Futura Medical Share Discussion Threads

[j777j] 08/12/2022 10:12

Huge news on the way as they go for green on the UK European launches.


FDA approval as good as in the bag as the co worked closely with the FDA along the way and have fulfilled all the requirement for sale and an OTC product



Recent article talking about the Cannabinoid development




All set to fly past 100p next year

[lbo] 08/12/2022 10:05

No just rampers like you pumping it all over the internet and social media! LOL








Last time there was a big pump was before a fundraising. What if the get knocked back or there is a delay in getting the De Novo medical device registration? Perjury they are thinking of trying to do yet another fundraising and secure their salaries for as long as possible as MED3000 fails to deliver any meaningful revenues to shareholders to justify anywhere near the current £140m market cap!

[vaston] 08/12/2022 10:03

SYME is about to fly claims ceo


V

[broomrigg] 08/12/2022 09:57

MORE strong buying this morning. Market getting short of stock yet?! Institutional buying?!UP we go! :-)

[lbo] 07/12/2022 23:42

The IPSOS research Futura refers to was first released by Futura back in 2017 and Futura admits on its website the pricing was based on ‘Manufacturers' Selling Prices 2018’. Before Viagra came off patent. Since then prices have fallen as more and more generics and alternative PDE5I drugs have come on the market. The outdated research was also based on a different ‘proposition’ as it was based on MED2002 before it failed its Phase 3 drug trial and was left just being a placebo medical device with completely different ‘mode of action’.and only passing ‘deficient’ ‘flimsy’ conformity medical device tests. So now MED3000 is just a medical device and the same substantiation case law willl still apply from the courts, ASA, FTC etc. All the effects of MED3000 can be replicated with any class 2 cooling lubricant/arousal gel.in an ED study. MED3000 still has no proven effect beyond a placebo in any adequately controlled study. While Oral PDE5I drugs have all proven effects beyond a placebo in many adequately controlled studies and even in the deficient FM71 the lowest possible dose of Tadalfil was still more effective then the placebo medical device gel MED3000.




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 products 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

[petroc] 07/12/2022 22:17

Hahaha! LiarBO said:
'Nobody references how old and outdated the Cello and IPSOS Futura research is now and that its not even based on Med3000?'

What he could have said is 'Nobody references how old and outdated LiarBO's research is now and it's not even based on MED3000'!
How many times have we seen LiarBO's comments referencing rubbish which is several years old and hardly ever related to MED3000? It beggars belief that he has the gall to say the same about other people's posts. It just underlines what a lying, deceiving stock basher he is. (*the answer to my question above is about 15 times a day.)

[lbo] 07/12/2022 12:59

And all based on an outdated assumption!

Nobody references how old and outdated the Cello and IPSOS Futura research is now and that its not even based on Med3000? It was carried out years ago and is based on Med2002 and on pricing before Viagra even came off patent! And that it was based just on asking questions about a very different MED2002 concept. A concept that went on to fail at phase 3. So it was not approved as a drug and no longer meets efficacy claims beyond a placebo in any adequately controlled study. Even the Cello survey was based on questions on MED2002 not a placebo medical device of questionable efficacy. Yet still that survey showed 46 per cent of the doctors interviewed in France did not even consider MED2002 was an improvement over PDE5 inhibitors. And that was even before MED failed at Phase 3 and was left just a placebo medical device!



˜The respondents were shown a concept about MED2002 as part of the market research though they did not use the product as it is currently in clinical development’

˜respondents believed that the product, once approved, is highly differentiated from existing products and that its claims’

And read the brokers research small print about ‘market penetration rates’, ‘accounting practices’, limited disclosure’, ‘in-market sales’

‘Our forecasts assume a MED3000 price of c $5/dose in the US and similar in EU, and whilst our market penetration rates continue to assume the clinical benefits seen in the trials are replicated consistently in a real-world setting, uptake will largely depend on the marketing experience and expertise of the relevant commercial partners’

given limited disclosure of precise terms in Europe (which includes multiple revenue layers based on various accounting practices) for simplicity we assume Futura Medical receives payments from partners that are equivalent to a royalty rate of 20% on in-market sales. In the US we assign a 90% risk adjustment pending regulatory authorisation.

[lbo] 07/12/2022 12:48

As they say. If the news is in the market then its in the price! All public knowledge!!!

