Futura Medical Share Discussion Threads

[lbo] 11/3/2023 10:34

So its now ‘lying and scamming’ that the FTC has jurisdiction over substantiation claims of all low class medical devices. Including Med3000 or Eroxon if/when it does manage to get FDA registration as De novo Medical device. Or that the basis of all the substantiation rulings is consistent regarding adequately controlled and blinded non deficient studies to substantiate claims of any effect beyond a placebo or even just an arousal gel made of the same alcohol, water, glycol and carbomer ingredients as Med3000/Eroxon.



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

[petroc] 11/3/2023 10:22

The multi-ID stock basher (aka LiamBooth, Leveraged, Citygirl, sbgae, LBO8 et al) is making contradictory claims to the results found in two clinical tests and a home use trial. The vast majority of users confirmed that Eroxon works. LiarBO can't show a single piece of evidence that shows otherwise, which is why he has to use spurious and unrelated links in an attempt to tar Eroxon.

[glavey] 11/3/2023 01:57

"Why is the share price stuck at 52"

I was wondering the same. Where is that 200p you mentioned? Guess still considerable patience is required, after all not much has happened with Futura for, how long is it, 20 years? What's another year or three. Or however long it takes for L.O. to exit.

Have you ordered your dose yet?

[lbo] 10/3/2023 22:24

So yet again please substantiate any of your false and misleading claims with non deficient evidence! And again for the umpteenth timeI am not making contradictory claims to the results found in two clinical tests and a home use trials. Quite the contrary. No ‘vast majority of users confirmed that Eroxon works’ any better then a placebo gel or even an arousal gel in any non deficient adequately controlled and blinded study. And I don’t nor does any consumer need to ‘show a single piece of evidence that shows otherwise’. The onus is on the advertiser or ramper making the implied claim that it works beyond a placebo gel or an arousal gel to have the evidence to substantiate that claim before it implies ‘it works’ and is ‘clinically proven’ beyond a placebo or even an arousal gel under the same deficient test circumstances. So the burden of proof to supply the evidence from an adequately placebo controlled study to substantiate ‘it works’ beyond what any placebo gel or even arousal gel would work in those same deficient trsts is on the advertiser/ramper making the claim that the product “it works’. The onus is also on that same advertiser/ramper to also disclose the limitations of the evidence if they were relying on deficient studies to make a claim ‘it works’



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.



It is the advertisers responsibility to hold evidence for the claims they make, and it is stipulated in the Advertising Codes that evidence must be held by the advertiser prior to making the claim. Advertisers must submit documentary evidence to the ASA to support any claims they make; the ASA will not seek out the evidence to establish the veracity of the claim for you.

[petroc] 10/3/2023 17:39

Nobody is asking the multi-ID stockbasher to show any evidence that Eroxon doesn't work. It would be a pointless exercise because there isn't any, and also because the multi-ID stock basher would only lie and mislead. And yet there are increasing amounts of evidence that show that Eroxon works. Two clinical trials and a home use test, and 100% of testimonials on the Farmaline website, all saying the same thing. Eroxon works.

[petroc] 10/3/2023 17:34

The multi-ID stock basher (aka LiamBooth, Leveraged, Citygirl, sbgae, LBO8 et al) is making contradictory claims to the results found in two clinical tests and a home use trial. The vast majority of users confirmed that Eroxon works. LiarBO can't show a single piece of evidence that shows otherwise, which is why he has to use spurious and unrelated links in an attempt to tar Eroxon.

[lbo] 10/3/2023 17:20

Yet again please substantiate any of your false and misleading claims with non deficient evidence! And I am not making contradictory claims to the results found in two clinical tests and a home use trials. Quite the contrary. No ‘vast majority of users confirmed that Eroxon works’ any better then a placebo gel or even an arousal gel in any non deficient adequately controlled and blinded study. And I don’t nor does any consumer need to ‘show a single piece of evidence that shows otherwise’. The onus is on the advertiser or ramper making the implied claim that it works beyond a placebo gel or an arousal gel to have the evidence to substantiate that claim before it implies ‘it works’ and is ‘clinically proven’ beyond a placebo or even an arousal gel under the same deficient test circumstances. So the burden of proof to supply the evidence from an adequately placebo controlled study to substantiate ‘it works’ beyond what any placebo gel or even arousal gel would work in those same deficient trsts is on the advertiser/ramper making the claim that the product “it works’. The onus is also on that same advertiser/ramper to also disclose the limitations of the evidence if they were relying on deficient studies to make a claim ‘it works’



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.



