Rainbow Rare Earths Phalaborwa project shaping up to be one of the lowest cost producers globally. Watch the video here.
Continuing on from my last post where i said " Shows us the clinical trial data comparing a lube vs baseline that shows highly significant improvement in erections in mild / moderate/severe patients.
They (lubes) certainly can't go making those claims otherwise ASA will get on there case for sure right?
Furthermore, the other posts or claims you make that lubes can show equivalence and make the same claims.
Well: The definition of equivalence under the MDR is that the devices are similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device
Thereby they (lubes) have to demonstrate: a lube, when vs baseline that shows highly significant improvement in erections in mild / moderate/severe patients.
Would that cause issues for lubes trying to show device equivalence, well Yes if they Lubes cannot demonstrate no clinically significant difference in the safety and clinical performance of the comparison device (Eroxon)
Plus it is really difficult to show equivalence: https://www.med-technews.com/medtech-insights/claiming-equivalence-under-the-eu-mdr/
https://www.mensjournal.com/health-fitness/when-sex-lube-goes-bad-whats-safe-what-works-and-what-to-avoid-w446463/
"for men suffering from erectile dysfunction issues, it can actually help you stay harder longer."
Shows us the clinical trial data comparing a lube vs baseline that shows highly significant improvement in erections in mild / moderate/severe patients.
Send us the clinical trial number please or the name of the lube or protocol title.
They (lubes) certainly can't go making those claims otherwise ASA will get on there case for sure right?
Clearly some people don't understand the obvious
Irrespective of the I/E criteria. The results show highly significant change from baseline within the same person.
The erections showed highly significant improvements when treated with GTN/Dermasys compared to no treatment.
Irrespective if the person was mild / moderate / severe when: in the last 3 months: ‘if they experienced erections sometime, rarely, most of the time, sometimes when (1) mechanical stimulation by yourself or your partner, or (2) visual stimulation?’
Mild / moderate / severe - also established in the 4 week no treatment period.
They compared within each person the results of IIEF-EF, SEP2 and SEP3
- 4 week run in period where they tried sex min of 4 times - without treatment
to
- DB period - at home, where they tried sex min of 4 times - with treatment (3 dose level of GTN or Dermasy)
Results showed within each person a highly significant (p<0.001) and clinically MEANINGFUL VS BASELINE across ALL three glyceryl trinitrate (GTN) treatment arms AND THE DERMASYS placebo arm for all three primary endpoints (IIEF-EF, SEP2 and SEP3)
"So what did the couples do in the FM57 HOME USE study before and after the 15 seconds of rubbing in MED3000 to the 10 minutes it took to work in 60%? "
They did the same as they always do and have done - that is why there was a 4 week run in period - without treatment -
(TO ESTABLISH THE BASELINE)
- During the screening period, subjects and their partners are required to make a minimum of four attempts at
sexual intercourse within a 4-week period (without treatment). They will be asked to complete questionnaires to
record their experiences after each sexual intercourse attempt (using the SEP [male subjects and their female
partners]) and at the end of the 4-week period (using the IIEF and PGI-S [male subjects only] and SEAR [male
subjects and their female partners]) according to a prescribed schedule of questionnaires. Subjects who cannot
comply with the minimum number of intercourse attempts or who exceed 25 on the IIEF-EF at the end of the
screening period will be excluded from the study.
- Then the double blind phase at home (TO COMPARE THE OUTCOME TO THE BASELINE)
At home, subjects or their partners should apply the investigational medicinal product (IMP) immediately prior to
sexual intercourse and make at least four intercourse attempts in each of the three 4-weekly periods during
treatment (Weeks 1–4, 5–8 and 9–12). The subjects and their partners will be asked to complete questionnaires
using electronic patient-reported outcomes (ePRO) to record their experiences after each sexual intercourse
attempt (using the SEP questionnaire and the onset and duration of action [erection] and erection hardness
questions at home [male subjects and their female partners]), and at the end of each of the three 4-week periods
during treatment (using the IIEF, PGI-S and PGI-C questionnaires [male subjects only], and the SEAR and GAQ
questionnaires [male subjects and their female partners]; to be completed at site visits for subjects and at home
for their partners if preferred)
RESULT:
Phase III FM57 trial is highly significant (p<0.001) and clinically MEANINGFUL VS BASELINE across ALL three glyceryl trinitrate (GTN) treatment arms AND THE DERMASYS placebo arm for all three primary endpoints (IIEF-EF, SEP2 and SEP3)
HIGHLY SIGNIFICANT VS BASELINE
PLUS:
"Easy to see how a water based menthol lubricant with the same very strict compliance to the inclusion and exclusion criteria" and "greater emphasis on patient training and therefore compliance to the treatment regimen" could be replicated in a clinical setting." - THEY NEED TO SHOW IT IN A CLINCAL TRIAL VS BASELINE. SHOW US SUCH A TRIAL.
