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FUM Futura Medical Plc

40.00
1.20 (3.09%)
Last Updated: 14:58:20
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
  1.20 3.09% 40.00 39.30 40.00 40.00 39.00 39.60 217,788 14:58:20
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
Pharmaceutical Preparations 0 -5.85M -0.0194 -20.10 117.28M
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 £117.28 million. Futura Medical has a price to earnings ratio (PE ratio) of -20.10.

Futura Medical Share Discussion Threads

Showing 13476 to 13491 of 21225 messages
Chat Pages: Latest  549  548  547  546  545  544  543  542  541  540  539  538  Older
DateSubjectAuthorDiscuss
02/9/2022
13:40
Persistent buying now.....looking good for another spike up
broomrigg
02/9/2022
13:40
Med3000 still cannot substantiate any claims of any proven effect beyond a placebo/sham effect to the FTC, ASA or Courts. As FM71 and FM57 were not adequately placebo/sham control studies according to the ASA and FTC assessments and rulings on medical devices.



In each of the six cases filed, FTC alleged that the companies not only lacked scientific substantiation for their claims regarding the health benefits of their CBD/CBG products, but also falsely represented that their claims were either scientifically proven or had been confirmed by the U.S. government.

Under the proposed orders settling FTC complaints in each of these cases, the companies and their owners are prohibited from making prevention, treatment, or safety claims similar to the ones the companies made about their products about any dietary supplements, foods, and drugs unless they have the human clinical testing to substantiate such claims, and are required to have competent and reliable scientific evidence for any other health-related product claims. Specifically, the testing must be: (1) randomized, double-blind, and placebo-controlled

lbo
02/9/2022
13:31
LiarBO just posted this: '...higher standard of ‘substantial evidence’ for drugs, which require studies with comparison groups that didn’t t receive the same treatment.' Which of course is exactly what happened in P3 when MED3000 was up against MED2005 with GTN. Although Dermasys was being used as the placebo in that trial, it was found to be just as good as MED2005 in treating ED, and soon became MED3000. So MED3000 definitely comes under that definition, having been tested with a comparison group receiving different treatment. But as LiarBO pointed out, as a device MED doesn't need to have been tested against a placebo, but it's good to know that it has been proven to work in a clinical setting.
petroc
02/9/2022
13:03
Long standing shareholders learned from Futura what clauses have been in previous deals that favour their partners just to get the deals signed and announced. But allows the partners to never have to launch or if they do launch never have to pay any real royalties. And even just hand back the rights with no real penalties after sitting on the rights and running down any patents eg Reckitt and CSD500https://futuramedical.com/media/2187/admission_doc.pdfa agreed percentage of the net sales value (after transport costs, sales tax, credit notes for returns and defective products and any settlement, retrospective, volume and promotional discounts) charged by LRC or any sub-licensee in relation to the Product.The royalty and the royalty advance may be reduced by such amount (if any) as is agreed or determined by an expert to be fair and reasonable if: (i) any patent application does not proceed to grant or any patent rights are determined to be unenforceable or are revoked or lapse; or (ii) an event occurs which in LRC reasonable opinion adversely affects the commercial viability of the licence agreement or the margins on sales of the Product; or (iii) a competing product is offered for
lbo
02/9/2022
13:00
Any update on an enforceable patent? LOL



‘The Company has conducted initial literature and in vitro based research that has shown the cooling from the evaporation of these specific combinations of solvents’



There is a risk that some claims will either be challenged in future (eg on the grounds of non-obviousness or existence of prior art) and/or that another technology may be employed to achieve a similar effect. The protracted development times mean the clock has been ticking on the original issued patents, reducing the protected commercial products




A smooth gel intended for alcohol soluble actives. Provides cooling effect upon application while leaving minimal residue




The cooling effect of a topically applied product can be evaluated using a validated handheld thermal imaging system. When the gel matrix is destroyed after application to the skin, the bound water and alcohol evaporates and a measurable cooling-effect results.

lbo
02/9/2022
12:50
Hence this from Liberum


We have unwound our risk adjustment to 95% driving an 11% upgrade in our target price to 121p.





121p v current share price 42p


+188% and that is super conservative as Eroxon will fly off the shelves

j777j
02/9/2022
12:27
Laughable lbo is still at it



Its going on sale soon in the EU and UK


Then the USA



It has passed all the requirements set out by the FDA to be sold OTC



See you in the £££'sss per share

j777j
02/9/2022
11:28
Could everyone please stop messaging LBO? When I read there's an advfn message I think it's important and log in to find these silly messages. A real bore!
dontshoutatonce
02/9/2022
10:42
Devices are subject to weaker standards than drugs because they’re regulated under a different law. The Medical Device Amendments of 1976 was intended to encourage innovation while allowing for a range of review standards based on risk, according to legal expert Richard A. Merrill. An array of corporate lobbying has since prompted Congress to ease regulations and make it easier for devices to get the FDA OK (here’s s one 2015 example).

Journalists need to scrutinize the claims
Journalists have a responsibility to report this lack of evidence, but they often don’t. Investigative journalist Jeanne Lenzer, who wrote a book about the under-regulated medical device industry, says more dogged reporting is needed: We really don’t t know what we’re re getting with many of these devices

Ninety-nine percent of devices never have to provide clinical data, thanks in part to the 2002 Medical Devices User Fee Act, which requires the FDA to use the ‘least burdensome route’ to approval.

