Futura Medical Share Discussion Threads

[petroc] 18/5/2023 17:49

That'll be the same website that also says this (good spot, LiarBO):

The efficacy of Eroxon has been demonstrated in two Phase 3 trials in 300 men with mild, moderate, and severe ED.

The first (FM 57) was a 12-week multi-centre double-blind trial in 250 men who all used Eroxon®. Before using the therapy, participants were monitored for four weeks to establish the extent of their ED. This was measured using three internationally authorised measures: IIEF-EF, SEP2 and SEP3.

Efficacy improved after the first dose and men achieved an erection within 10 minutes in 60% of applications. There were 3,792 intercourse attempts and two-thirds (63%) of men achieved or exceeded the Minimal Clinically Important Difference (MCID), which is the benchmark for a meaningful response.

The speed of onset was significantly faster than oral PDE5i medicines, which typically start to work within 30-60 minutes.

At 12 weeks, men using Eroxon showed significant improvement from baseline across all measures, with the response increasing in line with the severity of their ED. Four in five (80%) of those with the most severe ED met, and in some cases exceeded, MCID. In men with moderate ED, 59% met or, again in some cases, exceeded MCID and in those with mild ED it was 61%.

Reported side effects were minimal and significantly lower than those typically associated with PDE5i medicines.

[lbo] 18/5/2023 15:41

The UK HCP website that was advertised by Petroc on ADVFN also said:

‘when assessed against internationally accepted criteria for clinical effectiveness (Rosen and Araujo) the efficacy of Eroxon exceeded the minimal clinically important difference’

But the HCP Brochure on the same website references the specific study ‘Minimal clinically Important Difference Rosen et al 2011’

And its clear in that study that the MCID criteria were estimated based ONLY just on regular adequately controlled and blinded ORAL ED studies

The referenced Rosen study also clearly states in its limitations the results have not been replicated in ‘non pharmacologic studies’!!!!

And FM71 was clearly a non pharmacologic medical device gel study!!!!

So they are NOT internationally accepted criteria for ˜non pharmacologi studies’ according to the original reference research paper. Which is what the the medical device gel study FM71 was! A test that was totally uncontrolled, unblinded and ‘prone to bias’ and therefore known to show much higher placebo effect then just oral pharmacologic placebos in adequately controlled and fully blinded studies.

So now it can be claimed that consumers were being ‘duped’ by the multi-ID ramper advertising the HCP on bulletin boards when the inappropriate MCID comparison is 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] 18/5/2023 14:54

LiarBO cried defensively: 'Is that best you could do! Yes May is over April in terms of month! ROFLMAO'

What does that even mean? May is over? Just over halfway through, actually. In terms of month? I assume you're ROFLMAOing at your own stupidity in writing that nonsense.
Let's make it clear - you stated, 'Again I haven't mentioned Ivermectin in over a month.'

And yet it turns out you were banging on about Ivermectin just eighteen days previously. A harmless lie but it just proves yet again how lying is the pattern of all your posts, so much so you even try to defend it.

[lbo] 18/5/2023 12:37

petroc16 May '23 - 17:54 - 18832 of 18867'is the fact that it hasn't yet been tested against a placebo'Make a complaintQuickly and easily submit your ad complaint with us online.You can complain to us by:completing our online complaints form (click continue below),https://www.asa.org.uk/make-a-complaint.htmlYou 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

[lbo] 18/5/2023 12:30

Is that best you could do! Yes May is over April in terms of month! ROFLMAO

And whats really comical is how Petroc the proven ramper and liar reacts when he has yet again been caught out lying and scamming. His defence is always med3000/Eroxon is somehow above the consistent case law and substantiation principles applied by the FTC, the ASA and the courts! Doesn't he realise how transparent and nonsensical that sounds! Again a proven ramper trying to pretend low class medical devices can make any claims they want. And why would a regulatory body like FTC have anything to say yet about FUM or MED3000? Its not on sale yet in the USA and has not even been registered as a medical device yet in the USA. He is the only total fool and a scammer trying to pump FUM shares, because he made such bad investment decision to buy into the ‘placebo gel frenzy’ and now needs to get others to buy in so he can sell out before the market realises it will never be able to sell enough placebo male arousal gel with no enforceable patent to justify the current Futura Market Cap!

