ADVFN Logo

We could not find any results for:
Make sure your spelling is correct or try broadening your search.

Trending Now

Toplists

It looks like you aren't logged in.
Click the button below to log in and view your recent history.

Hot Features

Registration Strip Icon for charts Register for streaming realtime charts, analysis tools, and prices.

FUM Futura Medical Plc

39.40
0.60 (1.55%)
Last Updated: 10:12:45
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Futura Medical Plc LSE:FUM London Ordinary Share GB0033278473 ORD 0.2P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.60 1.55% 39.40 39.00 39.80 39.60 39.40 39.60 69,813 10:12:45
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
Pharmaceutical Preparations 0 -5.85M -0.0194 -20.31 118.48M
Futura Medical Plc is listed in the Pharmaceutical Preparations sector of the London Stock Exchange with ticker FUM. The last closing price for Futura Medical was 38.80p. Over the last year, Futura Medical shares have traded in a share price range of 24.10p to 67.00p.

Futura Medical currently has 300,712,293 shares in issue. The market capitalisation of Futura Medical is £118.48 million. Futura Medical has a price to earnings ratio (PE ratio) of -20.31.

Futura Medical Share Discussion Threads

Showing 17426 to 17439 of 21225 messages
Chat Pages: Latest  705  704  703  702  701  700  699  698  697  696  695  694  Older
DateSubjectAuthorDiscuss
12/3/2023
13:09
Still waiting for any response on where is the
‘lying and scamming’ that the FTC has jurisdiction over substantivation claims of all low class medical devices. Including Med3000/ Eroxon? Even if it does manage to get FDA registration just as De novo Medical device! Or how its ‘lying and scamming’ that the basis of all the substantiation rulings are consistent regarding adequately controlled and blinded non deficient studies being required to substantiate implied claims of any effect beyond a placebo or even just an arousal gel made of the same alcohol, water, glycol and carbomer ingredients as Med3000/Eroxon.



In terms of advertising and promotion, for most over-the-counter medical devices, the FDA and FTC exercise joint regulatory authority over product labelling and advertising. The FDA has primary jurisdiction over labelling for all medical devices and advertising for restricted devices (typically Class III), while FTC has primary jurisdiction over advertising of unrestricted medical devices (Class I and most Class II devices). The FDCA prohibits the distribution or receipt in interstate commerce of a misbranded medical device, which includes a device bearing false or misleading labelling. Claims in device labelling, including product websites, that are outside the scope of the device cleared uses can misbrand, and even adulterate the device, another prohibited act under the FDCA

lbo
12/3/2023
12:24
The HCP website that was provided by Petroc also contradicts his claims and says ‘when assessed against internationally accepted criteria for clinical effectiveness (Rosen and Araujo) the efficacy of Eroxon exceeded the minimal clinically important difference’ And the HCP Brochure on the same website references the study ‘Minimal clinically Important Difference Rosen et al 2011’

But its clear in that study that the MCID criteria were estimated based on regular adequately controlled and blinded and only oral ED studies.

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

So they are not internationally accepted criteria for ‘non pharmacologi studies’ like medical device gel studies like FM71 which are totally uncontrolled and prone to bias and known to have much higher placebo effect then oral pharmacologic placebos. In one study it was 3 times higher placebo effects.

So now its been shown the MCID is inappropriately being used in HCP marketing 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.

lbo
12/3/2023
12:03
The multi-ID stock basher (aka LiamBooth, Leveraged, Citygirl, sbgae, LBO8 et al) is making contradictory claims to the results found in two clinical tests and a home use trial. The vast majority of users confirmed that Eroxon works. LiarBO can't show a single piece of evidence that shows otherwise, which is why he has to use spurious and unrelated links in an attempt to tar Eroxon.
petroc
12/3/2023
12:02
Nobody is asking the multi-ID stockbasher to show any evidence that Eroxon doesn't work. It would be a pointless exercise because there isn't any, and also because the multi-ID stock basher would only lie and mislead. And yet there are increasing amounts of evidence that show that Eroxon works. Two clinical trials and a home use test, and 100% of testimonials on the Farmaline website, all saying the same thing. Eroxon works.
petroc
12/3/2023
11:34
14 minutes to respond - he must have been asleep.
joestalin
12/3/2023
10:33
And that HCP UK website you yourself linked confirms the ASA rulings on substantiation applied to Med3000 FM57 shows the 'surprising results' are a 'post hoc' 'false positive' findinghttps://hcp.eroxon.co.uk/FrequentlyAskedQuestionsEroxon was the placebo used in FM57'So now public complaints can be made about Med3000/Eroxon to the ASA. Thanks to Petroc. And the application of the same principles of the ASA ruling on another similar drug free Class 2b medical device gel to Med3000/Eroxon. Can now mean the ASA can also find similarly that the results of FM57 are a 'post hoc finding' and 'false positive'https://www.asa.org.uk/rulings/pro-bono-bio-entrepreneur-ltd-a17-400871.htmlMed3000 was just the placebo in the FM57 studyTherefore 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 'false positive' 'post-hoc finding'The CAP Code required that objective claims, including medical claims for a CE-marked medical device, be backed by evidencea 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 Directivehad 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 efficacyits reported effectiveness by the advertiser was a post-hoc finding due to the risk of that being a false positive finding
lbo
12/3/2023
10:12
Thank you for showing everyone yet again what an idiot you are, LiarBO. You can't even string a couple of sentences together, and yet here you are trying to convince everyone that you're the world's leading expert on all things medical!

