Futura Medical Share Discussion Threads

[lbo] 07/9/2022 12:12

A goopy messy medical device placebo gel is unfortunately no real competition for a discrete tablet in the young men who are talking viagra. Especially when anyone including Reckitt can launch their own alcohol and water gel and claim it too works by evaporative cooling.



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] 07/9/2022 11:59

I wonder will young men with psychological ED really prefer a messy indiscreet goopy gel or a tablet on those one night stands!? LOL





This decision was made following a reassuring assessment of the safety of the Viagra Connect, advice from the Commission on Human Medicines, and a public consultation



Viagra is approved for treatment in the UK and offered by the NHS because it is a safe and effective treatment. Viagra is also one of the world’s most widely used drugs and used by millions of men per year. When dealing in such substantial numbers of users not all side effects associated with Viagra can be proven to have actually been caused by Viagra. More then 1 in 100 suffer similar or worse common side effects from ingesting alcohol. But many still drink alcohol regularly they feel the positive effects outweigh the negative effects.

[black bird] 07/9/2022 10:59

revenue expected in results, need it to be so share price to fall if not blackbird

[lbo] 06/9/2022 19:17

Researchers call for stricter rules on drug-like medical deviceshttps://www.chemistryworld.com/news/researchers-call-for-stricter-rules-on-drug-like-medical-devices/4011093.articlegels 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 patientshttps://www.bmj.com/company/newsroom/concerns-over-regulation-of-oral-powders-or-gels-sold-as-medical-devices-in-europe/Concerns over regulation of oral powders or gels sold as medical devices in Europegels, sold as medical devices in the European Union (EU), aren't regulated to the same safety standards as those applied to medicinesAs 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 researchersMedDevs 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.

[lbo] 06/9/2022 19:11

Dangerous stuff indeed!



Devices are subject to weaker standards than drugs because they’re re re 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 (here’s s one 2015 example).

Journalists need to scrutinize the claims
Journalists have a responsibility to report this lack of evidence, but they often don’t t. 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 know what we’re re re 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 Ëœleast 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 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] 06/9/2022 19:03

Oh the Irony! Are you saying people should only trust the unpublished, not peer reviewed and selective ‘ data’ from just medical device studies which were not adequately controlled?


‘On ˜Certain statements in this Announcement are forward-looking statements, which include all statements other than statements of historical fact and which are based on the Company's expectations, intentions and projections regarding its future performance, anticipated events or trends and other matters that are not historical facts. These forward-looking statements may use words such as "aim", "anticipate", "believe", "could", "may", "intend", "estimate", "expect" and words of similar meaning. By their nature, all forward-looking statements involve risk and uncertainty because they relate to future events and circumstances which are beyond the control of the Company’

[lbo] 06/9/2022 12:55

Patients taking the male impotence drug were found to have a lower risk of having a heart attack or dying from heart failure than those not on the medication.



Viagra could help men to live LONGER: Blue pill prolongs life and prevents heart attacks in males with coronary artery disease, study finds



Taking Viagra halves the risk of men who suffer from type 2 diabetes dying from heart problems

[lbo] 06/9/2022 11:03

Again that’s your subjective view and the personal experience of a ramper who has admitted previously on this BB he doesn’t have ED and has not been diagnosed with ED. So does not require to be treated with any of the first line treatments. It is also not the standard of care based on all the objective evidence as recommended by many including the American Urological Association [AUA] And FYI in the FM71 results it was MED3000 that was associated with users feeling ill ‘ MED3000 although 4.3% users noted nausea’




The therapies have not been validated

I recommend what we have as standard of care, which includes pills, injections, penile prosthesis, and vacuum devices that we know work. Other therapies have not been included in the standard of care yet.

[mikethebike4] 06/9/2022 10:17

LBO

"Actually its the first line therapy recommended in the General practice guidelines on ED. Which would be based on all the available objective evidence. It would not be based solely on a rampers subjective and unqualified personal view. Or if a person just own shares in a company with a placebo gel alternative and who may have a vested interest and biased opinion."

In your dreams baby !

Which big Pharma are you representing today ?

Incidentally years ago when I tried your 'evening' pill it made me ill - I was advised not to take them - as recommended in the General practice guidelines on ED. Which would be based on all the available objective evidence.

I later found out that this reaction was far more common than people (big Pharma reps.)like you think

[lbo] 05/9/2022 15:42

Actually its the first line therapy recommended in the General practice guidelines on ED. Which would be based on all the available objective evidence. It would not be based solely on a rampers subjective and unqualified personal view. Or if a person just own shares in a company with a placebo gel alternative and who may have a vested interest and biased opinion.



First-line therapy

For most men with ongoing confirmed ED, first-line treatment will be a phosphodiesterase-5 inhibitor (PDE5I).



Phosphodiesterase 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil) are recommended as first-line therapy. With established safety profiles, these drugs are well tolerated and effective

GPC prescribing lead Dr Andrew Green:

'There is no doubt that sildenafil is a safe and effective drug, but unfortunately the development of erectile dysfunction can be a warning sign of the presence of significant other disease. Diabetes, alcohol misuse and prostate cancer may all present with difficulties sustaining an erection, and erectile dysfunction in itself is a risk factor for cardiovascular disease.



ED may be the first manifestation of a single clinical disease spectrum that will progress to include coronary artery disease (CAD) and peripheral artery disease (PAD) at a later stage. Indeed, in men with CAD, the prevalence of ED is as high as 75%.

[lbo] 05/9/2022 15:03

Actually it would appear that using something like an OTC placebo medical device gel like Med3000 could be much more dangerous then using Viagra after an appropriate assessment.



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



Patients taking the male impotence drug were found to have a lower risk of having a heart attack or dying from heart failure than those not on the medication.



Viagra could help men to live LONGER: Blue pill prolongs life and prevents heart attacks in males with coronary artery disease, study finds



Taking Viagra halves the risk of men who suffer from type 2 diabetes dying from heart problems

[lbo] 05/9/2022 14:53

Can’t see how a Med3000 placebo type gel can be safely sold with not even a pharmacy assessment like with Viagra etc. Also the problem then with MED3000 is the pharmacists will have to inform the consumer its just a placebo gel for psychological ED. Otherwise they may be held liable by the consumer for selling a misleading product.



But the EMEA's Committee for Medicinal Products for Human Use (CHMP), had major concerns over making Viagra available over-the-counter. A spokeswoman said: "If the drug is available without prescription, there is no medical supervision which could delay diagnosis of underlying disease. "The CHMP was particularly worried about the diagnosis of overt and silent cardiovascular disease, of which ED can be an early marker."



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.

[mike2042] 05/9/2022 12:23

Yawn - not relevant LBO, you are reaching with this latest, nonsense, 'what if' post.