RE:Corporate communications In every trial conducted (ever) the sham/placebo is designed to be non-therapeutic as to increase the odds of reaching statistical significance by reducing the therapeutic effect of the placebo to isolate as much as possible the therapeutic effect of the active device. But as we have seen with the LFP this was not the case. What is disingenuous with claiming that?
I am not sure how someone on Stockhouse with no scientific background in neurostimulation can venture to qualify the gap between the LFP and HFP as “so wide”. The goal of sham device is to replicate an active device, and in this case it was supposed to replicate the tingling sensation on the tongue that the HFP provides to the user. The maximum frequency is set by increasing it right before the point it becomes painful and turning it down a notch. The LFP was designed the other way around. The patient started at 0, and was asked to increase the frequency by turning a knob (a maximum frequency threshold was set) until he started feeling the tingling sensation on its tongue. Thus the gap, is not randomly chose or equal for each patient, it is just a function of providing the minimum amount of stimulation for the LFP and the maximum amount for the HFP. Without the tingling sensation (which is very well documented), patients would know they are part of the control arm and could potentially give up on the physiotherapy thus voiding the trial.
I truly believe Phil & Jonathan were genuinely ecstatic during the call and you could hear it in their voice. If we, simple monkeys, understand that these results are fantastic, imagine how they feel about it being scientists and having worked for years on this project. In short, they were incredibly encouraged by the “absolute” level of therapeutic effect, which had never been achieved before in history and in such a short period.
Investors on the other hand were focused on the relative therapeutic effect of the active arm vs the control arm, which did not reach statistical significance and thus did not reach its primary endpoint. Had the LFP not provided a therapeutic effect, it would have meant that the active device was most likely not providing a therapeutic effect itself. In this case, with most likely depicts the majority of the trials, “it can never be a good thing to "fail" the primary endpoint” given the implications. But not in this case.
Most amateur so-called biotech investors don’t do the extra work, and buy before the results are released expecting to make a quick buck on the pop. In this case, we are talking about a really illiquid stock, with amplified the impact on the share price. Overall, I am not sure you can draw any kind of conclusion regarding “corporate communication” based on that.
As for the SEDI “situation”, I am glad you have reached out and look forward to hearing management’s answer once you get a reply.
Best,
Prokofiev
miningfundi wrote: prokofiev, my principal concern regarding corporate reporting was regarding the trial results (see my earlier post below). In the "clarification" statement, management stated that the "... low-frequency pulse (LFP) version of the PoNS therapy, ... was intended in the trial design to be non-therapeutic." Surely this is disingenuous? Also, the CEO on a couple of occasions during the conference call stated that he was "ecstatic" with the results as the stock price plummeted.
RE:Clinical Results - Proven Efficacy
Thanks for your great insights prokofiev and steelinvestor. But in the context of the numerous anecdotal past PoNS studies and evidence (I have just read Norman Doidge's book), management must have had reliable knowledge of the probable outcome of the LFP, so why set the primary endpoint LFP/HFP gap so wide? Was it imposed on HSM or were the results of the LFP surprisingly good? Surely it can never be a good thing to "fail" the primary endpoint?
I am also troubled by the SEDI situation since it provides an excellent investing tool, and it
appears that HSM is not in compliance. I did make contact but they did not have an immediate answer and will get back to me.