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I think that is the point - this gets to market in the US via the FDA trial, then its good to go to US market.
Already approved in EU. Similarly if approved in other countries, it will get to market
It's going to happen either way (has for EU) and become a gel approved OTC for treatment of ED.
We know placebo effect occurs in all drug development, and varies a lot.
Placebo effect was seen in clinical trials with Viagra, cialis etc.
If Regulators ask for MED3000 to prove it is "substantially greater effect" than placebo shown in other studies of ED treatments - or against placebo, then they will have to. Until then, they don't need to prove it and can proceed with going to market.
Once in the market, then sure, I cannot predict the future and the real world will determine sales, revenue,
Proven against baseline - 4 weeks of no treatment
Do you think a placebo gel comparison will result in the same results, I doubt it, why, because it is shown to be nearly effective as first line treatment for ED. They don't say that about placebo gel or lubricants.
And let's face it they don't have to prove it to get to market .
WRONG AGAIN
RE: "Futura have clinically proven something that all lubricants and arousal gels can now based on equivalence also reclassify to 2b from 2a"
I will indulge your fiction. Let's say they get re-classified, it WILL NOT be because they demonstrated equivalence to MED3000. That will not happen, if you follow the actual regulations re characteristics (clinical, Tech and biological) they are not equivalent. Only way to show equivalence is follows LIAMBOOTH made up regulations.
At least I showed everyone the regulations clearly, your just going on a wing and prayer.
Let me indulge you some more. Name me a marketed Alcohol Lubricants you think can demonstrate equivalence to MED3000. Make your claim and I will go through the info and compare the three characteristics for you,
WRONG AGAIN LIAMBOOTH
RE "Yes it on the current available evidence it still will ‘ only help in a very limited sphere’ as FM57 only included men who
Subject answers ‘yes’ to the question regarding the presence of residual EF over the past 3 months: ‘At home over the past 3 months, have you experienced at least some growth of your ***** in response to: (1) mechanical stimulation by yourself or your partner, or (2) visual stimulation?’
I POTED THIS BEFORE
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)
LIAMBOOTH talking nonsense again again, making the same posts and same points and claims have all been mis proven already
RE your statement "The poor scientific efficacy proof of what actually is causing the effect in FM57"
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)
DOESNT MATTER IF THE CAUSE WAS UNKNOWN, IT WAS PROVEN TO SHOW IT WORKS AND SIFNIFICANT IMRPOVMENT ERECTIONS AGAINST BASELINE . Later investigated through in vitro tests
- Lubricants cannot claim this at all, unless you prove equivalence and that will not happen if you follow the actual regulations for proving medical device equivalence (Not Liambooths made up regulations of equivalence)
To clarify Typos in my last post:
"So essentially LIAMBOOTHS posts claiming Menthol Lubricants can claim equivalence to Eroxon and the focus is on MOA, Massaging, Alcohol based, safety DO NOT FIT THE ACTUAL REGULATIONS -"
Should have read
So essentially LIAMBOOTHS posts claiming Menthol Lubricants can claim equivalence to Eroxon and the focus is on MOA, Massaging, Alcohol based, safety DO NOT FIT ALL THE CHARECTERISTICS / CRITERIA NEEDED IN THE ACTUAL REGULATIONS TO DEMONSTARTE EQUIVALENCE
LIAMBOOTH you cannot circumvent, ignore, or pretend the relevant regulations don't exist to fit your agenda.
Stick to the regulations that show what you have to prove to show medical device equivalence, don't just make up nonsense and your own regulations.
Here are those relevant 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:”
Technical: the device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements;
Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;
Clinical: the device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.
PROVING medical device EQUIVALENCE is VERY DIFFICULT AND TECHNICAL as shown by the regulations.
YOU HAVE TO MEET all the characteristics (tech, clinical and biological) as per the regulations to show equivalence.
MENTHOL LUBRICANTS DO NOT fit all the criteria/characteristics in the relevant regulations I reference and link TO BE EQUIVALENT TO MED3000 . Different effect, absorption, substances, materials, clinical performance etc etc
Simple E.g., if the substances in a given menthol lubricants are not the same as MED3000 - it is not equivalent (see the link above)
= The MDR requires that biological characteristics shall be taken into consideration for the demonstration of equivalence, i.e., the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact, and with similar release characteristics of substances, including degradation products and leachables, as the presumed equivalent device
= The MDR has additional requirements for devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbed by or locally dispersed
So essentially LIAMBOOTHS posts claiming Menthol Lubricants can claim equivalence to Eroxon and the focus is on MOA, Massaging, Alcohol based, safety DO NOT FIT THE ACTUAL REGULATIONS -
Wrong Again LiamBooth
RE "‘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’,
Using a menthol gel. All equivalence. in FM57 can be demonstrated by using a class 2a device menthol lubricant therefore allowing a reclassification to class 2b based on what FM57 itself proved and the actual CE mark certification that MED3000 currently has"
I answered this before and showed you for being wrong as does my last post also.
