Futura Medical Share Discussion Threads

[lbo] 23/2/2023 12:45

Futura have never made any claims about any magic new chemical being formed from the Alcohol, water, glycol and carbomer ingredients. Futura never even mentioned the outrageous Petroc claims about some new chemical bond or new chemicals being formed from the ingredients in their patent application! Petroc is now implying Futura are selling something akin to beer or even worse something corrosive like hydrogen peroxide from its listed ingredients. And Futura is not listing that some new chemical/s are being formed from the ingredients they just list on the packaging. These are shocking revelations from the ramper against Futura. Next he will be claiming companies can sell beer to children packaged as bread if they only just list cereal, water and yeast as the ingredients and never mention that alcohol is being formed. Or that they can legally poison people with hydrogen peroxide if they only just gave them the listed ingredients of water, hydrogen and oxygen!



‘A product that contemporary technology does not understand must establish that this magic, actually works. Proof is what separates an effect new to science from a swindle . . . . If a condition responds to treatment, then selling a placebo as if it had therapeutic effect directly injures the consumer’

The only claims by Futura on its website and its patent application is evaporative cooling from the listed volatile solvent ingredients of alcohol and glycol. Volatile solvent Ingredients already used by other cooling arousal gels already on the market and well described by Glaxo previously



The Company has conducted initial literature and in vitro based research that has shown the cooling from the evaporation of these specific combinations of solvents



The cooling effect of a topically applied product can be evaluated using a validated handheld thermal imaging system. When the gel matrix is destroyed after application to the skin, the bound water and alcohol evaporates and a measurable cooling-effect results.



Kama Sutra Intensify Plus Female Arousal Gel Cooling 15 ml Ingredients: Water, Propylene Glycol, Denatured Alcohol



Carbopol Ultrez Polymer Carbopol ultrez is responsible for the consistency and texture of the gel. It is a water-soluble polymer that brings all the other ingredients together aesthetically. Thus, it contributes to the flow properties of this formulation, making it less sticky and easier to handle.

[petroc] 23/2/2023 11:48

Hahahaha! LiarBO really is a buffoon! He posts stuff like this as though it were true, and he clearly thinks everyone is stupid enough to believe it! He doesn't seem to realise how stupid it makes him look!

'Contrary to yet more false claims by Petroc. Futura have never made any claims about any magic new chemical being formed from the Alcohol, water, glycol and carbomer ingredients. Futura never even mentioned the outrageous Petroc claims about some new chemical bond or new chemicals being formed from the ingredients in their patent application! He is now implying Futura are selling something akin to beer or even worse something corrosive like hydrogen peroxide from its listed ingredients. And Futura is not listing that new chemicals are being formed from the ingredients they list on the packaging. These are shocking revelations from the ramper! Next he will be claiming he can sell beer to children packaged as bread if he only just lists cereal, water and yeast as the ingredients and never mentione that alcohol is being formed. Or that he can legally poison people with hydrogen peroxide as he only just gave them the listed ingredients of water, hydrogen and oxygen!'

LiarBO really excelled himself with that nonsense!

What I actually wrote to prove that LiarBO is clearly wrong when he claims that everything made from the same ingredients is inevitably the same:

LiarBO states that Eroxon is the same as other gels on the market, because they share the same ingredients.

Therefore he claims that hydrogen peroxide and water are the same, because they are both made from oxygen and hydrogen.

Therefore he claims that bread and beer are the same, and cause the same reaction in the consumer, because they are both made from cereal, water and yeast.

'LiarBO is clearly wrong on every level, and constantly proving to everyone that he will say anything, however ridiculous, to bash this stock.'

[lbo] 23/2/2023 11:40

The only ‘breathtaking sheer audacity’ is from a unqualified ramper who claims to know more then the ‘wider scientific and academic community’, the SMSNA, the ASA and the courts! LOL

The fact remains Med3000 is only a medical device and has no active pharmaceutical ingredients! It is only a lower class medical device: Futura has openly admitted it is using the ‘least burdensome’ route of just a De Novo medical device registration for Med3000. A pathway exploiting unblinded and uncontrolled studies the same as Futura has used that are ‘prone to bias’ results.

