Futura Medical Share Discussion Threads

[petroc] 20/11/2022 18:03

'The efficacy of Eroxon® is remarkable and has been shown to deliver clinically meaningful benefits to most sufferers with erectile dysfunction in two Phase 3 studies but with significantly lower adverse events than current first line therapy. With topical application, it will be of particular appeal to mild to moderate ED patients who want a fast onset of action. Lack of drug interactions with prescription products will enable the product to be used with other medications such as nitrates and other cardiovascular drugs. As such the product will be of great interest to the medical community' - Prof David Ralph

[lbo] 20/11/2022 17:27

Note how the ramper again didn’t link the proactive article. Proactive also gave T&C and the necessary disclaimers. The ramper has not and never does give any disclaimers when he claims ‘Facts’.

‘All information used in the preparation of this communication has been compiled from publicly available sources that we believe to be reliable, however, we cannot, and do not, guarantee the accuracy or completeness of this communication’

Opinions of and commentary by the authors reflect their current views, but not necessarily of the Company

The Company recommends that investors independently assess with an appropriately qualified professional adviser, the specific financial risks as well as legal, regulatory, credit, tax and accounting consequences.

Past performance is not a reliable indicator of future results. Performance forecasts are not a reliable indicator of future performance. The investor may not get back the amount invested or may be required to pay more.

Although the information and data in this communication are obtained from sources believed to be reliable, no representation is made that such information is accurate or complete. The Company, its affiliates and subsidiaries do not accept liability for loss arising from the use of this communication.

[petroc] 20/11/2022 16:57

From Proactive Investors: 'Futura Medical PLC (AIM:FUM, OTC:FAMDF) looks financially well set for the commercial phase of the journey of its lead product, MED3000 for erectile dysfunction.

Interim results for the group showed it had £6.68mln in the bank as of June 30, 2022, the period's end, with a further £910,000 in research and development tax credits set for payment in the second half.

This, it said, provided it with resources beyond the initial product launches of MED3000 and its expected US regulatory approval.

Branded Eroxon, the fast-acting gel has European regulatory clearance and, in August, received ‘highly positive results’ from its US phase III trial.

The company will file the data packages required by the US Food & Drug Administration later this month with the aim of approval in the first quarter of next year as the only ED treatment available over the counter in the States.

Eroxon will compete with existing blue pills on the speed of onset and will be targeted at men who have suffered side effects from using products such as Viagra and Cialis.

Plans are advanced for its launch in the first half of next year. Futura has a licensing agreement with Cooper Consumer Health for the rights to commercialise the gel throughout the European Economic Area, the United Kingdom and Switzerland.'

[lbo] 20/11/2022 14:31

The rampers hiding behind anonymous multi-ID names think they are above the EU law with regards to ‘misleading and aggressive practices’ and not giving any of the disclaimers Futura gives.



Unfair commercial practices

When you buy goods and services anywhere in the EU from a website, a local shop or a seller outside your home countrys EU law protects you against unfair commercial practices. When promoting, selling or supplying products, companies must give you enough accurate information to enable you to make an informed buying decision. Find out more about contract information. If they fail to provide this information, their actions may be considered unfair. You have the right to seek redress if you are treated unfairly.

Misleading and aggressive practices

You are protected against 2 main categories of unfair commercial practices: misleading practices, either through action (giving false information) or omission (leaving out important information) aggressive practices that aim to bully you into buying Certain commercial practices are prohibited in all circumstances. Some of the most common are listed below:

Whenever a product is advertised as therapeutic, curing allergies, reversing hair loss, helping you lose weight, etc. you have the right to know if such claims have been scientifically confirmed. In many cases, claims like these are not medically backed up and are simply too good to be true

[lbo] 20/11/2022 14:26

Same ASA rules regarding substantiating claims of of it being ‘proven’ will apply to MED3000 as applied to Flexiseq gel. Which is yet another class 2b medical device gel which could not substantiate it was clinically proven in any adequately controlled study against a placebo! LOL


As Study Placebo, Non-Drug Gel Not Qualified



Study comparing Flexiseq to a placebo gel might have helped substantiate claim drug free, sustainable approach to joint pain and stiffness, clinically proven to treat osteoarthritis

but marketer didn't provide those results when Advertising Standards Authority reviewed online ad claims challenged by a physician.



The CAP Code required that objective claims, including medical claims for a CE-marked medical device, be backed by evidence, if relevant, consisting of trials conducted on people. Flexiseq was 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.



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

Has the ASA assessed all the evidence?

It is the advertisers responsibility to hold evidence for the claims they make, and it is stipulated in the Advertising Codes that evidence must be held by the advertiser prior to making the claim. Advertisers must submit documentary evidence to the ASA to support any claims they make; the ASA will not seek out the evidence to establish the veracity of the claim for you. When submitting evidence for a new or breakthrough claims, sound data, relevant to the advertised claim(s), should be collated to form a body of evidence. The totality of this evidence is important; marketers should not ignore sound data that does not support the new claim, especially where current opinion is divided. Where evidence is limited to very few studies, the studies should have robust results to ensure the basis for the claim is sound.