So here is the point AGAIN
The criteria / characteristics to demonstrate equivalence is more than one trial and more than: Both alcohols, Both applied topically, Both massaged in, Both cause evaporated cooling
The actual criteria/ characteristic as per regulations is Technical, biological and clinical - to the point "These characteristics should be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device"
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.
Wrong Again Liambooth RE: "There is no burden as there is minimal proof of equivalence needed based on FM57 and what it only provides evidence of. That is the only equivalence threshold"
Just read the relevant regulations, which clearly state the characteristics are technical, biological and clinical equivalence. "These characteristics should be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device" NOT JUST WHAT IS SHOWN IN ONE CLINCIAL TRIAL.
It would be dumb for regulators to set regulations that limit proving equivalence to what is demonstrated in one clinical trial for a device. A device may have conducted several trials.
Here are real applicable and relevant regulations again for you and all, just read them. It is in black and white, not grey.
"For devices other than implantable devices and class III devices and where the manufacturer wants to claim equivalence, MDR Article 61 (3) is applicable”. - SO: This is the relevant regulation (MDR Article 61 (3) ) if you want to claim equivalence to Med300) / Eroxon which is class II medical device
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/)
It states in 3A: “The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:”
Technical: the device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements;
Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;
Clinical: the device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.
"These characteristics should be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device"
@ the Italian
Spot on, the burden of proof is not on Fum , it is on those trying to prove equivalence to Eroxon / Med3000.
Can they prove equivalence in accordance to the criteria as set out in the current regulations ? as I posted. I doubt it very much.
Wrong again, yet again and again
Re "Remember it’s all Class 2 equivalence. Not class 1 to Class 2 or Class 2 to Class 3. Basically, a class 2a lubricant can claim to be ‘functional’ or ‘problem-solving’ products (designed to relieve vaginal dryness during sex) or ‘pleasure-enhancing’ (designed to add fun and to enhance the pleasure of sexual activity)."
You have to claim equivalence to the device you claim to be equivalent too, i.e., your repeated claims menthol lubricants are equivalent to MED300 / Eroxon. BUT Eroxon is not claiming to be "designed to relieve vaginal dryness during sex) or ‘pleasure-enhancing’ (designed to add fun and to enhance the pleasure of sexual activity)."
So, let’s slow this down for you, take your time, I know you find this difficult
YOU CLAIM LUBRICANTS ARE EQUIVALENT TO MED3000 AGAIN AND AGAIN
So, why don’t you spell out how you or menthol lubricants are going to show they meet all the criteria (as per regulation) to prove equivalence to MED3000.
They have to meet all the criteria (technical, biological, clinical) as per the current regulations here (Link below. These are the CURRENT RELEVANT REGULATIONS TO ALL NON CLASS III Medical devices – so relevant and applicable to all other classes (inc MED3000 and Lubricants), Unlike your last misleading post re class I etc)
https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en.pdf
Let’s start with you explaining your claim menthol lubricants can show equivalence to med 3000:
- 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.
Watch the next link from Liambooth will digress and not answer the questions posted.
Here again if you need them
Spell out how you going to meet all the criteria (technical, biological, clinical) as per the current regulations here: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en.pdf
Lets start with you explaining your claim menthol lubricants can show equivalence to med 3000:
- 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.
And those are the easy ones to being with
Nope wrong again
RE "No Equivalence can be sought on the basis of the current MED3000 Ce mark. Lubricants are already on the market as class 2a and based on the MED3000 CE mark certification can submit to reclassify based on equivalence to the CE Mark of FM57 not anything else."
You posted it your self several times "a manufacturer of a medical device to use the technical documentation, post-market surveillance (PMS), post-market clinical follow-up (PMCF) and the scientific literature related to an already marketed device
THAT IS RELEVANT TO THE DEVICE YOU ARE TRYING TO PROVE EQUIVALENCE TO
Irrespective anyways, you still have to meet the criteria to prove / how Menthol Lubricants are equivalent to Eroxon in accordance to the current regulations and the criteria.
Spell out how you going to meet all the criteria (technical, biological, clinical) as per the current regulations here: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en.pdf
Lets start with you explaining you claim menthol lubricants can show equivalence to med 3000:
- 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.
And those are the easy one
I feel really embarrassed for you proving you so wrong on many occasions.
Don't digress by posting "As Trinity said in their own research “ 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”
That is nothing to do with proving equivalence and the criteria as set out in the actual relevant regulations I posted.
Makes you look even worse, if possible, for not being able to answer the questions on how menthol lubricants, meet the criteria as set out by the relevant and current regulations required to equivalence to Eroxon
Answer how the Menthol lubricants meet all the criteria as per current and relevant regulations?
I even helped you by posting the relevant regulations,
Wrong again on two account this time with your posts:
Firstly
re "All the safety requirements are already met. Therapeutic effectiveness does not need to be proven just equivalence which Futura has done with the FM57 study not the Med3000 gel itself."
