Futura Medical Share Discussion Threads

[mdi] 01/6/2024 20:58

Futura admitted they used the 'least burdensome approach' of a De novo medical device application to get the marketing authorisation hTtps://www.annualreports.com/HostedData/AnnualReportArchive/f/LSE_FUM_2020.pdf˜with MED3000 taking a 'least burdensome approach'hTtps://www.greenlight.guru/blog/when-to-throw-the-least-burdensome-flag-on-fda'when to throw the least burdensome flag on fda'This approach only requires a low class medical device to meet a threshold of 'reasonable assurance of some effect including the effect just being a placebo effect. Eroxon still has not been 'clinically proven' to have any effect beyond any similar Hydroalcoholic placebo gel in any fully blinded study. A standard that all PDE5i drugs meet.hTtps://www.healthnewsreview.org/toolkit/tips-for-understanding-studies/medical-devices/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 OKJournalists 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 devicesNinety-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 routeFor 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.

[mdi] 01/6/2024 15:03

Any similar hydroalcoholic gel can also now ‘meet criteria for same intended use’ of ‘cooling effect’ and ‘stimulates the nerve endings’ and be able to get equivalent FDA marketing authorisation as a similar low class medical device to Eroxon via the 510k pathway




˜ Voltaren vehicle gel application resulted in a rapid reduction of skin surface temperature’

‘The cooling effect was experienced by 94% subjects’

˜When the gel matrix is destroyed after application to the skin, the bound water and alcohol evaporates and a measurable cooling-effect results. Consumer satisfaction with a topical product is based on subjective criteria such as how the product feels and how it is perceived on the skin’




‘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’



‘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’

[takeiteasy] 31/5/2024 20:52

Crikey a 19 day gap in posting from 11/5 to 30/5 - whatever next.

I know, he might find some new insight that is actually helpful.

[bandflex] 30/5/2024 10:36

hxxps://www.haleon.com/content/dam/haleon/corporate/documents/investors/results/q1-2024/Haleon%20Q1%202024_Transcipt%201-May-2024.pdf.downloadasset.pdf

May 1st Haleon Q1 trading update analyst discussion, page 13. Hestler is Haleon CFO. Still looks like early 2025 for Eroxon launch in USA.

And then on Eroxon, the erectile dysfunction cream, we had said at full-year that we would
intend to launch it in 12 months. So that means now within ten. We are making good progress
on ramping up and building the production, so all these plans are tracking along nicely. And
then sort of once we get closer to the launch date, we would, of course, inform you about it.
So, excited about it. It progresses very much as planned. So next ten months, this should come
to the market then as well.
Bruno Monteyne: Thank you.
Tobias Hestler: Thanks, Bruno.

[petroc] 11/5/2024 11:21

Either MDI was up watching the Northern Lights or he was in Glavey's portakabin 'helping' with the night watchman duties! I mean, who else posts comments on FUM in the early hours of the morning apart from rabid stock bashers?

[takeiteasy] 09/5/2024 19:35

These are very basic A level accounting points and of no issue whatsoever for anyone who understands how financial accounting works. I took the trouble to explain this to you in more detail a while back so will not do so again :)

So this attempt fails at making any argument that you imply.

Please rest there genuinely - I know how desparate you are but there is a life to live...

[mdi] 09/5/2024 19:26

Really? So why are upfront payments contract liabilities?

‘upfront milestone payment which is to be recognised as a Contract Liability until satisfaction of the performance obligations’

Or ‘royalties not being recognised in full until it is highly probable that a significant reversal in the amount of cumulative revenue recognised will not occur’

And that ‘Futura will remain Legal Manufacturer’ and therefore can be held ‘responsible’ for all legal claims. Why aren’t any of the distributors accepting the same legal risks if they apparently fully accept Eroxon is not a sham device and the marketing is not misleading any men?

‘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’



‘Other variable considerations such as milestone payments and royalties are not recognised in full until it is highly probable that a significant reversal in the amount of cumulative revenue recognised will not occur. In managements opinion, that will be when the Groups customer confirms that the milestone has been met or that a royalty is due’

[takeiteasy] 09/5/2024 19:18

Who accepts this.

Everyone who is closely allied to the business i.e. management, suppliers and sales network - they are all marketing the firm on this basis.

There is simply no more to discuss on this matter.

Anyway time for me to sign off again.

[takeiteasy] 09/5/2024 18:56

This is simply so dull - we have had this argument 3 times - I accept the testing the firm has done (and so does everyone else) as a valid proxy for what is required.

Yes, you can endlessly state the regulations but when the firm has done the level of testing it has done then that is more than sufficient given the acceptance from all parties bar a few whining medics ....

You do not accept it - everyone knows you do not. So try another topic to discuss.

[takeiteasy] 09/5/2024 18:36

approval to sell yes in USA is fine..does not have to mean more than that..you worry endlessly about the wrong issues. it is not a sham device so stop trying to wind everyone up...what you fail to understand is as I have said before everyone knows what you know ...so why repeat yourself 100 times over...

[petroc] 09/5/2024 18:25

MDI, it's impossible to underestimate you.

[mdi] 09/5/2024 17:57

‘Men with erectile dysfunction (ED) who were in the placebo arm of clinical trials of phosphodiesterase 5 inhibitors (PDE5Is) had significant improvement in erectile function’



‘the placebo effect in RCT of iPDE5 for ED occurs at a rate as high as 50%’



‘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’



Placebo Treatment: Don't Eat It, Rub it!

˜indications to suggest that a topical placebo induces stronger effects than an oral placebo’