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Agreed Blaustien. The main thing with an erection is getting Nitrate Oxide into the corpus cavernosum. Now this I believe can only been done through the glands ***** rather than tablet etc due to the contraction etc. The DermaSys has clearly shown very positive results and has much better results than Vitaros another gel rubbed into the glands *****.
Vitaros also is more evidence that Dermasys is not just a placebo. If this was the case then over the three studies carried out you may have seen one anomaly of 60% but defiantly not three.
Thanks for responding DonDuck.
So left with needing confirmation as to the process for getting this through the 'device' route as far as the Nth Amercan market is concerned. The indication the company gave was that the European market consent was almost a given for DS as a 'device'. Your concern on how this would be accepted as a 'device' is something that the company will have to convey to shareholders.
The point about how management 'missed' the possible potential of DS was and remains a concern of mine as highlighted in my first post after the news.
@NoEasy
From a pharma regulatory point you could knock me over with a feather if the likes of EMA and FDA accept some attempt to make comparisons across completely unrelated studies and products as a reason not to do another study of DS to confirm it's effectiveness. From a regulatory agency's conservative viewpoint it would not even be comparing apples with oranges.
Also the 'finding' from the study reported yesterday was not part of the hypothesis and as good as that data might look, that study FAILED to meet it's primary endpoint.
In the end it is all conjecture and provides for huge uncertainty in the coming months.
The one thing that really surprises me - as MED delivery using DS had been quite widely tested before - is they had seemingly never had any signal about the potential confounding effect of DS when one considers the apparent size of effect seen in this study. That just seems hugely unlucky, but that is clinical development and why it is better to have a portfolio of products to offset the risk of failure in any single asset.
I imagine the guys at FM are having an absolutely awful few days as they will have put their hearts and souls into getting to where they've got to.
Some thoughtful & helpful posts guys thanks. Still feeling my way through here.
Don Duck is your concern that , "For me this is a biological effect that will need to be tested/proven against either a standard of care or a true placebo before a regulator would approve it.... ' , is in any way impacted by FrankMu's point that, 'DermaSys beat Vitaros (another erection activating cream) by far, which has active ingredients that must have beaten placebo during their trials.'
I believe that what Frank is saying, would in effect mean that DS would not necessarily need to be tested against a true placebo due to the result it had against Vitaros which of itself would have been tested against a true placebo. A result from one transposing itself onto the result of another so to speak.
Shoot me down if I've got your post wrong Frank.
Thanks as well Ananda.
@NoEasy
It is not unusual for the vehicle (in this case DS), less the active, to be used as a placebo and presumably in earlier studies FM had not seen a signal that DS had activity on ED. In hindsight (always easy eh!) they should have used an absolutely inert placebo I guess and there was a clue in the webcast yesterday that they think DS contains so far undetermined volatile chemicals that evaporate after application and cause local increases in nitric oxide(NO) levels. The biology of this is that the NO causes local vasodilation... which increases localised blood flow... and hey presto a response is seen.
For me this is a biological effect that will need to be tested/proven against either a standard of care or a true placebo before a regulator would approve it, meaning more studies/money needed etc... and for me that is where the real problem is as it creates a hugely uncertain and risky scenario that is likely to go negative.
Also how this could be approved as a device I do not understand but I guess FM have a clear idea as to this as they were confident enough to say so clearly yesterday and presumably they will tell us ASAP?
Blaustein good to see someone posting substance rather than what the price should be.
I was going to post this earlier but got distracted. I am not a medical person but logically something is nagging me here and the below was how I put it into words.
'Totally agree Bandit. Plenty of talk on here about what the price could be is rather overlooking why this is still 50% down from 7am yesterday. There is substance behind that drop I feel, at least until the company are more open about why they went with Ds as a placebo (that isn't)
This trial has for me not proven a new treatment that is effective above and beyond the psychological element. Was it something like 20% of ED is down to psychological causes?
How do we rule out that this trial, both the MED2005 and Ds results, were not affected by participants believing that the treatment was the real thing rather than it being the real thing. Using a true inert placebo may have also resulted in the same results we got from this trial indicating that it was psychological issues that influenced the results not the physiological effects of the compounds themselves i.e the compound doesn't work beyond a psychological level. We have not been allowed the opportunity to discover this by the use of Ds as a placebo.
There is a suspicion of wool being pulled over eyes here or papering over the cracks as you rightly put it. Are both MED2005 & Ds as good as each other and significantly offer a real opportunity here or are they both inert as far as physiologically treating ED is concerned?
Over to you management.'
Agree Light Bulb Moment Can't Be That Far Off ........Can It???
The SP is being held back because many potential investors believe that the observed results for Dermasys in ED are simply a placebo effect, and this is entirely understandable. In my posting of yesterday morning I suggested that the Dermasys formulation may, unwittingly, contain a Nitric Oxide releasing agent, similar in action to GTN, & Ken James seems to have subsequently endorsed this idea. But they need to firm up on this if they intend to bring the product successfully to market. Why are they unable to state what the active ingredient may be? It would do much to restore confidence.
My guess is that Dermasys contains, like many non-oily cosmetic preparations, Hyaluronic Acid, but that they have, uniquely, tweaked the molecule to make it absorbable (by using a shorter-chain derivative).
Hyaluronic Acid is a known Nitric Oxide releasing agent, as a Google search will reveal, acting directly on the endothelial wall of blood vessels to make them dilate. If I am correct (the precise formulation of Dermasys is a commercial secret & I am merely speculating) why on earth were they unaware that their placebo contained a potentially vasoactive substance? They should identify why Dermasys may have vasodilatory effects, because the impression they give at the moment is simply one of incompetence!