Futura Medical Share Discussion Threads

[lbo] 01/9/2022 12:12

Futura admitted in yesterday’s RNS that FM71 was a study designed that ‘included men who had organic and psychological ED, or a combination of both’. Those men with Psychological ED do not need Viagra unless they also had an underlying organic cause also.

All those men with Psychological ED are responding to the placebo effects of being in an ED study testing a so called ED gel which has the same ingredients as some arousal gels already on the market.



Can’t I just take a tablet?

Sure you can. Men get prescribed Viagra at the drop of a hat for physical and psychological erectile problems, but this is a pity because Viagra is often not necessary and then they start to rely on it simply for the placebo effect. If you can get an erection in one situation and not the other, you do not need Viagra.

[lbo] 01/9/2022 11:44

Seems to be a lot of misrepresentation going on. A medical device by definition unlike drugs has a primary mode of action that isn’t biological. Its mechanical with Med3000. It has no active pharmacological ingredients and to insinuate it does would mean it cannot be a medical device. Its the fact the gel needs be ‘massaged in’. So the onset time is the onset time of the ‘massage’; stimulation.

But Tadalafil is a tablet that is swallowed and has a pharmacological action. Although it could have been taken at the same time as when mechanical stimulation onset began with any standard arousal gel/cooling lubricant. And then a like for like non biological onset time comparison could have been made. Unlike just using the pharmacological onset comparison which is not a like for comparison.

[lbo] 01/9/2022 10:42

For a de novo device registration it only has to provide a study that meets‘ a reasonable assurance of safety and effectiveness for devices of this type’



De Novo-winning devices often lack effectiveness data, analysis shows

De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type.

[petroc] 01/9/2022 09:38

All very good points, J7, and what's more, totally relevant to the subject, unlike LiarBO's copy/pasted nonsense.

[j777j] 01/9/2022 08:38

"Whilst the primary endpoints focused on efficacy, the secondary endpoints examined the onset of action.

The data, USING FDA AGREED CRITERIA where patients experienced an erection, showed a highly statistically significant improvement (p<0.001) at 10 minutes.

This endpoint was included to demonstrate a rapid onset, which the oral tadalafil 5mg tablet comparator failed to show. Typically, oral PDE5 treatments take 30-60 minutes to work."


WOW!!!

[j777j] 01/9/2022 08:37

"There were two co-primary endpoints.

The first showed a highly statistically significant improvement in erectile function (p<0.001) against baseline at 24 weeks (measured by the gold standard, internationally recognised IIEF-EF score) across ‘pooled’ severities of ED (mild, moderate and severe).

The second showed a 5.73 unit change in IIEF-EF score versus baseline at 24 weeks.


This comfortably exceeded the 4 unit difference AGREED WITH THE FDA and defined as the Minimal Clinical Important Difference (MCID)

[j777j] 01/9/2022 08:32

Trinity Delta view: The successful outcomes from the critical FM71 study pave the way for MED3000 to be submitted for FDA review, as a De Novo medical device, for the OTC treatment of erectile dysfunction. The dossier, including data from FM57, is expected to be submitted by end-September, with US marketing authorisation likely by end-Q123. The excellent safety and tolerability profile, coupled with the rapid onset of action and now demonstrated longer-term efficacy, means MED3000 is well positioned to become a clearly differentiated ED product.




Will be worth ££££'s share

Simple maths 250 million ED sufferers even a small market share will produce massive revenues.



World's first clinically proven topically applied ED product that will give an erction within 10 mins

[j777j] 01/9/2022 08:27

Traded at 50p in OTC market in USA (FAMDF)


Interesting

[lbo] 31/8/2022 22:17

‘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] 31/8/2022 22:15

Probably because anyone including Reckitt can if there is such a huge market for a placebo gel launch similar alcohol and water gel placebo products that are rubbed in for ED. It will take on average 177 days to go through a 510k pathway.

