Futura Medical Share Discussion Threads

[lbo] 15/3/2023 09:22

The real‘ Losses’ will be by shareholders having to soon throw more money at trying to build a ‘long term’ ‘sustainable brand’ around basically what is an arousal gel with no enforceable patent on something that already exists in the market and is well described in the literature!



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




Voltarol Emugel vehicle is made of the same ‘evaporate cooling’ ingredients as in Eroxon

carbomer,
isopropyl alcohol,
propylene glycol,
water



‘TPR100 gave similar results to the gold standard, Voltarol 2% gel’



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. 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.



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

[lbo] 15/3/2023 08:05

Glavey no wonder that multi-ID name is 'Losses'! LOLLosses - 12 Sep 2022 - 10:24:12 - 13296 of 17205LBO getting shafted by his own shorts here!! Buy up and enjoy the ride to 100

[glavey] 15/3/2023 01:23

"Why is the share price stuck at 52"

Well, the good news is that the share price isn't stuck at 52 anymore. :-)



(I note a poster using the moniker "Losses" feels this is a good opportunity and suggests they bought more. Good luck to them. Whether this is averaging down or up they don't say, although I'm not sure that matters.)

[lbo] 14/3/2023 23:58

Even the market analysts know all Futura have done is paid for the research and paved the way to allow companies like Reckitt also claim all its class 2 medical device lubricants/arousal gels are also placebo treatments for Psychogenic ED!



‘You are the active ingredient’




Reckitt Benckiser was the defined leader and the ultimate four Personal lubricant vendors with leading brands such as Durex Play and K-Y Jelly.

KEY GROWTH FACTORS

Increasing prevalence of erectile dysfunction

9 Market Growth Enablers
9.1 Increasing Prevalence of Erectile Dysfunction




A placebo is anything that seems to be a "real" medical treatment -- but isn't. It could be a pill, a shot, or some other type of "fake" treatment. What all placebos have in common is that they do not contain an active substance meant to affect health







water-based warming gel Ingredients Stimulant Gel

Aqua, Glycerin, Propylene Glycol, Alcohol Denat, Carbomer


So arousal gels too can replicate all the associated Med3000 benefits and commercial potential the ramper lists. Especially in psychogenic ED sufferers who already reported responding to manual massage. Just like the inclusion criteria in the FM57 deficient test design selected for!

[lbo] 14/3/2023 18:03

And still no update on an enforceable patent for Med3000/Eroxon!

So basically if they are inclined any pharma company or lubricant company like Reckitt can launch their own placebo arousal Erectile gels made of alcohol, water, glycol and carbomer! ROFLMAO



Lilly’s CIALIS patent claims extending to “physiologically acceptable salt” found invalid for overbreadth and insufficiency



‘TPR100 gave similar results to the gold standard, Voltarol 2% gel’



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. 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.



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

[petroc] 14/3/2023 17:23

Yeah, like it was hard to buy Cialis previously!

[lbo] 14/3/2023 13:58

ROFLMAO

Did they mention the lack of enforceable patent? I note you have not posted all the disclaimers and assumptions the research is also relying on? Just like all the vague disclaimer language like ‘could be’, ‘should’, ‘seem’, ‘we believe etc etc etc!

Amazing how none of the issues announced today were ever mentioned before in their previous notes or when talking to management previously when they were all saying ‘expected Q1 2023’

All the rampers kept saying all the data needed had been submitted yet now its official more questions have been asked and more data is required!

So todays RNS proves their previous research notes and price targets did not come to pass! So it’s possible they will be wrong yet again!


J777J - 21 Dec 2022 - 12:33:20 - 15184 of 17192


Positive progress continues at Futura Medical, with MED3000 now under formal review at the FDA and decision
on marketing authorisation expected by the end of Q1 2023.

Regulatory progress continues
The FDA has formally accepted the regulatory submission dossier of
MED3000, indicating that it has successfully passed the initial technical
screening setting. This sets in motion a decision on US marketing
authorisation by the end of Q1 2023. This is in line with previously announced

And look how wrong you and they were 3 years just before the share price crashed to below 10p in December 2019!

