Futura Medical Share Discussion Threads

[haveapunt1] 11/5/2023 09:06

Communication from company this morning as follows:-

“Many thanks for your email.

We can confirm that all press releases are reviewed and approved by the NOMAD in advance of publication and we will release all press releases without delay and in accordance with the rules and regulation by which we must adhere to as a listed Company.

In relation to the FDA, we only ever release any updates once we have received formal minutes from the FDA, which was the case in the instance that you outlined below and these are issued without delay.”

My guess is they have been told bad news, and just waiting on minutes to be issued to then RNS.

The final paragraph strikes me as odd, added to which the drop in price by over 15%, and the increase volume in unloading today, which stikes me as a bit more of an urgent sell

[lbo] 11/5/2023 08:05

Something seems to have leaked with volume of trades so high so early? Along with the Haveapunt1 claim the other day on a public bulletin board. You would think the company would need to make some clarification statement now?

haveapunt 19 May '23 - 07:08 - 18753 of 18767

‘They knew the FDA had come back 2 weeks before notifying the market (given FUM said the data takes 4 weeks to prepare and we are expecting to issue in the next 2 weeks). This means they held back on notification to the market’

[lbo] 10/5/2023 19:58

Thanks again to Petroc for highlighting that Medical devices like Eroxon are more likely to be associated with causing harm to the users!



In the past 10 years, medical device quality issues have caused 83,000 patient deaths 409.5 million medical device units were recalled in 2016-2017, averaging 58.19 million units per quarter.



findings suggest that products introduced earlier in their development cycle are also more likely to increase the risk of harms




researchers found that medical devices that were first approved in the European Union were associated with a greater rate of safety issues than devices first approved by FDA

Researchers examined 309 devices, 206 of which were approved by the FDA and the EU. Sixty-three percent were approved first in the EU

The researchers found that the devices approved first by the EU were three times more likely to require safety alerts and recalls’

[lbo] 10/5/2023 19:56

So thats over 10 years and millions and millions of users!



A Viagra study also showed using a placebo was also just as likely to harm you. It compared some 4,500 patients taking the drug to about 3,100 on placebo. So based on that study Med3000 even as a placebo is just as likely to harm you as viagra

Millions and millions of men have used Viagra safely over many many years. So thats billions of doses taken. Yet its only linked to a few deaths. More men die from deaths associated with medical devices which Med3000 is. And even placebo gels like MED3000 claiming to be a treatment for ED with no appropriate assessment will be associated with deaths and thousands of reports of side effects if it ever manages to be even used by enough men over time. Even a man uses a placebo gel like Eroxon but who has an underlying condition like high blood pressure and drinks heavily yet delays getting appropriate could be associated as it was available OTC could result in a fatal outcome.

The objective data over many years of use. After appropriate assessment and correct use has proven Viagra to be effective and safe. Viagra has a well-established efficacy and tolerability profile. From its introduction in 1998 to 2016, over 64m men worldwide were treated with sildenafil citrate. 'The safety profile of sildenafil citrate is based on over 9,570 patients in 74 double blind placebo-controlled clinical studies as well as postmarketing surveillance that has been gathered over 10 years.' And correlation is not causation. Meanwhile there is no medium and long term safety data on Med3000 use in the real world.

[petroc] 10/5/2023 18:18

'Reviewing and analyzing the adverse effects of PDE5 inhibitors that have been reported to the FDA in a period of 10 years showed a total of 26,451 adverse events, of which death reports represent 8.3%. A total of 14,818 adverse events were reported with sildenafil used to treat erectile dysfunction and were associated with the highest number of death reports among the PDE5 inhibitors group, at 12.3%'

[lbo] 10/5/2023 15:55

Erectile dysfunction drugs linked to lower risk of heart problems






Cut Risk of Early Death From Heart Disease by 25 Percent

A large new study shows that men who take erectile dysfunction medication are less likely to experience heart failure, stroke, and heart attack.

[lbo] 10/5/2023 12:41

Expert Forum series on the hidden burdens of erectile dysfunction, moderator Arthur L. Burnett II, MD, MBA, and panelists Martin S. Gross, MD, John J. Mulcahy, MD, PhD, and Faysal Yafi, MD, FRCSChttps://www.urologytimes.com/view/erectile-dysfunction-and-the-emergence-of-direct-to-consumer-companies'that patient has lost an opportunity for being screened for other medical conditions with their ED. You get the guy who comes in to see you for ED; I have a routine...we do a Doppler, there's an arterial finding, we'll send those guys to be seen by a cardiologist, [and] we'll do some additional testing. Those guys are not getting a physical exam, they're not getting screened for other medical conditions'

[lbo] 10/5/2023 09:46

Reminds me of keifer recent post about what was being claimed as one of the ‘clinical implications’ of Eroxon.

