Futura Medical Share Discussion Threads

[lbo] 01/3/2023 16:09

'Eroxon, was the placebo used in FM57'Thanks for admitting that FM57 was not designed to study the placebo. It was designed to study Med2005 so the 'surprising results' are again post-hoc findings. And its also been shown that the efficacy of medical devices especially gels that are rubbed in are higher then 'normal' oral placebos. Its also been shown that FM57 was not a normal ED study as it had non normal inclusion criteria used in the normal ED studies that only had normal oral placebos. And the comparison to' accepted criteria for clinical effectiveness (Rosen and Araujo) the efficacy of Eroxon exceeded the minimal clinically important differences' only applies to normal ED studies with normal oral placebos. So the comparison is another misleading claik by the rampers.

[petroc] 01/3/2023 15:56

hxxps://hcp.eroxon.co.uk/

[petroc] 01/3/2023 15:55

Why are there no placebo controlled studies?

Eroxon, was the placebo used in FM57 and gave surprising results having efficacy approximately double that normally achieved in ED studies with regular placebos. Moreover, when assessed against internationally accepted criteria for clinical effectiveness (Rosen and Araujo) the efficacy of Eroxon exceeded the minimal clinically important differences.

[lbo] 01/3/2023 14:41

So the supposedly ’surprising results’ of FM57 are actually just a post hoc finding



What happened next gets to the FTC’s 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 “a statistical analysis conducted after the data have been collected in hopes of discovering statistical relationships that suggest cause and effect.”) The FTC’s concern is that unplanned, post hoc subgroup analyses pose a high risk of generating spurious findings.


And FM71 was uncontrolled and unblinded



study is “unlikely to yield reliable results, and generally won’t meet the FTC’s competent and reliable scientific evidence standard” unless it utilizes a control group, randomization, and double-blinding, and unless it returns results that are both statistically significant and clinically meaningful.

[lbo] 01/3/2023 14:31

The CAP Code required that objective claims, including medical claims for a CE-marked medical device, be backed by evidence, if relevant, consisting of trials conducted on people. Flexiseq was a certified Class IIb medical device (same as Med300/Eroxon) 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.

Therefore same substantiated principles will apply to MED3000/Eroxon

understood that Med3000/Eroxon had been used as the placebo treatment in that FM57 study, and therefore the researcher had initially believed Med3000/Eroxon had no therapeutic effect. The FM57 trial did not set out to measure the efficacy of Med3000/Eroxon.

therefore, considered that its reported effectiveness by the advertiser was a post-hoc finding

concerned that there was not an adequate placebo control for med3000/Eroxon in the FM71 trial. We, therefore, considered that the study did not provide adequate evidence for the claim “clinically proven

[petroc] 01/3/2023 14:12

LiarBO said 'Ah yes the old stick the head in the sand mentality rather then face the reality!'

The trouble is, LiarBO wouldn't recognise reality if it came up to him and punched him in the face.

I didn't know the LBO8 ID before, because I don't use twitter or telegram, but I'll add it to the long list of multi-IDs that LiarBO uses.

[lbo] 01/3/2023 12:46

Ah yes the old stick the head in the sand mentality rather then face the reality! A tried and tested evidence based investment strategy which promises great outcomes!

How many platforms are you ramping Futura on? Not as easy it seems to mute all the multi-ID rampers who are ramping across multiple platforms! LOL


Even Trinity Research who are paid by Futura has contradicted the rampers and had to openly admit the hypothesised effects ‘believes’ to be happening by Futura are ‘disputed’



˜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’




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.


Trinity also admitted no mechanism of action has to be even shown to just get a low class medical device registered.

But it does need to be shown and proven to substantiate its marketing claims of having any effect beyond a placebo or even arousal gel with the same alcohol, water, glycol and carbomer ingredients or fall foul of the FTC, ASA and the Courts.


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 a medical device’

[albert arthur] 01/3/2023 12:42

LBO, you win the award for being the first user I've had to mute in this platform... I'll be reviewing price here weekly...

