Futura Medical Share Discussion Threads

[petroc] 22/11/2022 19:05

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 resultsâ€͐2; 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.'

[petroc] 22/11/2022 19:04

LiarBO lying again. MED3000 has been proven to work in three trials. Just because LiarBO, a proven stock basher, says they aren't adequate, doesn't mean it's true. Those trials were 'adequate' enough to interest the EU regulators and the FDA and the scientific community. Sufficiently 'adequate' to interest both large and small investors. And, of course, 'adequate' enough to make LiarBO scuttle around like an idiot, frantically copy/pasting his stock bashing nonsense to keep his posts at the top of the pile to try and discourage ordinary, honest folk from making a few bob. I'd also like to know why he keeps trying to compare MED3000 with products that are already on the market. LiarBO, get this - MED3000 HASN'T BEEN RELEASED YET. IT'S NOT A 'PRODUCT' YET. IT CAN'T BE COMPARED WITH LONG STANDING TREATMENTS. IT CAN'T BE INCLUDED IN STANDARD OF CARE MEDICATIONS, BECAUSE IT'S NOT OUT YET! You stupid moron.

[lbo] 22/11/2022 18:25

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.

So how effective is MED3000 really?

The first thing to note is that MED3000 has never been shown to be more effective than any control treatment - because it was the control treatment.



CE-marking is no excuse for uncorroborated claims of efficacy. The successful CE certification of a medical device or remedy does not release companies from the obligation to prove the correctness of advertising statements.

The court did not concur with the defendant’s arguments. It stated that 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 product’s (alleged) therapeutic effectiveness is not (necessarily) examined.
In effect, the court enjoined the defendant from continuing the advertising of the product.

[lbo] 22/11/2022 17:39

Med3000 may have appeared to meet the requirements of the MDD but has not met the standard of substantiation of any effect beyond a placebo with adequately controlled and blinded studies according to EU case law relating to medical devices.



Assessment Upheld

The ASA noted that the product appeared to meet the requirements of the Medical Device Directive (MDD) but understood that the MDD did not harmonise EU law relating the advertising of medical devices, which was subject to Directive 2005/29/EC on unfair business to consumer commercial practices (including advertising) generally (Unfair commercial practices directive - UCPD). That meant that advertisers must still meet the requirements of the CAP Code, which reflected the provisions of UCPD. Under the CAP and BCAP Codes, medical claims could be made for CE-marked medical devices provided they complied with other requirements of the Codes, including those relating to substantiation. CE certification in itself does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims. There was no statistically significant difference between the outcomes for the treatment group (patients using the Aerosure device) and the control group (using an inactive sham device). The study was accordingly not adequate evidence of the efficacy

[petroc] 22/11/2022 16:52

There's LiarBO doing what he does best - lying and stock bashing! According to him, FM57 was the 'worst' trial because participants believed they were using gel with GTN. If his theory was correct, FM57 would have achieved the highest results. This is what actually happened though:
During FM57, over 60% of all patients experienced a meaningful difference in improvement of their erections using recognised assessment techniques.
FM71 results were 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.
Cooper undertook a consumer marketing home use test (HUT) in the UK, France, and the Netherlands. Men with self-diagnosed ED were supplied a four-pack sample of MED3000 with the appropriate packaging leaflet. The results were in line with those seen in the FM57 1,000 patient clinical trial, where over two-thirds of patients saw a clinically meaningful benefit.
In other words, MED3000 was found to be efficacious in 60% of patients, in all three trials, whether they believed it contained a known vasodilator, GTN, or not. LiarBO has also previously claimed that placebo effect can affect 'up to 50% of patients', so if (big 'if'!) he's correct, when you see improvements of 60% in three separate trials, you can bet your bottom dollar there's more than placebo effect going on here. He will of course try to rubbish these trials, saying they weren't placebo controlled, double blind blah blah blah, because he's such an expert in the field. Really he's just a charlatan trying to stop ordinary people making a few quid by investing here. He's nothing but a disgruntled ex-investor, crying into his beer. Don't take my word for it though, after all I'm a just a 'proven liar with multi IDs ramping all over the internet' lol! DYOR.

