Futura Medical Share Discussion Threads

[lbo] 08/12/2022 18:25

THE PLACEBO PROBLEM: HOW SCAMMERS TAKE ADVANTAGE OF A PSYCHOLOGICAL EFFECT
OPINION: The placebo effect is real. But so are the hucksters shilling it in bad

[losses] 08/12/2022 18:22

Exactly... constant updates shafting LBO with med3000

[lbo] 08/12/2022 18:18

Even Med3000 just as a placebo medical device gel OTC with no pharmacy will be associated with deaths.



This decision was made following a reassuring assessment of the safety of the Viagra Connect, advice from the Commission on Human Medicines, and a public consultation



Viagra is approved for treatment in the UK and offered by the NHS because it is a safe and effective treatment. Viagra is also one of the world’s most widely used drugs and used by millions of men per year. When dealing in such substantial numbers of users not all side effects associated with Viagra can be proven to have actually been caused by Viagra. More then 1 in 100 suffer similar or worse common side effects from ingesting alcohol. But many still drink alcohol regularly they feel the positive effects outweigh the negative effects.



Sildenafil and tadalafil are recommended firstline treatments for erectile dysfunction (ED). Sildenafil was legally reclassified to a pharmacy medicine in the UK in 2018.

The two-fold increase in the rate of primary care prescriptions in the past 10 years suggests that more men are being screened for, or seeking help for, ED. The higher rate of prescribing offers opportunity for monitoring of linked risk factors, such as diabetes mellitus, dyslipidaemia, and vascular disorders



Without medical diagnosis of the cause of the erectile dysfunction and of any potentially underlying serious medical conditions (such as CVD and diabetes), the risks associated with self-treatment of erectile dysfunction outweigh the benefits



Figures released by the British Association of Urological Surgeons show that 90 per cent of men with impotence have at least one underlying physical cause for their problem, with 40 per cent living with cardiovascular disease and 33 per cent with diabetes.

Cardiovascular disease is the leading cause of death globally, claiming an estimated 17.9 million lives each year according to the World Health Organisation.




European Court of Justice to Clarify Liability for Medical Device

[broomrigg] 08/12/2022 17:18

ADVFN Top lists: Constant gainersFUM: 8 consecutive blue days.Still cheap.Nuff said ;-)

[lbo] 08/12/2022 16:44

Placebos can be harmful especially medical devices which have undergone no long term safety studies. One of Med3000 safety studies on impedence and STI risks was on cadavers! A CE mark only requires ‘meets the General Safety’ requirements of medical devices.












researchers found that medical devices that were first approved in the European Union were associated with a greater rate of safety issues than devices first approved by FDA.

Researchers examined 309 devices, 206 of which were approved by the FDA and the EU. Sixty-three percent were approved first in the EU.

The researchers found that the devices approved first by the EU were three times more likely to require safety alerts and recalls.

[lbo] 08/12/2022 16:39

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

[lbo] 08/12/2022 16:35

Oral PDE5i drugs are the proven safe, effective and recommended first line therapy for ED. According to people and organisations who are qualified to make those recommendations. Are you calling the SMSNA and the AUA liars?

You have also deliberately and repeatedly misrepresented the side effects and risks of the recommended first line therapy. It has many years of objective data in millions of users supporting why it is still the recommended first line therapy. Unlike Med3000 which has no non deficient data supporting its efficacy and very little and very short term safety data only in a very few number of users. A placebo gel like Med3000 is not a validated standard of care. Or as the SMSNA referenced a ‘snake oil’






‘Its all in the American Urological Association [AUA] guidelines’

‘The therapies have not been validated’

“I recommend what we have as standard of care, which includes pills, injections, penile prosthesis, and vacuum devices that we know work. Other therapies have not been included in the standard of care yet’

The first line therapy recommended in the General practice guidelines on ED is oral PDE5I drugs. Which would be based on all the available objective evidence. It would not be based solely on a rampers subjective and unqualified personal view. Or if a person just own shares in a company with a placebo gel alternative and who may have a vested interest and biased opinion.



First-line therapy

For most men with ongoing confirmed ED, first-line treatment will be a phosphodiesterase-5 inhibitor (PDE5I).



Phosphodiesterase 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil) are recommended as first-line therapy. With established safety profiles, these drugs are well tolerated and effective

GPC prescribing lead Dr Andrew Green:

'There is no doubt that sildenafil is a safe and effective drug’

[lbo] 08/12/2022 16:23

Placebos including MED3000 too have lots of side effects. So does alcohol cause all those side effects yet you keep ingesting alcohol. Alcohol also causes more harm including being a cause of ED and associated with many more deaths per annum then all the oral PDE5i drugs put together have ever been.



A Viagra study also showed using a placebo was also just as likely to harm you. It compared some 4,500 patients taking the drug to about 3,100 on placebo. So based on that study Med3000 even as a placebo is just as likely to harm you as viagra.

[lbo] 08/12/2022 15:35

Futura has openly admitted in an RNS back in 2021 it was using the ‘least burdensome’ route of the De Novo medical device registration for Med3000. This only requires a low threshold of effect over baseline for ‘reasonable assurance’ of some effect including even just placebo effect for lower class medical device registration. This has allowed Futura like other medical device manufacturers exploit ‘the 2002 Medical Devices User Fee Act’ which requires the FDA to use the least burdensome route for that low class device. So the FM71 study was deficient as it was an uncontrolled and an unblinded study and ‘prone to bias’. So even if if Med3000 is given medical device registration. FM71 still has not met the standards of the FTC, ASA or EU
Courts to substantiate any claims of an effect beyond a placebo and the FTC has jurisdiction over the marketing claims of these lower class medical devices. Similar applies to FM57. It was not an adequately controlled study as it was designed to study Med2005 not the placebo MED3000 gel.



