Futura Medical Share Discussion Threads

[lbo] 23/11/2022 12:16

Some real effects and not just over baseline as in FM71 seen in the Avanafil study beyond just a placebo. Unlike MED3000 which hasn’t even been tested in a properly blinded and placebo controlled study in ANY men with ED!



Will MED3000 work if I have had a prostatectomy?

At this time we have not tested the product in patients who have undergone radical prostatectomy




The FDA has updated the label for avanafil (Stendra) to now include positive clinical trial data for use of the oral erectile dysfunction (ED) drug in men with ED after receiving radical prostatectomy.1

The new data are from a randomized, double-blind, parallel, placebo-controlled phase 3 trial (NCT00895011)

Both doses administered in the study led to a statistically significant improvement vs placebo for all 3 primary efficacy end points

[lbo] 23/11/2022 12:08

Pumpty dumpty sat on a wall and then pumpty dumpty had a great fall. Would it be yet another ‘kick’ from a discounted fundraising? The share price has done ‘wonders’ since the last one! ROFLMAO

Or is it a ‘kick’ from the usual rampers online as has been done so many times in the past! LOL



They will need a lot of money to market a placebo gel and pay off all the consumer and FTC actions over any misleading claims!



mikethebike4 - 11 Apr 2018 - 15:58:28 - 4091 of 11141

Company is massively over valued if you go by 'concrete' results !

mikethebike4 - 11 Apr 2018 - 15:14:56 - 4082 of 11141

I only try and bring some sort of balance into the equation to help the gullible not get carried away with fanciful future projections.
I would like nothing better than to be proved wrong about Mr Barder (our CEO since 2001) and to sale away into the sunset grasping 5 times as many £s in my fist as I paid for the shares
Unfortunately for people like J7J, Mr Barder has been through this advisors process before - with CSD500 - and look where we've got in 17 years - sales of the product did not even equal the money we paid him to be our CEO for 2017 !

mikethebike4 - 06 Dec 2017 - 10:32:27 - 3468 of 10591

"A couple of decent deals and will be back off to the races."
Do you have any idea of how long shareholders have been using these words

mikethebike4 - 23 Mar 2017 - 09:52:33 - 2560 of 10591

As someone who has been invested for many years and who attended an AGM years ago and complained to Barder about the very slow progress, I am very frustrated.
All the time the Board are drawing good salaries off the backs of shareholders money they have very little incentive to get off their backsides and get 'selling' - thats what running a company is all about at the end of the day!

mikethebike4 - 24 Feb 2020 - 09:11:58 - 7290 of 9713

why should it be any different this time when you've still got the same useless lot running the show

mikethebike4 - 07 Jan 2019 - 11:22:52 - 4692 of 9641

I repeat I very much hope you are right - no one would be happier than me if you are - however I stupidly (in hindsight) bought in when everything looked really rosy - we were told there were loads of 'distributors' all 'champing at the bit to get selling a wonderful industry disruptive product (which it still is incidentally) once the 2 year shelf-life problem was fixed. This was despite the fact that the Holland/Belgium distributor was quite happy and successful selling them with the original 18 months shelf-life
And where are we now years later - one tiny distributor from which Futura receives a total sales income only just about covering Mr Barders employment remuneration
I just hope this MED/TPR situation is not just a repeat of CSD. As to why I don't just sell up, well my shareholding is worth such a tiny proportion of what I paid for it I might just as well hang on in the hope that new shareholders getting in now are luckier than I was and I can get some of my money back - I think what we need is Mr Barders retirement - that should give the share price a kick

[dgdg1] 23/11/2022 10:45

Has someone tipped it now? If so who? Thanks

[j777j] 23/11/2022 09:40

Ken James Ex Glaxo is the right man to be working with the FDA.

Happy new year

[broomrigg] 23/11/2022 09:25

Loverly jubberly

[genierub] 23/11/2022 09:18

I know of a reputable firm that has tipped this. This is the time to get in.

[broomrigg] 23/11/2022 09:09

Love a blue start to the day ;-)

[lbo] 22/11/2022 23:35

Petroc has now posted on a public bulletin board that class 2b medical device gels which have a CE Mark but cannot substantiate any effect beyond a placebo are a ‘scam’ by ‘gangsters’ LOL

petroc 22 Nov '22 - 19:15 - 14137 of 14145

Flexiseq being a Russian scam, this makes interesting reading:



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.



