Rainbow Rare Earths Phalaborwa project shaping up to be one of the lowest cost producers globally. Watch the video here.
RE "Stop use and ask a doctor if you or your partner develops a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor."
Same warning on most creams, detergents cleaning products, hair products, industrial products, paint, etc etc - millions of products
Desperado - LMAO
Lets face it, Liambooths claims are making giant sweeping assumptions and accusations without hard evidence that the investigators and site staff deliberately made choices to effect the outcome of the clincial trial, when it comes to burning or stimulation. Breaking GCP ( I reported that already BTW)
The patient / partners did the rubbing in at home as they did the stimulation.
Basically what I am saying is, it is totally fabricated using a crystal ball and is utter rubbish, just like 99.9% of Liambooths posts
End of.
@Bucolic RE ""Just because someone or some website makes a claim about Med3000, it doesn't mean that it's true."
"Probably the truest words that booth has ever written. Shame he doesn't see the irony of them"
LMAO - you hit the nail on the head. Good post.
How desperate is Liambooth -"what happens when reports of burning in the real world setting go up?" - LMAO
LMAO - More likely it will not, given the safety profile. - of a samples size of 250, Penile burning (men) = 1.2% and Vulvovaginal burning (women) = 0.4%.
What is the point of the clinical trial, if people have crystal balls to make sweeping predictions like this on burning.
Or the point of the leaflet with instructions, side effects etc? - When it could simply say, "predict what you like because Liambooth says so".
They make wild assumptions like - in the real world the opposite will happen to what was shown in clinical trial (only saying it to scare you), but I have no evidence of that, I am just saying it using my crystal balls - Those are the unbalanced misleading folks
So desperate, it's embarrassing, no pride, just desperation, very very sad. Go and rub your crystal balls
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.
RE "The equivalent lubricant gel will contain menthol (an alcohol) and water." - The only equivalence is gel, water and alcohol. Nothing else (important anyway) like MED3000 is for ED. Lubricants cannot claim that and won't. No have so far. No matter how many time you say it, LMAO
So no gel, nothing, zilch, nada is getting to market for ED before Eroxon (https://eroxon.com/). And wont for a long while after., guaranteed.
Lubricants cannot meet the requirements to prove equivalence to MED3000
Time to go back to what he likes the most.
"Because only one mechanism of action was approved by the notified body. The only proven one. Mechanical stimulation."
That is not true, its is BS and construed to suit you point. Dermasys has its own mode of action, you said it before, as have may others but you choose to now not mention it because it doesn't suit your point
The cooling, evaporation and warming, specifically the way it uses the volatile and non volatile substances, designed to be dynamically unstable when exposed to the air; which is all proprietary knowledge.
Also, as per the patent there is specific substances, % of mixtures / substances, cooling temperature checks and experiments, cooling rates, ambient temp rates, PH, viscosity, clincial results, etc etc associated with MED3000.
All of this above is assessed for proving equivalence. and more have to be shown to be equivalent. Got no chance and you know your argument no validity and you have no credit.
It's fine for the same manufacture who can create a equivalent gel, but no chance for anyone else against a proprietary patent proetcted Dermasys.
Other manufactures, would have to create the gel form the start and that ain't going to happen.
"The problem is if nobody knows the precise mechanism of action beyond mechanical stimulation then how can any notified body deny menthol lubricants /gel being massaged in can’t be equivalent in FM57"
Hahaha, Equally, how can the notified body allow it if they cannot show equivalence to a MOA because as you state "nobody knows the precise mechanism of action beyond mechanical stimulation"
Either way wont be a problem for FUM.
Plus its not just about MOA to show equivalence. Stop misleading. The regulators look at everything to prove equivance and lubricants have not got any chance to be called equivalent to MED3000. Just look at the patent.
At the end of the day it is the effect that matter, and the effect is working. "Interestingly, the precise mechanism of action does not need to be elucidated for the regulators to be comfortable for a product to be approved as medical device".
"For MED3000 it appears that the effect arises from a combination of a first phase of marked, yet targeted, cooling within the first few minutes - a temperature change of up to 10?C has been measured - that happens as the volatile components of the DermaSys formulation evaporate rapidly. After this initial localised cooling, a second phase sees a sustained warming effect with the temperature recovering to slightly above the original temperature. As the glans area of the ***** has many sensory nerve endings there is a surge of activity that appears to involve the endogenous NO pathways specifically.
The initial response to such a cooling would be a vasoconstriction, with reduced blood flows. However, the contrasting warming phase is then associated with a rebound vasodilation, that leads to relaxation of the smooth muscles and marked
increase in local blood flows, with a resultant erection. Presumably the effect is comparable to the cold-induced vasodilation (CIVD) that occurs with extremities such as toes and fingers. Despite being a well-known effect, the mechanisms of CIVD are still disputed, but the pathways involved could well be similar.
Interestingly, the precise mechanism of action does not need to be elucidated for the regulators to be comfortable for a product to be approved as medical device."
Interestingly, it does the job, it works
Interestingly, going to market and be first OTC for ED
Interestingly, it works and patented (pending)
Interestingly, Market size is $3.6 billion
Interestingly, Approved in EU and soon to be approved in US and globally.
All very very interesting times ahead.
@LIAMBOOTH
As per regulations then you have to demonstrate things like the following
- Same absorption, metabolism, distribution and excretion?