For the few devices subject to a scientific review, the quality standards are flimsy. Randomized controlled trials–the gold standard–are infrequent. Most studies are unblinded, and thus prone to bias. The FDA settles for loosely defined “reasonable assuranceâ€? that a device is safe and effective, versus its higher standard of ‘substantial evidence’ for drugs, which require studies with comparison groups that didn’t t receive the same treatment. Thus, data that would never be sufficient to support the approval of a drug can result in the approval of a device used to treat the same condition, potentially diverting patients from effective drugs to less-effective devices,

lbo
02/9/2022
10:36
The following are a few of the common issues companies must resolve when determining whether the appropriate substantiation exists for their claims.

One important caveat to keep in mind is that, if an advertiser expressly states or implicitly suggests a certain level of scientific evidence exists, it must have at least that level of evidence. So, statements like ‘clinically proven" or “scientifically shown" require at least one or more clinical trials to support the claim. Additionally, an advertiser should not suggest a clinical trial has been conducted on the product if the study relied upon was conducted on a single ingredient or on another product.

the “gold standard" is a well-designed, double-blinded, placebo-controlled clinical trial appropriately conducted on the actual product. FTC has often required this standard in consent decrees, requiring two such studies for future claims made by companies governed by such decrees.





Any future prevention, treatment, or safety claims about dietary supplements, foods, and drugs, however, must be supported by competent and reliable evidence, defined as randomized, double-blind, placebo-controlled human clinical trials to support the claims.

lbo
02/9/2022
10:33
A class 2 CE Marked Medical Decice and a De Novo medical device registration still does not substantiate its ‘proven’ to have any effect beyond a placebo as there was no adequately controlled study.



Issue

Two complainants challenged whether the claims ‘clinically proven’ were misleading and could be substantiated.



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. We understood that the Aerosure Medic was classified as Class I medical device. Class I medical devices were generally CE-marked on a self-declaration basis. 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 of the device.

lbo
02/9/2022
09:36
If using an arousal gel is all the placebo that is needed for some men with Psychological ED. Then yes it may have less side effects. In FM71 only headaches and non cardiac chest pain were reported with Tadalafil. But MED3000 users also reported headaches and penile burning!And even in an unblinded, uncontrolled, parallel study still 'tadalafil showed a greater improvement in erectile function than MED3000'Then as was shown in the consumer HUT . In the real world men are unable to know if there is more serious underlying cause for their ED then just Psychological. Which is why treating ED OTC with a placebo gel is inappropriate especially if its based on deception
lbo
01/9/2022
14:20
https://pubmed.ncbi.nlm.nih.gov/19758285/the placebo effect in RCT of iPDE5 for ED occurs at a rate as high as 50%https://s4be.cochrane.org/blog/2014/10/13/richards-reviews-sham-devices-placebos/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.
lbo
01/9/2022
13:08
Yes all placebos have placebo effects. Not sure if anyone can patent a placebo effect or claim that one medical device placebo gel is any better then the next medical device placebo gel! ROFLMAO

‘The placebo response seems largely more important when the cause of [erectile dysfunction] is mainly due to psychogenic factors’




This placebo effect was most pronounced in men with post-traumatic stress disorder (PTSD), suggesting that for some men psychology is more important than physiology in dealing with erectile dysfunction, said lead researcher Alexander Stridh of the Karolinska Institute's department of clinical neuroscience, in Stockholm.
"The placebo response seems largely more important when the cause of [erectile dysfunction] is mainly due to psychogenic factors, as in post-traumatic stress disorder," Stridh said.
For this analysis, his team pooled data from 63 studies involving more than 12,500 men.
The studies showed that Viagra and its relatives had a strong effect helping men who had erectile dysfunction due to chronic illness.
"The studies included in this meta-analysis mainly were trials on men with [erectile dysfunction] due to cardiovascular disease, diabetes, etc.," Stridh said. "It is likely that there is a limit to how much the brain can influence erectile function when the problem is mainly dysfunctions in blood vessels or peripheral nerves."
But the researchers found that men in the placebo arm of these trials also experienced a small to moderate improvement of their erectile function. The placebo effect was notably stronger among men with PTSD.
"This paper highlights the importance of taking into account the underlying cause of [erectile dysfunction] in each individual, which could also help determine what the best treatment option would be," Stridh said. Some men might benefit more from psychotherapy, others with a pharmaceutical approach, he added.

lbo
01/9/2022
13:05
MED3000 has never been shown to have any effect beyond a placebo in any adequately controlled study. 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, but in trials of other placebos for various disorders, the effect of placebo over no treatment is often very small.
lbo
01/9/2022
11:39
The ASA, FTC and Courts will eventually have the last laugh at the 'swindle'Trinity Research even admit the hypothesised effects 'believed' to be happening by Futura are 'disputed' and they admitted no mechanism of action has to be even shown to get a medical device approved. But unfortunately it does to need be proven to substantiate its marketing claims or fall foul of the FTC, ASA and the Courts.https://www.ftc.gov/system/files/documents/public_statements/996984/p114505_otc_homeopathic_drug_enforcement_policy_statement.pdfA 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 devicehttps://www.discovermagazine.com/health/the-erection-of-a-placeboThere 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
lbo
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