research reports and media, page-2829

Interesting stuff.
Saw a docco on placebo effect a while ago and it’s quite incredible. Even to the point where sham surguries on lower back pain had a significant response on pain (ie they cut you open and stitch you up without doing anything!). Looking a bit further there are publications on this which state that placebo effect can be strong on subjective measures (like pain) but is less pronounced in objective measures.
We see this clearly in our data. The placebo arm in P2b responded to quite a degree in terms of pain score over time. However both the BML volume and also the biomarker data showed hardly any response in the placebo arm (and if anything a negative correlation in some measures). Our primary endpoint remains subjective pain scores and that’s the one we have to pass so the more we can mitigate it the better.
I guess you could get a situation where ‘believers’ are more prevalent in the placebo arm which skews the results but the larger numbers in P3 should randomise that out I guess?
I also thought that maybe they screen out people who have heard of pentosan or who are PAR shareholders, but the only exclusion criteria there are employees and family members of Paradigm. So larger numbers seems the way to smooth out this effect (it should tighten up the confidence intervals too).
More awareness right now might translate to a higher share price at present but not really contribute to greater chance of trial success or landing a deal before trial readout (surely the players are aware enough). Given the relatively low liquidity most investors seem to be here for the longer term.
But agree totally that the time is coming soon for a proper ramp up in comms and promotion to ensure a splash when the P3 results land, and start building some pent up demand for when we hit the shelves. Hard to know when that’s going to be but it’s even more the case if we have an earlier pathway to commercialisation (provisional/accelerated approval).
To be fair I think we’ve been in hiatus mode on PR due to transitional CEO role and the whole “lost year” of IND approval. But with a new CEO, the P3 in almost full swing and 008 results due soon, the time to push the button on a strong PR campaign seems ever closer.