Futura Medical Share Discussion Threads

[petroc] 24/8/2022 19:38

As I said, increasingly irrelevant.

[lbo] 24/8/2022 19:28

When studies are not adequately controlled so no effect beyond placebo can be substantiated and then the study results are not fully published for peer review then the results and data according to the FTC can be ‘sliced and diced’



What happened next gets to the FTCs allegation that the respondents, in effect, deceptively sliced and diced the data in search of a positive marketing message. According to the complaint, the respondents subjected the data to post hoc analyses of different subgroups of test subjects. (The complaint describes a post hoc analysis as statistical analysis conducted after the data have been collected in hopes of discovering statistical relationships that suggest cause and effect.) The FTC concern is that unplanned, post hoc subgroup analyses pose a high risk of generating spurious findings.




One specialist commentator felt that the clinical effectiveness has not been demonstrated. The absence of an adequate placebo (an inactive topical gel) for highlighted as a limitation by 3 commentators. One commentator said that without it, the clinical effectiveness could be attributed to the placebo effect of rubbing a gel

[petroc] 24/8/2022 18:52

Not only are LiarBO's posts increasingly boring, they are also totally irrelevant to the subject at hand. At this point I could talk about the positive results seen in the tests so far, eg a 60% improvement compared to LiarBO's claimed 50% that a placebo might offer, however I'll just let LiarBO carry on muddying the water with his irrelevant and pointless ramblings, which everyone can see exactly what they are - meaningless fluff.

[lbo] 24/8/2022 18:04

Issue

Two complainants challenged whether the claims “clinically proven” were misleading and could be substantiated.



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. We understood that the Aerosure Medic was classified as Class I medical device. Class I medical devices were generally CE-marked on a self-declaration basis. 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 of the device.

[broomrigg] 24/8/2022 17:05

Another upwards spike in the share price coming? Looking good here as we await news :-)

[lbo] 24/8/2022 15:28

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.




According to the FTC, Massachusetts-based NeuroMetrix, Inc. and its CEO, Shai Gozani, sold Quell—a transcutaneous electrical nerve stimulation device—to consumers, touting it as “clinically proven” and “FDA cleared” for widespread chronic pain relief. The FTC says that the defendants lack scientific evidence to support widespread chronic pain-relief claims, and their claims about clinical proof and the scope of FDA clearance for this use are false.

[lbo] 24/8/2022 14:39

Devices are subject to weaker standards than drugs because they’re 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’s OK (here’s one 2015 example).

Journalists need to scrutinize the claims
Journalists have a responsibility to report this lack of evidence, but they often don’t. Investigative journalist Jeanne Lenzer, who wrote a book about the under-regulated medical device industry, says more “dogged” reporting is needed: “We really don’t know what we’re 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” to approval.

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 didn’t 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,

[petroc] 24/8/2022 13:22

(Thanks, LiarBO. saves me doing the legwork. Feel free to copy/paste as many of those as you want.)

[petroc] 24/8/2022 13:20

Oh look! Here's another link that LiarBO posted - 'Eroxon going to market. VERY SOON
- FIRST GEL FOR ED TO OTC MARKET - NO OTHER GELS CAN. NO COMPETITION. NO BRAINER
- $3.6 billion market & conservative 5% share of that estimated as min
- Can be used with other products / medicine or recreationally (as some would)
- Less AE's than Cialis, Viagra etc
- Experts say efficacy approach that of fist line treatments
- EU approved, US approval in process, Global approvals ongoing
- UK / EU partnership / launch COMING SOON
- South America and Mexico launch COMING SOON
- China and SE Asia launch COMING SOON
- US go ahead COMING SOON
- Patent application in progress using patent lawyers - Approval COMING SOON
- Will help ED sufferers - COMING SOON TO MILLIONS of ED SUFFERERS GLOBALLY
- Fast-acting and helps you get an erection within 10 minutes. (FASTER THAN CIALIS, VIAGRA ETC)
- First fast-acting topical gel for erectile dysfunction available WITHOUT A DOCTORS PRESCRIPTION in Europe and the UK.
- No need for questionnaires or Pharmacist Assessment unlike first line treatments
- Eroxon® is clinically proven to treat erectile dysfunction and following a large Phase 3 clinical trial was approved in April 2021 for marketing in the EU and UK.

