anexploratory study and was not intended to be powered to obtain statistical significance.The aim is to provide novel scientific evidence to test the hypothesis that iPPS acts locallyin the knee joint of OA subjects as well as provide data on whether biomarker changescorrelate with clinical outcome (WOMAC pain and function assessments). Furtherevaluation on serum, synovial fluid and urine biomarker correlations, and further longerterm clinical outcomes are in progress."
This should almost be a headline warning. The company should have also reiterated that the PRIMARY ENDPOINT OF THIS STUDY WAS AT 56 DAYS. If you go back to the October update:
"Primary endpoint relating to synovial fluid biomarkers achieved and positivetop-line results reported for the PARA_OA_008 phase 2 clinical trial (n=61)."
They should have been banging home that the primary endpoint of the study already achieved and this update more exploratory.
Also in the 56 day the market importantly saw "WOMAC data has also been collected from baseline. iPPS treatment showed statisticallysignificant improvements at day 56 in pain, function, stiffness, and overall WOMAC scoresfor twice-weekly iPPS compared to the placebo arm. The proportions achieving ≥30%and ≥50% improvement in pain were 73% and 60%, respectively."
Impressive! Then at 168 a literal 'we almost wont even mention it':
"The twice-weekly iPPSgroup, showed trends of improvement (though not statistical) or stabilisation of cartilagepreservation compared to the placebo group."
Hence I discussed hyperbole from PR and co. YOu can't throw twice a week injections around as a major result at 56 days and then pretend no one will notice its not repeated at 168 days. This in my opinion is why the stock dropped. But the market has lost focus of the primary have already been achieved and the 168 days results not powered.Sorry to fans of PR, but the guy does himself and us no favours at times (still bitter about his fireside chat). Transparency and explanation - not hype at 56 days and then shrugs at 168 - is the key. There should have been careful explanation of exploratory nature (mainly of secondary endpoints and biomarkers) at the 168 day update. The researchers will use this data and the twice a week results at 168 days to refine future and existing studies and approaches to.
Hands up, I should have said "poorly reported" results rather than less than stellar, but the latter is clearly what the market felt from the way they were reported.
(20min delay)