Futura Medical Share Discussion Threads

[petroc] 18/12/2022 10:16

I notice you took 6 minutes to respond last night LiarBO. Get a grip!

[petroc] 18/12/2022 10:14

'Least burdensome' Hahaha! What, did you want them to do it the hardest way? You are an idiot, LiarBO!

[lbo] 17/12/2022 22:57

Futura has openly admitted in an RNS back in 2021 it was using the ‘least burdensome’ route of a De Novo medical device registration for Med3000.

This only requires a low threshold of effect over baseline for ‘reasonable assurance’ of some effect including even just placebo effect for lower class medical device registration.

This has allowed Futura, like other medical device manufacturers, exploit ‘the 2002 Medical Devices User Fee Act’. This act brought in via corporate lobbying by the medical device companies requires the FDA to use the least burdensome route to market for that low class device. So the FM71 study was deficient as it was an uncontrolled and an unblinded study and ‘prone to bias’ So even if if Med3000 is given medical device registration. FM71 still has not met the standards of the FTC to substantiate claims of an effect beyond a placebo and the FTC has jurisdiction over the marketing claims of these lower class medical devices. Similar applies to FM57. It was not an adequately controlled study as it was designed to study Med2005 not the placebo MED3000 gel.



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.



In terms of advertising and promotion, for most over-the-counter medical devices, the FDA and FTC exercise joint regulatory authority over product labelling and advertising. The FDA has primary jurisdiction over labelling for all medical devices and advertising for restricted devices (typically Class III), while FTC has primary jurisdiction over advertising of unrestricted medical devices (Class I and most Class II devices). The FDCA prohibits the distribution or receipt in interstate commerce of a misbranded medical device, which includes a device bearing false or misleading labelling. Claims in device labelling, including product websites, that are outside the scope of the device cleared uses can misbrand, and even adulterate the device, another prohibited act under the FDCA

[petroc] 17/12/2022 22:50

'It's all a ramper swindle'...hahahahahaha!

[petroc] 17/12/2022 22:49

Wake up, LiarBO! Although I'm sure your PC just woke you up with your alert to tell you someone has posted on the board, you sad knacker!

[petroc] 17/12/2022 17:55

Nobody cares what you've got to say, LiarBO.

[petroc] 17/12/2022 17:54

How's that stock bashing going, LiarBO?

[petroc] 17/12/2022 16:41

Poor old LiarBO, forging his lonely stock bashing path 24/7. What a loser!

[lbo] 17/12/2022 14:40

Yes MED3000 is a topically applied class 2b medical device gel just like that other topically applied drug free gel Flexiseq. Both in indications known to respond to placebos. Med3000 utilised its Dermasys transdermal technology while Flexiseq utilises its proprietary transdermal sequesome technology. flexiseq also failed its Phase 3 same as Med3000. So it became just another class 2b medical device drug free gel or ‘ Russian scam’ as you called that similar gel. They also got a loan from Knight and Knight also gave a loan to M8 who coincidentally have a deal with Futura!

petroc 22 Nov '22 - 19:15 - 14137 of 14145

Flexiseq being a Russian scam, this makes interesting reading:






As Trinity said about Futura funding requirements as their is no visibility on any meaningful revenue:

‘we have limited visibility on the potential timing and terms, given various structures and options could be considered. Importantly, current cash resources should be sufficient to reach beyond the anticipated US regulatory decision by end Q123’




The interest rate will decrease to 10% if Pro Bono Bio meets certain equity-fundraising targets.





Will Futura Medical (LON:FUM) Spend Its Cash Wisely?

That means it had a cash runway of around 13 months as of June 2022. That's not too bad, but it's fair to say the end of the cash runway is in sight

[petroc] 17/12/2022 13:54

What do you know about long term holders anyway? You sold out for a huge loss 5 years ago!