Irrespective, it will not change what is happening and coming next which is:
- Eroxon going to market.
- First OTC gel to market for ED
- $3.6 billion market
- 5% share of that estimated
- Can be used with other products / medicine
- Better safety profile that NSAIDS
- EU approved, US approval in process, Global approvals ongoing
- Patent application in progress using patent lawyers
- Will help ED sufferers
- Fast-acting and helps you get an erection within 10 minutes.
- First fast-acting topical gel for erectile dysfunction available without a doctor's prescription in Europe and the UK.
Irrespective of what mistic fortune teller Liambooth is predicting with him time machine and crystal ball.
Even if they do (and I do not agree that they have too) change wording on the packaging.
Someone suggested changing it to Eroxon - "as recommended by Laimbooth" Tried and Tested on b e l l e n d s.
All of the above is still going to happen.
What we do know Liambooth, in the past, and will in the future, continue to mislead, misinterpret, his posts and links deliberately for his own agenda. Even taking text from one article and adding word MED300 to make it look like ASA had a ruling against MED3000. Or the deliberate mislink to M8 profile, etc etc
The circumstance is this:
- Eroxon going to market.
- First OTC gel to market for ED
- $3.6 billion market
- 5% share of that estimated
- Can be used with other products / medicine
- Better safety profile that NSAIDS
- EU approved, US approval in process, Global approvals ongoing
- Patent application in progress using patent lawyers
- Will help ED sufferers
- Fast-acting and helps you get an erection within 10 minutes.
- First fast-acting topical gel for erectile dysfunction available without a doctor's prescription in Europe and the UK.
- Eroxon® is clinically proven to treat erectile dysfunction and following a large Phase 3 clinical trial was approved in April 2021 for marketing in the EU and UK.
Circumstances explained her https://eroxon.com/ and summed up well here
https://www.trinitydelta.org/research-notes/nearing-the-critical-point-in-erectile-dysfunction/
Big things to come for Eroxon
Question for you LIAMBOOTH, Why don't you answer?
As well as misleading deliberately the M8 profile in your post, Why did you also manipulate the text from the ASA Felxiseq case to make it look like in your post all the wording came from a ruling on Med30000. By replacing the word Flexiseq with Med3000? Care to tell the board why you did that?
Why is he deliberately doing this?
My Answer - He is deliberately Misleading and manipulating this board with his posts and references to suit his own agenda.
Keep posting the real information and articles highlighting where Eroxon is, which is about to be launched.
Question for you LIAMBOOTH,
As well as misleading deliberately the M8 profile in your post, Why did you also manipulate the text from the ASA Felxiseq case to make it look like in your post all the wording came from a ruling on Med30000. By replacing the word Flexiseq with Med3000? Care to tell the board why you did that?
Why is he deliberately doing this?
My Answer - He is deliberately Misleading and manipulating this board with his posts and references to suit his own agenda.
Keep posting the real information and articles highlighting where Eroxon is, which is about to be launched.
LIAMBOOTH being deceitful and misleading AGAIN.
LIAMBOOTH Posting the link in his last posts to Moksha8 Farmacéutica, S. de R.L. de C.V. - trying to show, Moksha 8 is small partner, link showing 60 employees and $2.82 million revenue
When the real deal as he knows is with Moksha 8 Inc (as per the deal, articles and RNS), HQ based in US
Real profile is 260 employees and $258m revenue, as shown here
https://www.apollo.io/companies/moksha8-Pharmaceuticals--Inc/54a1204f69702d94a4521d02?chart=count
and nice profile/INFO OF M8 shown here
https://craft.co/moksha8-pharmaceuticals
LIAMBOOTH SHOWN AGAIN TO BE DECITFUL AND MISLEADING? IS THAT THE HUNDRETH TIME THAT HAS HAPPENED?
A couple of more articles for those who may not have see them
http://www.labatecpharma.com/2021/09/29/labatec-pharma-sa-announces-exclusive-licensing-agreement-signed-with-futura-medical-to-commercialise-med3000-in-the-gulf-and-middle-east-region/
https://www.prnewswire.com/news-releases/m8-pharmaceuticals-announces-license-of-exclusive-rights-med3000-from-futura-medical-for-latin-america-301365521.html
Nicnack - the circumstance, yes your right it is this:
- Eroxon going to market.
- First OTC gel to market for ED
- $3.6 billion market
- 5% share of that estimated
- Can be used with other products / medicine
- Better safety profile that NSAIDS
- EU approved, US approval in process, Global approvals ongoing
- Patent application in progress using patent lawyers
- Will help ED sufferers
- Fast-acting and helps you get an erection within 10 minutes.