J777J 28 Nov '19 - 07:35 - 6443 of 14369

New 15 page buy note out today from Liberum.

A strong positive outcome would imply 149p share price.

[broomrigg] 14/3/2023 13:26

Thanks for posting those J777J

[j777j] 14/3/2023 12:53

From Trinity's note today "Cooper has a direct presence in the seven largest European markets, operating via distributors in the remaining countries. We believe the launches will cover these major geographies, including the UK, during 2023...Cooper is known to have high expectations for Eroxon’s commercial potential and its roll-out across Europe is keenly anticipated. The slippage of the expected FDA approval into Q223 is not unexpected, such novel products are often subject to requests for clarification. The more important aspect is that management reports these discussions as active and constructive. As we have noted previously, the market opportunity as the first clinically proven erectile dysfunction (ED) treatment available OTC (over-the-counter) and with a differentiated and rapid onset of action (ahead of typical oral PDE5 treatments) could be significant. Even modest success would be transformational for Futura Medical. Our valuation is £264m, equivalent to 94p per share."

[j777j] 14/3/2023 12:52

From Liberum's note today

"This small delay comes after some minor non-clinical questions were raised, and confirmatory data requested by the FDA.

The company expects to fully respond and submit requested data to the FDA by the end of the month. We have spoken to management and remain highly confident of US approval.

In fact, given that the only issues flagged by the FDA were minor, we are even more confident....We remain buyers with a target price of 121p...


.We are now in the final stages of the review, and the FDA has come back with additional questions on MED3000 and has asked for some minor non-clinical confirmatory data (which should take a matter of weeks to respond). Futura aims to respond by the end of this month, but it does mean that a decision on FDA regulatory approval is now expected in Q2 2023 (vs. by end of Q1 2023 previously). We have spoken to management and remain confident of FDA approval. The
additional questions do not seem related to the clinical data but to nonclinical data that can be generated both quickly and inexpensively. Given the company believes it is ready to submit responses by the end of March, the issues look easily surmountable. The issues flagged were, in our view, minor, and our confidence in approval remains intact, if not strengthened. This confidence is founded in the fact that the European regulatory agency has already approved MED3000, the excellent efficacy and safety data published to date, and that Futura has had six meetings now with the FDA, the latest in late February, so we feel that if there were any major issues that would have been flagged by now.

[lbo] 14/3/2023 12:12

Futura has openly admitted in previous RNS it is exploiting the ‘least burdensome’ pathway for De Novo Medical device registration for Med3000/Eroxon

‘ 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’

That ‘reasonable assurance’ that a device is effective includes just it being a placebo effect as no evidence from any adequately controlled and blinded study exists to substantiate any claims of an effect beyond a placebo gel!




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.

[losses] 14/3/2023 12:05

Added more around 44

[petroc] 14/3/2023 10:44

'FM71 results are highly positive, meeting all primary and secondary endpoints; are in line with data generated in the previous Phase 3 clinical study (“FM57”) and are broadly comparable with results from a recent “real world”, home user study.

Data demonstrates that MED3000 presents an effective clinically proven treatment for erectile dysfunction with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for Over the Counter classification.'

Yep, definitely flying colours! Just stop lying, LiarBO.

[petroc] 14/3/2023 10:01

LiarBO trumpeted '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.'

He fails to mention this:


...These results therefore support the regulatory submission for OTC designation and will enable Futura to finalise the OTC product label for a US filing.

FDA also requested an additional 24 week confirmatory clinical study, known as “FM71” and the protocol was agreed with FDA.

In August 2022, Futura announced positive results of FM71, and is on track to file the 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 USA'

In other words, testing has already been done to FDA's specific requirements and passed with flying colours, and all that remains is for the FDA to rubber stamp the deal.

So as usual LiarBO is trying to muddy the waters in order to bash the stock. No surprises there then.