Futura Medical Share Discussion Threads

[lbo] 10/12/2022 17:14

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 â '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 EUCourts 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.https://www.healthnewsreview.org/toolkit/tips-for-understanding-studies/medical-devices/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 OKJournalists 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 devicesNinety-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 routeFor 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.

[petroc] 10/12/2022 16:14

Stock bashing has become very common in the digital world and often occurs on online trading platforms. Sophisticated technology makes it easy for bashers to remain anonymous. As such, it can be difficult to track, identify, and stop bashers in their tracks.

As the internet makes participation in the stock market more accessible to more people, new investors emerging in the market are especially vulnerable to the tactics of stock bashers, and many investor boards exist to attempt to track perpetrators.

Though notoriously difficult to track, some bashers have been identified and prosecuted. From time to time, confessional essays about the tactics of bashers emerge online, although these essays are typically also either anonymous or pseudonymous. Many investors speculate this type of behavior tends to follow certain patterns, including a tendency for bashers to only bash stocks which are generally trending upwards and showing potential.

Having said that, financial regulators constantly monitor the markets for what they call bad actors or stock bashers. According to the Financial Industry Regulatory Authority (FINRA), investors may find it difficult to get information about these securities and any tidbits they may find can lead them to act even if it's misinformation. That's why FINRA warned investment firms and broker-dealers to put controls in place that would raise red flags on any suspicious activity

[lbo] 10/12/2022 14:52

The ramper has posted a link that there are many reasons why symptoms can improve over the course of using any ED treatment of which the placebo effect is only one.

Spontaneous recovery is another that the ramper has proven exists at very high rates in ED. Its why so many say they don’t need PDE5I drugs anymore as the ED just magically went away. Same would have applied during the uncontrolled Med3000 test. So the ramper has proved the tests were deficient

ROFLMAO

petroc8 Dec '22 - 18:26 - 14487 of 14511

‘spontaneous recovery of erectile function without further treatment’



In age-specific analysis, spontaneous recovery of EF was the most common reason for respondents aged 30 -39 years (58.8%

The proportion of discontinuation due to spontaneous recovery of EF was greater in the non-comorbid group (47.7%)



randomised clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups? A protocol for a meta- epidemiological study of PDE-5 inhibitors A particular treatment effect may exert both nonspecific and specific effects. A non-specific treatment effect is an outcome that does not arise according to an intended mechanism of action. This can be a response to a placebo but can also reflect a spontaneous symptom improvement

[petroc] 10/12/2022 12:47

Quick description of LiarBO and his lying, scheming, dishonest stock bashing ways -

Stock bashing has become very common in the digital world and often occurs on online trading platforms. Sophisticated technology makes it easy for bashers to remain anonymous. As such, it can be difficult to track, identify, and stop bashers in their tracks.

As the internet makes participation in the stock market more accessible to more people, new investors emerging in the market are especially vulnerable to the tactics of stock bashers, and many investor boards exist to attempt to track perpetrators.

Though notoriously difficult to track, some bashers have been identified and prosecuted. From time to time, confessional essays about the tactics of bashers emerge online, although these essays are typically also either anonymous or pseudonymous. Many investors speculate this type of behavior tends to follow certain patterns, including a tendency for bashers to only bash stocks which are generally trending upwards and showing potential.

Having said that, financial regulators constantly monitor the markets for what they call bad actors or stock bashers. According to the Financial Industry Regulatory Authority (FINRA), investors may find it difficult to get information about these securities and any tidbits they may find can lead them to act even if it's misinformation. That's why FINRA warned investment firms and broker-dealers to put controls in place that would raise red flags on any suspicious activity

[lbo] 10/12/2022 12:19

Saying there is no evidence it doesn’t work is not according to the FTC and ASA evidence it does work. Neither is it an a accepted defence for making false and misleading claims.

The onus is on the person/company or ramper making the questionable claims to be able to substantiate the claims to the FTC and ASA with evidence from adequately controlled studies.

Which you have repeatedly failed to do! Please show one adequately controlled study that can substantiate any effect beyond a placebo?

You cant even provide results from just a simple blind direct efficacy comparison study against a standard cooling lubricant/arousal gel and substantiate any claim its even having any effect beyond an arousal gel would in if the users were just duped into believing ‘it works’ LOL



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 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.