[lbo] 22/11/2022 15:49

Researchers call for stricter rules on drug-like medical devices



More oversight is needed over products in the grey area between medical device and medication

Powders, tablets and gels used like medications but registered as medical devices – the same category plasters and pacemakers fall into – need tighter controls, a team of clinical researchers has concluded after studying several such materials. Products that fall into this regulatory grey zone don’t need to prove their efficacy or safety in the same way pharmaceuticals do, which could be a concern for vulnerable patients

According to European regulations, medical devices are used for diagnosis, prevention or treatment of disease, but unlike drugs their primary mode of action isn’t biological. The definition includes everything from medical software to wound dressings and surgical instruments

Manufacturers need to demonstrate medical devices’ safety and performance. An organisation called a notified body then assesses the product’s conformity and grants it a CE mark. But Van Winckel and her colleagues found only poor clinical evidence for the three devices they investigated. Studies were small or of low quality, often missing placebo controls. In some cases, there was no data at all, for example to show the effect

The researchers also highlighted the lack of safety information in the devices’ instruction leaflets. There was no or little mention of interactions with other compounds, maximum safe dose or adverse effects



Oral powders or gels, sold as medical devices in the European Union (EU), aren’t regulated to the same safety standards as those applied to medicines

As a result, these products, which look like medicines, can be marketed with very limited clinical data and accompanied by poor quality product information.

require only certification with a ‘CE’ (quality) kitemark before the product can be marketed.

This process doesn’t require evidence of efficacy or safety from high quality clinical trials, as is the case for medicines.

It also means that these products can automatically be sold without a prescription across the EU, and actively marketed to patients and clinicians.

[petroc] 22/11/2022 15:11

MED3000 Regulatory Pathway
Futura's breakthrough, fast-acting topical gel formulation MED3000, will be the first clinically proven, pan-European topical treatment for adult men with ED available without a doctor's prescription.

Europe - EU approval granted April 2021
In April 2021, Futura announced that it had received its MDR EU Quality Management Certificate for the placing on the market of MED3000 as a Class 2B medical device known as MED3000 ("CE mark approval"). A Class 2B approval is by definition an approval allowing marketing of MED3000 as a treatment without the need of a doctor’s prescription across the European Union.

With the CE mark approval, this also paves the way for faster approval in many countries around the world including the Middle East, Africa, certain Far East countries and Latin America who allow “fast-track221; review based on their recognition of the EU CE mark. The CE marking is also recognised in Great Britain until 30 June 2023 and Futura has now received the new post-Brexit UKCA mark which will extend approval in Great Britain beyond this date.

[petroc] 22/11/2022 13:11

Real World Test.
As part of its due diligence, Cooper undertook a consumer marketing home use test (HUT) in the UK, France, and the Netherlands. The size of the HUT is not disclosed but would typically involve c 200 consumers. In this case men with self-diagnosed ED were supplied a four-pack sample of MED3000 with the appropriate packaging leaflet. The results were in line with those seen in the FM57 1,000 patient clinical trial, where over two-thirds of patients saw a clinically meaningful benefit. The importance of the HUT lies in the confirmation that MED3000 works as expected in a real-world setting. Longer-term use is being explored in the c 100 patient FM71 clinical trial, conducted over 24 weeks, to support the FDA application.

[petroc] 22/11/2022 13:08

Futura Medical has reported phase 3 data on its topical erectile dysfunction treatment MED3000, teeing it up to file for FDA approval of the therapy as an over-the-counter medicine by the end of the month. hxxps://www.fiercepharma.com/pharma/futuras-topical-erectile-dysfunction-therapy-hits-phase-3-goal-igniting-race-fda

[lbo] 22/11/2022 12:16

The EU courts have clearly ruled that uncontrolled and unblinded studies are deficient evidence. The Courts have also ruled CE marks are of limited significance in terms of substantiating efficacy claims. As have the ASA in the UK



Assessment

Upheld

The ASA noted that the product appeared to meet the requirements of the Medical Device Directive (MDD) but understood that the MDD did not harmonise EU law relating the advertising of medical devices, which was subject to Directive 2005/29/EC on unfair business to consumer commercial practices (including advertising) generally (Unfair commercial practices directive - UCPD). That meant that advertisers must still meet the requirements of the CAP Code, which reflected the provisions of UCPD. Under the CAP and BCAP Codes, medical claims could be made for CE-marked medical devices provided they complied with other requirements of the Codes, including those relating to substantiation.
CE certification in itself does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims.
There was no statistically significant difference between the outcomes for the treatment group (patients using the Aerosure device) and the control group (using an inactive sham device). The study was accordingly not adequate evidence of the efficacy



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

[petroc] 22/11/2022 12:08

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.

[petroc] 22/11/2022 12:06

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] 22/11/2022 12:06

Europe - EU approval granted April 2021
In April 2021, Futura announced that it had received its MDR EU Quality Management Certificate for the placing on the market of MED3000 as a Class 2B medical device known as MED3000 ("CE mark approval"). A Class 2B approval is by definition an approval allowing marketing of MED3000 as a treatment without the need of a doctor’s prescription across the European Union.

With the CE mark approval, this also paves the way for faster approval in many countries around the world including the Middle East, Africa, certain Far East countries and Latin America who allow “fast-track221; review based on their recognition of the EU CE mark. The CE marking is also recognised in Great Britain until 30 June 2023 and Futura has now received the new post-Brexit UKCA mark which will extend approval in Great Britain beyond this date.