Futura Medical Share Discussion Threads

[lbo] 03/5/2023 11:41

‘Journalists need to scrutinize the claims’



Devices are subject to weaker standards than drugs because they are 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

Journalists need to scrutinize the claims.

Journalists have a responsibility to report this lack of evidence, but they often dont. Investigative journalist Jeanne Lenzer, who wrote a book about the under-regulated medical device industry, says more dogged reporting is needed: We really dont know what we are 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

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 assurance that a device is safe and effective, versus its higher standard of substantial evidence for drugs, which require studies with comparison groups that didnt 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

[broomrigg] 03/5/2023 11:38

Thanks for posting that link Beanol....good write-up on which.co.uk

...."If you're looking for an alternative to Viagra and other erectile dysfunction medications, then you have a new, drug-free treatment at your disposal. "

...."A 12-week clinical trial by the brand found that 67% of subjects reported a significant improvement in their ability to achieve and maintain an erection. This rose to 80% of those with severe erectile dysfunction."

...."it's suitable for people who can’t use Viagra"

[beanol] 03/5/2023 11:08

Which review just out. Neutral non judgemental. Does report that 67% of users found it good. FUM appear to be winning the war of perception. My local small Boots sold out of their initial stocks. https://www.which.co.uk/news/article/eroxon-ed-gel-launches-in-uk-aRMxe4n7LOxO

[petroc] 03/5/2023 11:05

Ah yes, must be another blue day! LiarBO's got his fingers in his ears, eyes screwed shut, singing about humpty pumpty again!

BTW, I've saved LiarBO's old avatar of Gordon Gecko in the photos on my profile.

[lbo] 03/5/2023 10:58

And what could go wrong? The wonder placebo gel with no enforceable patent is selling out! LOLhttps://www.irishmirror.ie/lifestyle/health/arthritis-new-treatment-wonder-gel-2218173.amp2013Chemist shops sold out of new treatment three times since product came out in Juneflying off pharmacy shelves at the rate of 15,000 tubes a weekhttps://www.frogheart.ca/?tag=flexiseqFlexiseq, an innovative topical pain product that has sales of more than 3 million units since its U.K. launch last year.https://rusletter.com/articles/anatoly_chubais_spent__311_million_on_a_non-existent_ointmentIn 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.

[lbo] 03/5/2023 10:54

Pumpty dumpty sat on a wall!

But all the multi-ID rampers could’t eventually put pumpty dumpty back together again! LOL



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.



‘Because when somebody is running something that is semi fraudulent. They are probably pretty good at it. And they are working full time at it’



The Berkshire Hathaway CEO went on to say shorting overvalued stocks is also tricky because "people that have overvalued stocks... Are frequently on some scale between promoter and crook. And that's why they get there." He went on to add:

"And they also know how to use that very valuation to bootstrap value into the business, because if you have a stock that's selling at 100 that's worth 10, obviously it's to your interest to go out and issue a whole lot of shares. And if you do that, when you get all through, the value can be 50.

In fact, there's a lot of chain letter-type stock promotions that are sort of based on the implicit assumption that the management will keep doing that.

because if you have a stock that's selling at 100 that's worth 10, obviously it's to your interest to go out and issue a whole lot of shares. And if you do that, when you get all through, the value can be 50.

And if they do it once and build it to 50 by issuing a lot of shares at 100 when it's worth 10, now the value is 50 and people say, "Well, these guys are so good at that. Let's pay 200 for it or 300," and then they could do it again and so on"

According to Buffett, if you get caught up in one of these stock promotion schemes,"you can run out of money before the promoter runs out of ideas."

[petroc] 03/5/2023 10:51

Looks like LiarBO has been frantically deleting stuff, including his old Gordon Gecko avatar. Never mind, LiarBO, I've found it!

[lbo] 03/5/2023 10:48

So the so called ‘ other potential sources of income’ referenced by Liberum needs to be in place before July and they run out of money!

No wonder they all so anxious! If only that FDA De novo medical device registration would come in then they can all pump that and then dump on the news of the ‘other potential sources of income’ at an even more inflated price! Come on placebo gel Gods! Be good to the multi-ID rampers!




‘Therefore, from June 2022 it had roughly 13 months of cash runway’

‘it's fair to say the end of the cash runway is in sight’

[lbo] 03/5/2023 10:41

Oh and don’t forget all the other ‘advisors’ they are making payments to! On top of all the annual salaries, bonuses, expenses and options to management!