[lbo] 18/5/2023 10:35

Again I haven’t mentioned Ivermectin in over a month. But yes I stand by the fact it’s clear the ASA, FTC and Courts have all made rulings that subjective testimonials that ‘it works’ from deficient tests in conditions that are known to spontaneously resolve. Is not adequate proof ‘it works’ any better then any similar placebo would! ROFLMAO

Just like some were also of the subjective ‘opinion’ that Ivermectin was an effective treatment for COVID based also on deficient evidence from inadequately controlled studies. COVID like Psychogenic ED for many can spontaneously resolve whether treated or not.



‘folks observed that some who took Ivermectin did not get sicker and concluded its benefit. There were even lab studies that hinted at a benefit. But all involved small numbers of people. This is problematic, as most people recover from their episode of COVID whether treated or not’

But real non deficient studies which were adequately controlled proved Ivermectin has no effect!



The most important takeaway from the study is that ivermectin does not help improve outcomes from COVID-19 infection and thus should not be used as a treatment for COVID



Same scientific principle applies to the deficient Eroxon medical device tests in only a small number of people



‘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, but in trials of other placebos for various disorders, the effect of placebo over no treatment is often very small’

[lbo] 18/5/2023 09:26

So where exactly did I mention Ivermectin within the last month? Or is it the fact that you have been caught just repeating the exact same post which is not even relevant to the current discussion on the very relevant Flexiseq’! ‘hahaha’ indeed!

petroc - 30 Apr 2023 - 16:02:06 - 18488 of 18872

petroc - 30 Apr 2023 - 11:27:03 - 18470 of 18872

petroc - 21 Apr 2023 - 17:46:17 - 18213 of 18872

But yes conditions that can resolve spontaneously with no treatment. Can appear to be treated if you listen to subjective testimonials from deficient tests! But in reality in adequately placebo controlled blinded studies have no efficacy beyond a similar matched placebo!

Medical device claims that breach CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 Medicines, medical devices

‘Because the trial was not placebo-controlled’

‘had not provided adequate evidence to support the claim ‘clinically proven’ ‘concluded that the claim had not been substantiated and was misleading’



Assessment
Upheld

The ASA noted that the product appeared to meet the requirements of the Medical Device Directive (MDD) but understood that the MDD did not harmonise EU law relating the advertising of medical devices, which was subject to Directive 2005/29/EC on unfair business to consumer commercial practices (including advertising) generally (Unfair commercial practices directive - UCPD).

That meant that advertisers must still meet the requirements of the CAP Code, which reflected the provisions of UCPD. Under the CAP and BCAP Codes, medical claims could be made for CE-marked medical devices provided they complied with other requirements of the Codes, including those relating to substantiation.

CE certification in itself does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims.

There was no statistically significant difference between the outcomes for the treatment group (patients using the Aerosure device) and the control group (using an inactive sham device). The study was accordingly not adequate evidence of the efficacy



Because the trial was not placebo-controlled, we considered AcceleDent had not provided adequate evidence to support the claim AcceleDent, is also clinically proven to reduce the pain and discomfort associated with braces and aligners by up to 71%. We concluded that the claim had not been substantiated and was misleading.

On that point the claim breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 Medicines, medical devices, health-related products and beauty products.



Assessment
Upheld

The ASA noted that the product appeared to meet the requirements of the Medical Device Directive (MDD) but understood that the MDD did not harmonise EU law relating the advertising of medical devices, which was subject to Directive 2005/29/EC on unfair business to consumer commercial practices (including advertising) generally (Unfair commercial practices directive - UCPD).

That meant that advertisers must still meet the requirements of the CAP Code, which reflected the provisions of UCPD. Under the CAP and BCAP Codes, medical claims could be made for CE-marked medical devices provided they complied with other requirements of the Codes, including those relating to substantiation.
CE certification in itself does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims.

There was no statistically significant difference between the outcomes for the treatment group (patients using the Aerosure device) and the control group (using an inactive sham device). The study was accordingly not adequate evidence of the efficacy

[petroc] 18/5/2023 09:08

'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 study (12.1 Objective claims must be backed by
evidence, if relevant consisting of trials conducted on people. If relevant, the rules in this section apply to claims for products for animals. Substantiation will be assessed on the basis of the available scientific knowledge.) but an adequately controlled observational
human study might be sufficient in some circumstances.'

Yes, that's the bit of wording that LiarBO the stock basher keeps missing out, and then proclaiming what the ASA says.