‘De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device’

The average length of time for clearance under the traditional 510(k) pathway is 177 days,



‘a company must compare their product to one already cleared by the FDA and provide evidence that their product is substantially equivalent to the previously cleared (legally marketed) device. To be substantially equivalent, the product must meet criteria for the same intended use, have the same technology or (slightly) different technology but produces similar end results, and be safe and effective. Once pre-market clearance is received from the FDA the device can be distributed commercially immediately’

[lbo] 31/8/2022 22:07

LOL

Why did Ken say if Med3000 gets De Novo registered then it creates ‘a new category of OTC device’? Why would it be a ‘category&rsquo; unless he also expects others to do follow suit now with their own alcohol and water evaporative cooling placebo gels for Psychogenic ED.



A low- to moderate-risk technology authorized via the De Novo pathway establishes a new classification category that can then open a floodgate for comparable devices to enter the market via 510(k) clearance.

[lbo] 31/8/2022 18:33

So up to 72% of men under 40 who self treat with an OTC Med3000 medical device gel. Could be inappropriately and delaying treating the real underlying cause of their ED? So an OTC product like Med3000 could lead to a dangerous reversal in the ‘higher rate of prescribing’ that was seen with the the Pharmacists assessment with Sildenafil becoming a Pharmacy medicine and missing an ‘opportunity for monitoring of linked risk factors, such as diabetes mellitus, dyslipidaemia, and vascular disorders’.



There are a significant number of men under 40 who experience erectile dysfunction (ED). In the past, the vast majority of cases were thought to be psychogenic in nature. Studies have identified organic etiologies in 15-72% of men with ED under 40. Organic etiologies include vascular, neurogenic, Peyronie's disease (PD), medication side effects and endocrinologic sources. Vascular causes are commonly due to focal arterial occlusive disease. Young men with multiple sclerosis, epilepsy and trauma in close proximity to the spinal cord are at increased risk of ED. It is estimated that 8% of men with PD are under 40, with 21% of these individuals experiencing ED



Sildenafil and tadalafil are recommended firstline treatments for erectile dysfunction (ED). Sildenafil was legally reclassified to a pharmacy medicine in the UK in 2018.

The two-fold increase in the rate of primary care prescriptions in the past 10 years suggests that more men are being screened for, or seeking help for, ED. The higher rate of prescribing offers opportunity for monitoring of linked risk factors, such as diabetes mellitus, dyslipidaemia, and vascular disorders


Is that why Cooper wanted on the record that ˜Futura will remain Legal Manufacturer’

˜Legal manufacturer means the organisation responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market’

So FUM shareholders are ultimately held ‘responsible&rsquo; and liable not the Cooper shareholders for any claims and lawsuits!?

[lbo] 31/8/2022 17:51

I see nobody has still passed any comments on the risk of treating someone inappropriately with Med3000 OTC who has a combination of organic and psychological ED and getting a ‘positive result’. Yet the underlying organic cause of the ED still goes undiagnosed and untreated? That will not lead to a ‘positive result’.

Seems the Futura Consumer HUT RNS has contradicted the supposed ‘successful&rsquo; Human factors study RNS in terms of safety. As the HUT clearly included ‘men suffering from severe ED with significant co-morbidities&rsquo; which Med3000 did not seem to give the same ‘improvement&rsquo;. Yet the Human factors study RNS said men would understand from the packaging and labelling if Med3000 was suitable for them? Clearly it didn’t in the HUT study as men with ‘significant co-morbidities&rsquo; still self treated with an inappropriate treatment. So clearly they didn’t ‘correctly self-diagnose ED’ nor ‘make the correct self-selection decisions’

Futura said in the Human factor’s RNS that ‘It was demonstrated that individuals are able to correctly self-diagnose ED and to make correct self-selection decisions by considering their own health history and the instructions for use and warnings on the label. Overall, there was a very high degree of comprehension of the label and leaflet to increase confidence that the product will be used appropriately in an OTC setting’

FM71 ‘included men who had organic and psychological ED or a combination of both’. But those men had already seen a Physician and had the correct underlying cause for their ED diagnosed. In the real world with Med3000 OTC and not even a pharmacy assessment. They will self treating inappropriately if they have a ‘combination of both’ and on the surface seemingly getting a ‘highly positive result’ but underneath it could be the cause for their death. Especially if an OTC medical device product is claiming to be a ‘clinically proven treatment for ED with not even a pharmacy assessment ends up being the cause for them in not getting appropriately diagnosis and treated for the more serious underlying organic cause of the ED.





Hard proof erectile dysfunction leads to early death, study says