Futura Medical Share Discussion Threads

[mikethebike4] 14/11/2022 11:56

Come on Lbo let's have another lot of mis-information

Meanwhile just in case :-

Our main competitor - the little blue pill - has these problems

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

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

[lbo] 12/11/2022 23:23

ROFLMAO

FM71 was still another unblinded and uncontrolled study so the same relevant scientific principles apply according the FTC rulings that it is a deficient study to substantiate any effect beyond a a placebo. It has been admitted by Futura to be exploiting the ‘least burdensome’ pathway to medical device registration and only meet the low threshold of ‘reasonable assurance’ for a de novo medical device’ So also what the SMSNA asaid about FM57 is also relevant and still applies to FM71. It doesn’t substantiate ‘any improvements beyond the expected placebo effect. In order to truly determine the efficacy of this non-medicated gel in treating ED, researchers would need to design a new study with a different control’. The only bashing going on is of poor uncontrolled and unblinded anecdotal evidence. Otherwise according to the rampers we should all have been using Ivermectin based on poor anecdotal studies rather then COVID vaccines based on randomised controlled studies.



Administrative Law Judge Upholds FTC's Complaint that POM Deceptively Advertised Its Products erectile dysfunction claims were false and unsubstantiated because the study on which the company relied did not show that POM Juice was any more effective than a placebo.



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

[petroc] 12/11/2022 23:00

Hehehe! LiarBO is quoting SMSNA who never commented on how well MED3000 did in FM71. He just keeps posting unrelated garbage in the hope that gullible people will fall for his stock bashing nonsense!

[loobrush] 12/11/2022 19:23

LBO- what does that stand for !

It stands for LABOTOMY=a medical proceedure that removes part of the brain.

Now we know why LBO rants a load of rubbish all the time !

[petroc] 12/11/2022 18:21

In other words, it passed with flying colours. It's only LiarBO who doesn't agree, because he's a lying stock basher.

[petroc] 12/11/2022 18:20

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.

[lbo] 12/11/2022 15:19

LOL

Yet more misleading claims by Petroc the proven ramper! He has now falsely claimed the ‘FDA study was passed with flying colours’. According to who?



NOT THE FDA. The FDA has not said Med3000 ‘passed with flying’s colours’. The FDA will never approve any such false claims via the De Novo medical device least burdensome’ path. Not even Dr Authur Burnett has made any such comments on the results! LOL




Also where was it published ‘participants knowing full well what they were using’? Yet another false claim. It has not been published what the participants were told or believed about Med3000 before and during the uncontrolled and unblinded FM71 study. What we do know is there was many misleading claims online by rampers and some misreporting in the press about Med3000 before and during the FM71 study. We also know what it was claiming to be on the Futura website and in the press at the time of FM71



‘MED3000, is a topical gel developed specifically for the treatment of erectile dysfunction ("ED"). It is a fast-acting topical treatment’


So where is the published full details on all the FM71 study protocols like were published with FM57? What level of bias beside it being uncontrolled and unblinded may also have been in the FM71 study? 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 in FM71 the patient and those conducting the study enter into an intimate communicative relationship in which there is some element of bias. 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 those conducting the study.. This may lead to treatment outcome inaccuracies, with an over-reporting of efficacy and an under-reporting of treatment side effects





Futura has also openly admitted in the August RNS that FM71 was a study that ‘included men who had organic and psychological ED or a combination of both’.

Yet the results from each of those subgroups in FM71 haven’t been published? Only the headline pooled results were given in an RNS? Why the reluctance to publish all the data and prove Med3000 is not ‘a snake oil’ as referenced by the SMNA?

But then it was admitted after the consumer home use test that Med3000 didn’t perform well in ‘men suffering from severe ED with significant co-morbidities’? And that was only with a user having 4 samples! LOL

[petroc] 12/11/2022 13:59

That's better, LiarBO! I think I deserve more than 3 of your piles of rubbish whenever I post something that hurts you. You outdid yourself with 6 posts inside an hour, that's pretty good going! Having said that, I'm surprised it took you an hour to hit the copy/paste keys six times. And all I have to do is repeat this and you'll have to start all over again burying my comment which has obviously wounded you.

[lbo] 12/11/2022 12:28

When study results are not fully published for peer review then the results and data according to the FTC can be ‘sliced and diced’



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.

[lbo] 12/11/2022 12:23

Did the pooling of data in the press release on FM71,which only included 96 participants and was uncontrolled and unblinded, mean it was a very biased headline result?



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




the clinical effectiveness of FLEXISEQ has not been demonstrated. The absence of an adequate placebo (an inactive topical gel) for FLEXISEQ was highlighted as a limitation by 3 commentators. One commentator said that without it, the clinical effectiveness of FLEXISEQ could be attributed to the placebo effect of rubbing a gel onto the knee, instead of the Sequessome vesicles reaching the joint. Another commentator noted that pooling the results from studies using different placebo treatments may introduce bias into the meta-analysis results.




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] 12/11/2022 11:35

Again even if Med3000 does succeed in exploiting the ‘least burdensome’ De novo medical device path. It still won’t substantiate the rampers false and misleading claims to the FTC who has jurisdiction of any effect beyond a placebo in any adequately controlled and blinded study as it hasn’t undergone any! LOL



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] 12/11/2022 11:26

LOL

No full results of FM71 have ever been fully published or undergone any peer review. They haven’t even undergone any FDA De novo review yet and by Futura’s own admission is exploiting the ‘ least burdensome’ pathway so the review is only to a low standard of ‘reasonable assurance’



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.