- First fast-acting topical gel for erectile dysfunction available without a doctor's prescription in Europe and the UK.
- Eroxon® is clinically proven to treat erectile dysfunction and following a large Phase 3 clinical trial was approved in April 2021 for marketing in the EU and UK.
Circumstances explained her https://eroxon.com/ and summed uo well here
sums up pretty well
https://www.trinitydelta.org/research-notes/nearing-the-critical-point-in-erectile-dysfunction/
In the cicumstane
I think this sums up pretty well
https://www.trinitydelta.org/research-notes/nearing-the-critical-point-in-erectile-dysfunction/
Med3000 was developed and uniquely formulated using the DermaSys® platform. Med3000 has penetration and permeation enhancer components tailored to suit MED3000 specific therapeutic indication and desired speed of onset and duration of action.
Repeat - penetration and permeation enhancer components tailored to suit MED3000 specific therapeutic indication and desired speed of onset and duration of action.3
https://eroxon.com/
It shows:
Eroxon® is clinically proven to treat erectile dysfunction and following a large Phase 3 clinical trial was approved in April 2021 for marketing in the EU and UK.
Eroxon® will be the first fast-acting topical treatment for erectile dysfunction available without a doctor's prescription in Europe and the UK.
Eroxon® is fast-acting and helps you get an erection within 10 minutes.
Petty nice website, I like it.
- MED3000 is supported by efficacy and safety data from a range of studies including the completed Phase 3 study.
- MED3000 achieved all co-primary clinical endpoints against before treatment (baseline) with highly statistically significant p values of less than 0.001 in all instances.
- MED3000 also showed statistical improvements on both GAQ (Global Assessment Questionnaire) and SEAR (Self-Esteem And Relationship Questionnaire) secondary endpoints.
- MED3000 also showed meaningful clinical differences across all ED patient groups, mild, moderate and severe, which is a key evaluation criteria for regulators.
- MED3000 begins to work immediately in some patients, with 60% of patients seeing onset of their erection within 10 minutes of application.
- MED3000 had an excellent safety profile with very low incidence of adverse events in males and female partners.
- There was a high degree of consistency in the data sets across the different countries and between the two CROs running the study.
- Results demonstrated that MED3000 has the potential to be a highly effective, clinically proven, topical treatment for erectile dysfunction.
- Results enabled Futura to receive approval for MED3000 in the EU as a medical device and will enable Futura to pursue the medical device regulatory pathway for MED3000 in the US.
For full and more comprehensive information please see here.
https://www.futuramedical.com/what-we-do/med3000/med3000-clinical-programme/
Just come across this, probably been seen by all, but in the public domain. A bit date Aug 2021, altough its not reeasearch using a time machine and a crystal ball like Lamebooth
https://hbw.pharmaintelligence.informa.com/RS151698/Futuras-Drug-Free-Erectile-Dysfunction-Gel-On-Track-For-US-And-EU-Launch
https://eroxon.com/
It shows:
Eroxon® is clinically proven to treat erectile dysfunction and following a large Phase 3 clinical trial was approved in April 2021 for marketing in the EU and UK.
Eroxon® will be the first fast-acting topical treatment for erectile dysfunction available without a doctor's prescription in Europe and the UK.
Eroxon® is fast-acting and helps you get an erection within 10 minutes.
Petty nice website, I like it.
@martinel
He is talking to anyone reading this BB including existing and new PI's.
So misleading all
Staying stum and hoping he goes away, has not worked has it so far.
He ain't going away at all. You don't when it is is your job to post and bash a share.
Are you talking to yourself and disusing / arguing your own posts with yourself now, because you are making no sense:
You posted an argument that CSD500 (condom) failed, no royalties, Med3000 will do the same, blah blah.,
I came back and said you cannot compare CSD500 to MED3000, "Totally different products, totally’." first gel to OTC market for ED blah
You came back and said "‘ Totally different products, totally’. Sadly not supported by the facts. A lubricant with menthol can claim the exact same mode of action and effect as Med3000 "
Get yourself check out man, or take a break. No credibility, misleading and not making any sense
Stick to bashing other shares somewhere else.
I am about to give up on this fool, he has been proven totally false, misleading and no credibility.
Proves nothing.
When MED3000 hits the market, as first to OTC market, no competitor gel out there, in a 3.6billion market, grabbing market share, proved to work and does, sales will be made in there millions, and then royalties will be made.
Your argument, is because CD500 didn't sell this will not.
Totally different products, totally.
May companies have set backs, even big ones like Apple when they started out, you cannot use that to say tMED3000 will not be a success. It works and proven to work and will be First to OTC Gel for ED. Can be used with other treatment, much safer than Viagra and Cialis etc.
Approved in EU, soon to be approved in US.
deals done, more to come.
CE marked
Will smash it.