Futura Medical Share Discussion Threads

[mikethebike4] 13/9/2022 14:35

LBO

Is Tadalafil taken internally or applied to the organ in question ?

Is Tadalafil prescription only ?

Is Tadalafil sometimes used to treat high blood pressure ?

Does Tadalafil take 30 to 60 minutes to work ?

Does Tadalafil rely on you being sufficiently aroused to work ?

Does Tadalafil have side effects such as headaches, back pain, muscle aches, pain in your arms and legs, facial flushes, stuffy nose, and indigestion ?

Is Tadalafil not recommended to be taken with medicines called nitrates (often prescribed for chest pain !) This combination can cause dangerously low blood pressure ?

Is Tadalafil not suitable for some people ?

This is why there is a gap in the market for MED3000

[lbo] 13/9/2022 14:27

Yes back in 2016. Med still had GTN and was a drug. But since it failed its Phase 3 its only a medical device

There were also no oral PDE5I drugs approved to switch to Pharmacy by the MHRA. So the only alternative online back in 2016 was counterfeit Viagra which was usually contaminated with ‘toxins like boric acid, speed, and even rat poison and yes those toxins caused a lot of side effects!!! LOL

Since then Viagra has been approved to switch to Phamacy and is proven safe and effective. And yes any Lubricant/arousal gel can also have the same stimulation onset time as MED3000 and form part of foreplay and spontaneity! LOL





So why did you leave out the link attached to the post?

[lbo] 13/9/2022 13:27

So now there have been deals with Labatec, Menarini and Cooper. Yet Zero revenues have ever turned up in all the financial results after all these deals? Even though all the RNS said ‘ initial upfront payments’ at the times the deals were announced! Its CSD500 type deals all over again!!!

[lbo] 13/9/2022 13:08

So Dermasys vehicle gel and Voltaren vehicle gels are similar alcohol and water gels and both cause evaporative cooling when there is no drug to deliver!?

Both vehicle gels have the same ‘intended use, have the same technology or (slightly) different technology but produces similar end results, and be safe and effective’




‘We are not going to progress on this particular compound for normal commercial reasons which we do not wish to go into,GSK said.




VOLTAREN VEHICLE gel is the carrier substance of Voltaren Schmerzgel (German trade name) or Voltaren Emulgel (European trade name) drugs (NSAIDs), such as diclofenac

When the gel matrix is destroyed after application to the skin, the bound water and alcohol evaporates and a measurable cooling-effect results.

[lbo] 13/9/2022 13:06

177 days is all it will take to copy and have similar product on the market. No clinical studies required for copycat alcohol, water and glycol gels. And remember Futura still haven’t even shown that evaporative cooling is what is having any effect!



‘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’



‘This De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster’

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

[kinwah] 13/9/2022 12:52

I hold FUM so I want it to do well but I wonder how unique the cooling effect is. I noticed Hawaiian Tropic aftersun lotion had a similar cooling effect. Maybe people will find their own home-made alternatives to Eroxon.

[lbo] 13/9/2022 09:50

Yeah and lets ‘filter’ the ASA and the EU courts too! LOL

‘CE certification in itself does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims’

Med3000 has no evidence from any adequately controlled study to substantiate any effect beyond a placebo.




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



The court did not concur with the defendants arguments. It stated that the CE conformity assessment is neither an official approval procedure nor an administrative legal act. The so-called ‘notified bodies’ which carry out conformity checks and award the CE-certificates are private companies. The tests carried out by these companies therefore rather amount to plausibility checks, which, moreover, only concern individual aspects, for example, of a production process. A products (alleged) therapeutic effectiveness is not (necessarily) examined.
In effect, the court enjoined the defendant from continuing the advertising of the product.

[dontshoutatonce] 13/9/2022 09:45

Why don't you all filter LBO?

[haveapunt1] 13/9/2022 09:41

Lbo, nothing to do with it. As someone that is in the legal business, Cooper have just applied good business practice and risk management. Nothing more than I would expect

[lbo] 13/9/2022 09:34

And because of the massive legal risks. No wonder Cooper wanted it 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 under that organisation's own name, regardless of whether these operations are carried out by that organisation or on its behalf by a third party contract manufacturer’

Easy to see why Cooper paid nothing upfront as consumers will be lining up making claims that MED3000 was responding for ‘diverting patients from effective drugs to less-effective devices’

[haveapunt1] 13/9/2022 09:26

Proactive interview out. Launch H1 2023, rather disappointing but can live with that. My guess it is 2023 in order to protect the product / patent / copy cat risks.

[lbo] 13/9/2022 09:26

Seems to me nothing was ‘determined’ with the FDA based on the science not to use a placebo but rather the fact is ‘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’






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 don’t t 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 didn’t 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

[lbo] 13/9/2022 08:48

ROFLMAOSee James was thrown under the bus!'As a medical device, not drug, and given the mode of action, it was determined that a placebo control in the study was unnecessary," James said'The FTC and ASA wont accept 'James said' as substantiation to be able to prove any effect beyond a placebo as they have no adequately controlled studies to support their claims

[j777j] 13/9/2022 08:46

Trinity Delta


"Following the successful study the search for a US commercial partner has commenced and encouragingly a number of enquiries have been received."

[j777j] 13/9/2022 08:38

Why Futura Medical believes MED3000 could disrupt the market for PDE5i drugs like Viagra and Cialis