Circumstances explained here hxxps://eroxon.com/ and summed up well here
hxxps://www.trinitydelta.org/research-notes/nearing-the-critical-point-in-erectile-dysfunction/'

[lbo] 24/8/2022 11:33

Here is a company who made false claims about its medical device being ‘clinically proven’ and that the FDA had reviewed and ‘approved’ its medical device for its advertised pain relief and other health benefits. The FTC challenged all those claims as false and hit them with a judgement for $22 million. The FDA does not approve class 1 or 2 devices like Willow Curve or Med3000. And if there is no adequately controlled studies to support claims of ‘clinically proven’ for medical devices. They challenge that too and impose massive fines on companies that make claims that cannot be substantiated to consumers.

[lbo] 24/8/2022 11:29

Just like the misuse of ‘Clinically Proven’ without an adequately controlled study can cause companies trouble with the ASA and FTC. The same applies to misusing the term FDA ‘approval’ for class 1 and 2 medical devices. And relying on incorrect information from the press etc is no defence especially when the majority of those sources give disclaimers about the information they posted.



‘You have likely heard the terms Clearance, Approval, and Granted used many times throughout the medical device industry. Some of you may think these terms mean the same thing. Or you heard them used interchangeably, so you assumed it was no big deal to use one versus the other. That couldn’t be more wrong.The terminology you use does in fact matter. In worst cases, using it incorrectly can result in serious legal consequences for your business and the device you worked so hard to bring to market. Its important that companies know the differences between the three terms and understand when it is appropriate to use them. Lets dig in and look at the distinctions of Clearance vs. Approval vs. Granted: The misuse in terminology is also commonly seen in the media where these three terms are interchangeably used and imprinted somewhere in our memories to confuse us later. You may see press releases, or blog posts written by large, well-known medical device companies saying their 510(k) was just approved

Using that terminology isn’t just flat out wrong, it can also cause issues for your company’

[petroc] 24/8/2022 10:23

BTW LiarBO, I've never used Twitter in my life. You just can't stop lying, can you.

[petroc] 24/8/2022 10:22

Thanks for those links, LiarBO! I'll take a leaf out of your book and copy/paste a few. 'Facts
1) The FACT is the press, experts in ED, agreement between corporations, the Investment sites, Medical sites, FUM, BOD, Investor meeting and presentations, Regulatory Bodies, Notified bodies, Investors (not those claiming to be but real investors), basically everyone is writing it is proven and works. Shows efficacy reaching first line of treatment. FACT
2) The only people that do not agree that it is proven are two anonymous articles (Discovery and SMNSA) and lbo the stock basher. FACT'

[petroc] 23/8/2022 23:49

I must admit I'd like to reply with a witty comeback, but I don't need to. Your posts were just hilarious on their own! Thanks for making my job so easy, LiarBO!

[lbo] 23/8/2022 18:20

Wonder what the FDA would make of The ethics of Petroc and other rampers continually posting links to a website all over the internet with claims about Med3000. A website that as far I can see has never been officially acknowledged in any Futura RNS! But Futura clearly do give all the necessary disclaimers about it when you look at the disclaimers linked to it. Yet the rampers gave zero disclaimers when they were posting it all over the internet. Could the FDA say the rampers were unethically trying to influence the outcome of FM71 by hopefully convincing the participants it was a 'FACT' that Med3000 was 'clinically proven'petroc - 22 Jan 2022 - 12:51:18 - 10556 of 12886coming soonSee here.hxxps://eroxon.com/

[lbo] 23/8/2022 17:42

So how come he said he was ‘supportive217; and that it would be just a ‘valid addition to the armamentarium of treatments? Just like any and all placebos are when used appropriately and without deception.Seems it Pertroc’s
opinion for the lead investigator to say he is just ‘supportive217; yet it’s a ‘valid’ treatment option in his opinion before the study even recruits or is randomised. Yet it would not be ethical according to Petroc for the lead investigator to say anything at all then in March 2022 or even mention it as a possible innovation on the horizon. Even though the study at that stage had already recruited and the groups had been randomised at that point. Petroc seems to be suggesting that FM71 is a blinded and controlled FDA drug trial. It is NOT. It an open label medical device study for just an application to only register as a De Novo Medical device. Nothing more and it is not bound by the same FDA oversight as a blinded FDA drug trial.