One specialist commentator felt that the clinical effectiveness has not been demonstrated. The absence of an adequate placebo (an inactive topical gel) for highlighted as a limitation by 3 commentators. One commentator said that without it, the clinical effectiveness could be attributed to the placebo effect of rubbing a gel



As Study Placebo, Non-Drug Gel Not Qualified As Real Arthritis Remedy In UK

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 as effectively as a prescription painkiller," but marketer didn't provide those results when Advertising Standards Authority reviewed online ad claims challenged by a physician.

[lbo] 22/11/2022 19:54

ED is primarily a self-assessed condition (just like pain is) another ‘remarkable’ coincidence that gangsters’ ‘scammers’ and rampers are hoping to exploit the marketing of drug free medical device gels that cannot substantiate any effect beyond a placebo in any adequately controlled studies!

LOL


THE PLACEBO PROBLEM: HOW SCAMMERS TAKE ADVANTAGE OF A PSYCHOLOGICAL EFFECT

The placebo effect is real. But so are the hucksters shilling it in bad faith.





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.



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

[lbo] 22/11/2022 19:46

The FTC has challenged the same misleading claims from other medical devices companies as false and hit some of them with judgements for as much as $22 million. The FDA does not give ‘approval’ to any low class 1 or 2 devices like Willow Curve or Med3000. And if there is no adequately controlled studies to support claims of ‘clinically proven’ beyond a placebo effect for a medical device. The FTC also challenges that too and can impose massive fines on companies that make claims that cannot be fully scientifically substantiated to consumers.









Trinity Research even openly admitted before the hypothesised effects ‘believed’ to be happening by Futura are ‘disputed’ . Trinity admitted no mechanism of action has to be even shown to get a medical device approved. But it does need to be shown and proven to substantiate its marketing claims 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 device



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.

[lbo] 22/11/2022 19:35

It has been well described in the scientific literature that men receiving even an oral placebo in clinical trials for erectile dysfunction drugs experienced an improvement in their function. Its also well described how medical devices like gels that are rubbed in also have enhanced placebo effects.

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<0.0001), were younger than 45 years (odds=7.3, P<0.0001), had mild ED (baseline IIEF-EFD ≥17; odds>100, P<0.0001), and did not have diabetes (odds=4.5, P<0.0001). The likelihood of a placebo response decreased as ED duration increased (odds=0.74, P<0.0001).

The frequency of common adverse events was similar between placebo responders and nonresponders.



This placebo effect was most pronounced in men with post-traumatic stress disorder (PTSD), suggesting that for some men psychology is more important than physiology in dealing with erectile dysfunction, said lead researcher Alexander Stridh of the Karolinska Institute's department of clinical neuroscience, in Stockholm.

"The placebo response seems largely more important when the cause of [erectile dysfunction] is mainly due to psychogenic factors, as in post-traumatic stress disorder," Stridh said.

For this analysis, his team pooled data from 63 studies involving more than 12,500 men.
The studies showed that Viagra and its relatives had a strong effect helping men who had erectile dysfunction due to chronic illness.

"The studies included in this meta-analysis mainly were trials on men with [erectile dysfunction] due to cardiovascular disease, diabetes, etc.," Stridh said. "It is likely that there is a limit to how much the brain can influence erectile function when the problem is mainly dysfunctions in blood vessels or peripheral nerves."
But the researchers found that men in the placebo arm of these trials also experienced a small to moderate improvement of their erectile function. The placebo effect was notably stronger among men with PTSD.
"This paper highlights the importance of taking into account the underlying cause of [erectile dysfunction] in each individual, which could also help determine what the best treatment option would be," Stridh said. Some men might benefit more from psychotherapy, others with a pharmaceutical approach, he added.




A product that contemporary technology does not understand must establish that this ˜magic’ actually works. 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., 512 F.3d 858, 862-63 (7th Cir.

[petroc] 22/11/2022 19:15

And before LiarBO scoffs at Flexiseq being a Russian scam, this makes interesting reading: hxxp://rusletter.com/articles/anatoly_chubais_spent__311_million_on_a_non-existent_ointment

[petroc] 22/11/2022 19:07

'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

[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.