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If Ralph - who is a genuine & influential heavyweight in the ED field - believes what he asserts, then doubtless FUM would be happy for him to present the data at a national/international meeting (all expenses paid, natch), which would give them valuable publicity, but open it up to peer scrutiny.
The title could be "We trialed our product against a placebo, and as a consequence have decided to market the placebo!"
Standing room only, I would guess. Don't see it happening. Ditto the hoped-for paper in a scientific journal.
You've got to feel sorry for the Barder family (not to mention all PI's), who have invested real money into this product. Unlike the two time-expired ex-GSK board members, James & Clarke, with their comfortable pensions, these people are bleeding. Amazing that they are still taking advice from the main architects of this debacle. I guess they think that they have enough influence to swing it for them, with the FDA. But the FDA deal in facts.
For James & Clarke, bringing an erectogenic gel to market is hardly the pinnacle of their careers - these people are used to dealing with big Pharma at the top level. I doubt if James even bothered to evaluate the formulation for potential vasoactivity. Presumably he just assumed that DS' rapid clearance was simply a factor of its molecular configuration, without asking himself whether this was being assisted by increased blood-flow with a dilated sub-dermal venous plexus.
They really need good-quality independent advice.
Martin - I may be wrong, but was not Ralph jointly involved with the trials? I hope I am not misleading you - relying on possibly faulty memory!
It happens frequently that drug companies elicit endorsements from clinicians responsible for their drug evaluation, and they are rarely not forthcoming!
The best thing that the BOD could do to restore confidence is to bring in a really competent chemist with a decent rep, and get DS sorted! By all means keep Ken as a figurehead - his name may have some pull with the regulatory authorities.
The tragedy is that they may have a really hot product on their hands.
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Martin - Why doesn't Ken put himself up for a live Sharechat with a few of his happy investors? That should be fun! He's OK waffling on about drug products & licensing procedures (done it for years), but put him up against an independent expert & he could easily get torn apart (& then where would the SP go?).
Remember - he doesn't even seem to know whether DS is a placebo or a drug!
Agree. We need to know if there is an active vasoactive molecule in the DS formulation. If so, it has to undergo proper trials. This is what the FDA will want to know. Or do this bunch of loons expect American males to anoint their nether regions with a preparation of unquantified efficacy? It's either a placebo or it isn't. Simples.
The BOD are just spinning their wheels, the SP is in effective free-fall, barring the usual spikes & dips, and Thomas Browne has gone AWOL. I think Ken should go out & find him - his audience awaits.
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!
Shameless that the BOD seem to want to bring Dermasys rapidly to market as a proprietary topical agent based on its proven safety profile and the fact that it "seems to work" in ED. No attempt to perform further trials, identify the active molecule & mode of action, maximise efficacy or do anything professional that might provide real assurance & guidance to ED sufferers, already confused by a variety of penile gels with varying placebo effects.... And can't they understand that if they fail to evaluate it properly it will never achieve full earning potential? Better to let a more experienced outfit take it over if this is their attitude.
Let's assume that MED2005 contains Hyaluronic Acid, like many skin creams, but uniquely in fractionated form to promote absorption. Google" hyaluronic acid nitric oxide" and you will see that HA has been frequently implicated in nitric oxide release - basically the same phenomenon as with GTN. Pure speculation on my part, but perhaps a plausible explanation for the results. If so, we may be witnessing the birth of another therapeutic star.
Another point - the BOD have been entirely derelict in their duty by failing to analyse MED2005's formulation for potential vaso-activity before they used it as a placebo. Presumably Ken James' mistake primarily, but they are all implicated. That Phase III study was a great waste of time & money, but at least now we have a possible explanation for the non-linear dose-response curve to GTN noted in the Phase II studies.
Everyone has been caught flat-footed, including big Pharma, I suspect, who must be watching from the wings with a certain amount of concern. Happy days!
If FUM wish to commercialise Dermasys in ED, they are going to have to explain the science behind it. Up to now, the science has been wonky, which IMHO is why the big Pharma firms have stayed away. Just because FUM have a skin prep which crosses the dermal barrier doesn't mean that it is going to drag other molecules with it - there has to be a binding mechanism with the carrier agent, a transfer mechanism, and a release mechanism on the other side. This is simple molecular biology, and it looks as though the BoD don't understand it. And anyway, GTN is fairly lipophilic in its own right, which is why we spray it, rather than inject it. It doesn't really need much help to get absorbed..
Which is why the Phase II results baffled me...they seemed serendipitously more favourable than the science allowed. Since a great many medical discoveries have been made in this way, I invested. Anyone ignoring the power of serendipity is unwise.
Now it seems that Dermasys may contain a vasoactive substance in its own right, although a proper double-blind crossover trial with a genuine inert placebo would be required to establish this. If so, this could be an important discovery, provided the BoD have the expertise & ability to handle it correctly, which I rather doubt.
Interesting & completely unanticipated result. On the face of it, Dermasys appears to contain a biologically-active molecule of similar efficacy to GTN. Possibly therefore another nitric-oxide releasing agent. GTN is the best known, but there are other nitroso-hydrogels with the same property, capable of skin penetration, which have been researched. Had they not used Dermasys as placebo this would never have emerged.
The Board's performance is hardly impressive - only they know what is contained within their Dermasys formulation - but if it includes a vasoactive agent it should never have been used as a placebo. However, they may have blundered onto something. My guess is it may contain low-molecular weight hyaluronic acid fragments, since HMW hyaluronic acid - contained in many proprietary skin creams as a moisturising agent - does not effectively cross the dermal barrier, unlike the hyaluronan fragments. If so, they should have known that these oligosaccharides have been known since at least 2006 to activate nitric oxide synthase. But I reiterate - just a guess.
The high-polarity Xe-129 images remind me of the Kr-81m ventilation images that we used in V/Q lung imaging for suspected PE, back in the day. Kr took over from Xe-133, due to higher photon-flux, but not sure that it was ever licensed in the US. We got it from the MRC Cyclotron unit.
Saw a lot of COPD, mucous plugging, bronchospasm and occasional inhaled FB & unsuspected Lung Ca, over 30+ years of use. Not sure the MR adds very much - you don't need highly-resolved images of the chest wall and mediastinum when you're looking at the lung fields. Now retired from it all, but good to see that clinicians are finally showing an interest in regional pulmonary ventilation imaging per se. In my day there was zero interest, since conditions such as pulmonary fibrosis, COPD and the pneumoconioses etc were considered basically chronic & irremediable.
Technical indices starting to go positive. This may be a last opportunity to top-up at a reasonable price.
https://www.tradingview.com/symbols/LSE-FUM/technicals/
Can't see any reason why topical GTN gel shouldn't work as predicted, but despite rapid onset GTN is an extremely short-acting (plasma half-life 1- 4 mins) NO donor, . There are other NO donors around, used as patches to prevent angina. Hence GTN effect may not be prolonged unless MED2005 formulation permits high-level sustained drug release. Nevertheless, hope it works & IMHO still a reasonable buy right now, but may drop out on the (hopefully) pre Ph III release rise.