Futura Medical Share Discussion Threads

[lbo] 28/2/2023 12:12

Unlike you who cannot substantiate any if your false and misleading claims. Its easy to substantiate all your proven lies under you many proven multi-ID ramper names ramping all over the internet and multi bulletin boards! LOL





petroc - 23 Feb 2023 - 21:53:12 - 16545 of 16578

Why are there no placebo controlled studies?

Eroxon, was the placebo used in FM57 and gave surprising results having efficacy approximately double that normally achieved in ED studies with regular placebos. Moreover, when assessed against internationally accepted criteria for clinical effectiveness (Rosen and Araujo) the efficacy of Eroxon exceeded the minimal clinically important differences.





But Med3000/Eroxon is not a regular’ oral placebo. Its a medical device gel placebo which is massaged in and medical device placebos like gels are known to have higher placebo effects. So the comparison to only a ‘regular’ oral placebo is inadequate and not an equivalent like for like and is a misleading and deceptive comparison. The information given by the ramper was not ‘enough accurate information’ and involved the ‘omission’ of important information. Other important information has also also been omitted like the fact the fact that FM57 was designed to study to Med2005 not the placebo Med3000. So the results for the placebo Med3000 are according to similar rulings by the ASA. A ‘post hoc finding’ It has also been omitted about the non standard inclusion criteria in FM57 which were not the same criteria used in the the ‘ED studies with regular placebos’. So it only exceeded the accepted minimum criteria for clinical effectiveness in adequately oral placebo controlled studies for regular oral placebos. It has never been directly compared to an appropriate placebo gel nor showed any clinical difference to any placebo gel


‘When promoting, selling or supplying products, companies must give you enough accurate information to enable you to make an informed buying decision’

Misleading practices
You are protected against 2 main categories of unfair commercial practices: misleading practices, either through action (giving false information) or omission (leaving out important information)



‘the MDD did not harmonise EU law relating the advertising of medical devices, which was subject to Directive 2005/29/EC on unfair business to consumer commercial practices (including advertising) generally (Unfair commercial practices directive - UCPD). That meant that advertisers must still meet the requirements of the CAP Code, which reflected the provisions of UCPD. Under the CAP and BCAP Codes, medical claims could be made for CE-marked medical devices provided they complied with other requirements of the Codes, including those relating to substantiation’

‘When promoting, selling or supplying products, companies must give you enough accurate information to enable you to make an informed buying decision. Find out more about contract information. If they fail to provide this information, their actions may be considered unfair. You have the right to seek redress if you are treated unfairly’



Unfair commercial practices

When you buy goods and services anywhere in the EU from a website, a local shop or a seller outside your home countrys EU law protects you against unfair commercial practices. When promoting, selling or supplying products, companies must give you enough accurate information to enable you to make an informed buying decision. Find out more about contract information. If they fail to provide this information, their actions may be considered unfair. You have the right to seek redress if you are treated unfairly.

Misleading and aggressive practices

You are protected against 2 main categories of unfair commercial practices: misleading practices, either through action (giving false information) or omission (leaving out important information) aggressive practices that aim to bully you into buying Certain commercial practices are prohibited in all circumstances. Some of the most common are listed below:

Whenever a product is advertised as therapeutic, curing allergies, reversing hair loss, helping you lose weight, etc. you have the right to know if such claims have been scientifically confirmed. In many cases, claims like these are not medically backed up and are simply too good to be

[lbo] 28/2/2023 11:06

The only thing Med3000 has in common now with Viagra is the lack of patent!!! Its nearly a wonder why Pfizer didn’t want to license this medical device placebo gel to its Viagra brand? Or why Glaxo dumped it years ago! ROFLMAO



Med3000 is not even in the same class as viagra as Med3000 without the GTN is now left only as a low class medical device that works via sensation and placebo effects! Same as any cooling arousal gel would in the same deficient medical device tests that med3000 is relying on.



Even the market analysts know all Futura have done is paid for the research to allow competitors like Reckitt also claim all its class 2 medical device lubricants/arousal gels are also effective placebo treatments for Psychogenic ED!




Reckitt Benckiser was the defined leader and the ultimate four Personal lubricant vendors with leading brands such as Durex Play and K-Y Jelly.

KEY GROWTH FACTORS

Increasing prevalence of erectile dysfunction

9 Market Growth Enablers
9.1 Increasing Prevalence of Erectile Dysfunction

Med3000 is only a medical device and has no active pharmaceutical ingredients! It is only a low class medical device: Futura has openly admitted it is using the ‘least burdensome’ route of just a De Novo medical device registration for Med3000. A pathway exploiting unblinded and uncontrolled studies the same as Futura has used that are ‘prone to bias’ results.

This low class medical device path only requires a low ‘flimsy’ threshold of effect over baseline for ‘reasonable assurance’ of some effect including even just a placebo effect for lower class medical device registration! And it even appears as if the Med3000 medical device tests were designed to build in even more bias due to the use of non standard inclusion criteria and allow for increased spontaneous recovery being wrongly attributed to the use of Med3000.

This has allowed Futura, like other medical device manufacturers, to exploit ‘the 2002 Medical Devices User Fee Act’. This act brought in via corporate lobbying by the medical device companies requires the FDA to use the least burdensome route to market 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 Med3000 is given medical device registration. FM71 still has not met the standards of the FTC, ASA or the Courts to substantiate claims of an effect beyond a placebo or even an arousal gel. 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. So the efficacy of Med3000 in FM57 was a ‘post hoc’ finding.



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.

[j777j] 28/2/2023 11:03

LBO is trying to get people to short the biggest threat to Viagra for 25 years



Hmm ok go for it

[lbo] 28/2/2023 10:52

Must be getting close to the time for another fundraising?



The Berkshire Hathaway CEO went on to say shorting overvalued stocks is also tricky because "people that have overvalued stocks... Are frequently on some scale between promoter and crook. And that's why they get there." He went on to add:

"And they also know how to use that very valuation to bootstrap value into the business, because if you have a stock that's selling at 100 that's worth 10, obviously it's to your interest to go out and issue a whole lot of shares. And if you do that, when you get all through, the value can be 50.

In fact, there's a lot of chain letter-type stock promotions that are sort of based on the implicit assumption that the management will keep doing that.

because if you have a stock that's selling at 100 that's worth 10, obviously it's to your interest to go out and issue a whole lot of shares. And if you do that, when you get all through, the value can be 50.

And if they do it once and build it to 50 by issuing a lot of shares at 100 when it's worth 10, now the value is 50 and people say, "Well, these guys are so good at that. Let's pay 200 for it or 300," and then they could do it again and so on"

According to Buffett, if you get caught up in one of these stock promotion schemes,"you can run out of money before the promoter runs out of ideas."



˜Because when somebody is running something that is semi fraudulent. They are probably pretty good at it. And they are working full time at it’

[j777j] 28/2/2023 10:35

Us partner News

FDA news


EU launch news


Uk launch mews




= Vastly higher share price

[broomrigg] 28/2/2023 09:08

Very strong buying first thing peeps

[broomrigg] 28/2/2023 08:58

Blue yesterday, blue start today, shares solid at this level while we wait for news....looking forward to the next spike up..... 100p+

Well done all investors.

:-)

[lbo] 28/2/2023 08:57

And does the chart look good for enforceable patent!? LOL

[j777j] 28/2/2023 08:56

Chart looks good for 100p plus


Fasten seat belts news any day now