It is the advertisers responsibility to hold evidence for the claims they make, and it is stipulated in the Advertising Codes that evidence must be held by the advertiser prior to making the claim. Advertisers must submit documentary evidence to the ASA to support any claims they make; the ASA will not seek out the evidence to establish the veracity of the claim for you.

[petroc] 10/3/2023 16:42

The multi-ID stock basher (aka LiamBooth, Leveraged, Citygirl, sbgae, LBO8 et al) is making contradictory claims to the results found in two clinical tests and a home use trial. The vast majority of users confirmed that Eroxon works. LiarBO can't show a single piece of evidence that shows otherwise, which is why he has to use spurious and unrelated links in an attempt to tar Eroxon.

[petroc] 10/3/2023 13:59

The multi-ID stock basher (aka LiamBooth, Leveraged, Citygirl, sbgae, LBO8 et al) is making contradictory claims to the results found in two clinical tests and a home use trial. The vast majority of users confirmed that Eroxon works. LiarBO can't show a single piece of evidence that shows otherwise, which is why he has to use spurious and unrelated links in an attempt to tar Eroxon.

[lbo] 10/3/2023 13:43

Please substantiate any of your false and misleading claims with non deficient evidence!

And I am not making ‘contradictory claims to the results found in two clinical tests and a home use trial’. Quite the contrary. No’ vast majority of users confirmed that Eroxon works’ any better then a placebo gel or even an arousal gel in any non deficient adequately controlled and blinded study

And I don’t need to ‘show a single piece of evidence that shows otherwise’. The onus is on the advertiser or ramper making the implied claim that it works beyond a placebo gel or an arousal gel to have the evidence to substantiate that claim before it implies ‘it works’ and is ‘clinically proven’

So the burden of proof to supply the evidence from an adequately placebo controlled study to substantiate it works’ beyond what any placebo gel or even arousal gel would work in those same tests. Is on the advertiser/person making the claim that the product ˜it works’. The onus is also on that same advertiser/person to disclose the limitations of the evidence if they were relying on deficient studies to make a claim ‘it works’



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.



It is the advertisers responsibility to hold evidence for the claims they make, and it is stipulated in the Advertising Codes that evidence must be held by the advertiser prior to making the claim. Advertisers must submit documentary evidence to the ASA to support any claims they make; the ASA will not seek out the evidence to establish the veracity of the claim for you.

[petroc] 10/3/2023 12:46

The multi-ID stock basher (aka LiamBooth, Leveraged, Citygirl, sbgae, LBO8 et al) is making contradictory claims to the results found in two clinical tests and a home use trial. The vast majority of users confirmed that Eroxon works. LiarBO can't show a single piece of evidence that shows otherwise, which is why he has to use spurious and unrelated links in an attempt to tar Eroxon.

[lbo] 10/3/2023 12:03

And here are more proven false and misleading claims posted by Petroc as 'FACTS' on Advfn. Yet no patent has been 'coming soon' now well over a yeat later! And 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 10710What 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 dysfunctionSo 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.https://drbillsukala.com/what-does-clinically-proven-mean-in-advertising/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!

[petroc] 10/3/2023 09:55

The multi-ID stock basher (aka LiamBooth, Leveraged, Citygirl, sbgae, LBO8 et al) is making contradictory claims to the results found in two clinical tests and a home use trial. The vast majority of users confirmed that Eroxon works. LiarBO can't show a single piece of evidence that shows otherwise, which is why he has to use spurious and unrelated links in an attempt to tar Eroxon.

[lbo] 09/3/2023 22:18

Petroc himself has provided the evidence that there was ‘no placebo controlled studies’ for Med3000/Eroxon to substantiate any effect beyond a placebo!

petroc - 23 Feb 2023 - 21:53:12 - 16545 of 16566

Why 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’




Assessment

Upheld

The 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




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.



Assessment

Upheld

The 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