Futura Medical Share Discussion Threads

[lbo] 04/10/2022 14:19

The courts have have made rulings about medical treatment claims. The evidence must not be ‘deficient’ which all your ‘plenty of evidence’ is. As it was inadequately controlled with a placebo in FM57 and unblinded and uncontrolled in FM71 and the consumer test.




When making health-related claims, courts have consistently held that an advertiser must have a reasonable basis to make the claim at issue. This standard is satisfied where the advertiser possesses competent and reliable scientific evidence supporting the claim (citing Sterling Drug, Inc. v. FTC, 741 F.2d 1146 [9th Cir. 1984]). After reviewing the testimony of several experts at trial, Magistrate Denlow concluded that when an advertiser makes a medical, health-related claim it must possess a well-conducted, placebo controlled, randomized, double-blinded study, the gold standard. (Citing FTC v. SlimAmerica, Inc., 77 F. Supp. 2d 1263 [S.D. FLA].) Any lower level of evidence would be deficient.

[petroc] 04/10/2022 10:54

'Falsely claiming as there was no evidence to prove MED3000 didn't work'. Well well well, I'm a liar because I said that, eh? Someone is certainly lying. If you have evidence that MED3000 doesn't work, let's see it, LiarBO. If you don't produce that evidence, then that's further proof, if it were required, that you're a liar and I'm not. So give it your best shot, LiarBO. We're all waiting for this bombshell of yours.

[lbo] 03/10/2022 22:39

All of Petrocs ‘plenty of evidence’ is ‘deficient’



When making health-related claims, courts have consistently held that an advertiser must have a reasonable basis to make the claim at issue. This standard is satisfied where the advertiser possesses competent and reliable scientific evidence supporting the claim (citing Sterling Drug, Inc. v. FTC, 741 F.2d 1146 [9th Cir. 1984]). After reviewing the testimony of several experts at trial, Magistrate Denlow concluded that when an advertiser makes a medical, health-related claim it must possess a well-conducted, placebo controlled, randomized, double-blinded study, the gold standard. (Citing FTC v. SlimAmerica, Inc., 77 F. Supp. 2d 1263 [S.D. FLA].) Any lower level of evidence would be deficient.

[lbo] 03/10/2022 22:39

Yet again even more proven lies and misleading claims from Petroc. The SMSNA article asked was MED3000 a snake oil or the real deal. It went on to say MED3000 was too good to be true. Which is what a snake oil is. Too good to be true. Its even the title of a book: Snake Oil: Too Good to Be True



And the resource for the SMSNA article was not anonymous as Petroc falsely claimed it was. It was an article written by by Randy Dotinga, Contributing Writer, MedPage Today.

A Non-Medicated Gel to Treat Erectile Dysfunction: Snake Oil or the Real Deal?



In order to truly determine the efficacy of this non-medicated gel in treating ED, researchers would need to design a new study with a different control such as an oral placebo pill and demonstrate that the gel showed benefits beyond the other placebo method. Until then, this gel will likely remain just as it initially seems: too good to be true.

Resources:

Dotinga, R. (2021, April 20). Could a ‘Placebo’ Become the Next Big ED Treatment? MedPage Today.

[petroc] 03/10/2022 18:40

What was it you said the other day, LiarBO? Never trust anything said by anonymous posters on the internet, wasn't it? Something like that. And you didn't even realise the irony, as you continued to churn out your copy/pasted nonsense. How did that pan out for you today? Oh yes, just a 4% share price rise. Better luck tomorrow with your stock bashing, LiarBO.

[lbo] 03/10/2022 11:40

177 days is all it will take to copy and have similar product on the market. No clinical studies required for copycat alcohol, water and glycol gels. And remember Futura still haven’t even shown that evaporative cooling is what is having any effect!