ROFLMAO indeed.

petroc
11/3/2023
19:46
'Still waiting for a response on where is the
‘ying and scamming’ that the FTC has jurisdiction over substantivation claims of all low class medical devices.'

Well, if I could understand the question, perhaps I could respond accordingly.

In the meantime, nobody is asking the multi-ID stockbasher to show any evidence that Eroxon doesn't work. It would be a pointless exercise because there isn't any, and also because the multi-ID stock basher would only lie and mislead. And yet there are increasing amounts of evidence that show that Eroxon works. Two clinical trials and a home use test, and 100% of testimonials on the Farmaline website, all saying the same thing. Eroxon works.

petroc
11/3/2023
18:42
The HCP website that was provided by Petroc also says ‘when assessed against internationally accepted criteria for clinical effectiveness (Rosen and Araujo) the efficacy of Eroxon exceeded the minimal clinically important difference’ And the HCP Brochure on the same website references the study ‘Minimal clinically Important Difference Rosen et al 2011’

But its now clear from that exact study that the MCID criteria were estimated based on regular adequately controlled and blinded oral ED studies.

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

So they are not internationally accepted criteria for ‘non pharmacologi studies’or medical device gel tests which prone to bias and are known to have much higher placebo effect then oral pharmacologic placebos. In one study it was 3 times higher.

So now its been shown the MCID is inappropriately being used in HCP marketing 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.

lbo
11/3/2023
18:39
Petroc himself has provided the evidence that there was ‘no placebo controlled studies’ for Med3000/Eroxon to substantiate any effect beyond a placebo!

petroc - 23 Feb 2023 - 21:53:12 - 16545 of 16566

Why are there no placebo controlled studies?


So as the relevant and applicable ASA rulings have said â’There was no statistically significant difference between the outcomes for the treatment group’ patients using the eroxon gel device) and the control group (using an inactive sham device) eg arousal gel. As the website Petroc linked admitted there was ‘no placebo controlled studies’

˜The study was accordingly not adequate evidence of the efficacy’




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

lbo
11/3/2023
18:36
Still waiting for a response on where is the
‘lying and scamming’ that the FTC has jurisdiction over substantivation claims of all low class medical devices. Including Med3000/ Eroxon if/when it does manage to get FDA registration as De novo Medical device. Or that the basis of all the substantiation rulings is consistent regarding adequately controlled and blinded non deficient studies to substantiate implied claims of any effect beyond a placebo or even just an arousal gel made of the same alcohol, water, glycol and carbomer ingredients as Med3000/Eroxon.



In terms of advertising and promotion, for most over-the-counter medical devices, the FDA and FTC exercise joint regulatory authority over product labelling and advertising. The FDA has primary jurisdiction over labelling for all medical devices and advertising for restricted devices (typically Class III), while FTC has primary jurisdiction over advertising of unrestricted medical devices (Class I and most Class II devices). The FDCA prohibits the distribution or receipt in interstate commerce of a misbranded medical device, which includes a device bearing false or misleading labelling. Claims in device labelling, including product websites, that are outside the scope of the device cleared uses can misbrand, and even adulterate the device, another prohibited act under the FDCA

lbo
11/3/2023
16:43
The multi-ID stock basher (aka LiamBooth, Leveraged, Citygirl, sbgae, LBO8 et al) is making contradictory claims to the results found in two clinical tests and a home use trial. The vast majority of users confirmed that Eroxon works. LiarBO can't show a single piece of evidence that shows otherwise, which is why he has to use spurious and unrelated links in an attempt to tar Eroxon.
petroc
11/3/2023
11:21
Nobody is asking the multi-ID stockbasher to show any evidence that Eroxon doesn't work. It would be a pointless exercise because there isn't any, and also because the multi-ID stock basher would only lie and mislead. And yet there are increasing amounts of evidence that show that Eroxon works. Two clinical trials and a home use test, and 100% of testimonials on the Farmaline website, all saying the same thing. Eroxon works.
petroc
11/3/2023
10:38
So 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. It cannot even substantiate that is having any effect beyond what a standard cooling lubricant or arousal gel would if the user is just led to believe its 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 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 don’t 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 doesn’t 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.

lbo
Chat Pages: Latest  705  704  703  702  701  700  699  698  697  696  695  694  Older

Your Recent History

Delayed Upgrade Clock