Futura Medical Share Discussion Threads

[petroc] 31/12/2022 23:57

Unhappy New Year, LiarBO!

[lbo] 31/12/2022 17:32

Futura has openly admitted in an RNS back in 2021 it was using the 'least burdensome' route of just a De Novo medical device registration for Med3000.This only requires a low threshold of effect over baseline for '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' . 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 if Med3000 is given medical device registration. FM71 still has not met the standards of the FTC to substantiate 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.https://www.arnoldporter.com/-/media/files/perspectives/publications/2021/09/trends-and-developments.pdfIn 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

[lbo] 31/12/2022 17:28

FM57 was not a clinical study designed to study the Med3000 placebo gel!

And FM71 was not a clinical study with any adequate control to substantiate any claim of any effect beyond a placebo. It was only a medical device test exploiting the ‘least burdensome’ route of low class medical devices.



Uncontrolled Trials

This design incorporates no control arm. This design is usually utilized to determine pharmacokinetic properties of a new drug (Phase 1 trials). Uncontrolled trials are known to produce greater mean effect estimates than a controlled trial, thereby inflating the expectations from the intervention. There is a threat of inherent bias and results are considered less valid than RCT. Another issue is use of this design in spontaneously resolving maladies that might again overstate the effect



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.




Med3000 was also 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€ËÅ“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

[petroc] 31/12/2022 16:15

Over 60% of men, WHO HAVE ACTUALLY USED MED3000 IN 2 CLINICAL TRIALS AND A REAL WORLD TEST, confirmed that MED3000 worked for their ED. LiarBO, who has never even seen MED3000, let alone used it, says it doesn't work. Boo hoo!

[petroc] 30/12/2022 16:32

Another thing, LiarBO, nobody is under any obligation at all to tell you if they're selling, buying or holding, whatever they post. It really has nothing to do with you, particularly as you don't have a cent invested here. You're the one who should be revealing why you've been bashing this stock relentlessly for five years, even going to the extent of creating multiple aliases and spreading your lies and manipulation to other BBs.

[broomrigg] 30/12/2022 12:49

50p bid. .....loverly jubberly :-)

[petroc] 30/12/2022 11:42

Another thing, LiarBO, nobody is under any obligation at all to tell you if they're selling, buying or holding, whatever they post. It really has nothing to do with you, particularly as you don't have a cent invested here. You're the one who should be revealing why you've been bashing this stock relentlessly for five years, even going to the extent of creating multiple aliases and spreading your lies and manipulation to other BBs.