‘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’



‘This De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster’

De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device

The average length of time for clearance under the traditional 510(k) pathway is 177 days,



a company must compare their product to one already cleared by the FDA and provide evidence that their product is substantially equivalent to the previously cleared (legally marketed) device. To be substantially equivalent, the product must meet criteria for the same intended use, have the same technology or (slightly) different technology but produces similar end results, and be safe and effective. Once pre-market clearance is received from the FDA the device can be distributed commercially immediately

[lbo] 03/10/2022 11:38

Its already been admitted the Dermasy vehicle and Voltaren vehicle game similar results! LOL



‘TPR100 gave similar results to the gold standard, Voltarol 2% gel’



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. Consumer satisfaction with a topical product is based on subjective criteria such as how the product feels and how it is perceived on the skin. Therefore, appropriate questionnaires are of major importance for cosmetic products to assess the subjective perception not only of soothing and cooling effects but also of moistur- izing properties and fragrance.



A key element of Futura Medicals strategy is to reduce development risk through using well characterised existing agents that are reformulated with its proprietary DermaSys technology to create new products. This means intellectual property protection is limited to use patents for the individual products and umbrella patents for the technology. There is a risk that some claims will either be challenged in future (eg on the grounds of non-obviousness or existence of prior art) and/or that another technology may be employed to achieve a similar effect

[lbo] 03/10/2022 11:12

More like you are as thick as a plank of wood if you think it will be ‘major’ for Futura shareholders when anyone can copy it as it has no patent and even the evaporative cooling can be replicated with any similar alcohol gel eg Voltaren vehicle gel.

And ‘Major’ according to who? As always it has the disclaimer of just being ‘we believe’. Just like it was at one time believed PET500 and CSD500 would generate millions of pounds of revenues for shareholders. Yet they didn’t and both failed to meet previously believed expectations! ROFLMAO



And the only thing that differentiates Med3000 from Eddie is its a gel. Both are still class 2 medical devices! Just like a cooling lubricant is just a class 2 medical device too!

LOL

‘These forward-looking statements may use words such as "aim", "anticipate", "believe", "could", "may", "intend", "estimate", "expect" and words of similar meaning. By their nature, all forward-looking statements involve risk and uncertainty because they relate to future events and circumstances which are beyond the control of the Company’

[lbo] 03/10/2022 10:31

‘MED3000 is also expected to be the first major ED treatment available OTC in the USA’

‘Expected’ by who? LOL

And other class 2 medical devices OTC for ED already exist on the market in the USA!?



Eddie is a first-of-its-kind, wearable, FDA Class II erectile dysfunction device



‘Crowded’ OTC device market






What is Eddie by Giddy?

Eddie by Giddy is a nonprescription, wearable device for treating ED. It is a Class II medical device registered with the Food and Drug Administration (FDA), the government agency that regulates healthcare products in the United States. However, it is important to note that when a company registers a product with the FDA, it does not mean that the FDA has approved the product.

[glavey] 03/10/2022 09:33

"All going to plan"

Ah, you've sussed it out then, Broomrigg.

[glavey] 03/10/2022 09:30

Oh dear, looks like you may have to wait a little longer to get a dose, Pet.

[lbo] 03/10/2022 08:02

I note the disclaimer ‘We believe’

‘Certain statements in this Announcement are forward-looking statements, which include all statements other than statements of historical fact and which are based on the Company's expectations, intentions and projections regarding its future performance, anticipated events or trends and other matters that are not historical facts. These forward-looking statements may use words such as "aim", "anticipate", "believe", "could", "may", "intend", "estimate", "expect" and words of similar meaning. By their nature, all forward-looking statements involve risk and uncertainty because they relate to future events and circumstances which are beyond the control of the Company’



Clinically proven? Says who?

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

Not the ASA, the EU courts and FTC!

[losses] 03/10/2022 07:33

James Barder, Chief Executive Officer , Futura Medical said: "Today marks a pivotal milestone for Futura and highlights the regulatory progress we have made to develop and launch MED3000 globally. The submission of our marketing application in the US will pave the way for commercialisation of MED3000 in the biggest ED market worldwide with our key differentiator of a clinically proven treatment for ED with a rapid speed of onset. MED3000 is also expected to be the first major ED treatment available OTC in the USA which we believe will help improve access as well as treatment for many thousands of ED sufferers. We believe Eroxon, the brand for MED3000, is poised to become a major, trusted brand and treatment in the ED market worldwide."

[broomrigg] 03/10/2022 07:20

RNS out.All going to plan and looking good. :-)