[lbo] 01/3/2023 12:40

Mike and Joe can testify to that ( albeit they may be hostile multi-ID ramper witnesses at the moment) ROFLMAOJoeStalin - 30 Sep 2019 - 10:07:37 - 5937 of 10774FUTURA a winner for 2015 - says it all!JoeStalin - 18 Jul 2018 - 09:00:46 - 4354 of 10775'jam tomorrow' is a very easy promise to make.JoeStalin - 22 Jun 2018 - 14:12:24 - 4288 of 10775What's another year after all?At FUM, time is measured in decades.JoeStalin - 25 Apr 2018 - 16:07:34 - 4147 of 10775There seems to be an unlimited number of ways of saying "Jam tomorrow".JoeStalin - 21 Mar 2018 - 13:50:44 - 3985 of 10775A lifestyle company, but not for the shareholders.mikethebike4 - 11 Apr 2018 - 14:35:10 - 4072 of 11141Having had similar waffling, 'smoke-screen' answers from Mr Barder over the years which have turned out to end in exactly nothing I am loathe to give any credence to virtually everything he saysmikethebike4 - 11 Apr 2018 - 15:58:28 - 4091 of 11141Company is massively over valued if you go by 'concrete' results !mikethebike4 - 11 Apr 2018 - 15:14:56 - 4082 of 11141I only try and bring some sort of balance into the equation to help the gullible not get carried away with fanciful future projections.I would like nothing better than to be proved wrong about Mr Barder (our CEO since 2001) and to sale away into the sunset grasping 5 times as many £s in my fist as I paid for the sharesUnfortunately for people like J7J, Mr Barder has been through this advisors process before - with CSD500 - and look where we've got in 17 years - sales of the product did not even equal the money we paid him to be our CEO for 2017 !mikethebike4 - 06 Dec 2017 - 10:32:27 - 3468 of 10591"A couple of decent deals and will be back off to the races."Do you have any idea of how long shareholders have been using these wordsmikethebike4 - 23 Mar 2017 - 09:52:33 - 2560 of 10591As someone who has been invested for many years and who attended an AGM years ago and complained to Barder about the very slow progress, I am very frustrated.All the time the Board are drawing good salaries off the backs of shareholders money they have very little incentive to get off their backsides and get 'selling' - thats what running a company is all about at the end of the day!mikethebike4 - 24 Feb 2020 - 09:11:58 - 7290 of 9713why should it be any different this time when you've still got the same useless lot running the showmikethebike4 - 07 Jan 2019 - 11:22:52 - 4692 of 9641I repeat I very much hope you are right - no one would be happier than me if you are - however I stupidly (in hindsight) bought in when everything looked really rosy - we were told there were loads of 'distributors' all 'champing at the bit to get selling a wonderful industry disruptive product (which it still is incidentally) once the 2 year shelf-life problem was fixed. This was despite the fact that the Holland/Belgium distributor was quite happy and successful selling them with the original 18 months shelf-lifeAnd where are we now years later - one tiny distributor from which Futura receives a total sales income only just about covering Mr Barders employment remunerationI just hope this MED/TPR situation is not just a repeat of CSD. As to why I don't just sell up, well my shareholding is worth such a tiny proportion of what I paid for it I might just as well hang on in the hope that new shareholders getting in now are luckier than I was and I can get some of my money back - I think what we need is Mr Barders retirement - that should give the share price a kick

[lbo] 01/3/2023 12:36

But I agree. If you just listen to Futura announcements and the ‘directors believe’ everything does indeed sound very ‘simple’

Its nearly a wonder how all the previous products like PET500, TPR100, CSD500 were repeatedly delayed and then ultimately failed and the company still has zero revenues!



Over 50% of De novo applications are denied and some are placed on hold requiring further information. Which then resets the days back to day 1 if and when that information is even able to be submitted.

Like for example further evidence trom an adequately controlled sham gel study or even against just a standard cooling lubricant or blinded study versus an arousal gel


More than 60 De Novo submissions are submitted each year, but the number of De Novo Classification Requests granted ranged between 21 and 30 over the past three years. Therefore, the 50%+ of De Novo applications denied

could skew the % of De Novo that meets the MDUFA goal. There are two problems with this goal. First, the term ‘FDA Days’ is based on calendar days minus the number of days the submission was placed on hold, and we dont have any visibility into the number of days submissions are placed on hold. In the past, submissions could be placed on hold multiple times during the Refusal to Accept (RTA) screening process, and the FDA Days is reset to zero days each time the company receives an RTA hold letter. In addition, even after the submission is finally accepted, the FDA places the submission on hold when they request additional information (i.e., AI Hold). RTA and AI Hold periods can last up to 180 days, and during the Covid-19 pandemic, companies were allowed to extend this up to 360 days. How long does it take FDA to review De Novo submissions? FDA days are not the same as calendar days.

Only 23.8% of De Novo submissions were reviewed within 150 calendar days.

The FDA doesnt calculate the number of FDA days as calendar days, but there is no way to know how much time each De Novo spent on hold publicly.

[freddievas] 01/3/2023 12:22

Thanks AA. Good to have an adult on this thread.

[albert arthur] 01/3/2023 12:19

Talk here can be left simple. The timeline for the approval is end of Q1 2023 all the FDA want to know 1) Is it harmful?No 2) does it work?Yes!!! I have top Fibonacci target is have as a short term trade is circa £1.80p. See related RNS text with dates and FDA commentary.The FDA has now confirmed that the dossier is under formal review and has indicated that the dossier has successfully passed the initial technical screening. Based on the FDA's published target review period guidelines, granting of marketing authorisation remains on track to be achieved by the end of Q1 2023, in line with previously announced timelines.https://www.londonstockexchange.com/news-article/FUM/futura-medical-announce-milestone-year-for-med3000/15754917* FDA agreed co-primary endpoints met at 24 weeks, demonstrating a statistically significant improvement in erectile function compared to baseline, as well as achieving a clinically important improvement in erectile function at 24 weeks* Secondary endpoint met demonstrating a 10-minute onset of action, which was demonstrably faster than the well-known prescription oral medication used in the study* Exploratory endpoints demonstrated MED3000 achieved clinically important improvements in erectile function at all time points and was clinically effective in mild, moderate and severe ED sufferers* Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients on MED3000 and overall, with a highly favourable side-effect profile* MED3000 presents an effective clinically proven treatment for erectile dysfunction ("ED") with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for Over the Counter ("OTC") classification1* Futura on track to file dossier with the US FDA by the end of September, targeting marketing authorisation by the FDA of MED3000 in Q1 2023 as the first major ED treatment available OTC throughout the USAhttps://investegate.co.uk//futura-medical-plc--fum-/rns/highly-positive-fm71-phase-3-study-results/202208310700046658X/

