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Bucolic you said “ I believe it will probably be in single use ampoules. The reason behind my thinking is mainly the dosage, as the FM57 clearly showed marked differences in efficacy depending on dosage”
But FM57 was not a study designed to test MED3000. It was designed to test MED2005 with varying % strengths of the drug GTN against MED3000 the placebo which has not GTN. And since MED2005 failed in FM57 it clearly showed that there were no statistically significant differences in efficacy depending on dosage of GTN including in the placebo MED3000 group. So since MED3000 has no GTN there is no dosage of any GTN in the MED3000 gel.
FM57 products tested were
MED2005 0.2% GTN, 300 mg gel = 0.6mg GTN; MED2005 0.4% GTN, 300 mg gel = 1.2mg GTN;
MED2005 0.6% GTN, 300 mg gel = 1.8mg GTN; and Control vehicle – DermaSys® alone now called MED3000;
Single unit dose tubes to deliver 300mg of gel
Tomhuk. I predict that they will NOT have “US approval by the end of the year” and I am 100% sure of this.
Especially considering the FDA confirmatory study will take 6 months and “ first patient dosing expected H2 2021”
And as Futura said “ A 5th pre-submission meeting with FDA is planned for H2 2021 to define and confirm the detail of the work required for OTC application and Futura is targeting completion of the FM71 study and Human Factors study for Q2 2022”
Yes! I do have a prediction: £4bl for the outfit with an approach by a big Pharma.
Suppose it depends on packaging costs and if plastic ampoules or tubes are cheaper. I presume if a deal is signed for MED3000 it will be it be on net royalties as were the original deals in the Futura IPO prospectus.
8.3 a licence agreement dated 14 March 2003 between (1) the Subsidiary, (2) LRC Products Limited (“LRC”) and (3) the Company, pursuant to which the Subsidiary has granted an exclusive licence to LRC to manufacture, market, distribute and sell condom products incorporating the Subsidiary’s CSD 500 product (“Product”) for the lifetime of the relevant patents. The licence is worldwide, save that it will not initially extend to Japan.
LRC has agreed to make certain milestone payments to the Subsidiary following the grant of the first product licence in each of the USA, the EU, Asia Pacific and Japan.
LRC has agreed to pay the Subsidiary a significant royalty at an agreed percentage of the net sales value (after transport costs, sales tax, credit notes for returns and defective products and any settlement, retrospective, volume and promotional discounts) charged by LRC or any sub-licensee in relation to the Product. LRC has agreed to pay the Subsidiary minimum royalty advances in respect of each region on an annual basis for each of the first five years following product launch.
The royalty and the royalty advance may be reduced by such amount (if any) as is agreed or determined by an expert to be fair and reasonable if: (i) any patent application does not proceed to grant or any patent rights are determined to be unenforceable or are revoked or lapse; or (ii) an event occurs which in LRC’s reasonable opinion adversely affects the commercial viability of the licence agreement or the margins on sales of the Product; or (iii) a competing product is offered for sale.
Doubt MED3000 will be sold in ampoules
“The gel is supplied in a small single use tube designed to deliver a dose of 300mg of gel. This amount of gel (approximately the same size as a garden pea) is rubbed in”
Kevin, regarding the cost of the product and the way it's sold, I believe it will probably be in single use ampoules. The reason behind my thinking is mainly the dosage, as the FM57 clearly showed marked differences in efficacy depending on dosage, and also, as you said, people will be unwilling to fork out £50 for a tube.
Kevin. MED3000 will be supplied in single dose tubes. In the Futura results the illustrative packaging said it contained 4 single dose tubes. In the 2017 IPSOS research they assumed $5 per dose based on 2016 market prices. $5 would now be £3.58 per dose at current exchange rates. But in the FDA confirmatory study its being compared to Tadalafil 5mg. So maybe that is the up to date comparison for pricing. Tadalafil can be bought for under £1 per pill. So you can see where I am going here that the the 2017 research that the company is telling shareholders they believe demonstrates that MED3000 could generate a billion dollar in sales is outdated not only on current market prices. But also flawed as it was based on MED2002 which contained a vasodilator. MED3000 doesn't contain a vasodilator anymore so it may actually even need to be priced at a slight discount to Tadalafil 5mg.
