Futura Medical Share Discussion Threads

[takeiteasy] 09/5/2024 15:40

Of course the FDA is not going to offer any sort of warranty in the small print but that is standard legal practice and not worth jumping and down 100 times over.

[takeiteasy] 09/5/2024 15:37

Futura Medical Shares Rise After FDA Approves Erectile Dysfunction Treatment
12/06/2023 8:44am
Dow Jones News

Please note the word approves....

[mdi] 09/5/2024 15:20

Incorrect. Low class Medical devices like Eroxon do not get ‘approved’ by regulators.



‘Consumers may not be aware that, as the FDA explains, ‘Registration and Listing does not denote approval or clearance of a firm or their devices meaning that when you see ‘FDA registered’ or FDA listed’ in advertising it not indicative of the efficacy or safety of the product, no matter how much the marketer would like you to believe otherwise’



Dear Ken James:

‘FDA concludes that this device should be classified into Class II’

Page 3

Please be advised that FDA's decision to grant this De Novo request does not mean that FDA has made a determination that your device complies with other requirements of the FD&C Act or any Federal statutes and regulations administered by other Federal agencies

In

In 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

[takeiteasy] 09/5/2024 15:13

The regulator has approved it and so has the sales network. End of. No one on the planet apart from a few moaning medics and you has the slightest interest. The more successful eroxon is the less money the medics will make from their fewer client consultations as this allows direct client access to treatment bypassing medics where appropriate- no wonder some medics are not going to be cheerful :)

[mdi] 09/5/2024 13:51

Yet the fact remains. Med3000 is still unable to support any of its claims or even its speed of onset claims with evidence from any double-blind, randomized, placebo-controlled clinical trial to substantiate any efficacy beyond just using any similar non medicated placebo hydroalcoholic gel. So medical device clearance process of Eroxon was only completed to the ‘flimsy’, ‘least burdensome’ efficacy standard for a low class medical device. It was not completed to a standard to substantiate its ‘clinically proven’ beyond a placebo gel in any double blind study.



‘Its the gold standard in medicine: taking a treatment, and putting it head-to-head against a placebo to confidently declare whether it actually works. But for most medical (including Eroxon) devices, placebo trials have never been done’




Dear Ken James:

Page 3

Please be advised that FDA's decision to grant this De Novo request does not mean that FDA has made a determination that your device complies with other requirements of the FD&C Act or any Federal statutes and regulations administered by other Federal agencies



‘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’

[takeiteasy] 09/5/2024 13:48

The question was about a definition of a product - not a research validation processs query. The US regulatory bodies approval process was in 2023 and completed.

[mdi] 09/5/2024 13:47

Could be also claimed Eroxon is the real ‘cut and past job’ exploiting men with ED?

‘The ingredients in Eroxon® gel ”ethanol,[1] propylene glycol,[2] glycerine (also known as glycerol),[3] carbomer[4]

Costs €28.89 for 1.2ml or the equivalent of €2,407.50 / 100 ml



Aia* stimulating gel


€22,95 for 30ml or the equivalent of €76.50 / 100ml

Our stimulating gel is made of water and glycerin, also the two main components of our neutral lubricant. We have added some extras to the stimulating gel. Propylene glycol is a safe synthetic substance with a moisturizing effect. Alcohol Denat or Denatured Alcohol is also often used in natural cosmetics: it dissolves essential oils in the product and it is used to extract certain extracts from plants. Carbomer is an emulsifier and thickener. It ensures that the gel remains a nice, even substance that spreads nicely.

[takeiteasy] 09/5/2024 13:39

No answer to the question - just repeat a cut and paste job...

[mdi] 09/5/2024 12:57

The firm also confirmed MED3000 was taking a ‘least burdensome approach’



This approach only requires a low class medical device to meet the threshold of ‘reasonable assurance’ of some effect including the effect just being a placebo effect.So Eroxon still has not been ‘clinically proven’ to have any effect beyond a similar placebo hydroalcoholic gel in any fully blinded study. A standard that all PDE5i drugs meet.



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

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] 09/5/2024 12:16

The firm has confirmed this is no longer a placebo in the use case applied within our firm and with the product features as you are required to use them.

What every man and his dog wants to do elsewhere in different contexts is irrelevant to us as the use cases /experiment will always be different in one way shape of form.

Desparately tedious to keep say the opposite - why this excites you so much I have no clue.....just because other experts would prefer different experimental designs is also irrelevant to me as our sales network have accepted our logic.

[mdi] 09/5/2024 10:29

Another study that clearly shows a ‘placebo’ ‘non medicated hydroalcoholic gel’ has a placebo effect in ED studies and an ‘evaporative effect’ as its a hydroalcoholic gel also.





Men were first treated with tadalafil 10 mg once a day (OAD) for 4 weeks; if not successful, they were randomized in a double-blind, placebo-controlled design to receive placebo or a 1% hydroalcoholic T gel (50 mg/5 g gel)

Erectile function progressively improved over a period of at least 12 weeks in both the placebo and T treatment

[takeiteasy] 09/5/2024 07:11

It is very odd to contribute the same 1,000s of posts about the word placebo and demonstrate a lack of understanding what the term actually means.

Why not try to actually represent the correct position over this :)

[mdi] 08/5/2024 22:08

‘McVary has been principal investigator for more than 120 clinical trials, including many for the National Institutes of Health’

The study design should have been a like for like comparison of the two different pharmacological onset and massaging stimulation onset times. So an oral placebo plus massaging of Eroxon gel in one group. And Tadalafil and massaging of a similar placebo hydroalcoholic gel in the other group.


‘Kevin McVary, MD, a professor of urology at Stritch School of Medicine of Loyola University, outside of Chicago, and director of the Center for Male Health, criticized the study design and added that he did not believe MED3000 had been proven beneficial’

"Are they expecting the Cialis 5 mg to work within 10 minutes? Because it doesn't," McVary said. "It doesn't get absorbed into the bloodstream for about 2.5 hours."

[petroc] 08/5/2024 19:44

“A stupid man's report of what a clever man says can never be accurate, because he unconsciously translates what he hears into something he can understand.”

[mdi] 08/5/2024 18:26

‘Kevin McVary, MD, a professor of urology at Stritch School of Medicine of Loyola University, outside of Chicago, and director of the Center for Male Health, criticized the study design and added that he did not believe MED3000 had been proven beneficial’



Eroxon cream is safe to use for ED, but is only a placebo

Two trials have been completed, but only one was published. In the published trial, the results showed that the results for the active drug were only marginally better than a placebo, with about 37% of placebo recipients being satisfied with their experience versus 48% in those who received the active drug.

This means that about one man out of nine who used the active drug found it more helpful than a placebo. It also means that most people who were satisfied with the results were having a placebo response

[mdi] 08/5/2024 18:19

˜the placebo effect in RCT of iPDE5 for ED occurs at a rate as high as 50%’



‘Recent research has shown that the placebo effect is not only similar for medical devices to medical trials; it is considerably larger, the effect of a sham device is almost three times that of an oral placebo’



Placebo Treatment: Don't Eat It, Rub it!

‘indications to suggest that a topical placebo induces stronger effects than an oral placebo’

[mdi] 08/5/2024 10:50

The medscape article said ‘Erections were achieved in less than 10 minutes in 60.1% of men in the FM57 group and 44.9% of those in the FM71 group’ Futura have never before mentioned to shareholders this over 15% reduced effect seen in FM71?

[petroc] 07/5/2024 12:48

Ah, MDI/LBO etc, you're back! Did you manage to sneak some black crutchless panties in the basket, or did mummy insist on the brown and yellow Y fronts again?