Futura Medical Share Discussion Threads

[petroc] 22/8/2022 17:37

Ah yes, the old 50% claim. MED3000 has been proven to work in 60% of men with ED, so there is obviously something going on. Perhaps it's the fact that MED3000 is based on Dermasys, which is designed to penetrate the skin, whereas lubricants are designed to stay on the surface? By your logic, paracetamol manufacturers can't claim that it's any better than placebo because the mechanism (what you would call 'supposed magic') has not been proved. Lol indeed, you buffoon.

[lbo] 22/8/2022 15:40

LOL

Nobody is claiming placebos don’t work in ED.. And sham medical devices like gels have enhanced placebo effect especially as they are ‘rubbed’ in. Thats all been been shown before in ED studies and other medical device studies. But nobody. Not even Reckitt the market leader in lubricants/arousal gels could patent the placebo effect and nobody can get away with claiming their placebo gel is not a placebo gel when they cannot even show or substantiate how the supposed ‘magic’ evaporative cooling works. Or that it has even any effect beyond placebo effect in any adequate controlled study. And nobody can claim their alcohol and water gel is any better then any other water and alcohol evaporative cooling gel for ED. Again as they have no direct efficacy comparison studies against even a standard cooling arousal gel to substantiate those claims.



the placebo effect in RCT of iPDE5 for ED occurs at a rate as high as 50%



Recent research has shown that the placebo effect is not only similar for medical devices to medical trials; it is considerably larger – the effect of a sham device is almost three times that of an oral placebo.

[petroc] 22/8/2022 15:23

Reckit et al can come up with all the placebo gels they like, but there's no equivalence there with a gel that is a proven treatment for ED. Time will tell, of course. Anyway, you don't believe that MED3000 works, LiarBO, so in your opinion why would all these manufacturers want to churn out something that doesn't work? Or are you finally admitting that FUM are onto something with MED3000?

[lbo] 22/8/2022 14:17

Reckit (if there is such a huge and lucrative market for a placebo gel in ED) have all they need to get a similar alcohol and water gel registered and on market via the equivalence routes in a matter of days.

[lbo] 22/8/2022 14:05

LOL

A CE mark for a class 2 medical device can also be got be got in days via the EU equivalence route. Its far from a ‘rigorous’ process!

What took Futura so long was because the phase 3 FM57 was not designed to study Med3000 but was rather the failed study of Med2005 in which Med3000 was the placebo gel.

[lbo] 22/8/2022 11:05

So there you have it. Petroc is admitting he is a ramper and will have ‘moved on’ after he has ramped and tried to convince the naive to buy in so he can sell out.

And it wont take years to launch a similar alcohol and water gel product. It will take on average 177 days to go through a 510k pathway.

‘De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device’

The average length of time for clearance under the traditional 510(k) pathway is 177 days,



‘a company must compare their product to one already cleared by the FDA and provide evidence that their product is substantially equivalent to the previously cleared (legally marketed) device. To be substantially equivalent, the product must meet criteria for the same intended use, have the same technology or (slightly) different technology but produces similar end results, and be safe and effective. Once pre-market clearance is received from the FDA the device can be distributed commercially immediately’

[petroc] 22/8/2022 08:44

Stop lying, LiarBO. I've answered that question before, several times as you've posted it so many times. If anyone can make such a simple thing, why don't you give it a go? Of course, it'll take you a couple of years to bring it to market, by which time shareholders (not you)will have probably moved on to something else, having made their money. There's another lesson for you there - moving on. Something you should have done 5 years ago when you sold your holding at the bottom of the market, and yet you've held FUM responsible for your massive loss ever since, when in fact it was your ineptitude that lost all your money, and investing more than you could afford to lose. Prat.

[lbo] 22/8/2022 08:15

So no answer on the patent issues or that anyone can make a similar alcohol and water placebo gel and claim it too works by evaporative cooling! LOL

[lbo] 20/8/2022 12:17

And yet still no update on any enforceable patent! But how could anyone patent something that was already well described in the literature and can be challenged on non obviousness and prior art.



