Futura Medical Share Discussion Threads

[j777j] 31/8/2022 14:06

The results of the FM71 trial of MED3000 showed that the topical gel formulation achieved a significant improvement in erectile function compared to baseline at 24 weeks, across the range of mild, moderate and severe ED.The treatment also has a 10-minute onset of action that, according to Future, is "demonstrably faster" than the orally-dosed active comparator (tadalafil) used in the study, and also avoids the potential side effects of oral drugs for ED, which can take 30-60 minutes to take effect.

[lbo] 31/8/2022 14:02

Highly positive results from an unblinded and uncontrolled FM71 medical device study on a gel that is massaged in and was being claimed on the internet to be ‘clinically proven!? LOL

When the full results of FM71 be published for peer review? Why no comment form Arthur Burnett?



Placebo effect can be a social thing
Doctors’ beliefs influence patients’ pain, study finds.

Doctors were, in effect, transferring their own placebo response to thermedol to their patients, something the authors call the “socially transmitted placebo effect”.

Which, if you think about it, could come in very handy in an actual medical clinic.

“This finding… highlights the importance of explicit training in bedside manner when delivering information and interventions,”

[petroc] 31/8/2022 13:47

LiarBO is doing exactly as we said he would. Hahahaha! Dance for me, biatch!

[j777j] 31/8/2022 13:44

Here is one back




"the data are highly positive and in line with data previously published in the FM57 study, but importantly spanning 24 weeks rather than 12 weeks in the FM57 study. In FM71, MED3000 met both co-primary endpoints of exerting: i) a statistically significant (p<0.001) improvements vs. baseline across all erectile dysfunction patients (mild, moderate and severe); and ii) a clinically meaningful improvement in erectile function at 24 weeks versus baseline. The 5.73 IIEF-EF unit change at 24 weeks exceeds the 4-unit score difference (vs. baseline) internationally accepted as the Minimal Clinical Important Difference necessary to demonstrate a clinically meaningful therapeutic effect. Encouragingly, MED3000 exceeds this 4-unit level at each monthly time point, showing a durable effect over the 24-week period that in fact improved from beginning to end as individuals got presumably more accustomed to MED3000 usage."

[keifer derrin] 31/8/2022 13:44

FUM should be releasing their interim report in September. Let's hope they let the market know the plan to get MED to market

[j777j] 31/8/2022 13:43

he is absolutely hysterical.

He has been spending all morning copying and pasting articles

[lbo] 31/8/2022 13:23

So Dermasys and Voltaren vehicle gels are similar alcohol and water gels and both cause evaporative cooling when there is no drug to deliver!?



“We are not going to progress on this particular compound for normal commercial reasons which we do not wish to go into,” GSK said.




VOLTAREN VEHICLE gel is the carrier substance of ˜Voltaren Schmerzgel’ (German trade name) or ˜Voltaren Emulgel’ (European trade name) drugs (NSAIDs), such as diclofenac

When the gel matrix is destroyed after application to the skin, the bound water and alcohol evaporates and a measurable cooling-effect results.

[lbo] 31/8/2022 13:13

Why did Ken mention at the end of the interview that it will create a new ‘OTC category’? I wonder why! LOL

Probably because anyone including Reckitt can launch similar alcohol and water gel placebo products that are rubbed in for ED. 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’

[broomrigg] 31/8/2022 13:04

LBO finally shows up..... bang goes the balanced discussion.

[sos100] 31/8/2022 12:46

when you get REPEATED deramping or negative posts with no basis it's normally a sign of good things to come :)

[lbo] 31/8/2022 12:32

What happened next gets to the FTCs allegation that the respondents, in effect, deceptively sliced and diced the data in search of a positive marketing message. According to the complaint, the respondents subjected the data to post hoc analyses of different subgroups of test subjects. (The complaint describes a post hoc analysis as statistical analysis conducted after the data have been collected in hopes of discovering statistical relationships that suggest cause and effect.) The FTC concern is that unplanned, post hoc subgroup analyses pose a high risk of generating spurious findings.