‘Commercial execution is key’

‘The next steps are EU launches (due to start during H123), FDA marketing clearance (potentially by end Q123)

‘we have limited visibility on the potential timing and terms, given various structures and options could be considered. Importantly, current cash resources should be sufficient to reach beyond the anticipated US regulatory decision by end Q123, and to secure a US deal, assuming a positive regulatory outcome catalyses discussions’

‘The first wave of launches is anticipated during H123, which could potentially include the UK. The next wave will likely include the rest of the key markets of France, Germany, Italy, and Spain, with the third wave being the distributor-led smaller geographies. A contract manufacturer is in place for commercial production and first orders have already been received from Cooper’

[penciles2] 07/12/2022 11:58

Thanks just done it

[penciles2] 07/12/2022 11:43

Just wish LBO would FO now

[lbo] 07/12/2022 11:38

LOLThe exact same was said back in March 2021 at the time of the last pump and then dump on the fundraising RNS!

[losses] 07/12/2022 11:30

LBO getting shafted slowly... each time he opens his filthy gob of lies the price rises haha

[lbo] 07/12/2022 10:26

Ah the old ramper market manipulation scam on no news but they suggest they know news is coming! Didn’t the company themselves say first manufacturing orders received? Yet no mention again of quantity! So the rampers use multi-IDs all over the internet trying to get the naive to buy in so they can sell out before it all unravels! Saw it before from the rampers ahead of all the other previous failures when sales did not meet ramper expectations that were pumped all over the internet!





Even poor mike knows all about buying in when the rampers proclaim all looks ‘rosy’

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

[broomrigg] 07/12/2022 10:11

Persistant buying AGAIN this morning. Market are going to have to mark these higher if they aren"t sitting on much stock and it continues like this.News on first sales is due soon folks ;-)

[lbo] 06/12/2022 12:27

Yet not a mention about MED being launched by any of the distributors!? Who remembers Bizzy diamond getting Goedele! Were enough condoms even sold to cover her fees? LOL



Maybe Leslie from his flat will be the big distributor behind a big launch for the UK! ROFLMAO

As Liberum said all the price targets are based on assumptions it sells and the risks have only moved from regulatory to execution risk. And Futura’s execution of bringing PET500, CSD500 and TPR100 to maktet have all been disasters! Yet Reckit has similar products to each of Futuras failed products still on the market (KY Duration) (Durex warming/Durex intense condoms) (Nurofen pain gel). They even admitted they can’t take on the likes of Reckitt. And that was with a product that had patent protections and some real clinically proven USPs against standard condoms. Which MED3000 does not have any of!



˜Futura does not have the marketing or regulatory resources to support the day-to-day requirements in a growing compliance-driven medical device market’

˜the immediate potential for substantial royalties is low in the absence of a large global brand 'carrier' to take the product forward’

[j777j] 06/12/2022 10:57

News on several fronts fairly imminent now



Average price target remains up near 100p,with strong upgrades likely on newsflow.

[broomrigg] 06/12/2022 10:47

Strong buying this morning.....up we go again folks ;-)

[lbo] 05/12/2022 19:27

There has been well known incidents of medical devices causing harm and having to be totally recalled.









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.


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 products 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 ËœCE (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.

[lbo] 05/12/2022 19:22

The only ‘real travesty of the truth’ is you suggesting the use of placebo medical device is even safe when there is a no medium to long term safety studies to validate that. One of the safety studies for MED was just on cadavers!



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.

[lbo] 05/12/2022 19:15

The same way you are warned about the risk of ingesting alcohol. Yet you admit to continue to ingest alcohol! .You have also deliberately and repeatedly misrepresented the side effects and risks of the recommended first line therapy. It has many years of objective data in millions of users supporting why it is still the recommended first line therapy. Unlike Med3000 which has no non deficient data supporting its efficacy and very little and very short term safety data only in a very few number of users.



A Viagra study also showed using a placebo was also just as likely to harm you. It compared some 4,500 patients taking the drug to about 3,100 on placebo. So based on that study Med3000 even as a placebo is just as likely to harm you as viagra.



‘Its all in the American Urological Association [AUA] guidelines

The therapies have not been validated’

i recommend what we have as standard of care, which includes pills, injections, penile prosthesis, and vacuum devices that we know work. Other therapies have not been included in the standard of care yet’

The first line therapy recommended in the General practice guidelines on ED is oral PDE5I drugs. Which would be based on all the available objective evidence. It would not be based solely on a rampers subjective and unqualified personal view. Or if a person just own shares in a company with a placebo gel alternative and who may have a vested interest and biased opinion.



First-line therapy

For most men with ongoing confirmed ED, first-line treatment will be a phosphodiesterase-5 inhibitor (PDE5I).



Phosphodiesterase 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil) are recommended as first-line therapy. With established safety profiles, these drugs are well tolerated and effective

GPC prescribing lead Dr Andrew Green:

'There is no doubt that sildenafil is a safe and effective drug’

[lbo] 05/12/2022 17:12

Yes one step closer to the next bluediamondcondom.com and Kabey Pharmaceutical type launches all over again but now with MED3000! New obscure companies being set up again! LOL

What did ever happen to Kabey? ROFLMAO