Thats why the multi-ID rampers are out in force pumping ahead of the news about where the next lump of money to keep the gravy train from crashing off the tracks is coming from! LOL


‘Dr Hilary Jones, TV GP and an adviser to the Eroxon ED Information Panel (EEDIP)’




Futura does use the services of a number of Key Opinion Leaders (KOLs) on an advisory basis which may result, at times, in financial payments being made’

[lbo] 03/5/2023 10:36

Look at how much it cost just to do a poster presentation at ESSM



Eroxon - 7.920

[broomrigg] 03/5/2023 10:36

100,000 shares just been bought above market. Maybe it was LBO? Don't be silly, the clueless nutjob is stone broke and back living with his mommy the last 5 years lolllllll

[lbo] 03/5/2023 10:34

But how could they need more money screeched’ the multi-ID rampers! The wonder gel is selling out and money is pouring in! Or is it? LOL




Product revenue represents net invoice less estimated volume discounts, which are considered to be variable consideration and include significant estimates. Other variable considerations such as 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. In management’s opinion, that will be when the Groups customer confirms that the milestone has been met or that a royalty is due



a 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

[lbo] 03/5/2023 10:25

The multi-ID ramper also claimed onADVFN it was 'FACTS' Med3000/Eroxon was 'clinically proven'But now Futura has admitted on the HCP website none of the Eroxon studies were adequately placebo controlled!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'https://www.asa.org.uk/rulings/actegy-ltd-g20-1053158-actegy-ltd.htmlAssessmentUpheldThe 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 efficacyhttps://pocketdentistry.com/asa-ruling-on-orthoaccel-technologies-inc-ta-acceledent/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.https://www.asa.org.uk/rulings/actegy-ltd-g20-1053158-actegy-ltd.htmlAssessmentUpheldThe 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] 03/5/2023 10:21

petroc 1 May '23 - 16:08 - 18519 of 18523'Boots are a different matter entirely'The Multi-ID ramper is just proven wrong over and over again!! ROFLMAOhttps://polaris.brighterir.com/public/futura_medical/news/rns/story/xp9z11w/exporthttps://www.boots-uk.com/newsroom/news/boots-launches-brand-new-online-marketplace/https://www.boots-uk.com/suppliers/become-a-boots-marketplace-seller/Launching in Spring 2023, Boots Marketplace will allow brands of any size to seamlessly list their products on boots.comhttps://www.rns-pdf.londonstockexchange.com/rns/3928V_1-2023-4-4.pdfProduct revenue represents net invoice less estimated volume discounts, which are considered to be variable consideration and include significant estimates. Other variable considerations such as 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. In management's opinion, that will be when the Groups customer confirms that the milestone has been met or that a royalty is duehttps://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

[lbo] 03/5/2023 10:19

Yet again the multi-ID ramper cannot substantiate any of his false and misleading claims with any non deficient evidence! Just like all the multi-ID ramper claimed 'FACTS'. Just more and more proven lies. And here Futura are over a year later and still no enforceable patent. Ironic the proven liar said 'soon' and Joe said everything with Futura is measured in 'decades'So where is the enforceable patent over a year later?petroc - 21 Jan 2022 - 18:03:42 - 10541 of 10710What is not to love Eroxon /MED3000 - HERE ARE THE FACTS- Patent application in progress using patent lawyers - COMING SOONSo basically any company or lubricant manufacturer like Reckitt can launch their own placebo arousal Erectile gels made of alcohol, water, glycol and carbomer! Even Pfizer or Boots could launch a similar arousal gel under its already established Viagra type brands and claims like Futura its placebo arousal gel is 'clinically proven' in deficient tests to have an effect in Psychological ED!ROFLMAOhttps://www.jdsupra.com/legalnews/lilly-s-cialis-patent-claims-extending-6978893/'Lillys CIALIS patent claims extending to physiologically acceptable salt found invalid for overbreadth and insufficiency'https://indigo.bluematrix.com/indigo/Viewer.action?info=U7Z%2F%2BSxWYbPQB8QtqH%2Bh5KgushbvU5dK'TPR100 gave similar results to the gold standard, Voltarol 2% gel'https://www.dovepress.com/testing-topical-products-specifically-to-reduce-inflammatory-pain-from-peer-reviewed-fulltext-article-JPRVoltarol Emugel vehicle gel is made of the same ˜evaporative cooling' ingredients as in Eroxon. Its even off patent same as Dermasys is!carbomer,isopropyl alcohol,propylene glycol,waterhttps://www.perrigo.com/press-release/perrigo-announces-store-brand-equivalent-voltarenr-arthritis-pain-available-us-majorPerrigo Company plc today announced that it has launched the store brand equivalent of over-the-counter ("OTC") Voltaren® Arthritis Pain (diclofenac sodium topical gel, 1%) to its retail partners and the product is now available in the U.S. nationwidehttps://www.gskhealthpartner.com/content/dam/cf-consumer-healthcare/health-professionals/en_IN/pdf/article-1.pdfThe 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. Consumer satisfaction with a topical product is based on subjective criteria such as how the product feels and how it is perceived on the skin. Therefore, appropriate questionnaires are of major importance for cosmetic products to assess the subjective perception not only of soothing and cooling effects but also of moisturizing properties and fragrance.https://www.edisoninvestmentresearch.com/?ACT=18&ID=10479A key element of Futura Medicals strategy is to reduce development risk through using well characterised existing agents that are reformulated with its proprietary DermaSys technology to create new products. This means intellectual property protection is limited to use patents for the individual products and umbrella patents for the technology. 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