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interesting and very positive posts this afternoon.for once i'm grateful to booth for highlighting the very positive nature of the fda trial contruct. i totally understand and accept the desirability of extending the inclusion criteria .this will (assuming a reasonably positive outcome), greatly strengthen the robustness to the trial data. i expect, in that event, fum will have no difficulty in maintaining a clinically proven statement despite the lack of a placebo comparator. furthermore, the fact that fum have been happy to accept what may be more rigorous trial criteria, strongly suggests significant confidence in the outcome,.bear in mind fum did not have to agree to an fda trial at all.they could have rested on their laurels and marketed in eu on basis of ce mark and gone for other areas without fda. clearly they are confident of the outcome and i am very encouraged by this. i think we should all be very grateful to booth for drawing this positive aspect to out attention.
Hey Italian, I agree.
The minutes signify agreement between the FDA and Futura on the detailed clinical study design (protocol) for the small confirmatory clinical study, FM71, to be conducted prior to formal regulatory submission as a DeNovo Medical Device.
FM71 is designed to provide supplementary efficacy data to the previously reported FM57 study with a “least burdensome” approach and modest cost. Whilst the overall design is similar to that of the previous large phase 3 FM57 study that recruited approximately 1000 patients, no placebo (sham) cohort is required, hence the study is relatively smaller in size with approximately 100 patients.
Very positive regardless.
operative words being"least burdensome"ss.indicates positivity towards the trial success imo.
"Impression". It is clear what is being tested you numpty.
This is what you get from people paid to twist the narrative
astonishingly asinine post.so the fda have agree to a trial to test something but they are not clear as to what it is! this one will run and run.lol
it is undergoing clinical trial testing with the following objectives, meaning : FM71 is designed to provide supplementary efficacy data to the previously reported FM57 study
With the efficacy data collected it is clinically proven, whether someone who is more of less less qualified / not qualified at all to make such claims, it is still irrelevant. It will be the regulatory and standards authoritiies that will determine the claim made and if the agree on a case by case basis not flexiseq or another example.
But they have the clinical data to show it if efficacious for improved ED from baseline.
Primary Outcome Measures :
Improvement in EF in patients receiving MED3000 gel [ Time Frame: 24 weeks ]
Demonstrate an improvement of erectile function in patients randomised to receive MED3000 using the IIEF-EF patient reported out outcome instrument.
Mean change of EF from baseline score (Rosen et al 2011) [ Time Frame: 24 weeks ]
Observe a mean change from baseline (IIEF-EF) is greater or equal to the minimal clinically importance difference as published in Rosen et al 2011
Secondary Outcome Measures :
Onset of Action speed of MED3000 (onset of erection) [ Time Frame: 24 weeks ]
Demonstrate a speed of onset of action from application of MED3000 gel to the time when patient notices their erection starting.
Onset of Action speed of MED3000 (penetrative sex) [ Time Frame: 24 weeks ]
Demonstrate a speed of onset of action from application of MED3000 gel to the time when the patients is able to have penetrative sex.
Other Outcome Measures:
Difference from baseline scores (MED3000 and tadalafil) [ Time Frame: 24 weeks ]
Estimate a difference between MED3000 and tadalafil in improvement compared to baseline of IIEF-EF
Mean change in IIEF- EF from baseline scores [ Time Frame: 20 weeks ]
Evaluate the mean change from baseline (IIEF-EF) at Weeks 4, 8, 12, 16 and 20 post-randomisation
Proportion of patients reporting improvement in IIEF-EF scores as per Rosen et al 2011 [ Time Frame: 24 weeks ]
Evaluate the proportion of patients reporting a meaningful improvement in IIEF-EF scores according to the criteria published by Rosen et al 2011
Mean score change in questions 3 and 4 in IIEF [ Time Frame: 24 weeks ]
Evaluate the mean change from baseline scores in questions 3, and 4 of the IIEF assessed at every 4 weeks after randomisation
Mean change in baseline score (other IIEF domains) [ Time Frame: 24 weeks ]
Evaluate the mean change from baseline of other IIEF domains assessed every 4 weeks after randomisation
SEAR evaluaiton [ Time Frame: 24 weeks ]
Evaluate the sexual intercourse experience using the Self-Esteem And Relationship questionnaire.
Safety [ Time Frame: 24 weeks ]
Evaluate the safety of MED3000 and tadalafil using the occurence and severity of treatment-emergent adverse events and standard physical and laboratory assessments.
to the point it is improved to go to market in the EU and that is what matters and it does work and show to improved ED. Cannot argue that it does not work.
Does it work = A BIG FAT YES IT WORKS
Works for mild moderate and severe ED.
US and other markets coming
going global
3.6billion market
Cant stop it.
