Futura Medical Share Discussion Threads

[lbo] 27/11/2022 19:39

David Ralph also made some interesting comments about MED2005 being the same as a lubricant in this chat in Feb 2019. Before Med2005 failed in its Phase 3 drug trial. And Futura's hand was forced to go down the route of getting the placebo Med3000 gel approved as a medical device.

Go to 6 min 45 seconds in and you will hear him say many couples use lubrication and its not too much different from that. But he could say that with MED2005 as it still contained GTN and had not yet failed so it was different. But now MED3000 with no drug is just the same as rubbing on a cooling lubricant/arousal gel made just of alcohol, water, glycol and a carbomer that the man believes is an effective treatment for ED.





GSK also knew it was just a lubricant having placebo effects all along. Even before it failed phase 3. And now with the GTN ˜penile enhancer’ action removed after the phase 3 failure of Med2005/2002. Med3000 is nothing more then a lubricant with placebo effects when users are led to believe ‘it works’ to treat ED.



No Goopy ED Gel in GSKs Futura

[lbo] 27/11/2022 19:30

And along with the patent issues. The Cello and IPSOS research you keep quoting is not even based on Med3000. It was based years agon on Med2002 and on pricing back in 2018before Viagra even came off patent. And that it was just based on asking questions about a very different MED2002 concept. A MED concept that even went on to fail at phase 3. So MED was not approved as a drug and it no longer meets efficacy claims in any adequately controlled study. Even the Cello survey was based on questions on MED2002 not a medical device of questionable efficacy. Yet still it showed 46 per cent of the doctors interviewed in France did not even consider MED2002 was an improvement over PDE5 inhibitors. And that was before MED failed at Phase 3.



‘‘The respondents were shown a concept about MED2002 as part of the market research though they did not use the product as it is currently in clinical development’’
‘
respondents believed that the product, once approved, is highly differentiated from existing products and that its claims’

But its not highly differentiated anymore from any other similar medical device lubricants/arousal gels made from the samd ingredient alcohol, water, glycol and cobomer
that can also replicate every effect of MED3000..

[broomrigg] 27/11/2022 19:25

Be nice to see 50p this week.

[lbo] 27/11/2022 14:18

More lies! They said ‘assume’! And ‘if’

They are assuming the original Med2002/2005 patents which expire in 2025 in EU and USA in 2028 will provide some protection to Med3000. Thats a big assumption as the original patent was an umbrella patent covering Dermasys with GTN



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 protracted development times mean the clock has been ticking on the original issued patents, reducing the protected commercial product


And no enforceable additional patent has still been granted. The patent application is still pending and its even questionable if it protects Med3000 as its all about ‘ methods of measuring the cooling abaility of a topical composition’ LOL

And Dermasys on its own has no patent anymore as Dermasys itself dates back to 2002.



Status Pending

[petroc] 27/11/2022 13:28

Futura does have patent protection on Med3000 as per this from Liberum

"We currently assume that Futura’s patent protection on MED3000 expires in
2028 however the company has filed for additional patent protection that, if
granted, would last until 2040."

[lbo] 27/11/2022 13:16

Even Dermasys on its own has no patent anymore. Its just a trademark name now. And even the Dermasys trademark predates by many years the umbrella patents covering MED2005 (Dermasys and GTN) and TPR100 (Dermasys and Diclofenac) which are all expiring soon also.

from Trinity in a previous note regarding the MED2005 patent:

‘long development period resulted in a material erosion of the patent life, with the original formulation patent expected to expire in 2025’

Dermasys is even older then Med2005 so is off patent now

2002 plus 20 years = 2022




GlaxoSmithKline unexpectedly handed back the development rights to Futuras erectile dysfunction gel. We are not going to progress on this particular compound for normal commercial reasons which we do not wish to go into, GSK said.



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.




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





Under the terms of the agreement, Thornton & Ross will conduct the manufacturing scale-up of TPR100 and hold rights to manufacture, market and distribute the product in the UK for the lifetime of the product's patents, which run to at least 2028 in the UK

It has also been admitted that the Dermasy vehicle and Voltaren vehicle gave similar results so anyone can just market the Voltaren vehicle alone as a drug free cooling sensation placebo gel and claim its having the same effect in ED.



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

[lbo] 27/11/2022 13:07

Actually Dermasys was developed to deliver GTN but that failed at Phase 3. Dermasys in MED3000 which was the placebo in that failed Phase 3 is just a medical device now and delivers nothing now but a cooling sensation! LOL




And yes the ‘ placebo effect’ in ED is ‘remarkable’






There 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] 27/11/2022 11:36

Yes just like any placebo gel has the same ‘potential’ including an arousal gel if the man just believes its a treatment for ED! ROFLMAO



The placebo effect is that observed in the placebo arm of a clinical trial, and is produced by the placebo psychobiological phenomenon in addition to other factors, such as spontaneous remission, regression to the mean, biases, and judgment errors.



PLO = Placebo (identical gel to MED2005 but without the active pharmaceutical ingredient glyceryl trinitrate)



After Phase III Failure, UK Firm Pushes Placebo to Treat Erectile Dysfunction



Expectations of having received the drug can be modulated if the subjective effects of a drug inform the individual that active medication has been administered and increase expectations of drug effects.

˜You are the active ingredient’

[lbo] 26/11/2022 21:29

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.



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