Yes ‘BIAS’

This low class medical device path only requires a low ‘flimsy’ threshold of effect over baseline for ‘reasonable assurance’ of some effect including even just a placebo effect for lower class medical device registration! And it even appears as if the Med3000 medical device tests were designed to build in even more bias due to the use of non standard inclusion criteria and allow for increased spontaneous recovery being wrongly attributed to the use of Med3000.

This has allowed Futura, like other medical device manufacturers, to 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 Med3000 is given medical device registration. FM71 still has not met the standards of the FTC, ASA or the Courts to substantiate claims of an effect beyond a placebo or even an arousal gel. 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. So the efficacy of Med3000 in FM57 was a ‘post hoc’ finding.



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.

[petroc] 23/2/2023 09:14

Hahahaha! LiarBO really is a buffoon! He posts stuff like this as though it were true, and he clearly thinks everyone is stupid enough to believe it! He doesn't seem to realise how stupid it makes him look!

'Contrary to yet more false claims by Petroc. Futura have never made any claims about any magic new chemical being formed from the Alcohol, water, glycol and carbomer ingredients. Futura never even mentioned the outrageous Petroc claims about some new chemical bond or new chemicals being formed from the ingredients in their patent application! He is now implying Futura are selling something akin to beer or even worse something corrosive like hydrogen peroxide from its listed ingredients. And Futura is not listing that new chemicals are being formed from the ingredients they list on the packaging. These are shocking revelations from the ramper! Next he will be claiming he can sell beer to children packaged as bread if he only just lists cereal, water and yeast as the ingredients and never mentione that alcohol is being formed. Or that he can legally poison people with hydrogen peroxide as he only just gave them the listed ingredients of water, hydrogen and oxygen!'

LiarBO really excelled himself with that nonsense!

What I actually wrote to prove that LiarBO is clearly wrong when he claims that everything made from the same ingredients is inevitably the same:

LiarBO states that Eroxon is the same as other gels on the market, because they share the same ingredients.

Therefore he claims that hydrogen peroxide and water are the same, because they are both made from oxygen and hydrogen.

Therefore he claims that bread and beer are the same, and cause the same reaction in the consumer, because they are both made from cereal, water and yeast.

'LiarBO is clearly wrong on every level, and constantly proving to everyone that he will say anything, however ridiculous, to bash this stock.'

[lbo] 22/2/2023 21:29

There is zero non deficient evidence to substantiate Med3000 works beyond a placebo gel or even an arousal gel made of the same alcohol, water, glycol and carbomer ingredients in any adequately controlled and blinded study



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.

[lbo] 22/2/2023 21:16

Contrary to yet more false claims by Petroc. Futura have never made any claims about any magic new chemical being formed from the Alcohol, water, glycol and carbomer ingredients. Futura never even mentioned the outrageous Petroc claims about some new chemical bond or new chemicals being formed from the ingredients in their patent application! He is now implying Futura are selling something akin to beer or even worse something corrosive like hydrogen peroxide from its listed ingredients. And Futura is not listing that new chemicals are being formed from the ingredients they list on the packaging. These are shocking revelations from the ramper! Next he will be claiming he can sell beer to children packaged as bread if he only just lists cereal, water and yeast as the ingredients and never mentione that alcohol is being formed. Or that he can legally poison people with hydrogen peroxide as he only just gave them the listed ingredients of water, hydrogen and oxygen!



The Company has conducted initial literature and in vitro based research that has shown the cooling from the evaporation of these specific combinations of solvents



The cooling effect of a topically applied product can be evaluated using a validated handheld thermal imaging system. When the gel matrix is destroyed after application to the skin, the bound water and alcohol evaporates and a measurable cooling-effect results.



Kama Sutra Intensify Plus Female Arousal Gel Cooling 15 ml Ingredients: Water, Propylene Glycol, Denatured Alcohol



Carbopol Ultrez Polymer Carbopol ultrez is responsible for the consistency and texture of the gel. It is a water-soluble polymer that brings all the other ingredients together aesthetically. Thus, it contributes to the flow properties of this formulation, making it less sticky and easier to handle.

[petroc] 22/2/2023 19:13

LiarBO states that Eroxon is the same as other gels on the market, because they share the same ingredients.

