Futura Medical Share Discussion Threads

[lbo] 03/3/2023 18:10

The HCP website also says ‘ when assessed against internationally accepted criteria for clinical effectiveness (Rosen and Araujo) the efficacy of Eroxon exceeded the minimal clinically important differences’

And the HCP Brochure references ‘Minimal clinically Important Difference Rosen et al 2011’

But its clear the MCID criteria were estimated based on regular adequately controlled and blinded oral ED studies. The Rosen study clearly states in its limitations the results have not been replicated in non pharmacologic studies. So they are not accepted criteria for medical device gels!

So now the MCID is misleadingly being used to make a indirect cross comparison to non regular inadequately blinded medical device gel studies.



MCIDs were estimated using data from 17 randomized, double-blind, placebo-controlled, parallel-group clinical trials of the phosphodiesterase type 5 inhibitor


limitations

Current analyses were based on 17 clinical trials of tadalafil. Results need to be replicated in studies using other PDE5-Is or in nonpharmacologic intervention studies.

[petroc] 03/3/2023 18:07

Thanks for continuing to repost the link to that Eroxon website, LiarBO. Great advertising for a great product that's going to hit the market very soon!

[petroc] 03/3/2023 18:05

The lady doth protest too much, methinks.

[lbo] 03/3/2023 17:56

The HCP website Petroc linked also clearly admits

‘Eroxon was the placebo used in FM57’.

So applying the sme principles of the ASA ruling on another similar drug free Class 2b medical device gel. Will mean the ASA will also find similarly that the results of FM57 are a post hoc finding



Med3000 was just the placebo in the FM57 study

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 will therefore consider that its reported effectiveness by Futura was a ‘post-hoc finding’

The CAP Code required that objective claims, including medical claims for a CE-marked medical device, be backed by evidence

a certified Class IIb medical device. We understood that the device certification was granted by a body within the European Member States that had been designated to carry out conformity assessments under the Medical Device Directive

had been used as the placebo treatment in that study, and therefore the researcher had initially believed it had no therapeutic effect. The trial did not set out to measure the efficacy

its reported effectiveness by the advertiser was a post-hoc finding due to the risk of that being a false positive finding

[lbo] 03/3/2023 13:55

The ASA, FTC and Courts will decide. Unlike the multi-ID rampers who have no jurisdiction in the real world. The Courts will have real jurisdiction and the case law is consistent

petroc - 23 Feb 2023 - 19:49:11 - 16541 of 16805



All anyone would have to do now is submit the complaint about the UK website the multi-ID advertised on ADVFN



You can complain to us if: you're a member of the public, you work for a competitor or you’re associated with a group with an obvious interest

iYou can complain to us by: completing our online complaints form (click continue below) You will need: information about the ad, including where and when you saw it if possible, a photo, video or screenshot of the ad (please note, if we do not have sufficient detail to help us to locate the ad you have concerns about, we may not be able to proceed with an assessment of your complaint) a few minutes to fill in our form online

It’s been shown that Med3000/Eroxon is not a ‘regular’ oral placebo.

Its a medical device gel placebo which is massaged in and medical device placebos like gels are known to have higher placebo effects.

So the indirect comparison to only a ‘regular’ oral placebo is inadequate and not an equivalent like for like and is a misleading and deceptive comparison.

So yet again the information given by the ramper was not ‘enough accurate information’ and involved the ‘omission’ of important information.

Other important information has also also been omitted like the fact the fact that FM57 was designed to study Med2005. Not to study the placebo Med3000. So the surprising results for the placebo Med3000 are according to similar rulings by the ASA. A ‘post hoc finding’. It has also been omitted about the non standard inclusion criteria in FM57 which were not the same criteria used in the the ËœED studies with regular placebo’

Also its been admitted that in FM71 the lowest possible dose of Tadalafil was still overall more effective then Med3000. And if the clinical effectiveness of medical device placebo gels are higher then the effectiveness in a direct adequately controlled study would be smaller. So it only exceeded the accepted minimum criteria for clinical effectiveness in indirect cross comparison for adequately oral placebo controlled studies for regular oral placebos.

It has never been directly compared to an appropriate placebo sham gel nor showed any accepted minimum clinical difference to any placebo gel or even an arousal gel.

The HCP website gives all the admission evidence that Med3000/Eroxon has not undergone an adequately controlled and blinded study with a similar sham placebo gel or even an arousal gel

‘Why hasn't a double blind study been conducted?’
It was not possible to double-blind FM71 as the two treatment arms were not matched; a topical gel and a tablet’

And the claim is again inaccurate. A double blind study could have been done and matched the two treatment arms by giving one group tadalafil and an arousal gel made of alcohol,water,glycol and carbomer and the other group Med3000 gel and a regular oral placebo!
But it is another admission that the ‘two treatment arms were not matched’ and if they were not ‘matched’ then neither is a cross comparison between a regular oral placebo ED study and a non regular gel placebo study ‘matched’

[petroc] 03/3/2023 13:43

Just like when LiarBO states that Eroxon doesn't work, he doesn't offer a shred of evidence to support his case, and instead just calls everyone else liars. What a massive scam artist he is!

[petroc] 03/3/2023 13:39

Heh heh heh! So predictable! And so wrong!

[lbo] 02/3/2023 22:20

Thanks to Petroc

petroc - 23 Feb 2023 - 19:49:11 - 16541 of 16805



All anyone would have to do now is submit the complaint about the UK website he advertised on ADVFN



You can complain to us if:

you're a member of the public, you work for a competitor or you’re associated with a group with an obvious interest
it's something we cover (if you’re unsure, call us on the number below) and you’re happy to limit your complaint to three issues

You can complain to us by:

completing our online complaints form (click continue below)

You will need:

information about the ad, including where and when you saw it
if possible, a photo, video or screenshot of the ad (please note, if we do not have sufficient detail to help us to locate the ad you have concerns about, we may not be able to proceed with an assessment of your complaint)
a few minutes to fill in our form online

[petroc] 02/3/2023 21:17

*and LBO8 on Twitter, let's not forget.