Futura Medical Share Discussion Threads

[mdi] 09/5/2024 19:43

Yes ‘accounting’ for the financial accountability of making ‘clinically proven’ claims that cannot be substantiated with evidence from any double blind placebo controlled study



˜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’




˜The $35 million US Activia® settlement is the largest-ever for a lawsuit alleging false advertising of a food product’

‘A California consumer filed the class-action suit against The Dannon Company alleging the companys claims that its probiotic yogurt offers clinically and scientifically-proven health benefits were false and seeking compensation for US customers who purchased the products based on the marketing campaign’



‘companies deceptively touted’

‘clinically proven’

Class members with proof of purchase are eligible to recover up to $65. Those without proof may recover up to $20.

The companies also agreed to change all references from ‘clinically proven’ and science proved’‚ on Neuriva labeling and ancillary marketing ‘clinically tested’ and ‘science tested’ or other similar language.

Magistrate Judge Jonathan Goodman of the U.S. District Court for the Southern District of Florida granted preliminary approval April 23.

Plaintiffs attorneys will seek up to $2.9 million for fees and expenses. They will also seek incentive awards up to $2,000 each for five class representatives.




Clinically proven? Says who?

When they say ‘clinically proven’ your first question should be, oh yeah, says who?

It is possible the company selling the supplement, infomercial ab gadget, or balance device did a poorly controlled ‘study’ where they had people try the product and then tell the company about their results.

While this seems logical enough, it does not constitute legitimate research.

[takeiteasy] 09/5/2024 19:35

These are very basic A level accounting points and of no issue whatsoever for anyone who understands how financial accounting works. I took the trouble to explain this to you in more detail a while back so will not do so again :)

So this attempt fails at making any argument that you imply.

Please rest there genuinely - I know how desparate you are but there is a life to live...

[mdi] 09/5/2024 19:26

Really? So why are upfront payments contract liabilities?

‘upfront milestone payment which is to be recognised as a Contract Liability until satisfaction of the performance obligations’

Or ‘royalties not being recognised in full until it is highly probable that a significant reversal in the amount of cumulative revenue recognised will not occur’

And that ‘Futura will remain Legal Manufacturer’ and ‘responsible’ for all legal claims. Why aren’t any of the distributors accepting the legal risks if they apparently fully accept Eroxon is not a sham device and the marketing is not just misleading men?

‘Legal manufacturer means the organisation responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under that organisation's own name’



‘Other variable considerations such as milestone payments and royalties are not recognised in full until it is highly probable that a significant reversal in the amount of cumulative revenue recognised will not occur. In managements opinion, that will be when the Groups customer confirms that the milestone has been met or that a royalty is due’

[takeiteasy] 09/5/2024 19:18

Who accepts this.

Everyone who is closely allied to the business i.e. management, suppliers and sales network - they are all marketing the firm on this basis.

There is simply no more to discuss on this matter.

Anyway time for me to sign off again.

[mdi] 09/5/2024 19:17

‘more than sufficient given the acceptance from all parties bar a few whining medics’

Also not according to EU court rulings on CE marks



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.



˜the CE conformity assessment is neither an official approval procedure nor an administrative legal act. The so-called ‘notified bodies’ which carry out conformity checks and award the CE-certificates are private companies. The tests carried out by these companies therefore rather amount to plausibility checks, which, moreover, only concern individual aspects, for example, of a production process. A products (alleged) therapeutic effectiveness is not (necessarily) examined’

[takeiteasy] 09/5/2024 18:56

This is simply so dull - we have had this argument 3 times - I accept the testing the firm has done (and so does everyone else) as a valid proxy for what is required.

Yes, you can endlessly state the regulations but when the firm has done the level of testing it has done then that is more than sufficient given the acceptance from all parties bar a few whining medics ....

You do not accept it - everyone knows you do not. So try another topic to discuss.

[takeiteasy] 09/5/2024 18:36

approval to sell yes in USA is fine..does not have to mean more than that..you worry endlessly about the wrong issues. it is not a sham device so stop trying to wind everyone up...what you fail to understand is as I have said before everyone knows what you know ...so why repeat yourself 100 times over...

[petroc] 09/5/2024 18:25

MDI, it's impossible to underestimate you.

[mdi] 09/5/2024 17:57

‘Men with erectile dysfunction (ED) who were in the placebo arm of clinical trials of phosphodiesterase 5 inhibitors (PDE5Is) had significant improvement in erectile function’



‘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’

[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 efficacy 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.



‘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.