Futura Medical Share Discussion Threads

[lbo] 03/10/2022 11:40

177 days is all it will take to copy and have similar product on the market. No clinical studies required for copycat alcohol, water and glycol gels. And remember Futura still haven’t even shown that evaporative cooling is what is having any effect!



‘There is no evidence for the evaporative mode of action from the clinical trials. To show that the evaporation is what makes MED3000 work, you'd need to compare it to a non-evaporative gel’



‘This De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster’

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

[lbo] 03/10/2022 11:38

Its already been admitted the Dermasy vehicle and Voltaren vehicle game similar results! LOL



‘TPR100 gave similar results to the gold standard, Voltarol 2% gel’



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. Consumer satisfaction with a topical product is based on subjective criteria such as how the product feels and how it is perceived on the skin. Therefore, appropriate questionnaires are of major importance for cosmetic products to assess the subjective perception not only of soothing and cooling effects but also of moistur- izing properties and fragrance.



A key element of Futura Medicals strategy is to reduce development risk through using well characterised existing agents that are reformulated with its proprietary DermaSys technology to create new products. This means intellectual property protection is limited to use patents for the individual products and umbrella patents for the technology. 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

[lbo] 03/10/2022 11:12

More like you are as thick as a plank of wood if you think it will be ‘major’ for Futura shareholders when anyone can copy it as it has no patent and even the evaporative cooling can be replicated with any similar alcohol gel eg Voltaren vehicle gel.

And ‘Major’ according to who? As always it has the disclaimer of just being ‘we believe’. Just like it was at one time believed PET500 and CSD500 would generate millions of pounds of revenues for shareholders. Yet they didn’t and both failed to meet previously believed expectations! ROFLMAO



And the only thing that differentiates Med3000 from Eddie is its a gel. Both are still class 2 medical devices! Just like a cooling lubricant is just a class 2 medical device too!

LOL

‘These forward-looking statements may use words such as "aim", "anticipate", "believe", "could", "may", "intend", "estimate", "expect" and words of similar meaning. By their nature, all forward-looking statements involve risk and uncertainty because they relate to future events and circumstances which are beyond the control of the Company’

[lbo] 03/10/2022 10:31

‘MED3000 is also expected to be the first major ED treatment available OTC in the USA’

‘Expected’ by who? LOL

And other class 2 medical devices OTC for ED already exist on the market in the USA!?



Eddie is a first-of-its-kind, wearable, FDA Class II erectile dysfunction device



‘Crowded’ OTC device market






What is Eddie by Giddy?

Eddie by Giddy is a nonprescription, wearable device for treating ED. It is a Class II medical device registered with the Food and Drug Administration (FDA), the government agency that regulates healthcare products in the United States. However, it is important to note that when a company registers a product with the FDA, it does not mean that the FDA has approved the product.

[glavey] 03/10/2022 09:33

"All going to plan"

Ah, you've sussed it out then, Broomrigg.

[glavey] 03/10/2022 09:30

Oh dear, looks like you may have to wait a little longer to get a dose, Pet.

[lbo] 03/10/2022 08:02

I note the disclaimer ‘We believe’

‘Certain statements in this Announcement are forward-looking statements, which include all statements other than statements of historical fact and which are based on the Company's expectations, intentions and projections regarding its future performance, anticipated events or trends and other matters that are not historical facts. These forward-looking statements may use words such as "aim", "anticipate", "believe", "could", "may", "intend", "estimate", "expect" and words of similar meaning. By their nature, all forward-looking statements involve risk and uncertainty because they relate to future events and circumstances which are beyond the control of the Company’



Clinically proven? Says who?

When they say “clinically proven,” your first question should be, “oh yeah, says who?”

Not the ASA, the EU courts and FTC!

[losses] 03/10/2022 07:33

James Barder, Chief Executive Officer , Futura Medical said: "Today marks a pivotal milestone for Futura and highlights the regulatory progress we have made to develop and launch MED3000 globally. The submission of our marketing application in the US will pave the way for commercialisation of MED3000 in the biggest ED market worldwide with our key differentiator of a clinically proven treatment for ED with a rapid speed of onset. MED3000 is also expected to be the first major ED treatment available OTC in the USA which we believe will help improve access as well as treatment for many thousands of ED sufferers. We believe Eroxon, the brand for MED3000, is poised to become a major, trusted brand and treatment in the ED market worldwide."

[broomrigg] 03/10/2022 07:20

RNS out.All going to plan and looking good. :-)

[lbo] 03/10/2022 06:12

Again just saying there is no evidence it doesn’t work. Is not, according to the FTC and ASA, evidence it does work!

Petroc is trying to ‘swindle’ others

His only defence is to keep saying there is no evidence to prove MED3000 doesn’t work. And the reason why the evidence can’t be produced is because the study has not been carried out. But the onus is not on the FTC or ASA to carry out this study or provide the evidence it doesn’t work.

The onus is on those trying to make the questionable claims to have the evidence to substantiate them. And they must according to the FTC and ASA have this evidence before they can make a claim ‘it works’. Which Petroc cannot do. So yet again he has failed to be able to substantiate his claims. He is also according to the FTC ‘misleading’ others when he claims there is ‘plenty of evidence’ MED3000 does work. As he continually fails to disclose the major limitations of the ‘plenty of evidence’. As all the evidence is from inadequately controlled or unblinded studies. So it doesn’t prove MED3000 has had any effect itself. It only proves yet again that ED studies have placebo effects.