[lbo] 20/11/2022 14:16

According to who is it ‘clinically proven’ and a ‘breakthrough’? Not the FDA, ASA or the FTC!. Only the rampers are posting those unsubstantiated claims based on ‘directors belief’ or ‘directors opinion’ and without giving all the necessary disclaimers that Futura gives.










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] 20/11/2022 12:42

Futura has admitted in an RNS back in 2021 it was using the ‘least burdensome’ route which only requires a ‘flimsy’ threshold of change just over baseline for ‘reasonable assurance’ for just a de novo medical device registration. This has allowed Futura exploit ‘the 2002 Medical Devices User Fee Act, which requires the FDA to use the least burdensome route’ So the FM71 study was deficient as it was an uncontrolled and unblinded study and ‘prone to bias’.FM71 still has not met the standards of the FTC to substantiate any claims of any effects beyond a placebo and the FTC has jurisdiction over the marketing claims of these lower class medical devices.



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.



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



De Novo-winning devices often lack effectiveness data, analysis shows

[petroc] 20/11/2022 11:27

I think the FACT that the results met all primary and secondary endpoints speaks for itself.

FM71 Clinical Results
FM71 results are highly positive, meeting all primary and secondary endpoints; are in line with data generated in the previous Phase 3 clinical study (“FM57”) and are broadly comparable with results from a recent “real world”, home user study.

Data demonstrates that MED3000 presents an effective clinically proven treatment for erectile dysfunction with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for Over the Counter classification.

It is expected to provide an alternative to existing ED treatments, that require a doctor’s prescription, for those patients seeking fewer systemic side-effects, and a spontaneous intercourse experience. It also provides an important treatment option for those patients who are currently precluded from using current prescription treatments such as those men taking nitrate medication.

Futura is on track to file the dossier with the US FDA by the end of September, targeting marketing authorisation by the FDA of MED3000 in Q1 2023 as the first major ED treatment available OTC throughout the USA.

[petroc] 20/11/2022 10:36

MED3000 was approved in April 2021 as a medical device in the EU and becomes the first clinically proven, pan-European OTC topical treatment for erectile dysfunction available without a doctor’s prescription. In April 2022 Futura also received approval for a UKCA mark.

The CE mark approval of MED3000 from the EU Notified Body paves the way for approval in many countries around the world, including in Latin America, the Middle East, Africa and the Far East regions, with many countries considering "fast-track" review based on recognition of the EU CE mark.

MED3000 is a unique and highly differentiated easy to use topical gel for erectile dysfunction which has Phase 3 clinical data demonstrating highly statistically significant improvement across all ED patient severities and recently approved in the EU as a medical device with potential over the counter peak sales of US$650 million1.

[joestalin] 19/11/2022 18:54

He doesn't have a shred of evidence that MED doesn't work.

[petroc] 19/11/2022 17:50

LiarBO said 'The rampers feeble attempts at deflecting is so predictable every time they are proven to be wrong!' Hahaha! Not only can he barely string a few words together, he is yet to prove anyone wrong! What a fool, thinking that if he keeps repeating the word 'proven', it will make it so. Hehehe! He doesn't have a shred of proof that MED doesn't work.

[petroc] 19/11/2022 17:16

Poor old LiarBO has to rely on copy/pasting his nonsense repeatedly so that his warped point of view is the only one seen. If he had one shred of real evidence that MED3000 doesn't do exactly what Futura claim that it does, he would be trumpeting it to the rafters, instead of posting irrelevant and out of date links to try and make his point. On the other hand, the evidence continues to mount that MED3000 is efficacious in the treatment of ED. Even the FDA accept that it works, which is why they asked for a longer trial than FM57 to ensure it is still efficacious over a six month period instead of three months. The answer to that is a foregone conclusion, because FM57 results showed an increase in efficaciousness as the trial went on. (This was an old post of mine written before FM71. See? I was right about the foregone conclusion - MED3000 passed with flying colours!) (LiarBO's not the only one who can copy/paste, you know!)

[petroc] 19/11/2022 17:13

FM71 Clinical Results
FM71 results are highly positive, meeting all primary and secondary endpoints; are in line with data generated in the previous Phase 3 clinical study (“FM57�) and are broadly comparable with results from a recent “real world�;, home user study.

Data demonstrates that MED3000 presents an effective clinically proven treatment for erectile dysfunction with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for Over the Counter classification.

It is expected to provide an alternative to existing ED treatments, that require a doctor’;s prescription, for those patients seeking fewer systemic side-effects, and a spontaneous intercourse experience. It also provides an important treatment option for those patients who are currently precluded from using current prescription treatments such as those men taking nitrate medication.