Futura Medical Share Discussion Threads

[joestalin] 18/8/2022 16:05

All of LBO's comments are a repetition to me. They all say "(Filtered)".

[mikethebike4] 18/8/2022 16:00

Lbo

Bit rich of you as King repetition to use this phrase 'Sounds very familiar!'

[lbo] 18/8/2022 11:36

Sounds very familiar! LOL

[lbo] 17/8/2022 14:43

Ironic you bring up the partner contracts as supposedly being a good sign all is well with the product.It just brings us back to the non obviousness and prior art patent issues and competitors using the Voltaren vehicle alcohol and water gel to launch an equivalent evaporative cooling gel.



‘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’


Some shareholders realised from the IPO prospectus what type of clauses were in previous contracts (with LRC/SSL/Reckitt and most likely later with Church & Dwight etc) that favoured the partners just to get the deals signed and announced. But then allowed the partners to never have to launch or if they did launch never have to pay any real royalties. And even just hand back the rights with no real penalties after sitting on the products doing nothing. Which the partners were probably right to do looking at the poor sales volumes achieved by partners like Bizzy diamond and Kabey. Yet the brokers and Futura ‘believed’ they were going to capture a significant percentage of the condom market? Unfortunately those ‘beliefs’ never materialised but they had given all the necessary disclaimers as are they doing now too. Unlike the rampers who give no disclaimers.



a agreed percentage of the net sales value (after transport costs, sales tax, credit notes for returns and defective products and any settlement, retrospective, volume and promotional discounts) charged by LRC or any sub-licensee in relation to the Product.

The royalty and the royalty advance may be reduced by such amount (if any) as is agreed or determined by an expert to be fair and reasonable if: (i) any patent application does not proceed to grant or any patent rights are determined to be unenforceable or are revoked or lapse; or (ii) an event occurs which in LRC reasonable opinion adversely affects the commercial viability of the licence agreement or the margins on sales of the Product; or (iii) a competing product is offered for sale

[petroc] 17/8/2022 14:18

LiarBO's last two posts were just as irrelevant as his previous stinkers. Get a grip, LiarBO!

[lbo] 17/8/2022 14:13

https://buse.de/en/insights/ce-marking-is-no-excuse-for-uncorroborated-claims-of-efficacy/The court did not concur with the defendant's 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 product's (alleged) therapeutic effectiveness is not (necessarily) examined.In effect, the court enjoined the defendant from continuing the advertising of the product.there is consistent case-law on the (limited) significance of CE markings.

[lbo] 17/8/2022 14:03

So now Petroc is accusing the author of not making sense. Even though ‘Richard Lehman is a primary care physician and academic who writes a weekly journal review for all the big medical journals’

And yet more evidence:


Researchers call for stricter rules on drug-like medical devices



gels used like medications but registered as medical devices – the same category plasters and pacemakers fall into – need tighter controls, a team of clinical researchers has concluded after studying several such materials. Products that fall into this regulatory grey zone don’t need to prove their efficacy or safety in the same way pharmaceuticals do, which could be a concern for vulnerable patients



Concerns over regulation of oral powders or gels sold as medical devices in Europe

gels, sold as medical devices in the European Union (EU), aren’t regulated to the same safety standards as those applied to medicines

As a result, these products, which look like medicines, can be marketed with very limited clinical data and accompanied by poor quality product information.

there was insufficient or no information on: the derivation of the products; the ratio of the relevant constituents; toxicity; factors affecting absorption and potential interactions with other drugs; maximum safe doses; and potential long term harms.

Although no evidence of side effects associated with the three products has been published, there is no proof of safety either, note the researchers

MedDevs for use in Europe are regulated by a business arm of the EU called GROW, rather than the European Medicines Agency, and require only certification with a ‘CE’ (quality) kitemark before the product can be marketed.

This process doesn’t require evidence of efficacy or safety from high quality clinical trials, as is the case for medicines.

[petroc] 17/8/2022 13:52

Absolutely nothing LiarBO said in his last three posts makes any sense. He just contradicts himself with every sentence, trying to sound like he knows what he's talking about. Just more examples of LiarBO's bluster and smokescreens in his unending quest to scupper MED3000. Ain't gonna work, LiarBO! Everyone has seen right through your lies and manipulations. MED3000 works, end of.

[lbo] 17/8/2022 11:24

As I said



The issue with this being that the alternative for a placebo drug being a tablet, in medical drug trials, is a sham device in medical device trials, and with sham devices/interventions come ethical issues and fears for patient safety.

Recent research has shown that the placebo effect is not only similar for medical devices to medical trials; it is considerably larger – the effect of a sham device is almost three times that of an oral placebo.

This proves the case for the need of medical devices to be approved based on trials that compare them at first to sham devices. Once effectiveness has been proved at an early stage it is no longer necessary sham devices be used in comparison, therefore minimizing ethical concerns.