If we examine booth the basher's exact words, as he frequently says we should, we can draw our own conclusions.
"Yes I am a private investor so I research my investments thoroughly and repeatedly. If I make bad investments I lose money."
Clearly he sees FUM as a bad investment, as proved by all the negative posts he makes. He doesn't want to lose money - who does?- so therefore he doesn't have any shares in FUM, or maybe a couple so he can turn up at shareholder meetings and make a nuisance of himself.
The most compelling part of his statement is the fact he says "I am a private investor..." rather than "I am invested in FUM"
We have seen time and time again how booth uses his words to twist the meaning of something, so it's perfectly clear he is not a FUM investor. Which begs the question, what is he doing here? The only logical explanation is to bash the stock.
This has all been said before, of course, but I felt the need to highlight it again in case a visitor to this board wasn't aware of the history.
pleasw note the anonymous author of the superficial smsna article does not claim to have carried out any independent in depth assessment of the data, which it ends by conceding has been sufficient to lead to the grant of a c/e mark and to lead the fda to sanction its own trial. nothing to see here folks!
nothing revelatory here.hardly surprising that if companies make broad and unsubstantiated claims they will get their knuckles rapped.cant imagine anyone would think otherwise.nothing to suggest fum or its licensees will do this.
Message is loud and clear, MED3000 shown and clinically proven to improve ED function from baseline for mild moderate and sever
To the extent that experts says it is approaching the efficacy of first line treatment such as Viagra Cialis etc .
It improved ED and shown to do so and works.
"Can’t be scientifically substantiated with the studies not being placebo controlled so can’t be claimed in the EU according to EU court rulings, UK according to ASA rulings or USA according to FTC rulings."
Says who, You and the two articles you keep linking. One is anonymous author of the superficial smsna article does not claim to have carried out any independent in depth assessment of the data (as noted by many on here again and again)
The other is by Neuroskeptic, who is anonymous also.
Who are you also, are you speaking / representing the FDA, ASA, EU notified body?. No. You are a share basher and that's all.
Don't get ahead of your station as a employee, who's objective is to bash shares and think you speak for those that matter.
In fact you don't matter at all, neither do the two articles, what matters is the regulatory authorities., and one has approved already MED3000 for EU.
If it is good for the people and the organisations that matter, i.e., the regulatory authorities such as EU notified bodies, FDA, etc etc then its is good for me that it is clinically proven
Because Liambooth says it is not, doesn't mean bleep, like the rest of the garbage and scaremongering he is pedling on direction for those you are reporting too.
it most certainly is not a fact. each case would have to be considered and decided upon on its own facts and not in vacuo.neither article supports booth's statement in the slightest.
wrong.each case is decided on its individual merits and facts.precedents are relevant but can be distinguished in the legal sense if individual facts differ.there is no fact here ,merely opinion.
Each case has different data, objectives, information, claims , marketing material, facts, merits, etc etc
They are determined on a case by case basis and The Italian says.
until they the authorities say so, the rest if noise
desperation gone mad! i repeat each case will be assessed on its individual facts and merits. issues cannot and should not be pre -judged in advance. precedence can and should serve as a guide, but individual facts determine the actual outcome.
The experts, press, medical journals: Eroxon / Med3000 is clinical proven and it is. Medically a clinically proven over and over again. Approved in EU by actual regulatory bodies.
The share basher is claiming it is not. I wonder what his motive and instructions from his bosses are allegedly?
Paid to make such claims, maybe as allegedly since March 2021 (the spike)?
He does not matter, never has, he is not from FDA, ASA, EU notified bodies, he is from nothing that matters. He doesn't matter, and neither does his biased instructed opinion. Paid and directed to have an opinion maybe? likely?
Well yes, Make your own assessment.
Clinically proven as per all these links (hundreds more and not just 2 LMAO). M8 and Labatech sign agreement based on it is proven. they are experts, not numpties that don't matter like Liambooth.
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://moksha8.com/18.html
Signed agreements, both Labatech and M8, and that is not mentioning the South Asia deal.
LMAO at idiots who try to say they know better than corporations, experts, regulatory authorities and agencies and the signed agreements. I guess allegedly they are paid to have biased opinions and are directed.
https://www.sharesmagazine.co.uk/news/market/LSE20210319070003_3916209/Futura-Receives-Recommendation-for-Approval
https://www.proactiveinvestors.co.uk/companies/news/948153/futura-medical-confirms-eu-ce-mark-for-med3000-has-been-granted-948153.html
https://www.otctoolbox.com/industry-news/futuras-med3000-gains-ce-mark-in-europe
https://www.trinitydelta.org/research-notes/med3000-receives-ce-mark-as-a-class-iib-device/
Who are you also, are you speaking / representing the FDA, ASA, EU notified body?. No. You are a employed basher right?
