Futura Medical Share Discussion Threads

[lbo] 09/11/2022 12:37

LOL

No they published only ad hoc and pooled results from a small (less then one hundred participants) deficient unblinded and uncontrolled medical device study. The study they say ‘included men who had organic and psychological ED, or a combination of both’. Why haven’t they given then the efficacy data in each subgroup over time? None of what they have said still does not substantiate any effects beyond a placebo according to the FTC rulings.



What happened next gets to the FTCs allegation that the respondents, in effect, deceptively sliced and diced the data in search of a positive marketing message. According to the complaint, the respondents subjected the data to post hoc analyses of different subgroups of test subjects. (The complaint describes a post hoc analysis as statistical analysis conducted after the data have been collected in hopes of discovering statistical relationships that suggest cause and effect.) The FTC concern is that unplanned, post hoc subgroup analyses pose a high risk of generating spurious findings.



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.

[petroc] 09/11/2022 11:29

They published enough data to show that you were completely wrong, LiarBO. Chucking three massive steaming piles of copy/pasted repetitions won't hide it.

[lbo] 09/11/2022 11:04

Yet another feeble attempt at deflection by Petroc the proven liar. Fm71 was a unblinded and uncontrolled study. The full study design and all the full results have never been fully published or fully peer reviewed. The only information and data anyone has seen is an RNS press release which gave some 'pooled' data but not all of it. Futura by their own admission has admitted it is exploiting the ‘least burdensome’ route of the De novo medical device pathway



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.



When Futura describe the efficacy of MED3000, they are talking about improvement seen over the course of the treatment period known as 'change vs. baseline'.

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'

[lbo] 09/11/2022 10:55

The rates of Viagra use are increasing in young men because they are young and take even higher risks with alcohol etc!



They want something they believe is effective and discreet. Even in FM71 which was unblinded and inadequately controlled it was still proven that a low dose of Tadalafil was STILL MORE EFFECTIVE THEN MED3000! The same reason why some even take twice the recommended dose! These young men dont want a messy indiscreet placebo gel that they then have to explain their need for a placebo gel or their ‘performance anxiety’ to their one night stand or new partner! LOL

[lbo] 09/11/2022 10:50

Even placebos like Med3000 can cause side effects!

In FM71 alone. 4.3% of MED3000 users had headaches and 4.3% of MED3000 users also noted nausea.

And an instance of mild local burning was noted in MED3000 users too. Ouch!



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.



A new review of data from 250,726 trial participants has found that 1 in 20 people who took placebos in trials dropped out because of serious adverse events (side effects). Almost half of the participants reported less serious adverse events. The adverse events ranged from abdominal pain and anorexia to burning, chest pain, fatigue, and even death.

[mikethebike4] 09/11/2022 10:39

We all know what comes with Viagra don't we ?

Viagra side effects

Viagra may cause some unwanted side effects.

Side effects may include:

sensitivity to light
muscle aches
heartburn
nose bleeding
flushed skin
problems falling asleep
tingling in the arms, feet, legs, or hands
numbness in the arms, feet, legs, or hands
headache
diarrhea
heartburn
trouble differentiating between colors like blue and green
seeing a blue tinge on things

Viagra may also cause serious side effects that require immediate medical attention. Symptoms may include:

chest pain
fainting
blurred vision
severe, sudden loss of vision
ringing in ears
sudden loss of or decrease in hearing
dizziness
rash
burning during urination
itching during urination
shortness of breath that worsens
an erection that lasts longer than 4 hours and may be painful

Who would risk it - obviously Mr LBO does - he's dead keen

[mikethebike4] 07/11/2022 10:42

..........................ITS THE LBO SHOW .........................................

[lbo] 06/11/2022 08:40

Petroc is a proven ramper who is also now trying to claim he is a more reliable source then the courts, the ASA and FTC rulings. It has been repeatedly proven he is only relying on ‘deficient evidence’ from a subjective and vested interest which gives all the necessary disclaimers. Yet he continues to repeatedly post false and misleading claims that he cannot substantiate. The ASA, FTC and the Courts are all reliable sources of information and rely on all the objective evidence and the opinion of the wider scientific and academic community. While the rampers false and unsubstantiated claims with zero disclaimers just keep confirming they are trying to just ‘swindle’ the naive into only hear their ramping lies and get them
to buy shares so the rampers can sell out at their expense. That is the definition of a ramper like Petroc engaging in illegal
market manipulation.