Therefore he claims that hydrogen peroxide and water are the same, because they are both made from oxygen and hydrogen.

Therefore he claims that bread and beer are the same, and cause the same reaction in the consumer, because they are both made from cereal, water and yeast.

LiarBO is clearly wrong on every level, and constantly proving to everyone that he will say anything, however ridiculous, to bash this stock.

I doubt very much that FUM have ever claimed anything outrageous about changing things on a molecular level. Why would they? Eroxon has been proven to work for ED by over 60% of men WHO HAVE ACTUALLY USED IT. And that's the real stuff, not all the creams and unguents that LiarBO plays with in his bedroom. Even LiarBO's favourite Dutchman who has left 2 reviews on the Farmaline website has given Eroxon 4 stars (80%) because it worked for him even though he wasn't 'in the mood'.

[petroc] 22/2/2023 19:11

There's loads of evidence that Eroxon works. There's absolutely none that suggests it doesn't.

[lbo] 22/2/2023 17:43

Even Trinity Research who are paid by Futura has contradicted the rampers and had to openly admit the hypothesised effects 'believes' to be happening by Futura are 'disputed'https://www.discovermagazine.com/health/the-erection-of-a-placebo˜There is no evidence for the evaporative mode of action from the clinical trials. To show that the evaporation is what makes MED3000 work, you'd need to compare it to a non-evaporative gel'https://www.ftc.gov/system/files/documents/public_statements/996984/p114505_otc_homeopathic_drug_enforcement_policy_statement.pdfProof is what separates an effect new to science from a swindle . . . . If a condition responds to treatment, then selling a placebo as if it had therapeutic effect directly injures the consumer. FTC v. QT, Inc.Trinity also admitted no mechanism of action has to be even shown to just get a low class medical device registered.But it does need to be shown and proven to substantiate its marketing claims of having any effect beyond a placebo or even arousal gel with the same alcohol, water, glycol and carbomer ingredients or fall foul of the FTC, ASA and the Courts.Trinity research:Presumably the effect is comparable to the cold-induced vasodilation (CIVD) that occurs with extremities such as toes and fingers. Despite being a well-known effect, the mechanisms of CIVD are still disputed, but the pathways involved could well be similar. Interestingly, the precise mechanism of action does not need to be elucidated for the regulators to be comfortable for a product to be approved as a medical deviceâ€

[petroc] 22/2/2023 16:20

There's loads of evidence that Eroxon works. There's absolutely none that suggests it doesn't.

[lbo] 22/2/2023 14:48

The issue still remains that even if the MED3000 De novo medical device application is not denied or put on hold requesting further information. The Med3000 gel still cannot substantiate any effect beyond a placebo with any adequately controlled study to the FTC or ASA. It cannot even substantiate that is having any effect beyond what a standard cooling lubricant or arousal gel would if the user is just led to believe its a real treatment for their ED.

>

Over 50% of De novo applications are denied and some are placed on hold requiring further information. Which then resets the days back to day 1 if and when that information is even able to be submitted.

Like for example further evidence trom an adequately controlled study or even against just a standard cooling lubricant or blinded study versus an arousal gel





More than 60 De Novo submissions are submitted each year, but the number of De Novo Classification Requests granted ranged between 21 and 30 over the past three years.

Therefore, the 50%+ of De Novo applications denied could skew the % of De Novo that meets the MDUFA goal.

There are two problems with this goal. First, the term ‘FDA Days’ is based on calendar days minus the number of days the submission was placed on hold, and we don’t have any visibility into the number of days submissions are placed on hold.

In the past, submissions could be placed on hold multiple times during the Refusal to Accept (RTA) screening process, and the ‘FDA Days’ is reset to zero days each time the company receives an RTA hold letter.

In addition, even after the submission is finally accepted, the FDA places the submission on hold when they request additional information (i.e., AI Hold).

RTA and AI Hold periods can last up to 180 days, and during the Covid-19 pandemic, companies were allowed to extend this up to 360 days.

How long does it take FDA to review De Novo submissions?

FDA days are not the same as calendar days. Only 23.8% of De Novo submissions were reviewed within 150 calendar days. The FDA doesn’t calculate the number of FDA days as calendar days, but there is no way to know how much time each De Novo spent on hold publicly.