Futura Medical Share Discussion Threads

[lbo] 21/9/2022 11:37

MED3000 is just a medical device which cannot substantiate any effect beyond a placebo in any adequately controlled study. Yet Oral PDE5Is can substantiate an effect beyond a placebo and have a proven mode of action.

MED3000 main competitors are just other similar medical devices like arousal gels or cooling lubricants which can replicate every action of MED3000.



˜whether it be the placebo effect, evaporation, or just, well, mechanical stimulation’

Trinity Research even admit the hypothesised effects ˜believed’ to be happening by Futura are ˜disputed’ and Trinity admitted no mechanism of action has to be even shown to get a medical device approved. But unfortunately it does need to be proven to substantiate its marketing claims or fall foul of the FTC, ASA and the Courts.



A 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:

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

[glavey] 21/9/2022 07:39

"for the treatment of ED, which is gently 'rubbed on' for 15 seconds and then voila - a stiffy."

For someone with clinical ED, not a hope in hell!

[petroc] 20/9/2022 18:31

There's no comparison between MED3000 and the other products they've discussed, BB. FUM are concentrating on getting MED out there now. Approval received from EU and FDA means targeted effort is required. There'll be time for the other stuff later. Most LTHs will have taken some profits on the rises, knowing that the share price will drop again before the next announcement - a fairly consistent pattern and certainly nothing to be alarmed by.

[black bird] 20/9/2022 17:21

pain relief, seem#s dead, no news. med 3000 dead ? is it going the same way, fum should be giving an update oct 2022. the directors of fum should take notice, no revenue in results, share price down as i said it would , why no news on pain relief. BB

[petroc] 18/9/2022 14:23

Glad to see you've remembered your instructions, LiarBO. When I say jump, you say how high? Lol!

[lbo] 18/9/2022 13:14

Its been proven that psychogenic ED is highly prone to respond to even just oral Placebos.

Placebo Effect Found to Improve Erectile Dysfunction



Its also been shown that medical device topical placebos like gels can also have enhanced placebo effects



Recent research has shown that the placebo effect is not only similar for medical devices to medical trials; it is considerably larger, the effect of a sham device is almost three times that of an oral placebo.



Placebo Treatment: Don't Eat It, Rub it!

indications to suggest that a topical placebo induces stronger effects than an oral one.

[lbo] 18/9/2022 13:08

The placebo effect of ‘rubbing’. Just like with MED3000. When in FM57 and FM71 the men believed they were rubbing in a gel containing GTN a known vasodilator drug ie a Viagra type gel. Yet there was no difference in outcome between rubbing the placebo Med3000 or the Med3000 GTN gel as its all a placebo effect of ‘rubbing’




Researchers blindfolded a group of people and told them that their right arms were being rubbed with a poison ivy plant. Consequently, all the people’s arms reacted with itching, boils and redness - all the classic symptoms of poison ivy. Not very surprising - until you find out that the plant used for the study was just a harmless shrub.

The placebo effect is an amazing phenomenon. It basically means that the body reacts to a “fake” stimulus or treatment for no other reason than we THINK that the body is supposed to react in a certain way. There is no “objective” reason for the reaction.

Take for example an experiment where a group of people think they are being exposed to poisonous ivy (see quote above). Really, they are simply being exposed to a completely harmless substance. But even so they react as you would expect if they actually had the poison applied to their body. The expectation of a reaction was enough for a rash to break out as well as itching and boils.

[lbo] 18/9/2022 12:51

Yeah two class 2b medical device gels that both require ‘rubbing’ in have to have any perceived subjective effect over baseline have no equivalence! LOL

Even though they are also both the same class of medical device gels and both went through the exact same medical device registration. Both are classed as medical devices because they ONLY have a physical mode of action and both contain no active drug to deliver. Both are also regulated under the exact same Medical Devices Directive and both also had no adequately controlled study to substantiate any effect beyond a placebo.