[albert arthur] 01/3/2023 12:04

No not the bot (the bot is part of the app), but in the app I'm going to launch very soon, tracks pending FDA stocks 1 month out of approval.... This one flagged last night. Hence me being here today.

[lbo] 01/3/2023 12:02

‘True fact’! Albert is connected to other multi-ID rampers and has been publicising (some say ramping) Futura on Telegram message groups, podcasts and websites for years after he admits to “ buy” in and then promote what he already owns and “think will go up”


Albert Arthur8 Dec '21 - 10:48 - 10123 of 16732

That’s my bot… Tweeting for me.

LBO8 Dec '21 - 10:51 - 10124 of 16732

And has your bot also been touting Futura on certain podcasts, websites and on Telegram messaging groups?

Albert Arthur8 Dec '21 - 11:16 - 10125 of 16732

Bot streams to Twitter and Telegram



‘True Fact’! Sounds very familiar!?



But they did not disclose to their followers while promoting those stocks that they planned to sell shares once prices or trading volumes rose, the DOJ and SEC alleged. The influencers gained a profit by pumping the stock prices and then selling once they rose

[broomrigg] 01/3/2023 10:45

Well said re. FDA Albert A.....just so you know, most of us have the LBO nutjob filtered, he is irrelevant with his cut 'n paste nonsense, bitter at selling out sub 10p around 5 years ago. Before that he spent around 15 years ramping FUM. He is a 1st class nut.

FUM on the constant gainers board again today, 3rd consecutive day of gains......



:-)

[albert arthur] 01/3/2023 10:32

True fact 1) FDA should come this month, described in multiple RNS, safety and efficacy endpoints passed. True fact 2) it's appears LBO has spent 40% of his life the last 4 years, talking down and Erectile Dysfunction share.

[lbo] 01/3/2023 09:12

Or the De Novo medical device registration could be put on hold. Here is another false and misleading claim being made by one of the multi-ID rampers. Could well be a reason to place the medical device application on hold and request further information and a new long term safety study pre-medical device registration to substantiate this claim as its contrary what is being claimed by Futura Medical.


petroc - 25 Feb 2023 - 16:58:49 - 16592 of 16693

3. No contraindication with other treatments.




If you have a medical condition you may need to speak to a doctor to discuss your condition to see if the product is suitable for you to use.

We have not conducted studies on MED3000 in combination with PDE5is and it is not included on our proposed label. It is likely that a post-approval study will be needed to demonstrate synergy.


And the issue still remains that even if the MED3000 De novo medical device application is not denied or put on hold requesting further information.

The Med3000 gel still cannot substantiate any effect beyond a placebo with any adequately controlled study to the FTC or ASA who will have jurisdiction over any false or misleading claims. It cannot even be substantiated that it is having any effect beyond what a standard cooling lubricant or arousal gel would if the user is just led to believe they too are a real treatment for their ED.



Over 50% of De novo applications are denied and some are placed on hold requiring further information. Which then resets the days back to day 1 if and when that information is even able to be submitted.

Like for example further evidence trom an adequately controlled sham gel study or even against just a standard cooling lubricant or blinded study versus an arousal gel


More than 60 De Novo submissions are submitted each year, but the number of De Novo Classification Requests granted ranged between 21 and 30 over the past three years. Therefore, the 50%+ of De Novo applications denied

could skew the % of De Novo that meets the MDUFA goal. There are two problems with this goal. First, the term ‘FDA Days’ is based on calendar days minus the number of days the submission was placed on hold, and we dont have any visibility into the number of days submissions are placed on hold. In the past, submissions could be placed on hold multiple times during the Refusal to Accept (RTA) screening process, and the FDA Days is reset to zero days each time the company receives an RTA hold letter. In addition, even after the submission is finally accepted, the FDA places the submission on hold when they request additional information (i.e., AI Hold). RTA and AI Hold periods can last up to 180 days, and during the Covid-19 pandemic, companies were allowed to extend this up to 360 days. How long does it take FDA to review De Novo submissions? FDA days are not the same as calendar days.

Only 23.8% of De Novo submissions were reviewed within 150 calendar days.

The FDA doesnt calculate the number of FDA days as calendar days, but there is no way to know how much time each De Novo spent on hold publicly.

[albert arthur] 01/3/2023 08:11

FDA due this month.