In Q2 2022 national applications will need to be made and the Company, in consultation with its commercial partners, will decide those countries in which to file applications and considered necessary to protect the commercial interests of MED3000. If national applications are successful



Most third party challenges to patentability occur in front of national or regional patent offices. WIPO recently released a summary of data regarding the extent to which third parties are challenging patentability at the international level. Any member of the public can file Third Party Observations against a PCT application during the international phase.





‘The Company has conducted initial literature and in vitro based research that has shown the cooling from the evaporation of these specific combinations of solvents’



There is a risk that some claims will either be challenged in future (eg on the grounds of non-obviousness or existence of prior art) and/or that another technology may be employed to achieve a similar effect. The protracted development times mean the clock has been ticking on the original issued patents, reducing the protected commercial products




A smooth gel intended for alcohol soluble actives. Provides cooling effect upon application while leaving minimal residue




The cooling effect of a topically applied product can be evaluated using a validated handheld thermal imaging system. When the gel matrix is destroyed after application to the skin, the bound water and alcohol evaporates and a measurable cooling-effect results.

[lbo] 19/8/2022 15:19

Oh dear. The rampers cant keep up!

Med3000 is also going through the same Do Novo medical device registration process. So even if it does get registered as a medical device. All that does is open the floodgates for copy cats if there’s supposedly such a lucrative market for just an alcohol and water gel that supposedly treats ED by some ‘magic’ way. LOL

The FDA reviewed the One Male Condom through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device. The average length of time for clearance under the traditional 510(k) pathway is 177 days, a company must compare their product to one already cleared by the FDA and provide evidence that their product is substantially equivalent to the previously cleared (legally marketed) device. To be substantially equivalent, the product must meet criteria for the same intended use, have the same technology or (slightly) different technology but produces similar end results, and be safe and effective. Once pre-market clearance is received from the FDA the device can be distributed commercially immediately.

[joestalin] 19/8/2022 15:15

All of LBO's comments are a repetition to me. They all say "(Filtered)".

[lbo] 19/8/2022 15:10

A placebo gel that anyone can copy is doomed for failure for obvious ‘normal commercial reasons’ and Glaxo knew it!



The cooling effect of a topically applied product can be evaluated using a validated handheld thermal imaging system. When the gel matrix is destroyed after application to the skin, the bound water and alcohol evaporates and a measurable cooling-effect results.



˜There is a risk that some claims will either be challenged in future (eg on the grounds of non-obviousness or existence of prior art) and/or that another technology may be employed to achieve a similar effect. The protracted development times mean the clock has been ticking on the original issued patents, reducing the protected commercial product’



GlaxoSmithKline unexpectedly handed back the development rights to Futuras erectile dysfunction gel. We are not going to progress on this particular compound for normal commercial reasons which we do not wish to go into, GSK said.

[lbo] 19/8/2022 15:08

The rampers are just desperate to try deflect that there has been no update on any enforceable patent. So even if Med3000 does get registered as a De Novo device. Then anyone eg Reckitt can do the same if they believe there actually is a genuine market for just an alcohol and water placebo gel for Erectile Dysfunction. The final nail in the coffin for the last of the Futura products and Futura.



The FDA reviewed the One Male Condom through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

The average length of time for clearance under the traditional 510(k) pathway is 177 days,



a company must compare their product to one already cleared by the FDA and provide evidence that their product is substantially equivalent to the previously cleared (legally marketed) device. To be substantially equivalent, the product must meet criteria for the same intended use, have the same technology or (slightly) different technology but produces similar end results, and be safe and effective. Once pre-market clearance is received from the FDA the device can be distributed commercially immediately.

[petroc] 19/8/2022 14:55

Poor old LiarBO just can't stop lying, can he? I said '...rehashing comments made by board members...' and he translates that to 'He is now claiming that Mike and Joe were making everything up...' I suppose we shouldn't be surprised by that, as all he's ever done is twist what people say, misrepresent expert opinion, manipulate the dialogue and so on, in his perverse mission to try and bring FUM down just because he lost all his money by investing like a rank amateur. I am surprised, however, that he forgot about the condoms, CSD500, when he stated '...not one product on the market...' He jolly well should remember that they went on the market, because that's where all his money went. He invested far more than he could afford to lose in FUM thinking that CSD500 was going to go large, but it failed and he sold his holding for pennies. You'd think that kind of life event would stick in his tiny little mind, particularly as he's been bashing the stock from that moment, five years ago. What a sad, sad loser.