- Similar relevant critical performance which is also outlined in the MEDDEV 2.7/1 rev. 4.
- physicochemical properties such as intensity of energy
- both devices should be used for the same clinical condition or purpose including similar severity and stage of disease and also have similar relevant critical performance which is also outlined in the MEDDEV 2.7/1 rev. 4. (NOTE CRITICAL PERFORMACE)
- no clinically significant difference in the safety and clinical performance between the device in question and the device presumed to be equivalent. NOTE The clinical performance of Eroxon shows - highly significant improvement in erections in mild / moderate/severe patients, as measured against baseline in changes of IIEF-EF, SEP2 and SEP3
Can you demonstrate the equivalence of these points in Alcohol lubricants? And saying its only FM57, or ‘evaporative mode of action’ , ‘combination of volatile components’, ‘ stimulates nerve sensors’, by a cooling and recovery warming effect’, ‘leading to smooth muscle relaxation, tumescence and erection’ IS NOT ENOUGH, READ THE REGS IN BLACK AND WHITE NOT GREY.
“The efficacy of the DermaSys product approaches the efficacy of current first-line therapy but with significantly lower adverse events. With topical application, it will be of particular appeal to patients who want a fast onset of action,” said Professor David Ralph, Consultant Urologist at University College London and past president of the European Society of Sexual Medicine. “Lack of drug interactions with prescription products will enable the product to be used with other medications such as nitrates and other cardiovascular drugs. It can also be used in conjunction with other ED products to improve overall efficacy to patients.”
LIAMBOOTH RE "A menthol Lubricant massaged in will meet the technical, biological and clinical characteristics of MED3000 in FM57"
Totally made up bogus statement as usual from you.
Prove it by naming a market lubricant that will then and we can all then compare the characteristics - I bet you wont because it is all a fabrication of your imagination
Are you going to do this and prove it, or totally ignore this, like you done many challenges before to validate your claims, because you know they purely subjective aligned with your agenda
Keep fabricating the actual regulations.
The real regulations ones are here
MDR Article 61 (3) - https://www.medical-device-regulation.eu/tag/mdr-article-61/
MDR Article 61 (3) States “ Note 3 (a) - it is demonstrated that the device subject to clinical evaluation for the intended purpose is equivalent to the device to which the data relate, in accordance with Section 3 of Annex XIV
Section 3 of Annex XIV (https://www.medical-device-regulation.eu/2019/08/14/annex-xiv/)
RE "That inclusion criteria will also allow some Lubricant manufacturers submit on equivalence to MED3000 in FM57 and get reclassified from class 2a Medical devices to 2b.
You don't even show the equivalence regulations that back up your statements - beacuse they are false statements as usual.
Lurbicants can submit for equivalence as much but wont get it unless you meet the three characteristics as per regulations
Section 3 of Annex XIV (https://www.medical-device-regulation.eu/2019/08/14/annex-xiv/)
It states in 3A: “The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:”
They can change from class 2a to 2b, still cannot claim as Med3000 can, improve ED.
We been over this again and again, even offered you the chance to name a marketed lubricant and i will compare the 3 characteristics.
LIAMBOOTH - All Misleading and proven to be again and again
and RE "And I made no implication that anyone “ deliberately breached any protocol.
Yes you clearly did "I am implying they trained the participants to include more foreplay including visual stimulation and especially more manual stimulation"
As the only training in the protocol clearly is for "Training in the use of subject questionnaires and IMP application".
And including any text referring to re enforced. It is clear, it is a protocol
RE
"And there is a lot “training” mentioned and reinforced training talked about in the protocol. And why would participants need to be trained so much to answer questions? And you do know “IMP application” means applying the gel? Still not sure how much “training” someone needs to just rub a gel in?"
- Is a total blag.
Liambooth RE Your Statement (s) there are many
" I am implying they trained the participants to include more foreplay including visual stimulation and especially more manual stimulation. And I agree with the idea that as far as has been implied by Futura. The only training given was how to apply the gel? Does that really require training? Does the rubbing of a gel in for 15 seconds even need “training’?
"But what we do need to know is where the participants being trained to incorporate more foreplay before they applied the gel and after? And what were they trained to do from 15 seconds to the 10 minutes it too for the gel to have an effect in 60%?"
You know the only training in the protocol is "Training in the use of subject questionnaires and IMP application"
What you make allegations by stating "" I am implying they trained the participants to include more foreplay including visual stimulation and especially more manual stimulation." means the clinical staff at the investigator site (not FUM staff) deliberately breached the protocol and therefore are breach of GCP. You are implying the Clinical data is false / manipulated. https://www.ct-toolkit.ac.uk/routemap/gcp-and-serious-breach-reporting/
This is a serious claim, that needs to be forwarded to the CRO's / investigator sites and regulatory authorities, your claim is in the public domain now.
I kept a copy anyway.
Also, who applied to doses and where - at home and by the patients in their own home by themselves or their patients. So there will be variance in their application techniques, any stimulation, visual or otherwise etc etc. Nothing to do with investigator site staff. Whether they had engaged in more simulation - or as you accuse them, being deliberately being coached by investigator site staff, it is very grey area and weak argument but a serious allegation of breach of protocol and GMP.
Was there any CAPA raised against the investigator sites to substantiate your claims?