One specialist commentator felt that the clinical effectiveness has not been demonstrated. The absence of an adequate placebo (an inactive topical gel) for highlighted as a limitation by 3 commentators. One commentator said that without it, the clinical effectiveness could be attributed to the placebo effect of rubbing a gel

[lbo] 31/8/2022 12:28

This placebo effect was most pronounced in men with post-traumatic stress disorder (PTSD), suggesting that for some men psychology is more important than physiology in dealing with erectile dysfunction, said lead researcher Alexander Stridh of the Karolinska Institute's department of clinical neuroscience, in Stockholm.
"The placebo response seems largely more important when the cause of [erectile dysfunction] is mainly due to psychogenic factors, as in post-traumatic stress disorder," Stridh said.
For this analysis, his team pooled data from 63 studies involving more than 12,500 men.
The studies showed that Viagra and its relatives had a strong effect helping men who had erectile dysfunction due to chronic illness.
"The studies included in this meta-analysis mainly were trials on men with [erectile dysfunction] due to cardiovascular disease, diabetes, etc.," Stridh said. "It is likely that there is a limit to how much the brain can influence erectile function when the problem is mainly dysfunctions in blood vessels or peripheral nerves."
But the researchers found that men in the placebo arm of these trials also experienced a small to moderate improvement of their erectile function. The placebo effect was notably stronger among men with PTSD.
"This paper highlights the importance of taking into account the underlying cause of [erectile dysfunction] in each individual, which could also help determine what the best treatment option would be," Stridh said. Some men might benefit more from psychotherapy, others with a pharmaceutical approach, he added.

[lbo] 31/8/2022 12:25

Will they be publishing all the data and the results from each subgroup for peer review? eg Organic ED verus Psychological ED etc

Or just giving the pooled results? LOL


‘96 male patients clinically diagnosed with a mix of mild, moderate and severe ED against baseline (pre-treatment). Subjects were recruited from United States (African Americans), Poland, Georgia and Bulgaria and included men who had organic and psychological ED or a combination of both’



Predictors of Erectile Function Normalization in Men With Erectile Dysfunction Treated With Placebo

Odds estimates indicated the largest likelihood of placebo response occurred in men who were black (odds=20.2, P<0.0001), were younger than 45 years (odds=7.3, P<0.0001), had mild ED (baseline IIEF-EFD ≥17; odds>100, P<0.0001), and did not have diabetes (odds=4.5, P<0.0001). The likelihood of a placebo response decreased as ED duration increased (odds=0.74, P<0.0001).

[haveapunt1] 31/8/2022 12:12

The company has made it clear there is no need for a placing. See RNS 26 April 22 "Current cash runway extends beyond initial MED3000 launches expected over the next year and expected US regulatory approval in 2023, assuming no contributions from milestone payments or other revenues."
Pretty clear to me. NO RAISE.

[lbo] 31/8/2022 12:05

Sinking ship come to mind!

But at the least the results from the not adequately controlled study were all positive! Or were they?

All FM71 shows is a placebo gel has placebo effects in ED. Nothing that wasn’t known beforehand



‘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.

[keifer derrin] 31/8/2022 11:57

interview with James B.

[keifer derrin] 31/8/2022 11:26

what is all this talk of placing. They have stated they have enough money, even without the milestone payments to bring this to market.

[dgdg1] 31/8/2022 11:12

Most likely reason for the drop is that there is a placing coming, say at 40p, but this doesn't really bother me, as it won't need to be a big one, and once it's done the price should rise.

[dgdg1] 31/8/2022 11:05

He will most likely say that a) there is no patent, which is not true because the company keep saying that there is, and b) that the study shows it is less effective than Cialis, but on this I would say that on the larger previous study of Cialis quoted by Futura, the effectiveness of Cialis was similar to MED, and also that even if this is so MED still has significant advantages - no prescription needed, no side-effects, can be used by those who aren't allowed to use Cialis and similar drugs, and fast onset. So there should still be plenty of demand for MED.

[j777j] 31/8/2022 11:01

Feel for the punters that got stung at 51p this am

The problem in a bear market is the instis slam rallies into the unsuspecting hands of retail punters.

[petroc] 31/8/2022 10:58

I have to say I took a little profit this morning, I'll probably come back in when the share price slides back to 30p, which is the usual pattern for this stock. Still have the majority of my holding because I believe in this, just waiting for the big one. Punters might be a little singed on this, but don't lose heart! We've all been there at some stage! Anyone thinking that LiarBO has disappeared, think again. When the share price rocketed on the EU approval was when he started firing on all stock bashing cylinders! In fact, that was when he opened multiple aliases, eg LiamBooth on LSE and started spreading his poison over there. Right now he's just waiting for the euphoria to blow over as he studies the RNS, furiously looking for negative points that he can use. He'll probably start with me having taken a little profit, and accuse me of pump & dumping, then he'll move on to J7 and compare some of his ramping posts to today's call for calm. We know he's going to say all this so it doesn't bother LTHs as we're used to his nonsense and anti-FUM propaganda. Another thing he'll take issue with is the use of the term FDA approval that's being bandied about today. He's got several copy/paste comments ready to go on that score, like anyone cares!

[haveapunt1] 31/8/2022 10:44

Think we will drop back under 40p now (roll eyes)

[j777j] 31/8/2022 10:31

Punters burned as usual on this stock


Lombard probably offloading into this bear market