Futura Medical Share Discussion Threads

[lbo] 17/1/2023 16:38

See how the rampers dont want any of this known!

>

Over 50% of De novo applications are denied and some are placed on hold requiring further information. Which then resets the days back to day 1 if and when that information is even able to be submitted.

Like for example further evidence trom an adequately controlled study or even against just a standard cooling lubricant or blinded study versus an arousal gel





More than 60 De Novo submissions are submitted each year, but the number of De Novo Classification Requests granted ranged between 21 and 30 over the past three years.

Therefore, the 50%+ of De Novo applications denied could skew the % of De Novo that meets the MDUFA goal.

There are two problems with this goal. First, the term ‘FDA Days’ is based on calendar days minus the number of days the submission was placed on hold, and we don’t have any visibility into the number of days submissions are placed on hold.

In the past, submissions could be placed on hold multiple times during the Refusal to Accept (RTA) screening process, and the ‘FDA Days’ is reset to zero days each time the company receives an RTA hold letter.

In addition, even after the submission is finally accepted, the FDA places the submission on hold when they request additional information (i.e., AI Hold).

RTA and AI Hold periods can last up to 180 days, and during the Covid-19 pandemic, companies were allowed to extend this up to 360 days.

How long does it take FDA to review De Novo submissions?

FDA days are not the same as calendar days. Only 23.8% of De Novo submissions were reviewed within 150 calendar days. The FDA doesn’t calculate the number of FDA days as calendar days, but there is no way to know how much time each De Novo spent on hold publicly.

[lbo] 17/1/2023 16:31

No the question cannot be answered in two sentences as its only a De novo medical device application!



More than 60 De Novo submissions are submitted each year, but the number of De Novo Classification Requests granted ranged between 21 and 30 over the past three years. Therefore, the 50%+ of De Novo applications denied could skew the % of De Novo that meets the MDUFA goal.

There are two problems with this goal. First, the term ‘FDA Days’ is based on calendar days minus the number of days the submission was placed on hold, and we don’t have any visibility into the number of days submissions are placed on hold.

In the past, submissions could be placed on hold multiple times during the Refusal to Accept (RTA) screening process, and the ‘FDA Days’ is reset to zero days each time the company receives an RTA hold letter.

In addition, even after the submission is finally accepted, the FDA places the submission on hold when they request additional information (i.e., AI Hold).

RTA and AI Hold periods can last up to 180 days, and during the Covid-19 pandemic, companies were allowed to extend this up to 360 days.

How long does it take FDA to review De Novo submissions?

FDA days are not the same as calendar days. Only 23.8% of De Novo submissions were reviewed within 150 calendar days. The FDA doesn’t calculate the number of FDA days as calendar days, but there is no way to know how much time each De Novo spent on hold publicly.

[mikethebike4] 17/1/2023 16:27

JakNife

Don't rely on anything LBO says - ask him why he was kicked off the LSE thread

[lbo] 17/1/2023 15:39

Med3000 has been submitted for medical device registration only as a low class medical device via the De Novo 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 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



More than 60 De Novo submissions are submitted each year, but the number of De Novo Classification Requests granted ranged between 21 and 30 over the past three years.

Therefore, the 50%+ of De Novo applications denied could skew the % of De Novo that meets the MDUFA goal.

There are two problems with this goal. First, the term “FDA Days” is based on calendar days minus the number of days the submission was placed on hold, and we don’t have any visibility into the number of days submissions are placed on hold. In the past, submissions could be placed on hold multiple times during the Refusal to Accept (RTA) screening process, and the “FDA Days” is reset to zero days each time the company receives an RTA hold letter. In addition, even after the submission is finally accepted, the FDA places the submission on hold when they request additional information (i.e., AI Hold). RTA and AI Hold periods can last up to 180 days, and during the Covid-19 pandemic, companies were allowed to extend this up to 360 days.

How long does it take FDA to review De Novo submissions?

FDA days are not the same as calendar days. Only 23.8% of De Novo submissions were reviewed within 150 calendar days. The FDA doesn’t calculate the number of FDA days as calendar days, but there is no way to know how much time each De Novo spent on hold publicly.

[lbo] 17/1/2023 14:23

So Petroc the liar is now claiming on the record that medical device rulings on substantiation of an effect beyond placebo and the CAP code will not apply to all lower class medical devices including MED3000 which is just a class 2 medical device!? Thats his biggest lie yet!

But at least now we have yet another one of his lies on the record on a public bulletin board



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




Because the trial was not placebo-controlled, we considered AcceleDent had not provided adequate evidence to support the claim AcceleDent, is also clinically proven to reduce the pain and discomfort associated with braces and aligners by up to 71%. We concluded that the claim had not been substantiated and was misleading.

On that point the claim breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 Medicines, medical devices, health-related products and beauty products.