Shame LSE don't do nothing about such corrupt practices in general.
Don't get ahead of your station as a grunt.
In fact you don't matter at all, neither do the two articles, what matters is the regulatory authorities., and one has approved already MED3000 for EU.
If it is good for the people and the organisations that matter, i.e., the regulatory authorities, the commercial deals and agencies such as EU notified bodies, FDA, etc etc then its is good for me that it is clinically proven
read the disclaimers
SMSNA
"Disclaimer
The information on this website is intended for educational purposes only. It is not intended to be used for the diagnosis or treatment of any specific medical condition, which should only be done by a qualified physician or health care professional."
And you keep claiming it should be accepted LMAO. Even they say. It's educational only, but seek professional opinion by "qualified physician or health care professional."
Kalmbach (Discovery) article posted..says payment etc?
Your interactions with organizations and/or individuals, including payment and delivery of goods or services, and any other terms, conditions, warranties or representations associated with such dealings, are solely between you and such organizations and/or individuals. You should make whatever investigation you feel necessary or appropriate before proceeding with any online or offline transaction with any of these organizations or individuals.
You agree that Kalmbach Publishing Co. shall not be responsible or liable for any loss or damage of any sort incurred as the result of any such dealings. If there is a dispute between participants on this site, or between users and any third party, you understand and agree that Kalmbach Publishing Co. is under no obligation to become involved. In the event that you have a dispute with one or more other users, you hereby release Kalmbach Publishing Co., its officers, employees, agents and successors in rights from claims, demands and damages (actual and consequential) of every kind or nature, known or unknown, suspected and unsuspected, disclosed and undisclosed, arising out of or in any way related to such disputes and/or our service.
Violation of any of these agreements will result in the termination of your account with the sites. While we prohibit such conduct and content on our site, you understand and agree that Kalmbach Publishing Co. cannot be responsible for the content posted on its sites and you nonetheless may be exposed to such materials and that you use the sites at your own risk.
Is that it disclaimers? all your links also have disclaimers?
Your point it mute as you should be.
If only your employers told you to S T FU.
Don't get ahead of your station as a grunt. May be seek your employers guidance on improvement needed.
In fact you don't matter at all, neither do the two articles, what matters is the regulatory authorities., and one has approved already MED3000 for EU.
The FACT is the press, experts, agreement between corporations, the Investment sites, Medical sites, FUM, BOD, Investor meeting and presentations...basically everyone is writing medically proven
The only people that are non are two anonymous articles and a employed share basher.
LMAO FACTS
except the share bnasher FACT.,
Your argument is flawed re "because its been written something is clinically proven that is substantive evidence to claim it’s clinically proven. That is false."
Whereas you been claiming because it is written in 2 anonymous articles (Discovery and SMSNA) and you write it in posts - then it must be true. What BS, you just contradicted yourself and made your self look a bigger fool than usual.
Why do you posts the articles then , if you don't believe a written word?
Hundreds of articles, experts in ED, companies involved, BOD, Investor relations, Media are all saying it works, expect the paid basher and 2 anonymous article.
Go figure that logic, actually that is easy, just think, employed with an agenda.
https://www.thepharmaletter.com/article/futura-medical-out-licenses-med3000-for-key-latin-american-markets
https://www.investments.bankofscotland.co.uk/markets-and-insights/market-news/article/?id=7436227&type=bsm
https://www.biospace.com/article/futura-files-for-further-pre-submission-meeting-with-the-fda-following-receipt-of-its-phase-3-clinical-study-report/
yes you claimed because it was written in the 2 anonymous articles (discovery and SNSMA) it is not clinically proven.
Why deny it now? why backtrack now? You made the claim hundreds of time. And now you back track and say " haven’t claimed anything is because it was ‘written’ by anyone."
You claimed and referenced the two articles with links hundreds of times in your posts, and I paraphrase the hundreds of times you posted it, that you claimed as it says in these articles , cannot claim clinically proven.
Stop lying.
Yo made these claims, and is all over your history. Why are you denying it now?
You claim we (the rest of this board) cannot accept anything written in any articles, that says it is clinical proven, but you accept whatever is written in those 2 anonymous articles that you keep quoting and linking hundreds of times, anonymous at that.
Everyone look back at his posts making the claims and posting the links to 2 anonymous articles.
Now he is denying it.
You quoted directly from those articles hundreds of times, claiming they were correct
and now you say "I haven’t claimed anything is because it was ‘written’ by anyone."
You quoted the articles directly, even using words from the discover articles as your own "sheer chutzpah"
All the direct quotes form them articles are all over you posting history.
Just see his history and the two links he keep posting ( I wont post again)
But it is the discovery articles and SNSMA
Caught out again, lying blatantly