Futura Medical Share Discussion Threads

[lbo] 02/9/2022 19:02

Same applies to MED3000 as applied to Flexiseq gel. Which is also a class 2b medical device gel

As Study Placebo, Non-Drug Gel Not Qualified



Study comparing Flexiseq to a placebo gel might have helped substantiate claim “drug free, sustainable approach to joint pain and stiffness, clinically proven to treat osteoarthritis

but marketer didn't provide those results when Advertising Standards Authority reviewed online ad claims challenged by a physician.



The CAP Code required that objective claims, including medical claims for a CE-marked medical device, be backed by evidence, if relevant, consisting of trials conducted on people. Flexiseq was 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.

[j777j] 02/9/2022 17:12

EU and UK launch imminentWatch this spaceAll FDA requirements for the latest study were met and passed with flying coloursEnjoy your bankruptcy

[lbo] 02/9/2022 16:58

Not sure if anyone can patent a placebo effect or claim that one medical device placebo gel that is ‘massaged’ in an ED study is any better then the next medical device placebo gel in another ED study that could also be ‘massaged in’ and also cause ‘evaluation cooling’ ROFLMAO

‘The placebo response seems largely more important when the cause of [erectile dysfunction] is mainly due to psychogenic factors’




This placebo effect was most pronounced in men with post-traumatic stress disorder (PTSD), suggesting that for some men psychology is more important than physiology in dealing with erectile dysfunction, said lead researcher Alexander Stridh of the Karolinska Institute's department of clinical neuroscience, in Stockholm.
"The placebo response seems largely more important when the cause of [erectile dysfunction] is mainly due to psychogenic factors, as in post-traumatic stress disorder," Stridh said.
For this analysis, his team pooled data from 63 studies involving more than 12,500 men.
The studies showed that Viagra and its relatives had a strong effect helping men who had erectile dysfunction due to chronic illness.
"The studies included in this meta-analysis mainly were trials on men with [erectile dysfunction] due to cardiovascular disease, diabetes, etc.," Stridh said. "It is likely that there is a limit to how much the brain can influence erectile function when the problem is mainly dysfunctions in blood vessels or peripheral nerves."
But the researchers found that men in the placebo arm of these trials also experienced a small to moderate improvement of their erectile function. The placebo effect was notably stronger among men with PTSD.
"This paper highlights the importance of taking into account the underlying cause of [erectile dysfunction] in each individual, which could also help determine what the best treatment option would be," Stridh said. Some men might benefit more from psychotherapy, others with a pharmaceutical approach, he added.

[lbo] 02/9/2022 16:54

Futura admitted in yesterday RNS that FM71 was a study designed that ˜included men who had organic and psychological ED, or a combination of both. Those men with Psychological ED do not need Viagra unless they also had an underlying organic cause that required viagra.All those men with Psychological ED are responding to the placebo effects of being in an ED study testing a so called ED gel which has the same ingredients as some arousal gels already on the market.https://www.ebtc.ie/penetration-hard-get-hard/Can't I just take a tablet?Sure you can. Men get prescribed Viagra at the drop of a hat for physical and psychological erectile problems, but this is a pity because Viagra is often not necessary and then they start to rely on it simply for the placebo effect. If you can get an erection in one situation and not the other, you do not need Viagra.

[j777j] 02/9/2022 16:47

Nice break out



Off to the races and LBO get slaughtered

[petroc] 02/9/2022 16:21

And of course not only was MED3000 tested against a group using a different treatment in the Phase3 trial, it was tested against a Taladafil cohort in FM71. In both of those tests MED3000 surpassed expectations and is now a certified, proven treatment for ED. Plus of course the real world testing carried out recently. And LiarBO can't see it. Or should I say, WON'T see it. There are none so blind as those that will not see.

[lbo] 02/9/2022 16:21

Or men could just use any cooling arousal gel/cooling lubricant and get the same mechanical, cooling and placebo effect as MED3000 if they want less side effects then Tadalafil which worked better.

[lbo] 02/9/2022 15:30

Futura admitted in March 2021 FM71 was going through the least ‘burdensome route’. FM71 was not a phase 3 drug trial as has been misreported by some. It was just a study for a De Novo Medical Device registration that was uncontrolled and unblinded.



Devices are subject to weaker standards than drugs because they’re 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 OK (here’s 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 t t know what we’re re 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’

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 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] 02/9/2022 15:27

hxxps://www.fiercepharma.com/pharma/futuras-topical-erectile-dysfunction-therapy-hits-phase-3-goal-igniting-race-fda

[petroc] 02/9/2022 15:22

Broomrigg, that'll be FOMO - people not wanting to be out of this in case something happens over the weekend. Fingers crossed!

[lbo] 02/9/2022 14:42

What standards are applied to evidence? The position taken by the ASA is a tried and tested one which has developed over the course of many years. It reflects the opinion of the wider scientific and academic community, rather than judgements made solely by the ASA




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] 02/9/2022 14:40

Persistent buying now.....looking good for another spike up