Let me commence by saying that I contacted the company to request confirmation or denial of a meeting with the FDA in the past six months. The company confirmed that it didn’t meet with the FDA.
As POH hasn’t announced that they’ve met with the FDA, it hadn’t occurred to me, nor probably to other shareholders, that they might have already done so.
But then the respected poster Southoz (post on 06/05) asserted that they had – doubtlessly causing people to think twice and recheck company announcements. The search would have revealed that POH has made no such announcement. But wait, Southoz clearly stated that POH had met with the FDA “a few months ago”. If one assumes that Southoz wouldn’t lie, but also knows there's been no announcement, one is led to the following intrepretation– that POH did meet with the FDA, didn’t announce this fact to the market but did inform some privileged person/s, who then sold out while the average punter was left clueless and poorer. Oh… and then the company compounded its sins by deliberately lying to me about the meeting.
By anyone's standard that's a damaging allegation, but ultimately that is the interpretation that one is led to, if Southoz was telling the truth.
A further suggestion made by Southoz is that POH reported that more trials are required, after meeting with the FDA, causing the halving of the shareprice.
That more pre-Phase 2 trials were required (the pharmacokinetic trial to assess delivery profile, the multiple application site trial and the non-clinical toxicity trial) was flagged in March last year and detailed in the 2014 AGM presentation and then again in the July Opioid Patch Program Update. Three studies (API sensititisation/ irritation, patch wearability/durability and formulation stability), which are due to be completed this quarter, were also detailed in the 2014 Annual Report, which was released on April 17. Whichever trials were referenced in the comment “POH report that more trials are required”, these trials certainly weren’t announced just prior to the halving of shareprice in early March.
Thus, there is no evidence that POH has met with the FDA, indeed there is a company denial. There is certainly no evidence that “more trials” are a consequence of meeting with the FDA. There is also no evidence that the reporting of “more trials” is linked to the halving of the shareprice which occurred in March.
Now, after I’ve asked for supporting evidence, the previous statement “a few months ago POH met with the exam kings of the world” has been replaced with the vague reply and question “POH said they were going to meet with the FDA .... so have they or haven't they?”
For me this raises a disturbing question. Why would a poster, especially one who consistently stresses the need for validated data/evidence, not bother to verify his claims? Yes Southoz….that’s exactly the problem, isn’t it?
By all means, feel free to offer your scientific expertise, feel free to offer your insight, feel free to offer your skeptical viewpoint. But please ensure that your facts are correct, especially before making the kind of damaging claims that serve to stick the knife into both the company and its shareholders during an already tough time.
POH Price at posting:
3.1¢ Sentiment: Hold Disclosure: Held
(20min delay)