Futura Medical Share Discussion Threads

[petroc] 29/6/2022 13:17

Thank you for demonstrating how you copy/paste nonsense. At least it got your name to the top of the pile again, eh, LiarBO? Lol.

[lbo] 29/6/2022 13:09

I wonder how fast the remaining shareholders cash will be burned through on just an alcohol and water placebo gel that has no patent and if there is any real market for it can be replicated by any similar arousal gel containing alcohol and water.





Voltaren vehicle gel is the carrier substance of the topical Voltaren products. This vehicle gel is especially formulated to be easily applied on the skin, while providing some sensory benefits. The present study aims to substantiate the widely perceived hydrating and cooling effect of Voltaren vehicle gel.




The FDA reviewed the One Male Condom through 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. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

The average length of time for clearance under the traditional 510(k) pathway is 177 days,




a company must compare their product to one already cleared by the FDA and provide evidence that their product is substantially equivalent to the previously cleared (legally marketed) device. To be substantially equivalent, the product must meet criteria for the same intended use, have the same technology or (slightly) different technology but produces similar end results, and be safe and effective. Once pre-market clearance is received from the FDA the device can be distributed commercially immediately.

[petroc] 29/6/2022 12:33

Poor old LiarBO has completely lost the plot! His problem is that he sold his holding at a huge loss about 5 years ago, and since then has devoted his life to bashing the stock out of revenge, so much so that he's forgotten why the rest of us are here! This board is for people who are invested in AIM, or want to, so they are looking for an exchange of information to try and make some money. LiarBO pretends to be appalled that I'm waiting for the share price to rise so I can sell some or all of my stock at a profit, he's clearly forgotten what investing is all about. He's also forgotten that before he lost all his money by buying and selling FUM shares, he used to post good news about the various holdings he had because he wanted them to do well so he could make some money. (It's all there in his posting history) But then the stupid idiot invested more than he could afford to lose in FUM, expecting CSD500 to do well and make him a fortune, but it didn't and he sold at the bottom of the market. What a prat! The rest is history, and the sad old stock basher just sits in his bedroom, copy/pasting nonsense in an attempt to manipulate the share price downwards so that everyone can lose like he did.

[petroc] 29/6/2022 12:20

Btw, LiarBO, thank you for copy/pasting my remark that showed you up for the stock basher you are when I shot down your pathetic comment about passing the FDA trial would not be adequate.

[lbo] 29/6/2022 11:25

Its all an elaborate marketing 'swindle' until an effect beyond placebo can be shown in an adequately controlled study. https://www.ftc.gov/system/files/documents/public_statements/996984/p114505_otc_homeopathic_drug_enforcement_policy_statement.pdfA 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.Trinity Research even admit the hypothesised effects 'believed'™ to be happening by Futura are 'disputed' and no mechanism of action has to be even shown to get a medical device approved. But it does to need be proven to substantiate its marketing claims.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’https://www.discovermagazine.com/health/the-erection-of-a-placeboThere 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] 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.