Futura Medical Share Discussion Threads

[lbo] 29/6/2022 11:11

The rampers are just trying to pump it so they can dump it and get out at the expense of the naive



petroc - 28 Jun 2022 - 17:48:30 - 12325 of 12340

it'll be adequate for people to rush out and buy it, and it'll be adequate for the share price to rocket and makes lots of money for LTHs. What will happen next? Will it be a real, long term success? Who knows? I don't know and LiarBO certainly doesn't know. I will probably have sold my holding by then

[petroc] 29/6/2022 09:26

Duh - MED3000 is not actually for sale yet, you stupid stock basher, which is why they talk about its potential. Don't worry your ugly fat head about it too much, LiarBO, as soon as it hits the shelves its potential will be realised.

[lbo] 28/6/2022 21:31

‘MED3000 has the potential’. Why do Futura say Med3000 only ‘has the potential’? Why are Futura very careful in their wording and keep giving the necessary disclaimers unlike the rampers.



‘You are the active ingredient’

[petroc] 28/6/2022 21:19

...and the more he posts, the more you smell his fear.

[lbo] 28/6/2022 19:36

https://amp.theguardian.com/science/blog/2012/apr/03/homeopathy-why-i-changed-my-mindPlacebo effects are notoriously unreliable; the patient who benefits today might not do so tomorrow. Placebo effects also tend to be small and short-lived.In order to generate a placebo response in a patient, we do not need to administer a placebo. All treatments come with the free bonus of a placebo effect as long as clinicians administer them with compassion and empathy. So why only rely on part of the total therapeutic response? Is this not short-changing the patient?https://www.discovermagazine.com/health/the-erection-of-a-placeboSo 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.When Futura describe the efficacy of MED3000, they are talking about improvement seen over the course of the treatment period (which was 1 month in the first trial, 3 months in the second), 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, implying that the placebo caused the improvementThere 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, but in trials of other placebos for various disorders, the effect of placebo over no treatment is often very small.Even looking at the change vs. baseline, the improvement in the placebo (MED3000) group was actually very modest in the first trial. In response to the question "Has the treatment you have been taking improved your erectile function?", only 26% of patients answered "yes" for the placebo (MED3000).In the second trial, MED3000 seemed to do a lot better. Why is this? Well, Futura themselves offered some interesting answers to this question on their FAQ.Futura emphasized that the second study had a longer treatment period ("The study ran for 12 weeks versus 4 weeks where we noticed improvement in efficacy between 4 and 12 weeks.") They also pointed to "very strict compliance to the inclusion and exclusion criteria" and "greater emphasis on patient training and therefore compliance to the treatment regimen" in the second trial.The problem is, if MED3000 makes it to market, the real world may not be like the second trial. In the real world, there are no exclusion criteria, because anyone could buy this product without a prescription. There will be no patient training, other than maybe a leaflet. In the real world, I doubt anyone would continue to use the product for over 1 month, if it's not working by then, to experience the benefits at 3 months

[lbo] 28/6/2022 19:24

Just like the CE Mark. A grant to be registered as a De Novo device is not an 'approval' by the FDA of any efficacy claims.'the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type'https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercoursethe De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type.

[lbo] 28/6/2022 19:19

More false claims. Its only a de novo medical device registration that has been applied for FM71 will also include 20 African American patients (from a US medical centrehttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6834358/Odds estimates indicated the largest likelihood of placebo response occurred in men who were black, were younger than 45 years, had mild ED, and did not have diabetes. The likelihood of a placebo response decreased as ED duration increased. The frequency of common adverse events was similar between placebo responders and nonresponders

[petroc] 28/6/2022 18:19

'FM71 will be a 6 month (24 weeks) duration study versus FM57 which was conducted over 3 months (12 weeks) to reassure the FDA that the EFFICACY DOES NOT DIMINISH over a longer period of time. It is Futura's belief that this is unlikely as in the FM57 study efficacy improved from the first to third month of patient use. Two co-primary endpoints will measure the significant clinically meaningful effect as calculated using the Rosen and Araujo statistical method, a standard assessment technique for measuring Patient Reported Outcomes, which was also used in study FM57 in which MED3000 exceeded the minimal clinically important difference as defined by Rosen et al.' Looks like the FDA already recognise the efficacy of MED3000 then.

[lbo] 28/6/2022 17:51

The rampers are continually making false claims and giving no disclaimers. Even Futura give the necessary disclaimers.



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.

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



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.

[lbo] 28/6/2022 16:47

Even FM71 will not be an adequately controlled study.



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

[broomrigg] 28/6/2022 16:32

Good update this morning :-)

[lbo] 28/6/2022 16:09

The SMSNA call it a ‘snake oil’ and the FTC a ‘swindle’



But the anonymous rampers are desperate to try get the naive on BBs to believe the rampers know more then the SMSNA, FTC, ASA and the wider scientific community.

[lbo] 28/6/2022 15:57

Just like in the failed IDEA-033 studies in which Flexiseq was the placebo which were then relied on to get it also approved as a class 2b medical device gel. Med3000 had been used as the placebo treatment in the FM57 study on Med2005 and therefore the researcher had initially believed Med3000 had no therapeutic effect. The trial did not set out to measure the efficacy of Med3000. therefore, considered that its reported effectiveness by the advertiser was a post-hoc finding

also concerned that there was not an adequate placebo control for Med3000 in the trial. therefore, considered that the study did not provide adequate evidence for the claim clinically proven



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



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.