Futura Medical Share Discussion Threads

[vaston] 28/11/2022 10:53

Wow check this out.

[lbo] 28/11/2022 10:39

Bias and Fraud

There are numerous biases in medical research that render evidence from such research systematically misleading. Some of these biases are exacerbated by conflicts of interest, including fantastic financial incentives. The most important biases in medical research include confirmation bias, design bias, analysis bias, and publication bias. Arguably, some forms of bias, such as publication bias, should be considered as fraud. The pervasiveness of bias in medical research justifies one of the premises of the master argument for medical nihilism. Medical research is malleable due to the many biases, and such malleability allows for the production of evidence that suggests medical interventions are effective, whether or not they are in fact effective.



What method-issues to consider when assessing Risk of Bias
Concealment of randomization
Those enrolling patients are aware of the group (or period in a cross-over trial) to which the next enrolled patient will be allocated (major problem in “pseudo” or “quasi” randomized trials with allocation by day of week, birth date, chart number etc.)

Blinding
Patient, caregivers, those recording outcomes, those adjudicating outcomes, or data analysts are aware of the arm to which patients are allocated (or the medication currently being received in a cross-over trial)

Loss to follow-up
Loss to follow-up and failure to adhere to the intention to treat principle in superiority trials; or, in non-inferiority trials, loss to follow-up and failure to conduct both analyses considering only those who adhered to treatment, and all patients for whom outcome data are available

Selective outcome reporting
Incomplete or absent reporting of some outcomes and not others on the basis of the results

Use of unvalidated outcome measures (e.g., patient-reported outcomes)

[lbo] 28/11/2022 09:59

Considerations in the design of clinical trials for erectile dysfunction



The use of randomized controlled trials (RCTs) that are double-blinded and placebo-controlled is no doubt the optimum design for addressing clinical questions in ED and of paramount importance being the systematic and standardized approaches in the stages of design in order to avoid undesirable bias.

[lbo] 27/11/2022 22:46

Without medical diagnosis of the cause of the erectile dysfunction and of any potentially underlying serious medical conditions (such as CVD and diabetes), the risks associated with self-treatment of erectile dysfunction outweigh the benefits



Figures released by the British Association of Urological Surgeons show that 90 per cent of men with impotence have at least one underlying physical cause for their problem, with 40 per cent living with cardiovascular disease and 33 per cent with diabetes.

Cardiovascular disease is the leading cause of death globally, claiming an estimated 17.9 million lives each year according to the World Health Organisation.




European Court of Justice to Clarify Liability for Medical Device

[petroc] 27/11/2022 22:38

A stock basher is someone who manipulates the market to cause a drop in asset prices.
Stock bashers disseminate misinformation in the hopes that investors will believe the false claims and sell their stock before the price drops.
These individuals often target low-priced companies that have little to no available information on the market and may have positions in assets whose prices fall.
Some bashers may act alone or in groups or they may work on behalf of other individuals.
Stock bashing is illegal and may be subject to fines and prosecution.

[petroc] 27/11/2022 22:37

Interestingly, as part of its due diligence, Cooper undertook a consumer
marketing home use test (HUT) in the UK, France, and the Netherlands. The
size of the HUT is not disclosed but would typically involve c 200 consumers.
In this case men with self-diagnosed ED were supplied a four-pack sample of
MED3000 with the appropriate packaging leaflet. The results were in line
with those seen in the FM57 1,000 patient clinical trial, where over two thirds of patients saw a clinically meaningful benefit. The importance of the
HUT lies in the confirmation that MED3000 works as expected in a realworld setting. Longer-term use is being explored in the c 100 patient FM71
clinical trial, conducted over 24 weeks, to support the FDA application.

[lbo] 27/11/2022 22:26

And the only part of the current patent application that is ‘novel and inventive’ is the way Futura measures the so called cooling in the lab! Futura has openly admitted there is nothing novel in the ‘cooling from the evaporation of these specific combinations of solvents’ as it was already in the literature! LOL

So the so called novel and inventive’ part of the patent wont even protect Futura from competitors making similar gels and making the same evaporative cooling claims!

‘in Q2 2022 it confirmed the novel and inventive nature of the application,





methods of measuring the cooling abaility of a topical composition


GSK described a much better way to measure the cooling of a similar alcohol and water gel in real life!



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 Company has conducted initial literature and in vitro based research that has shown the cooling from the evaporation of these specific combinations of solvents

[lbo] 27/11/2022 22:09

Why has there been no update on any enforceable patent?



In Q2 2022 national applications will need to be made and the Company, in consultation with its commercial partners, will decide those countries in which to file applications and considered necessary to protect the commercial interests of MED3000. If national applications are successful



Most third party challenges to patentability occur in front of national or regional patent offices. WIPO recently released a summary of data regarding the extent to which third parties are challenging patentability at the international level. Any member of the public can file Third Party Observations against a PCT application during the international phase.


And how does a company expect to patent something that was clearly already described in research literature!? LOL



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] 27/11/2022 22:06

Trinity Research even openly admitted before the hypothesised effects ‘believed’ to be happening by Futura are ‘disputedâ’ . Trinity admitted no mechanism of action has to be even shown to get a medical device approved. But it does need to be shown and proven to substantiate its marketing claims or fall foul of the FTC, ASA and the Courts.

Trinity research:

Presumably the effect is comparable to the cold-induced vasodilation (CIVD) that occurs with extremities such as toes and fingers. Despite being a well-known effect, the mechanisms of CIVD are still disputed, but the pathways involved could well be similar. Interestingly, the precise mechanism of action does not need to be elucidated for the regulators to be comfortable for a product to be approved as a medical device



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.

[petroc] 27/11/2022 21:41

Stock bashing has become very common in the digital world and often occurs on online trading platforms. Sophisticated technology makes it easy for bashers to remain anonymous. As such, it can be difficult to track, identify, and stop bashers in their tracks.

As the internet makes participation in the stock market more accessible to more people, new investors emerging in the market are especially vulnerable to the tactics of stock bashers, and many investor boards exist to attempt to track perpetrators.

Though notoriously difficult to track, some bashers have been identified and prosecuted. From time to time, confessional essays about the tactics of bashers emerge online, although these essays are typically also either anonymous or pseudonymous. Many investors speculate this type of behavior tends to follow certain patterns, including a tendency for bashers to only bash stocks which are generally trending upwards and showing potential.

Having said that, financial regulators constantly monitor the markets for what they call bad actors or stock bashers. According to the Financial Industry Regulatory Authority (FINRA), investors may find it difficult to get information about these securities and any tidbits they may find can lead them to act—even if it's misinformation. That's why FINRA warned investment firms and broker-dealers to put controls in place that would raise red flags on any suspicious activity.

[petroc] 27/11/2022 20:51

The Internet can be ideal for stock bashers. Message boards and other media allow people to quickly exchange information without verification, although some communities may police themselves to keep the quality of the conversation high. Bashers may sign up for new accounts, establish a reputation, and then start claiming that a company is in trouble and stock prices could drop. They can also show up on comments sections on news articles and other resources to distribute false information.

If a stock basher can be identified, steps may be taken. In cases where the activity is clearly illegal, information may be provided to authorities to help them apprehend the culprit. Companies victimized by a stock basher may be able to claim financial damages and could request court orders to limit the basher’s activities in the future. For example, they could ask that a known stock basher be barred from participation in communities of investors online.

[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