Futura Medical Share Discussion Threads

[lbo] 17/5/2023 17:54

ROFLMAO!

Not even the paid for house brokers are forecasting any profits for the foreseeable! Why is that? Could it be because its just a placebo medical device gel still with no enforceable patent? And Liberum openly admitted ‘ lack of visibility with regards to either timing or quantum of these revenues’. And Futura have even admitted in the results they will need to ‘work hard’ to try turn Eroxon ‘into a long term, profitable and trusted brand’. And also don’t forget the Dermasys vehicle on its own doesn’t even have a patent anymore! And the original Med2002 patent which was for Dermasys delivering a drug GTN so questionable if it offers any protection to Eroxon a medical device. Also expires 'August 2025 in Europe. And the patent on TPR100 product, in limbo for years, expires 2028 in UK.


˜When A Claimed Trade Secret Isn't In Fact A Secret’






Currently unprofitable and not forecast to become profitable over the next 3 years

Its now middle of May 2023 and 5 and half months later! LOL



at December 2022, Futura Medical had cash of UK£4.0m

˜Therefore, from December 2022 it had roughly 7 months of cash runway. To be frank, this kind of short runway puts us on edge’




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 managements 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

[petroc] 17/5/2023 17:04

'And yet just more unsubstantiated false and misleading claims that cannot be substantiated with any non deficient evidence and also based yet again on totally false and erroneous assumptions!' Cries LiarBO.

Nope. All true and verified.

LiarBO is nothing but a massive liar.

[lbo] 17/5/2023 16:06

Also just like the UK HCP website that was advertised by Petroc on bulletin boards 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 cleary a non pharmacologic medical device gel study!!!!

So they are clearly 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.

[lbo] 17/5/2023 14:50

˜Journalists need to scrutinize the claims''prone to bias'https://www.healthnewsreview.org/toolkit/tips-for-understanding-studies/medical-devices/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 OKJournalists 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 devicesNinety-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 routeFor 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

[banzai5] 17/5/2023 12:35

What's your angle on this LBO?Why do you put so much time and effort on this board?

[lbo] 17/5/2023 10:53

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] 17/5/2023 10:32

'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 10:24

Still no explanation from any multi-ID ramper how a company could enforce a patent on a placebo arousal effect in deficient tests and an evaporative cooling effect that Futura has publicly admitted was previously published!!https://www.londonstockexchange.com/news-article/FUM/update-on-positive-eu-regulatory-discussions/14421486'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'https://patents.google.com/patent/WO2021116651A1/enI even wonder why Futura didn't just use a more simple 'validated handheld thermal imaging' method to measure the evaporative cooling effect in their patent application! LOLhttps://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. The voltarol vehicle is even off patent same as is the Dermasys vehicle gel 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.

[lbo] 17/5/2023 10:16

Dermasys on its own dates back to 2002 and on its own doesn’t even have a patent anymore! Thats why they applied for a new patent which still has not been granted and even if it does is questionable if it would protect against competitors if inclined launching their own placebo arousal gels made of alcohol, water, glycol and carbomer!



A 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



‘The DermaSys(R) technology was originally developed by Futura for use in the Company's topical treatment for erectile dysfunction, MED2002’



Eroxon

the trademark (UK No 2,320,890 (Class 5)) for which the Company has applied, for the product also known as MED 2000




Like the brokers admitting in their previous research that they are assuming the original Med2002/2005 patents which expire in 2025 in EU and USA in 2028 will provide some protection to Med3000 until then. Thats a big assumption as the original MED patent was an umbrella patent covering Dermasys with GTN. Med3000 now is just Dermasys on its own and dates back to 2002 and is now just a medical device delivering only a cooling sensation via ‘evaporative coolingâ€

[lbo] 17/5/2023 09:31

It did go up! But what goes up can come down especially when its based on a ‘placebo gel frenzy’ pumped by multi-ID rampers all over the Internet and social media. Yet has no enforceable patent!









Anyone who bought below 10p and sold above 70p back in March 2021 has done very well! LOL Or like Lombard Odier who managed to sell a lot of shares ahead of the fundraisings at 7p and 8p and then bought them all back and more in the fundraisings. Lombard Odier and some would still have an average price well below 20p!



From 2004

‘Former insurance broker James Barder became involved with Futura having made an investment in what was a private company; pre-Viagra, he, some family and friends all thought it a 'bit of a laugh' initially, but are now very serious. Together they speak for around 25% of the company and many of them came in at the equivalent of 1p a share’

[idomeneo] 17/5/2023 08:35

I've got an irritating micro-position which has been showing red in my portfolio for ages. Why can't the managers get it to go up (the share price that is!)?