Futura Medical Share Discussion Threads

[lbo] 15/3/2023 15:46

Any shorters now have Petroc to thank for providing all the evidence on a public forum needed for a complaint to the ASA about Eroxon



The HCP UK website Petroc advertised and introduced first into evidence on February 23rd on ADVFN admits



‘Eroxon was the placebo used in FM57’

So public complaints can now be made about Med3000/Eroxon to the ASA thanks to Petroc. And the application of the same principles of the ASA ruling on another similar drug free Class 2b medical device gel to Med3000/Eroxon could now mean the ASA can also find similarly that the results of FM57 are a ‘post hoc finding’ and ‘false positive’



Med3000 was just the placebo in the FM57 study

Therefore Futura had initially believed Med3000 had no therapeutic effect.

The FM57 study did not set out to measure the efficacy of Med3000.

The ASA will therefore consider that its reported effectiveness by Futura was a â€false positive’ ‘post-hoc finding’

The CAP Code required that objective claims, including medical claims for a CE-marked medical device, be backed by evidence

a certified Class IIb medical device. We understood that the device certification was granted by a body within the European Member States that had been designated to carry out conformity assessments under the Medical Device Directive

had been used as the placebo treatment in that study, and therefore the researcher had initially believed it had no therapeutic effect. The trial did not set out to measure the efficacy

its reported effectiveness by the advertiser was a post-hoc finding due to the risk of that being a false positive finding

[lbo] 15/3/2023 15:39

Joe it is 2023 and you are still posting on here too! How long nos before they need more money from shareholders? Brokers all still forecasting losses for this year! ROFLMAO

JoeStalin - 30 Sep 2019 - 10:07:37 - 5937 of 10774
FUTURA 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 10775
What's another year after all?
At FUM, time is measured in decades.


JoeStalin - 25 Apr 2018 - 16:07:34 - 4147 of 10775
There seems to be an unlimited number of ways of saying "Jam tomorrow".


JoeStalin - 21 Mar 2018 - 13:50:44 - 3985 of 10775
A lifestyle company, but not for the shareholders.




Here's a startling fact: between 80% and 90% of new product launches fail, according to multiple studies including Harvard Business Review. Each year, more than 30,000 new products hit the market, from companies large and small, and year after year, history is littered with dead carcasses



Research at the Ehrenberg-Bass Institute shows new product launches can be a risky undertaking for brand owners. Investigating 83,719 new product introductions over an eight-year period, the research finds around one in four new products failed to survive one year after launch. This failure rate increased to around 40% two years after launch.



Why Most Product Launches Fail

[joestalin] 15/3/2023 15:29

We certainly don't.



The problem is that he has nothing else to do all day.

[lbo] 15/3/2023 15:13

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

Futura has openly admitted in previous RNS it is exploiting the ‘least burdensome’ pathway for De Novo Medical device registration for Med3000/Eroxon

‘ 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’

That ‘reasonable assurance’ that a device is effective includes just it being a placebo effect as no evidence from any adequately controlled and blinded study exists to substantiate any claims of an effect beyond a placebo 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.

[lbo] 15/3/2023 14:49

So there it is. Petroc himself has provided the evidence that it is he who is 'lying and scamming' on bulletin boards. The link he provided on ADVFN admits ˜no placebo controlled studies' for Med3000/Eroxon to substantiate any effect beyond a placebo!petroc - 23 Feb 2023 - 21:53:12 - 16545 of 16566Why are there no placebo controlled studies?So as the relevant and applicable ASA rulings have said 'There was no statistically significant difference between the outcomes for the treatment group' (patients using the eroxon gel device) and the control group (using an inactive sham device) eg arousal gel. As the website Petroc linked admitted there was 'no placebo controlled studies''The study was accordingly not adequate evidence of the efficacy'https://www.asa.org.uk/rulings/actegy-ltd-g20-1053158-actegy-ltd.htmlAssessmentUpheldThe ASA noted that the product appeared to meet the requirements of the Medical Device Directive (MDD) but understood that 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.CE certification in itself does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims.There was no statistically significant difference between the outcomes for the treatment group (patients using the Aerosure device) and the control group (using an inactive sham device). The study was accordingly not adequate evidence of the efficacyhttps://pocketdentistry.com/asa-ruling-on-orthoaccel-technologies-inc-ta-acceledent/Because the trial was not placebo-controlled, we considered AcceleDent had not provided adequate evidence to support the claim AcceleDent, is also clinically proven to reduce the pain and discomfort associated with braces and aligners by up to 71%. We concluded that the claim had not been substantiated and was misleading.On that point the claim breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 Medicines, medical devices, health-related products and beauty products.https://www.asa.org.uk/rulings/actegy-ltd-g20-1053158-actegy-ltd.htmlAssessmentUpheldThe ASA noted that the product appeared to meet the requirements of the Medical Device Directive (MDD) but understood that 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.CE certification in itself does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims.There was no statistically significant difference between the outcomes for the treatment group (patients using the Aerosure device) and the control group (using an inactive sham device). The study was accordingly not adequate evidence of the efficacy

[petroc] 15/3/2023 14:25

Oops! Don't want to bury Joe's link!

[lbo] 15/3/2023 13:31

‘manipulative and devious activities?’ Indeed!!!! LOL

Petoc implied it was a fact that Eroxon/Med3000 was ‘clinically proven’ beyond a placebo. Yet the HCP website he linked has now proven these were not ‘FACTS’ as it said no adequately placebo controlled study had been carried out!

petroc - 21 Jan 2022 - 18:03:42 - 10541 of 10710
What is not to love Eroxon /MED3000 - HERE ARE THE FACTS

- Patent application in progress using patent lawyers - COMING SOON

- Eroxon® is clinically proven to treat erectile dysfunction


So Med3000 also will never have FDA approval to claim its ‘clinically proven’. Even the implied claim that it is ˜clinically proven’ beyond a a placebo is a false claim according to the FTC as Med3000/Eroxon cannot substantiate that claim with any adequately controlled and blinded study.



Clinically proven? Says who?

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

It is possible the company selling the supplement, infomercial ab gadget, or balance device did a poorly controlled study where they had people try the product and then tell the company about their results.

While this seems logical enough, it does not constitute legitimate research.

Or that Med3000 will never have FDA approval to make any claims of an effect beyond placebo. Especially just exploiting the De Novo medical device least burdensome route to market and not carrying out any adequately controlled and blinded studies to substantiate claims of any effect beyond a placebo. Only drugs can claim FDA approval. Med3000 is not a drug. Its just a low class medical device!



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.

[lbo] 15/3/2023 13:24

LOL

Pumpty dumpty sat on a wall! The desperation of posting ‘recycled version from a couple of years’

‘Most consider insider ownership a positive because it can indicate the board is well aligned with other shareholders. However, on some occasions too much power is concentrated within this group’

'petroc - 23 Nov 2022 - 18:00:42 - 14168 of 14546

I won't care, of course, because I'll have moved on,'



But they did not disclose to their followers while promoting those stocks that they planned to sell shares once prices or trading volumes rose, the DOJ and SEC alleged. The influencers gained a profit by pumping the stock prices and then selling once they rose




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

[joestalin] 15/3/2023 13:07

That one:-





Watch loser boy bury this one!

[petroc] 15/3/2023 13:07

Oops! Don't want to bury Joe's link!