The criteria is not only safety - as I spelled out
Secondly
Re "Medical devices: conformity assessment and the CE mark. Class IIa devices: A manufacturer is required to declare that its Class IIa device conforms to the requirements in the MDD as well as the Medical Devices Regulations 2002. It also needs to apply to a notified body to carry out a conformity assessment to approve its declaration. The type of assessment chosen can be: (a) an examination and testing of each product or homogenous batch of products (Annex IV of the MDD); (b) an audit of the production quality assurance system (Annex V of the MDD); (c) an audit of final inspection and testing (Annex VI of the MDD); or (d) an audit of the full quality assurance system (Annex II of the MDD)"
You are quoting the old regulation MDD, the MDR is the current regulation. Plus the criteria you quote is quality assurance, not proving equivalence of medical devices.
The criteria is as I posted it in the links, read it again.
Fuethermore how are you going to meet this criteria
= The MDR requires that biological characteristics shall be taken into consideration for the demonstration of equivalence, i.e. the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact, and with similar release characteristics of substances, including degradation products and leachables, as the presumed equivalent device
Remember:
MED3000 is a unique formulation of DermaSys® using volatile and non-volatile components tailored for the treatment of ED
DermaSys® - This is FUM's unique patented technology which is designed to deliver clinically proven effective medical treatments via the skin. DermaSys® is a versatile and bespoke technology
All this has to be done post Launch as Bucolic very clearly mentioned and also highlighted, the need of a contract. But more pertinently, Each formulation is patented / under patent
Good luck with demonstrated "Similar kind and duration of contact, and with similar release characteristics of substances, including degradation products and leachables"
Wrong again as the criteria is more than: Both alcohols, Both applied topically, Both massaged in, Both cause evaporated cooling
The other criteria - how are you going to prove equivalence in these as per the article:
- " no clinically significant difference in the safety and clinical performance between the device in question and the device presumed to be equivalent" 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
Also how you going to demonstrate these criteria?
- 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.
Part 2
This article goes into the detail of proving equivalence and what the three characteristics (Technical, Biological and clinical) mean. https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en.pdf
The takeaway points in the article are (and there are many other that say the same):
= The conditions of use shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance between the device in question and the device presumed to be equivalent
= The MDR requires that biological characteristics shall be taken into consideration for the demonstration of equivalence, i.e. the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact, and with similar release characteristics of substances, including degradation products and leachables, as the presumed equivalent device
= The MDR has additional requirements for devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbed by or locally dispersed in the human body. For the consideration of equivalence, the substances shall be the same.
= Those devices are not medicinal products, but for the conformity assessment they shall comply with the relevant requirements laid down in Annex I to Directive 2001/83/EC17 for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions. This means that for the demonstration of equivalence under the MDR, those aspects shall also be taken into consideration
= 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.
= The overall considerations of equivalence shall conclude whether the listed technical, biological and clinical characteristics in the MDR are similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device
= If a manufacturer is not able to demonstrate sufficient levels of access to the data relating to the presumed equivalent device and needed for the consideration of equivalence, equivalence claims cannot be made for the purpose of conformity assessment.
Proving equivalence is very difficult and Menthol Lubricants do not fit the criteria in the relevant regulations I reference and link . Different effect, absorption, substances, materials, clinical performance etc etc
So essentially the posts claiming Menthol Lubricants can claim equivalence to Eroxon and the focus is on safety only are IMO as shown above in the links a load of …..
Part 1
Regarding the claims / posts “Menthol Lubricants are already classed as 2a. They will be able to meet each of the equivalence standards of the current class 2b CE Mark to MED3000 and submit to be reclassified immediately ie the mechanical massage claim and the evaporative cooling claim”
And
“We already know the notified bodies focus more on safety which won’t be an issue for Lubricants which are already approved as class 2b and “A product’s (alleged) therapeutic effectiveness is not (necessarily) examined”
Both are very wrong claims / posts – when you look at the relevant regulations, let me explain.
"For devices other than implantable devices and class III devices and where the manufacturer wants to claim equivalence, MDR Article 61 (3) is applicable”. - SO: This is the relevant regulation (MDR Article 61 (3) ) if you want to claim equivalence to Med300) / Eroxon which is class II medical device
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/)
It states in 3A: “The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:”
Technical: the device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements;
Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;
Clinical: the device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.
TO BE CONTINUED….
I wonder what ASA would have to say when a lube says is can show equivalence and highly significant improvement in erections in mild / moderate/severe patients through the data contained in this patent search, which is not a clinical trial using the lube.
Clearly you missed the obvious that link / article is not a clinical trial, it is a patent search paper using key words.
"2. Methods
The patent document search was carried out in order to provide the largest number of patents
corresponding to the topic of interest, using international patent classifications or keywords, in order
to allow representative research on the various uses of menthol, focused on the treatment of erectile
dysfunction"