ADVFN Logo

We could not find any results for:
Make sure your spelling is correct or try broadening your search.

Trending Now

Toplists

It looks like you aren't logged in.
Click the button below to log in and view your recent history.

Hot Features

Registration Strip Icon for default Register for Free to get streaming real-time quotes, interactive charts, live options flow, and more.

FUM Futura Medical Plc

40.50
1.70 (4.38%)
28 Mar 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Futura Medical Plc LSE:FUM London Ordinary Share GB0033278473 ORD 0.2P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  1.70 4.38% 40.50 39.70 40.50 40.00 39.00 39.60 309,491 16:35:16
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
Pharmaceutical Preparations 0 -5.85M -0.0194 -20.62 120.28M
Futura Medical Plc is listed in the Pharmaceutical Preparations sector of the London Stock Exchange with ticker FUM. The last closing price for Futura Medical was 38.80p. Over the last year, Futura Medical shares have traded in a share price range of 24.10p to 67.00p.

Futura Medical currently has 300,712,293 shares in issue. The market capitalisation of Futura Medical is £120.28 million. Futura Medical has a price to earnings ratio (PE ratio) of -20.62.

Futura Medical Share Discussion Threads

Showing 14376 to 14389 of 21225 messages
Chat Pages: Latest  585  584  583  582  581  580  579  578  577  576  575  574  Older
DateSubjectAuthorDiscuss
19/11/2022
13:41
The Courts, FTC and ASA have all ruled the so called evidence from unblinded and uncontrolled tests and home use testimonials to be deficient. These are the facts of what is defined as deficient and what is not and that deficient evidence according to the courts and FTC rulings cannot be used to substantiate any claims beyond a placebo effect.

Again just saying there is no evidence it doesn’t work is not according to the FTC and ASA evidence it does work! Not even Futura have dared make the false claims the ramper has made on ADVFN! Unlike the ramper Futura has given all the necessary disclaimers! ROFLMAO

The onus is on the person/company making the questionable claims to be able to substantiate the claims to the FTC and ASA with evidence from adequately controlled studies.

Which you have failed to do yet again! Please show one adequately controlled study that can substantiate any effect beyond a placebo?

You cant even provide results from just a simple blind direct efficacy comparison study against a standard cooling lubricant/arousal gel and substantiate any claim its even having any effect beyond an arousal gel would! I wonder why? LOL



Advertising and labeling claims are a primary way companies try to grab consumer attention and distinguish one product from another. As the market becomes crowded, competition has increased and claims have become increasingly aggressive and, sometimes, overreaching. Companies must balance the desire to sell products against the fundamental principle that material claims must be substantiated with the appropriate level of support. If not, companies are at risk of action from regulatory agencies such as FTC and FDA, offices of state attorneys general, local district attorneys, competitors and, of course, plaintiffs lawyers.

The primary regulator of advertising claims is FTC.

FTC identifies principles that are generally accepted to yield reliable test results. A well-designed and carefully controlled study with the blinding of both subjects and researchers is generally viewed as more likely to yield reliable results.

Advertisers must carefully consider each claim and ensure that proper support exists. Otherwise, in this era of ‘claims litigation," a company may find itself on the receiving end of unwanted action from a variety of sources.

lbo
19/11/2022
13:35
Interestingly, 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 realworld 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
19/11/2022
13:32
Whatever LiarBO says about the evidence that MED3000 works, he can't deny the existence of that evidence. On the other hand, evidence of any nature at all that it doesn't work does not even exist, except in LiarBO's tiny little mind. If it did, surely he would have copy/pasted it about a million times by now.
petroc
19/11/2022
13:32
˜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’

The onus is on the ramper not anyone else to substantiate their false claims with non deficient evidence. Claiming others can’t disprove ‘it works’ because no adequately controlled study has been carried out by the advertiser is not a defence accepted by the Courts and FTC! LOL



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
19/11/2022
13:26
Just waiting for LiarBO to publish his evidence that MED3000 doesn't work..... I'm not holding my breath, obvs.
petroc
19/11/2022
13:25
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
19/11/2022
13:23
FM57 CONCLUSIONS
MED3000 consistently showed statistical improvements against before treatment (baseline) with clinically important differences across all ED severities.
MED3000 also showed statistical improvements on both GAQ (Global Assessment Questionnaire) and SEAR (Self-Esteem And Relationship Questionnaire) secondary endpoints.
MED3000 also showed meaningful clinical differences across all ED patient groups, mild, moderate and severe, which is a key evaluation criteria for regulators.
MED3000 begins to work immediately in some patients, with 60% of patients seeing onset of their erection within 10 minutes of application.
MED3000 had an excellent safety profile with very low incidence of adverse events in males and female partners.
Results demonstrated that MED3000 has the potential to be an effective, clinically proven, topical treatment for erectile dysfunction.
Results enabled Futura to receive approval for MED3000 in the EU as a medical device and will enable Futura to pursue the medical device regulatory pathway for MED3000 in the US.

petroc
19/11/2022
08:58
And the only ‘agreed criteria’ with the FDA is the established agreed criteria of the de novo medical device registration pathway. Futura openly admitted at the start they were exploiting the ‘least burdensome’ de novo process to get Med3000 approved as a low unrestricted class medical device. So it will be the FTC who has final jurisdiction over claim substantiation.