Med3000 was the placebo in FM57. Therefore Futura had initially believed Med3000 had no therapeutic effect. The FM57 study did not set out to measure the efficacy of Med3000. The ASA and the FTC will therefore consider that its reported effectiveness by Futura was a ‘post-hoc finding’



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

[petroc] 18/9/2022 12:41

Only in LiarBO's tiny little mind is there any equivalence. Besides, LTHs have a proven track record of backing AIM - that's why we're here after all. Unlike LiarBO who has no holding here and going by his comparison has probably got a stake in some Russian scam somewhere. There's definitely something underhand going on with him.

[petroc] 18/9/2022 11:59

Don't know why LiarBO puts Russian backed scam in inverted commas as though it's not true. This link makes for interesting reading. hxxp://rusletter.com/articles/anatoly_chubais_spent__311_million_on_a_non-existent_ointment

[lbo] 18/9/2022 11:40

Just shows how little some know about how Futura ended up with the same idea as a ‘Russian backed scam’ of marketing just a placebo alcohol and water gel as a medical device gel for ED. LOL

Some shareholders will remember Glaxo walked away from both TPR100 and MED2002 as Dermasys only effect with no drug eg diclofenac or GTN to deliver. Is just a placebo skin cooling when it evaporates.







with Johnson & Johnson McNeill division having returned US rights to IDEA-033 recently



12 week clinical trial was originally deemed a failure when the investigational product IDEA-033 (Ketoprofen-in-vehicle), failed to show a statistically significant benefit compared with the topical control, then known as TDT 064 (now known as flexiseq)

Flexiseq like MED3000 is just another class 2b medical device gel placebo

[lbo] 18/9/2022 00:47

Flexiseq is a class 2b medical device gel that is rubbed in. Same as MED3000 is a class 2 medical device gel that is rubbed in. FLEXISEQ is classed as a medical device because it has a physical mode of action and contains no active drug. Same as MED3000. Both gels are regulated under the Medical Devices Directive. It like MED3000 had no adequately controlled study to substantiate any effect beyond a placebo. Because like Med3000. Flexiseq (TDT064) too was just the placebo in a failed phase 3 study of the transdermal delivery of the drug ketoprofen (IDEA-033). Both Flexiseq (based on Transferome skin delivery) and Med3000 (based on Dermasys skins delivery) were originally designed to deliver drugs through the skin. Yet both failed at phase 3 so then they were left with trying to market the placebo.

Just like Med3000 was the placebo in the failed FM57. A study designed to study Med2005. Flexiseq (TDT064) gel was the placebo gel in the study of the failed IDEA-033 gel (similar to Futuras TPR100 gel)

So yes it seems Futura got the same idea from a ˜Russian backed scam’’! LOL

So exactly the same as Futura had believed its class 2 medical device gel Med3000 had no therapeutic effect. The FM57 trial did not set out to measure the efficacy of Med3000. Therefore the ASA will consider that the reported effectiveness of Med3000 by Futura was a post-hoc finding, due to the risk of that being a false positive finding. The ASA will also be concerned that there was not an adequate placebo control for Med3000 in the FM57 trial.



And the percentage who have subjectively reported an improvement is only over baseline. Still doesn’t substantiate a claim that the improvement reported had even anything to do with the gel itself.



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.




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

[lbo] 17/9/2022 20:59

Flexiseq also tried to make similar unsubstantiated claims about its gel. Is is also just a class 2b medical device that is rubbed in. Same as MED3000 and went through the exact same CE Mark medical device registration. It too was originally just the placebo in the failed phase 3 drug trial for the transfersome transdermal vehicle plus ketoprofen drug.





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

[lbo] 17/9/2022 20:51

Yet again the proven liar is proven wrong! A medical device gel that needs to be massaged in would have a higher placebo effect then the placebo effect of just taking a tablet.



‘Recent research has shown that the placebo effect is not only similar for medical devices to medical trials; it is considerably larger “ the effect of a sham device is almost three times that of an oral placebo’



These results were published in a paper entitled: “Placebo treatment for varicosity: don’t eat it, rub it!”



suggest that a topical placebo induces stronger effects than an oral one.