Futura Medical Share Discussion Threads

[broomrigg] 16/3/2023 06:53

Good post keifer derrin....thanks for that.

[lbo] 15/3/2023 18:57

It wont take long for Reckitt to launch a similar alcohol, water, glycol and Carbopol arousal gel product for men via the 510k pathway!

A 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 immediatelyââ

[lbo] 15/3/2023 18:40

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’



˜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’




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. 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 deviceââ‚

[lbo] 15/3/2023 17:10

The HCP UK website Petroc advertised and introduced into evidence on ADVFN admits



‘Eroxon was the placebo used in FM57’

So no matter what Petroc claims public complaints can now be made about Med3000/Eroxon to the ASA as he provided the clear admission FM57 was not adequately controlled to study the placebo Med3000/Eroxon. So the results of FM57 are a ‘post hoc finding’ and a ‘false positive’



Med3000 was just the placebo in the FM57 study Therefore Futura had initially believed Med3000 had no therapeutic effect.

The FM57 study did not set out to measure the efficacy of Med3000.

The ASA will therefore consider that its reported effectiveness by Futura was a ‘ false positive’ ˜post-hoc finding’

The CAP Code required that objective claims, including medical claims for a CE-marked medical device, be backed by evidence

a certified Class IIb medical device.

We understood that the device certification was granted by a body within the European Member States that had been designated to carry out conformity assessments under the Medical Device Directive had been used as the placebo treatment in that study, and therefore the researcher had initially believed it had no therapeutic effect. The trial did not set out to measure the efficacy its reported effectiveness by the advertiser was a post-hoc finding due to the risk of that being a false positive finding

[petroc] 15/3/2023 16:24

What standards are applied to evidence?

The position taken by the ASA is a tried and tested one which has developed over the
course of many years. It reflects the opinion of the wider scientific and academic
community, RATHER THAN JUDGEMENTS MADE SOLELY BY THE ASA.
There are many aspects that are taken into consideration when evidence is reviewed
and each claim is judged on its merits alongside the evidence presented to support it.
Evidence submitted for health claims should normally include at least one adequately controlled experimental human study (12.1 Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. If relevant, the rules in this section apply to claims for products for animals. Substantiation will be assessed on the basis of the available scientific knowledge.) but an adequately controlled observational human study might be sufficient in some circumstances.

Yes, that's the bit of wording that LiarBO the stock basher keeps missing out, and then proclaiming what the ASA says.

As you can see, there is no mention in the CAP code of having to pass a placebo controlled trial for a medical device. A simple, adequately controlled human trial is sufficient, and Eroxon has been through two of those, and a Home Use Test, and passed with flying colours.

So everyone can see (again) that LiarBO is lying and manipulating the information in order to bash the stock.