[joestalin] 19/8/2022 12:57

All of LBO's comments are a repetition to me. They all say "(Filtered)".

[lbo] 19/8/2022 11:32

More ‘smoke screen’ from Petroc. He should get a job with the Eroxon arketing department! If he doesn’t have one already!!! LOL

He is now claiming Mike and Joe were making everything up they said about all the ‘waffling̵7; and ‘smoke-screen’, ‘jam tomorrow’ and it being a ‘lifestyle company’ but not for shareholders? But what is a fact is that the company has been listed for many many years with many many failures. And still has basically the same BOD. With not one product on the market and still zero sales! Its also a fact this BB is called Futura a winner for 2015 and its now 2022 and many many questions still go unanswered!

[lbo] 18/8/2022 18:51

And how ironic Mike!? ROFLMAO

mikethebike4 - 11 Apr 2018 - 14:35:10 - 4072 of 11141
Having had similar waffling, 'smoke-screen' answers from Mr Barder over the years which have turned out to end in exactly nothing I am loathe to give any credence to virtually everything he says

mikethebike4 - 11 Apr 2018 - 15:58:28 - 4091 of 11141
Company is massively over valued if you go by 'concrete' results !

mikethebike4 - 11 Apr 2018 - 15:14:56 - 4082 of 11141
I only try and bring some sort of balance into the equation to help the gullible not get carried away with fanciful future projections.
I would like nothing better than to be proved wrong about Mr Barder (our CEO since 2001) and to sale away into the sunset grasping 5 times as many £s in my fist as I paid for the shares
Unfortunately for people like J7J, Mr Barder has been through this advisors process before - with CSD500 - and look where we've got in 17 years - sales of the product did not even equal the money we paid him to be our CEO for 2017 !

mikethebike4 - 06 Dec 2017 - 10:32:27 - 3468 of 10591
"A couple of decent deals and will be back off to the races."
Do you have any idea of how long shareholders have been using these words

mikethebike4 - 23 Mar 2017 - 09:52:33 - 2560 of 10591
As someone who has been invested for many years and who attended an AGM years ago and complained to Barder about the very slow progress, I am very frustrated.
All the time the Board are drawing good salaries off the backs of shareholders money they have very little incentive to get off their backsides and get 'selling' - thats what running a company is all about at the end of the day!

mikethebike4 - 24 Feb 2020 - 09:11:58 - 7290 of 9713
why should it be any different this time when you've still got the same useless lot running the show

mikethebike4 - 07 Jan 2019 - 11:22:52 - 4692 of 9641
I repeat I very much hope you are right - no one would be happier than me if you are - however I stupidly (in hindsight) bought in when everything looked really rosy - we were told there were loads of 'distributors' all 'champing at the bit to get selling a wonderful industry disruptive product (which it still is incidentally) once the 2 year shelf-life problem was fixed. This was despite the fact that the Holland/Belgium distributor was quite happy and successful selling them with the original 18 months shelf-life
And where are we now years later - one tiny distributor from which Futura receives a total sales income only just about covering Mr Barders employment remuneration
I just hope this MED/TPR situation is not just a repeat of CSD. As to why I don't just sell up, well my shareholding is worth such a tiny proportion of what I paid for it I might just as well hang on in the hope that new shareholders getting in now are luckier than I was and I can get some of my money back - I think what we need is Mr Barders retirement - that should give the share price a kick

[lbo] 18/8/2022 18:49

Really Joe? LOLJoeStalin - 30 Sep 2019 - 10:07:37 - 5937 of 10774FUTURA a winner for 2015 - says it all!JoeStalin - 18 Jul 2018 - 09:00:46 - 4354 of 10775'jam tomorrow' is a very easy promise to make.JoeStalin - 22 Jun 2018 - 14:12:24 - 4288 of 10775What's another year after all?At FUM, time is measured in decades.JoeStalin - 25 Apr 2018 - 16:07:34 - 4147 of 10775There seems to be an unlimited number of ways of saying "Jam tomorrow".JoeStalin - 21 Mar 2018 - 13:50:44 - 3985 of 10775A lifestyle company, but not for the shareholders.