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



Med3000 was just the placebo in the FM57 study Therefore Futura had initially believed Med3000 had no therapeutic effect. The FM57 study did not set out to measure the efficacy of Med3000. The ASA will therefore consider that its reported effectiveness by Futura was a ‘post-hoc finding’

The CAP Code required that objective claims, including medical claims for a CE-marked medical device, be backed by evidence

a certified Class IIb medical device. We understood that the device certification was granted by a body within the European Member States that had been designated to carry out conformity assessments under the Medical Device Directive

had been used as the placebo treatment in that study, and therefore the researcher had initially believed it had no therapeutic effect. The trial did not set out to measure the efficacy

its reported effectiveness by the advertiser was a post-hoc finding due to the risk of that being a false positive finding

[lbo] 17/1/2023 12:08

Mike has decided to get involved in the pumping after years of losses and ‘giving credence’ to what the company said. He openly admitted he is ‘loathe’ to believe anything they say now. So now its obvious he is in bed with Petroc telling lies and ironically in his own words now trying to the ‘gullible̵7; to ‘get carried away’. Desperately hoping to get his money back and dump before its too late!

'petroc - 23 Nov 2022 - 18:00:42 - 14168 of 14546

I won't care, of course, because I'll have moved on,'


mikethebike4 - 11 Apr 2018 - 14:35:10 - 4072 of 11141

Having had similar waffling, 'smoke-screen' answers from Mr Barder over the years which have turned out to end in exactly nothing I am loathe to give any credence to virtually everything he says

mikethebike4 - 11 Apr 2018 - 15:58:28 - 4091 of 11141

Company is massively over valued if you go by 'concrete' results !

mikethebike4 - 11 Apr 2018 - 15:14:56 - 4082 of 11141

I only try and bring some sort of balance into the equation to help the gullible not get carried away with fanciful future projections.
I would like nothing better than to be proved wrong about Mr Barder (our CEO since 2001) and to sale away into the sunset grasping 5 times as many £s in my fist as I paid for the shares
Unfortunately for people like J7J, Mr Barder has been through this advisors process before - with CSD500 - and look where we've got in 17 years - sales of the product did not even equal the money we paid him to be our CEO for 2017 !

mikethebike4 - 06 Dec 2017 - 10:32:27 - 3468 of 10591

"A couple of decent deals and will be back off to the races."
Do you have any idea of how long shareholders have been using these words

mikethebike4 - 23 Mar 2017 - 09:52:33 - 2560 of 10591

As someone who has been invested for many years and who attended an AGM years ago and complained to Barder about the very slow progress, I am very frustrated.
All the time the Board are drawing good salaries off the backs of shareholders money they have very little incentive to get off their backsides and get 'selling' - thats what running a company is all about at the end of the day!

mikethebike4 - 24 Feb 2020 - 09:11:58 - 7290 of 9713

why should it be any different this time when you've still got the same useless lot running the show

mikethebike4 - 07 Jan 2019 - 11:22:52 - 4692 of 9641

I repeat I very much hope you are right - no one would be happier than me if you are - however I stupidly (in hindsight) bought in when everything looked really rosy - we were told there were loads of 'distributors' all 'champing at the bit to get selling a wonderful industry disruptive product (which it still is incidentally) once the 2 year shelf-life problem was fixed. This was despite the fact that the Holland/Belgium distributor was quite happy and successful selling them with the original 18 months shelf-life
And where are we now years later - one tiny distributor from which Futura receives a total sales income only just about covering Mr Barders employment remuneration
I just hope this MED/TPR situation is not just a repeat of CSD. As to why I don't just sell up, well my shareholding is worth such a tiny proportion of what I paid for it I might just as well hang on in the hope that new shareholders getting in now are luckier than I was and I can get some of my money back - I think what we need is Mr Barders retirement - that should give the share price a kick

[lbo] 17/1/2023 12:04

Yet more and more lies from the rampers! As Glavey suggested its all just based on same BS from rampers pumping the shares on bulletin boards and all over the internet!





LBO - 12 Sep 2022 - 10:41:12 - 13297 of 14873

Not short. But anyone who went short from March 2021 is still seriously in the money even if they hadn’t covered when it was down below 30p! LOL

Suspect shorters would be looking to again build short positions on the back of any further share price strength with the De Novo device registration submission announcement, possibly the ramping even around a test launch online somewhere in the EU/UK. Basically what happened with CSD500 until ultimately the realisation sets in there is no real prospect of any significant revenues especially as similar products are launched and ultimately the Med3000 product is deemed a failure. As Liberum said the risks have only moved from regulatory to execution risk. And their execution of bringing PET500, CSD500 and TPR100 to maktet have all been disasters! Yet Reckit has similar products to each of Futuras failed products still on the market (KY Duration) (Durex warming/Durex intense condoms) (Nurofen pain gel). They even admitted they cant compete with the likes of Reckitt. And that was with a product that had patent protections and some real clinically proven USPs against standard condoms. Which MED3000 does not have.against standard cooling lubricants/arousal gels already on the market.

[mikethebike4] 17/1/2023 11:37

Sorry JakNife

LBO has been desperately trying to dominate this thread for his own revenge purposes

Ignore him he has shorted this share

[glavey] 17/1/2023 09:01

Far more interesting is why the share price elevates on no real news. I'm reminded of a black hole into which 'things are sucked'. Particularly delightful is the little dance conducted by the s/p, as though it might be bouncing around the rim.