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.



In terms of advertising and promotion, for most over-the-counter medical devices, the FDA and FTC exercise joint regulatory authority over product labelling and advertising. The FDA has primary jurisdiction over labelling for all medical devices and advertising for restricted devices (typically Class III), while FTC has primary jurisdiction over advertising of unrestricted medical devices (Class I and most Class II devices). The FDCA prohibits the distribution or receipt in interstate commerce of a misbranded medical device, which includes a device bearing false or misleading labelling. Claims in device labelling, including product websites, that are outside the scope of the device cleared uses can misbrand, and even adulterate the device, another prohibited act under the FDCA

[lbo] 08/12/2022 15:28

Med3000 is not in the same class. Its only a medical device. Med3000 has not even proven an effect beyond a placebo in any adequately controlled study or even a standard cooling lubricant/arousal gel. And even in FM71 it proven less effective then the lowest possible dose of Tadalafil.



More oversight is needed over products in the grey area between medical device and medication

Powders, tablets and gels used like medications but registered as medical devices the same category plasters and pacemakers fall into need tighter controls, a team of clinical researchers has concluded after studying several such materials. Products that fall into this regulatory grey zone don’t need to prove their efficacy or safety in the same way pharmaceuticals do, which could be a concern for vulnerable patients

According to European regulations, medical devices are used for diagnosis, prevention or treatment of disease, but unlike drugs their primary mode of action isn’t biological. The definition includes everything from medical software to wound dressings and surgical instruments

Manufacturers need to demonstrate medical devices safety and performance. An organisation called a notified body then assesses the products conformity and grants it a CE mark. But Van Winckel and her colleagues found only poor clinical evidence for the three devices they investigated. Studies were small or of low quality, often missing placebo controls. In some cases, there was no data at all, for example to show the effect

The researchers also highlighted the lack of safety information in the devices instruction leaflets. There was no or little mention of interactions with other compounds, maximum safe dose or adverse effects



Oral powders or gels, sold as medical devices in the European Union (EU), aren’t regulated to the same safety standards as those applied to medicines

As a result, these products, which look like medicines, can be marketed with very limited clinical data and accompanied by poor quality product information.

require only certification with a CE (quality) kitemark before the product can be marketed.

This process doesn’t require evidence of efficacy or safety from high quality clinical trials, as is the case for medicines.

It also means that these products can automatically be sold without a prescription across the EU, and actively marketed to patients and clinicians.

[mikethebike4] 08/12/2022 14:00

Viagra IS the main competitor - try looking beyond your nose !

[lbo] 08/12/2022 13:03

Viagra is not the main competitor. The main competitors are other similar class 2 medical devices like cooling lubricants/arousal gels which can replicate every effect that Med3000 claims. Viagra has also proven efficacy beyond a placebo in many phase 3 drug trials and safety data over many years in millions of users. Med3000 has not! Even in the deficient FM71 Med3000 was still less effective then the lowest dose of Tadalafil. And Placebos like Med3000 also cause side effects and in FM71 MED3000 caused headaches, nausea and penile burning!



A Viagra study also showed using a placebo was also just as likely to harm you. It compared some 4,500 patients taking the drug to about 3,100 on placebo. So based on that study Med3000 even as a placebo is just as likely to harm you as viagra

[lbo] 08/12/2022 10:21

The ‘huge news’ is public knowledge’ and that Med3000 is just a placebo medical device arousal gel! And lower class medical devices never get FDA ‘approval’. They are not drugs and only have to meet the ‘flimsy’ medical device threshold of reasonable assurance of some effect (including it just being a placebo effect). MED3000 is only applying for De Novo medical device registration and exploiting the ‘least burdensome’ pathway. It still does not have any evidence from any adequately controlled studies to substantiate any effect beyond a placebo to the FTC. It will not have FDA approval to claim anything. All the brokers admit the risk is now execution risk as they also know its going to be difficult to sell a placebo gel which is no different to any other cooling lubricant/arousal gel made just of alcohol, water and glycol and get away with claims that cannot be substantiated by any adequately controlled studies! LOL



‘Commercial execution is key’

˜The next steps are EU launches (due to start during H123), FDA marketing clearance (potentially by end Q123)

‘we have limited visibility on the potential timing and terms, given various structures and options could be considered. Importantly, current cash resources should be sufficient to reach beyond the anticipated US regulatory decision by end Q123, and to secure a US deal, assuming a positive regulatory outcome catalyses discussions’

‘The first wave of launches is anticipated during H123, which could potentially include the UK. The next wave will likely include the rest of the key markets of France, Germany, Italy, and Spain, with the third wave being the distributor-led smaller geographies. A contract manufacturer is in place for commercial production and first orders have already been received from Cooper’

[j777j] 08/12/2022 10:12

Huge news on the way as they go for green on the UK European launches.


FDA approval as good as in the bag as the co worked closely with the FDA along the way and have fulfilled all the requirement for sale and an OTC product



Recent article talking about the Cannabinoid development




All set to fly past 100p next year

[lbo] 08/12/2022 10:05

No just rampers like you pumping it all over the internet and social media! LOL








Last time there was a big pump was before a fundraising. What if the get knocked back or there is a delay in getting the De Novo medical device registration? Perjury they are thinking of trying to do yet another fundraising and secure their salaries for as long as possible as MED3000 fails to deliver any meaningful revenues to shareholders to justify anywhere near the current £140m market cap!