Futura Medical Share Discussion Threads

[mdi] 20/2/2024 15:11

Also a CE Mark for a low class medical device does not mean efficacy is proven either.



Eroxon Is Not a Medication?

No. Because it lacks an active ingredient, the EU granted MED3000 a CE mark which classifies it as a medical device not a medication. Thats important because in European markets, medical devices dont have to show any sort of improvement in symptoms; they just have to meet specific safety standards.

In other words, the CE mark proves only that Eroxon is safe, not that it works.



Does it work?

MED3000 was recently granted a CE mark as an approved medical device in the EU. Does this mean it works? No. Unlike drugs, medical devices don't need to be proven efficacious to be sold; they only need to show conformity with safety regulations, which the CE mark indicates.

So how effective is MED3000 really?

The first thing to note is that MED3000 has never been shown to be more effective than any control treatment - because it was the control treatment.

When Futura describe the efficacy of MED3000, they are talking about improvement seen over the course of the treatment period (which was 1 month in the first trial, 3 months in the second), known as 'change vs. baseline'.

Large improvements vs. baseline are common in the placebo groups in clinical trials of a wide range of conditions. This improvement is sometimes attributed to the 'placebo effect',

[takeiteasy] 20/2/2024 15:10

MDI - filtered.

There was a double blind placebo trial - it met the end point. Yes, you may drive the price back down to 35p with all this nonsense - but as I said before you have lost the argument.

[mdi] 20/2/2024 15:05

Only proven to the threshold of a ‘least burdensome’ approach for low class medical device of reasonable assurance of some effect including it just being a placebo effect. Still not proven to be ‘clinically proven’ beyond a placebo gel effect in any fully blinded study according to the FTC threshold.

‘All manufacturers of "health-related products" must now support their efficacy claims with gold-standard double-blind, randomized, placebo-controlled clinical trials’



˜The FTC and the Food and Drug Administration (FDA) share jurisdiction over the marketing of dietary supplements, foods, drugs, devices, and other health-related products




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 OK

Journalists 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 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 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.

[takeiteasy] 20/2/2024 14:53

60% success rate is acccurate and proven For the 5,000th time the results were already achieved. The consumers are protected as this is what we state on the label. QED.
Please write to the management and tell them what they state on the label is "Not accurate" - you are beyond hope...

[takeiteasy] 20/2/2024 13:47

Once FDA was made aware of the 60% success rate from phase 2 the only extra information they needed was a phase 3 open label study against cialis/viagra to compare safety outcomes.

The "does it work" question had already been confirmed in phase 2.

To go backwards now and say perhaps I need to check our gel against say KY jelly which has no active ethanol effect is simply not required.

[broomrigg] 20/2/2024 13:34

The one upside of him still being around is that we can rub his nose in it.

[takeiteasy] 20/2/2024 09:25

"In 2015, researchers thought that caffeine, a stimulant, would trigger penile blood flow, finding that men who drank two to three cups of coffee per day had the lowest rates of erectile dysfunction." so a swig of expresso and pop on our little gel and start the fun - perhaps we need to market exoron at costa shops :) dyor etc

[broomrigg] 19/2/2024 18:43

Would be nice to see a rise past 50p this week and 60p soon after that. Of course any good news re roll-out in the US and we should smash that out of the park 🚀

[takeiteasy] 19/2/2024 17:08

Petroc, imagine getting plasma injected into your manhood - just about certain to cause a droop - a total and utter non starter. We have hopefully moved their product firmly back to the drawing boards :)

[2 solaris] 19/2/2024 14:46

Lovely bit of blue, this will really start to motor as more and more people get to hear about the product and it becomes available in more and more (at least 12 now by April)countries around the world. What's not to like?

PS Even the chart is in a rising trend!

[2 solaris] 19/2/2024 14:11

For those who missed it, here is the video from 12 days ago.



'Looking ahead, Futura anticipates further global expansion with more than ten country launches expected by April, surpassing initial forecasts.'

[takeiteasy] 19/2/2024 13:34

all the arguments have now been addressed to my satisfaction - so perhaps time to stop posting here :)
sit back watch and enjoy....dyor

[seagreen] 19/2/2024 13:30

petroc I never filter anyone ...what's that saying keep your friends close and your enemies even closer....I have to say the content is a tad pathetic and fairly easy to debunk...especially over the appalling side effects of the blue pills for the very people who need them to function.