I was thinking about the cost of the product. Viagra costs 5 quid a tablet on the boots website (cheaper if you buy more) a tube of this lotion has to be reasonable. If it contains 10 applications people won’t spend 50 quid on a tube of lube so they need to get the balance right around profit and cost so it sells. I think once we get the 1st q results with how it’s selling that’s when it’s sp starts to reflect its true price but it could take a year until the USA market gets a supplier and the Asia market starts making money so maybe Christmas time this year maybe the time we start to see a massive hike. I’m teems of how much I really don’t know how much it will reach I just hope it does a Tesla and goes crazy (Tesla will drop like a stone Soon IMO)
I too think this will develop into a bit of a monster stock. I also have a few investor friends that are in heavy here, however, they all have a very different idea of what “Monster” is. The predictions, based on getting good trading deals on their CE certificate, range from £1 to £4 by the end of the summer (That’s not including US approval by the end of the year)
Does anyone have any thoughts/predictions?
Let’s just unpack your theory.A week last Thursday the share price began to tank in the afternoon.There were hundreds of sells. I think ,it’s gone down to 45p, I have made a good profit, I will bank it,and buy in lower.The following day it goes up to 60p on the release of the RNS.Unfortunately you cannot trade on hindsight.Clearly some people do make good profits trading. I have invested because I strongly believe that we are on the cusp of something really big.Regards
Hi , I hope you continue to do well with this share and your strategy , however , I find it incredible that you do not seem to realise that there are different investment strategies other than your own .I would hope that most people on this board realise that there is a benefit from selling a share for 51p and , should they wish , buying it back as it falls to 46p . If people don’t see that , it could well be the reason that 90% of PIs lose money on the markets . I sincerely hope you do well from this , but if you cannot see an advantage of selling , then buying back cheaper then you are severely restricting your chances of becoming one of the 10% ... Have a good weekend .
Exactly, it’s now when - not if - this share will rise significantly.
I was the one who mentioned that 90% of PI’s loose money. I can assure you I am not one of them .In fact I bought shares at 7p in two placings ago.Do the maths! The reason I am massively in profit is because I have not attempted to trade the market.The problem for this share is the poor history of James Barder’s attempts at commercial deals in the past.We now have recruited specialists to negotiate deals. I cannot understand punters selling at this pivotal point in our story.But they just confirm my point: 90% don’t ever make a profit.Think on.
At the end of the week I have Just looked at the negative replies that have been posted in response to my single contribution from the beginning of the week .Such replies help me reinforce many of my conclusions that can be gained by glancing through such chat and suffice to say ....monitoring the replies is an interesting social experiment exercise .The sentiment on this share appears to abound from unsubstantiated Hope accompanied by , as yet, no further positive news .It is clear the Market Maker’s have a clear grasp of this Share , and as a previous comment highlighted , it is no wonder 90% of shareholders lose money on the AIM market , I would assume that contributor will include themself in that statistic .... No doubt this will generate more responses from the wisdom that abounds on these chat pages . I will monitor with bated breath .... ( ps - the SP was 51p at the time I initially posted , it is now 46p...)
Prescription only not OTC big difference
Derek - don't you have anything else to do?
Email them and ask them have they heard of MED3000/Eroxon and do they have any similar product planned as Futura mentioned their Astroglide brand in their studies
There was no significant difference between MED2005 and commercial lubricants on integrity of human epidermal membranes compared to KY warming (p=0.58) and Astroglide (p=0.30).
you are overlooking Vitaros
Fake news Liam, Nothing there for Erectile disfunctiion, Futura’s is the first gel and only to treat ED and also it’s over the counter,and available to those who can’t take viagra or don’t want systemic action all over the body from a pill and would rather have a topical gel, what’s not too like, get in quick
The NHS recommend lubricants for Erectile disorders? Would that be because it helps with massage?