Remember, the anonymity of the Internet should make you skeptical of what anyone says if you don’t know who they are. Before making a buy or sell decision on a stock, make sure you are dealing with a reliable source. And if that source is an anonymous stock forum poster, that source is rarely reliable.

Here are 15 ways you can identify the stock discussion board ramper. I’ve seen the same behaviors in the stock rampers across many stock forums. Once you know the warning signs, you can learn to spot the ramper much more easily: They attack those who disagree with their lofty predictions. They cannot back up their arguments with a rational discussion, so they resort to petty name calling and telling others who disagree with them that they are ‘full of it’

[petroc] 05/11/2022 12:11

Higher, LiarBO! Higher! Hehehe!

[lbo] 05/11/2022 11:38

Its also all a feeble attempt at deflecting from the fact that Med3000 still has no enforceable patent either. If anyone can even be able to enforce a patent on a placebo effect! LOL

Even Dermasys on its own has no patent anymore. Its just a trademark name now. And even the Dermasys trademark predates by many years the umbrella patents covering MED2005 (Dermasys and GTN) and TPR100 (Dermasys and Diclofenac) which are all expiring soon also.

from Trinity in a previous note regarding the MED2005 patent:

‘long development period resulted in a material erosion of the patent life, with the original formulation patent expected to expire in 2025’

Dermasys is even older then Med2005 so is off patent now

2002 plus 20 years = 2022




GlaxoSmithKline unexpectedly handed back the development rights to Futuras erectile dysfunction gel. We are not going to progress on this particular compound for normal commercial reasons which we do not wish to go into, GSK said.



The cooling effect of a topically applied product can be evaluated using a validated handheld thermal imaging system. When the gel matrix is destroyed after application to the skin, the bound water and alcohol evaporates and a measurable cooling-effect results.




The DermaSys(R) technology was originally developed by Futura for use in the Company's topical treatment for erectile dysfunction, MED2002





Under the terms of the agreement, Thornton & Ross will conduct the manufacturing scale-up of TPR100 and hold rights to manufacture, market and distribute the product in the UK for the lifetime of the product's patents, which run to at least 2028 in the UK

[lbo] 05/11/2022 11:32

Petroc is a proven liar using Multi-IDs all over the internet to try pump Futura. He lied when he said the evaporative cooling effect of Dermasys could not be replicated. The ramping liars can try childish tactics to deflect but cannot filter the facts that have repeatedly proven to be liars! LOLpetroc - 20 Feb 2020 - 10:14:36PDT, as Dermasys has been Futura's core product for several years, and upon which they base their marketing strategy, I very much doubt that it's easy to replicate faithfully or legally. Besides, there are many "wonder creams" out there that claim to do the job,(a friend tells me), and yet research still continues for something that actually does.https://www.pharma-mkting.com/blog/no-goopy-ed-gel-in-gsks-futura/We are not going to progress on this particular compound for normal commercial reasons which we do not wish to go into, GSK saidhttps://www.gskhealthpartner.com/content/dam/cf-consumer-healthcare/health-professionals/en_IN/pdf/article-1.pdfThe cooling effect of a topically applied product can be evaluated using a validated handheld thermal imaging system. When the gel matrix is destroyed after application to the skin, the bound water and alcohol evaporates and a measurable cooling-effect results.Voltaren vehicle gel application resulted in a rapid reduction of skin surface temperature by 5.1°C after only 3 minhttps://www.edisoninvestmentresearch.com/?ACT=18&ID=10479There is a risk that some claims will either be challenged in future (eg on the grounds of non-obviousness or existence of prior art) and/or that another technology may be employed to achieve a similar effect. The protracted development times mean the clock has been ticking on the original issued patents, reducing the protected commercial product

[lbo] 05/11/2022 11:20

The only jumping being done is by the rampers. You jumped on the bandwagon of trying to swindle others! Now you are so desperate to try jump off the sinking ship of lies you have to just keep telling more and more lies to desperately keep it afloat! Pure comedy watching it unfold! ROFLMAO



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.

Trinity Research even openly admitted 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 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 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.

[petroc] 05/11/2022 11:14

Heheheh! Jump, LiarBO, jump!