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

lbo
18/11/2022
19:03
Sorry, LiarBO, but where was I proven to be wrong? Apart from the fact that your rambling first paragraph was barely literate, it contained not a shred of evidence to prove I was wrong. Yet another LiarBO misdirection. You just say I'm proven wrong, and expect people to believe you without providing any proof. Just cements the fact that you are a charlatan as I said previously.
On the subject of Taladafil being more effective than MED3000, that was never in question. The USP of MED3000 is as a safe and risk-free alternative to pills, which are contra-indicated in swathes of men, and also with a much quicker onset time. In FM71, both MED3000 and tadalafil exceeded the minimal clinically important differences at all time points and for all ED severities, however, overall tadalafil showed a greater improvement in erectile function than MED3000. MED3000 achieved the FDA agreed criteria for proving a rapid onset of action at 10 minutes where patients noticed an erection whereas tadalafil did not achieve the agreed criteria. MED3000 also showed a more favorable side effect profile compared to tadalafil. So if the placebo effect is equal in MED and PDE5i as LiarBO repeatedly claims, why didn't the PDE5i cohort achieve erections in 10 minutes? The only possible answer is that both treatments were working, and MED3000 working a lot quicker than Taladafil.

petroc
18/11/2022
18:25
Will all the data ever be fully published and the results from each subgroup for peer review? eg Organic ED verus Psychological ED etc?

Or just giving the vague pooled results in mild, moderate and severe? Is that pooling mild organic with moderate and severe Psychogenic? Which subgroup had a fall off from week 16 to 20? How is this fall off and just in time recovery before the end of the study explained? Why has Arthur Burnett made no public statement after the study supposedly had such great results? LOL


‘96 male patients clinically diagnosed with a mix of mild, moderate and severe ED against baseline (pre-treatment). Subjects were recruited from United States (African Americans), Poland, Georgia and Bulgaria and included men who had organic and psychological ED or a combination of both’



Predictors of Erectile Function Normalization in Men With Erectile Dysfunction Treated With Placebo

Odds estimates indicated the largest likelihood of placebo response occurred in men who were black (odds=20.2, P

lbo
18/11/2022
18:06
Petoc yet again proven to be wrong! LOL

‘lack of efficacy represented the most important reasons for PDE5i discontinuation’

And what was the ultimate outcome in FM71 even with it being unblinded and uncontrolled!?

overall Tadaladil was still more effective then MED3000’

And its not surprising since its been shown placebos in Viagra studies also caused similar side effects. It compared some 4,500 patients taking the drug to about 3,100 on placebo. And even in FM71 which was a study in less then a hundred men. Med3000 caused headaches, nausea and penile burning!

ROFLMAO

And let’s not even get into the fall off in the mean IIEF change from baseline in FM71 with Med3000 from week 16 to week 20 and then somehow managed (in an uncontrolled and unblinded study) to be brought back up before week 24! LOL



Percentage change from baseline has the lowest statistical power and was highly sensitive to changes in variance.



Large improvements vs. baseline are common in the placebo groups in clinical trials of a wide range of conditions. This improvement is sometimes attributed to the 'placebo effect', implying that the placebo caused the improvement

There are many reasons why symptoms can improve over the course of a trial, of which the placebo effect is only one. To measure the actual effect of a placebo, we would need to compare the placebo to a control group who got no treatment at all. This hasn't been done for MED3000


ED is primarily a self-assessed condition.

Clinical assessment of the therapeutic intervention is not done with a measurable laboratory value or physical finding but is derived from patient reporting and indirectly from partner perception.

In the course of ED evaluation, therapy selection, and outcome assessment, the patient and physician enter into an intimate communicative relationship in which there is some element of bias. Physician bias arises from the desire to achieve an excellent response without side effects, and patient bias may occur in the additive unconscious need to please the physician. This may lead to treatment outcome inaccuracies, with an over-reporting of efficacy and an under-reporting of treatment side effects

lbo
18/11/2022
17:57
Well LBO the reason I repeat my stuff over and over (like you do) is because I do not have the time nor inclination to argue the toss with the likes of you who have been slung out of the LSE for de-ramping for financial gain or pure revenge for some imagined sleight. I have a full life outside of Futura and wish to devote as little of my time as possible to it and your repetitive self
mikethebike4
18/11/2022
17:35
'It's actually because of lack of efficacy.' quoted the stock basher, LiarBO. If you click on the link he thoughtfully provided, it actually says this, 'Six main reasons of PDE5i dropout were identified in the evaluated trials. Partner-related problems and lack of efficacy represented the most important reasons for PDE5i discontinuation, although no significant difference among factors was detected. In conclusion, despite their high efficacy and easy administration, the discontinuation rate and dissatisfaction with PDE5i are still very high. Our data showed that no single factor plays a major role in PDE5i dropout, suggesting that the discontinuation rate is usually because of a combination of both medical problems and psychosocial and relational factors.'
Did you spot LiarBO's massive lie there? He stated that lack of efficacy is the main reason for dropouts, and yet the article he linked states the reason as a combination of factors. The data showed no single factor, yet LiarBO states that there was just one, and goes on to claim that MED3000 will therefore 'have even higher dropout rates! ROFLMAO' What an absolute charlatan he is! If anybody can ever be bothered looking into his posts carefully, there are always glaring inconsistencies like that, and yet he brands everyone else liars and rampers!

petroc
18/11/2022
13:32
Its also ironic that Futura references an article on their website to try support its ‘potential’ that actually proves the ramper is wrong yet again. As side effects are not even the main reason for men discontinuing PDE5 inhibitors! LOL



Corona G., First-generation phosphodiesterase type 5 inhibitors dropout: a comprehensive review and meta- analysis, Andrology, 2016,



Its actually because of lack of efficacy. So MED3000 with its even more questionable efficacy and again proven less efficacious in FM71 then the lowest dose of Tadalafil means MED3000 will have even higher dropout rates! ROFLMAO

lbo
Chat Pages: Latest  585  584  583  582  581  580  579  578  577  576  575  574  Older

Your Recent History

Delayed Upgrade Clock