I hear Astroglide will piggyback on the MED3000 CE Mark and get its Astroglide warming approved too as as a massage erectile device
Isn't it strange that booth is now claiming that GTN had an effect, because the company had claimed that for years. So he is now the only one saying that the trial should actually have been considered a success for MED2005 (GTN) rather than a failure even though he constantly likes to remind us that the trial failed! But of course the company would have been the first to present it as a success if it could, yet it couldn't because the MED3000 without the GTN produced exactly the same result. The facts are clear that the effect was the same with and without GTN leading to the only possible conclusion which is that MED3000 works by itself. The only argument you could make (which you constanty do) against MED3000 is that maybe everything was just a placebo effect. Fair enough, but against that you have the weight of opinion of all those prominent urologists as well as the FDA clearly tending strongly towards accepting that MED3000 is effective, as well as the CE mark providing proof that the EU experts were satisfied with the proof provided. You are of course free to disagree (or to pretend to) but I would rather go with independent experts, who presumably understand better than me or you how strong any placebo effect is likely to be.
And I can see you accept that your argument about "what were they doing for 9 minutes 45 seconds" is of course just a red herring - so you are just falling back on the same old suggestion thay maybe it's all just a placebo effect, to which the answer is as I mentioned above.
Only 250 participants had MED3000 alone. Thats a fact. The 750 that had GTN cant be included if you now want to just look at MED3000. The active cohorts cant now be redefined as placebos all of a sudden because the overall study failed. For the past 18 years the company claimed GTN was having an effect albeit small as shown in phase 2. So we have to assume GTN was still having some small effect in the other 750. What it points to is a large placebo effect in all the cohorts especially in the actual placebo cohort due to the cooling/warming sensation making them think they were in the active cohort. And yes there was counselling in the form of training. Even just getting some medical attention has been shown to have a placebo effect.
And you have summed it up yourself
“Obviously they were doing what they always do when they don't use the gel, but clearly it doesn't usually work for them, but when they used the gel then suddenly there was no ED - so three guesses what solved the ED problem?”
Because normally they were not in a drug trial that they knew was testing an ED gel. So the warming sensation besides being pleasant reinforced the bias they had the active gel. So I only need one guess what solved the problem “placebo effect”
Yet more attempts to confuse from booth. MED3000 was tested in 1000 patients, 250 of whom had it by itself, the other 750 had various strenghts of GTN added. Ultimately they all performed equally well, showing that it was the MED3000 rather than the GTN which was having the effect. So it was shown in 1000 patients not 250.
Why mention counselling, there was no counselling?
What other stimulation was involved for the 9 mins 45 seconds? Another of your absurd arguments that you keep repeating. Obviously they were doing what they always do when they don't use the gel, but clearly it doesn't usually work for them, but when they used the gel then suddenly there was no ED - so three guesses what solved the ED problem?
And of course those urologists quoted by Futura don't seem to share your views.
And then more rambling about CSD500 and what you think happened there without any evidence.
I slightly disagree and do believe the data that MED3000 “worked” in the FM57 study. But the reality is it was only in 250 people that the placebo was tested as the study was divided in to four cohorts as FM57 was not designed to study the placebo MED3000 but rather MED2005. Also reality is far removed from studies with exclusion/inclusion criteria and training etc. You will see
baseline improvement in ED just with counselling alone and no other interventions.
Med3000 worked immediately for some via the massaging of the glans. For others it worked by combination of that manual stimulation and then the Thermal sensation +/- the placebo effect that they then thought that sensation meant they were in the active GTN arm. Also we don’t know what other sexual stimulation was also involved from 15 seconds to 9min 45 seconds which it took for the 60% to see an effect. Did the couples just sit there after rubbing the gel in for 15 seconds and do nothing else?
But like with CSD500 the performance bar is low to get a Medical device approved in the EU. I also think CSD500 worked but just not well enough in the real world for it to be successful and keep consumers coming back to purchase it. Also in hindsight some of the studies of CSD500 versus standard condoms were probably also displaying some placebo effects. While in reality in the real world the opposite occurs as most consumers expectations of what “works” are much higher then those that sign up for studies. So if people go around and say this is a gel that works as well as Viagra then it will never be able to match that expectation. Just like CSD500 was never going to live up to the expectation of being a “Viagra condom”
And you say "When a Share does very well on AIM there is invariably something amiss . " What an absurd statement. And further "scientific proof" of MED3000 not working is, believe it or not, from the "pattern" of what people are saying on this board - "This chat classically follows this pattern". And you would have us believe that is why you sold your shares.
And you make sure to point out "I am not bitter" - hmm, based on your claimed story of having done well from buying and selling the shares several times, why would you have a reason to be bitter? A bit of a slip there, I think.