Advertising and labeling claims are a primary way companies try to grab consumer attention and distinguish one product from another. As the market becomes crowded, competition has increased and claims have become increasingly aggressive and, sometimes, overreaching. Companies must balance the desire to sell products against the fundamental principle that material claims must be substantiated with the appropriate level of support. If not, companies are at risk of action from regulatory agencies such as FTC and FDA, offices of state attorneys general, local district attorneys, competitors and, of course, plaintiffs lawyers. The primary regulator of advertising claims is FTC. FTC identifies principles that are generally accepted to yield reliable test results. A well-designed and carefully controlled study with the blinding of both subjects and researchers is generally viewed as more likely to yield reliable results. Advertisers must carefully consider each claim and ensure that proper support exists. Otherwise, in this era of ˜claims litigation," a company may find itself on the receiving end of unwanted action from a variety of sources.

[petroc] 02/10/2022 19:17

Still waiting for LiarBO, the proven stock basher, to produce some evidence that states that MED3000 doesn't work. Won't hold my breath though, because that evidence doesn't exist. On the other hand, there's plenty of evidence to say that it does work.

[lbo] 02/10/2022 18:46

Now Petroc the proven liar is trying to rely on poor reporting as his ‘evidence’. Yet all those reports are all given with disclaimers.



Devices are subject to weaker standards than drugs because they are regulated under a different law. The Medical Device Amendments of 1976 was intended to encourage innovation while allowing for a range of review standards based on risk, according to legal expert Richard A. Merrill. An array of corporate lobbying has since prompted Congress to ease regulations and make it easier for devices to get the FDA OK

Journalists need to scrutinize the claims
Journalists have a responsibility to report this lack of evidence, but they often dont. Investigative journalist Jeanne Lenzer, who wrote a book about the under-regulated medical device industry, says more dogged reporting is needed: We really dont know what we are getting with many of these devices

Ninety-nine percent of devices never have to provide clinical data, thanks in part to the 2002 Medical Devices User Fee Act, which requires the FDA to use the least burdensome route

For the few devices subject to a scientific review, the quality standards are flimsy. Randomized controlled trials, the gold standard, are infrequent. Most studies are unblinded, and thus prone to bias. The FDA settles for loosely defined reasonable assurance’that a device is safe and effective, versus its higher standard of substantial evidence for drugs, which require studies with comparison groups that didnt receive the same treatment. Thus, data that would never be sufficient to support the approval of a drug can result in the approval of a device used to treat the same condition, potentially diverting patients from effective drugs to less-effective devices.



De Novo-winning devices often lack effectiveness data, analysis shows

[petroc] 02/10/2022 18:25

'A gel that can cure male impotence has been invented by a British firm – and it works in a jiffy.

The rub-on potion vows to get things up and running in five to 10 minutes.

It contains just alcohol and water, and trials on 1,000 men across Europe have proved to be far from a flop.

Med3000 worked for 60 per cent of them – and the hard evidence has left scientists and doctors stunned that such a basic combination of ingredients could solve a problem for millions of men.

Experts at Guildford-based Futura Medical initially made a gel using ­explosive nitro glycerine, but it failed to detonate trialists’ love lives.

But alcohol, normally blamed for bedroom droops, did the trick. “You put a small blob of the gel on the end and rub it in for 15 seconds,” said Futura senior manager Ken James.

“First the user feels a cool sensation, then it warms up. In about a third of couples, the woman rubbed the gel in. We hope to get it approved this year.”

The firm hopes Med3000 will rival Viagra pills, which take at least an hour to act. “Our gel even works on severe erectile dysfunction,” said Ken. “There have been 12,000 acts of intercourse using it and it has been very well received.”

[lbo] 02/10/2022 18:00

Oh what a proven liar. Petroc is! LOL.

All Petrocs claims are ‘ false and unsubstantiated’. This is according to the FTC. Because all the ‘plenty of evidence’ Petroc the proven liar is relying on. While giving no disclaimers. Unlike Futura who do give disclaimers. ‘did not show that’ MED3000 ‘was any more effective then a placebo’. Petroc has ‘deceptively advertised’ MED3000 to other investors. FULL STOP.

ROFLMAO.



Administrative Law Judge Upholds FTC's Complaint that POM Deceptively Advertised Its Products

erectile dysfunction claims were false and unsubstantiated because the study on which the company relied did not show that POM Juice was any more effective than a placebo

[petroc] 02/10/2022 16:24

FFS, LiarBO, use your comma key! You make yourself. A laughing stock by. Putting in all those. Superfluous full. Stops. Moron. And thank you for repeating my post that there is plenty of evidence that MED3000 does work. I see you still haven't found any evidence to the contrary.

[lbo] 02/10/2022 15:46

ROFLMAO

The FTC, the SMNA and the Courts are not anonymous and all agree without an adequately controlled and blinded study. Then Petroc yet again is just a proven liar. Who has made yet more ‘false and unsubstantiated’ claims

Petroc - 29 Sep 2022 - 14:49:18 - 13525 of 13569

there is plenty of evidence that MED3000 does work. Just because it hasn't been tested against a placebo doesn't nullify the good results it has achieved





Administrative Law Judge Upholds FTC's Complaint that POM Deceptively Advertised Its Products

the prostate cancer claims were false and unsubstantiated because, among other reasons, the study the POM respondents relied on was neither blinded nor controlled.

the erectile dysfunction claims were false and unsubstantiated because the study on which the company relied did not show that POM Juice was any more effective than a placebo.