[lbo] 17/8/2022 11:20

Seems the rampers are back telling lies!



In medicine before determining that a treatment is acceptable it needs to undergo a large number of trials; one of the final stages of these trials are clinical trials; namely controlled clinical trials.

What controlled means is that the new treatment is compared with an old treatment or with placebo. A placebo is a fake treatment given to patients who will not be taking the new treatment.

Patients are given a placebo to overcome the placebo effect, which is when patients get better because they feel they are taking treatment.

It is commonplace in clinical trials for drugs, that a patient will be given a placebo that looks similar to the new treatment and leaves the patients thinking they have taken the new treatment. This is not the case however with regards to medical devices.

[lbo] 17/8/2022 11:18

The FDA always requires placebo controlled drug trials. But Med3000 is not a drug. Its only seeking registration as a class 2 medical device. It is NOT getting FDA approved. However with certain high risk implantable medical devices it may not be ethical to ask for placebo sham devices to be implanted. But since Med3000 is only a class 2 device gel. It could easily have been compared to another class 2 placebo gel like an arousal gel.



Selling brass as gold harms consumers independent of any effect on pain. Since the placebo effect can be obtained from sugar pills, charging $200 for a device that is repre- sented as a miracle cure but works no better than a dummy pill is a form of fraud. Thats not all. A placebo is necessary when scientists are searching for the marginal effect of a new drug or device, but once the study is over a reputable professional will recommend whatever works best.
Medicine aims to do better than the placebo effect, which any medieval physician could achieve by draining off a little of the patient’s blood. If no one knows how to cure or ameliorate a given condition, then a placebo is the best thing going. Far better a placebo that causes no harm (the Q-Ray Ionized Bracelet is inert) than the sort of nostrums peddled from the back of a wagon 100 years ago and based on alcohol, opium, and wormwood. But if a condition responds to treatment, then selling a placebo as if it had therapeutic effect directly injures the con- sumer. See Kraft, Inc. v. FTC, 970 F.2d 311, 314 (7th Cir. 1992) (a statement violates the FTC Act “if it is likely to mislead consumers, acting reasonably under the cir- cumstances, in a material respect�).

[petroc] 17/8/2022 11:02

Funnily enough, the article where LiarBO picked up his little 'gold standard' quote which he uses regularly is actually particularly interesting. It pitches many good reasons for not using placebos in clinical trials. Here's one snippet - 'The Office for Human Research Protection (OHRP) published guidelines in 2008 for the use of placebo and methods to minimize the risk associated with it. The guidelines state, “Placebos may be used in clinical trials where there is no known or available (i.e., FDA-approved) alternative therapy that can be tolerated by subjects.” The use of placebos in controlled clinical trials must be justified by a positive risk-benefit analysis, and the subjects must be fully informed of the risks involved in the assignment to the placebo group. Continued assignment of subjects to placebo is unethical, once there is good evidence to support the efficacy of the trial therapy.' There's plenty more like that which shoots LiarBO's opinion right out of the water. No surprises there, then. Oh dear, indeed!

[lbo] 17/8/2022 11:01

Maybe thats whats behind the recent pump? They know they need to raise millions and millions in cash from investors to fight all the FTC claims! LOLHere is another company who made false claims about its medical device being clinically proven and that the FDA had reviewed and approved its medical device for its advertised pain relief and other health benefits. The FTC challenged all those claims as false and hit them with a judgement for $22 million. The FDA does not approve class 1 or 2 devices like Willow Curve or Med3000. And if there is no adequately controlled studies to support claims of 'clinically proven' for medical devices. They challenge that too.https://www.ftc.gov/business-guidance/blog/2020/06/lights-out-unsubstantiated-pain-relief-claims-and-deceptive-native-advertisinghttps://www.ftc.gov/system/files/documents/cases/physicians_complaint.pdfhttps://www.consumerprotectionreview.com/2020/09/ftc-enters-into-22-million-settlement-with-manufacturer-of-willow-curve-regarding-unsubstantiated-pain-relief-claims-and-deceptive-native-advertising/

[lbo] 17/8/2022 10:48

Oh dear so no news on any adequately controlled study being carried out? Even FM71 and a De Novo medical device registered will still not support any claims of any effect beyond a placebo as FM71 is still an unblinded study and has no adequate control. It will still show placebo effects.

[sos100] 17/8/2022 10:03

small rises are better....attract the right kind of investor

[broomrigg] 17/8/2022 07:22

Be great to see 45p this week ;-)

[j777j] 17/8/2022 06:53

Trinity Delta


The depth of due diligence suggests a strong commitment from
Cooper, that should be sustained in the longer term given contractual marketing
spend.

We currently value Futura Medical at £264m, equivalent to 92p per share
but expect to review this as visibility on expected launch timings increases and
also when the results of the FM71 trial are made public.





Expect massive broker upgrades going forward.