‘fast access to patients and reducing workload in General Practice and Pharmacy for patients that typically need to be referred to a prescriber’

Not sure ‘fast’ is not where serious risks arise that patients with more serious underlying disease for their ED could be missed and OTC products (especially a drug free medical device gel which presents as ‘clinically proven’ like a medicine) with no pharmacy assessment at all leads to delays in diagnosis and treatment of the real underlying problem!?


keifer derrin - 15 Mar 2023 - 17:31:42 - 17261 of 18759

Dactions on the LSE FUM board has joined the Webniar - this is what he's put in the post - all going in the right direction...


I have today received my confirmation to attend next week's webinar as follows:

Details
The webinar will provide an overview of the clinical data and clinical implications of Eroxon® Stimgel and what this means for you and your patients.

Eroxon® Stimgel
- Available over-the-counter in pharmacies providing fast access to patients and reducing workload in General Practice and Pharmacy for patients that typically need to be referred to a prescriber.

[keifer derrin] 09/5/2023 11:47

haveapunt1 - you might be right, but the FDA are well known to not hit their time lines which is why I think FUM said by the end of the 2nd qtr.

But FUM are pretty lousy at keeping investors informed. I've emailed them plenty of times and they just come back with rubbish answers. But then in their defense they are a small oompany with not many staff.

LBR - don't bother responding as I've got you filtered you waste of a human being...

[lbo] 09/5/2023 10:01

I mean its not that difficult for a class 2 ED device to get registered is it? But they will never have ‘FDA approval’ or be allowed claim they have!




Regulation: Eddie is not approved by the FDA, though it is an FDA-registered class II medical device for maintaining an erection in men with erectile dysfunction, meaning the FDA is aware of the device but hasn’t confirmed its safety or effectiveness.

What Experts Say About Eddie

It’s difficult to confirm how well the Eddie works due to a lack of published research, says Dr. Shah. Results of a clinical trial sponsored by Giddy and posted on the company’s website show that 93% of participants reported higher quality erections during use, 95% noted an increase in achieving erection long enough to orgasm, and 81% said they were more satisfied with their erections. However, these results are not published in a peer-reviewed medical journal—making the data difficult to validate.

[lbo] 09/5/2023 09:42

‘FUM management have been selective in updating the market’

Really? That is a serious accusation about FUM management not releasing material information in timely manner to the market?

For me way the issue still remains that even if the MED3000 De novo medical device application is not denied or put on hold requesting further information. The Med3000/Eroxon gel still cannot substantiate any effect beyond a placebo with any adequately controlled study to the FTC or ASA. It cannot even substantiate that is having any effect beyond what a standard cooling lubricant or arousal gel would if the user is just led to believe its a real treatment for their ED.



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

[haveapunt1] 09/5/2023 07:39

3rd October 2022 RNS, allow a further 2 weeks to actually submit, so say FDA 150 day clock started 17th October. Plus 150 days would take us to 16 March 2023.

RNS 14th March notifying the market of the FDA request for further information. There are two options.

Either a) the FDA notified FUM around the target 150 day area, or b) the FDA notified FUM around two weeks before the RNS was issued which would concur with the recent company interview (that the data would take 4 weeks and we aim to submit by the end of March).

Therefore, the likely timeline could be:-
FDA submission circa 17 October 2022
FDA RFI circa 1 March 2023
Clock therefore stops around day 133
RNS 29 March 23 confirms resubmission to the FDA and clock recommences

Todays date (9 May), is a further 42 days from resubmission.

This therefore takes the FDA clock to day 175

[haveapunt1] 09/5/2023 07:08

My guess is yet again the FDA have asked further questions and FUM management have been selective in updating the market. You only have to work back from the timeframes and listen to the interview. They knew the FDA had come back 2 weeks before notifying the market (given FUM said the data takes 4 weeks to prepare and we are expecting to issue in the next 2 weeks). This means they held back on notification to the market. You then work back from September initial submission to early March, and you’re around 130 days, so let’s say 130 days clock stopped. Clock started again 40 plus days ago as of today. That’s 160 days. Doesn’t stack up

[petroc] 05/5/2023 23:03

Hahaha! Your defensive posts are getting weaker and weaker each time you post them!