As you can see, there is no mention in the CAP code of having to pass a double blinded, placebo controlled trial for a medical device. A simple, adequately controlled human trial is sufficient, and Eroxon has been through two of those, and a Home Use Test, and passed with flying colours.

So everyone can see (again) that LiarBO is lying and manipulating the information in order to bash the stock.

[lbo] 17/5/2023 19:00

No ‘thicko’. Nobody said anything as its not a conversation! LOL A linked article stated that and I quoted the linked article in my post. But the irony of the multi-ID ramper posting on a public bulletin board that Flexiseq gel is a ˜Russian scam’ backed by a ‘Russian gangster’. Again this is what Petroc actually posted! Which by that definition also means Eroxon is a English AIM market scam!? LOL

Look how money has been lost trying to market that drug free gel that is rubbed in for another indication pain also known to respond to placebos! Why did Liberum Futura could

And look at how much it cost just to do a poster presentation at ESSM for Eroxon and the increase in administrative costs and fees just to even get Eroxon on the market!

‘Administrative costs were GBP2.74 million for the period ended 31 December 2022 compared to GBP2.09 million for the period ended 31 December 2021. This is an increase on the prior year and partly driven by higher costs associated with supporting commercial partners’ ‘In addition, there were some one-off costs incurred relating to fees associated with negotiating and concluding commercial arrangements for MED3000.



Eroxon - €7,920




Flexiseq was 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.

[petroc] 17/5/2023 18:44

LiarBO said 'In 2017, PBB was on the verge of bankruptcy, because it could not pay interest on the loan of 15 million pounds, taken in 2015 by the Canadian Knight Therapeutics.

I wonder why!'

I've told you why many times over, LiarBO. Flexiseq is a Russian scam, taken over by a government gangster, who gave the transportation rights to his brother, and then made a series of loans from various places. Laundering money could hardly be more obvious.

Only a lying stock basher like you would try to compare Eroxon to Flexiseq.

[lbo] 17/5/2023 18:22

Again Petroc proven to be making false and misleading claims yet again! I said ‘ profits’!

‘first meaningful revenues’ is not same as saying first meaningful profits!

So whats ‘meaningful’ and who defines it? ‘Directors belief’? He didn’t say millions!? He didn’t even say significant? So whats the actual revenue forecast as its seems not even the house broker Liberum will even give a rough guesstimate! I wonder why? Will it even be enough to cover all the Directors salaries, bonuses and share options? And what about the possible consumer lawsuits? Is that why the FD referenced in the recent results the fine print that‘ milestone payments and royalties are not recognised in full until it is highly probable that a significant reversal in the amount of cumulative revenue recognised will not occur’?

And note he clearly said ‘first’ and clearly not continuing, regular or repeat meaningful revenues! LOL

JoeStalin - 22 Jan 2018 - 11:16:41 - 3640 of 17304

Only a clown thinks selling a few packs at all makes for a business.




2013


Chemist shops sold out of new treatment three times since product came out in June flying off pharmacy shelves at the rate of 15,000 tubes a week



Flexiseq, an innovative topical pain product that has sales of more than 3 million units since its U.K. launch last year.



In 2017, PBB was on the verge of bankruptcy, because it could not pay interest on the loan of 15 million pounds, taken in 2015 by the Canadian Knight Therapeutics.

I wonder why! Liberum mentioned ‘other potential sources of income’ So that sounds like a convertible loan type transaction to keep the gravy train on the tracks a little longer!? Perhaps based on the De Novo medical device registration and similar to the Co-High transaction in China? Although that deal didn’t turn out great as Atlantis dumped those cheap shares they got converting their loan and never made any progress on advancing Med3000/Eroxon in China!



REGENCY VIEW:

The launch of Eroxon is a pivotal moment, but before investors get too excited its important to keep in mind Futuras flaccid financials:

Futura has been burning through cash for several years and has a relatively small ‘cash runway’ based on its current free cash flow.

Whilst cashflow should significantly improve as Eroxon is rolled out, investors are likely to be diluted when Futura inevitably recapitalise.

[petroc] 17/5/2023 18:11

Yet more lies from LiarBO. 'ROFLMAO!

Not even the paid for house brokers are forecasting any profits for the foreseeable!'

James Barder announced last month:

'We continue to focus on achieving US regulatory approval in the near term and progressing commercial discussions. We look forward to updating shareholders during 2023 as well as reporting first meaningful revenues at our interims in September 2023.'