not sure if they will respond to Bellicapelli admin with more details about the lotion as they didn't reveal any info by themselves being aware that everyone out there is so hyped about it.
Italian Hair Loss Lotion To Hit The Market In 2016
- Thread starter paleocapa89
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Just a reminder THIS is the first legitimate correspondence from Fidia back in early 2016.
Dear Mr POTATOUSERNAME (just changed this)
Concerning your request, we would like to provide you some details regarding this project.
With regard to the remedy for alopecia studied by Professor Brotzu, in collaboration with the researchers at the University of Cagliari for the part of formulation development, Fidia points out that it is a scientific discovery with very interesting potential, which prompted the company to acquire intellectual property and to work for it to become a real opportunity for all patients who are afflicted by this problem.
It is fundamental now to implement the usual development path to ensure first that the efficacy and safety of the remedy are in compliance with the requirements of the latest regulations governing the production of products for the health of people, and then define the best solution to make it available to patients.
Fidia aims to start the clinical study in March 2016, according to a defined protocol and whose formulation will then have to be developed industrially.
We are unable to forecast now the effectiveness and tolerability results, that will have to be supported by the same study, with statistically significant findings.
We are therefore conscious that it is premature to define a date for the product launch, we hope it will be in 2017 based on the study results.
We kindly ask you to be very careful in circulating this news and please refer always to us in case of any further request.
Best regards
xxxxxxxx
Responsabile Comunicazione
(details removed just now)
Dear Mr POTATOUSERNAME (just changed this)
Concerning your request, we would like to provide you some details regarding this project.
With regard to the remedy for alopecia studied by Professor Brotzu, in collaboration with the researchers at the University of Cagliari for the part of formulation development, Fidia points out that it is a scientific discovery with very interesting potential, which prompted the company to acquire intellectual property and to work for it to become a real opportunity for all patients who are afflicted by this problem.
It is fundamental now to implement the usual development path to ensure first that the efficacy and safety of the remedy are in compliance with the requirements of the latest regulations governing the production of products for the health of people, and then define the best solution to make it available to patients.
Fidia aims to start the clinical study in March 2016, according to a defined protocol and whose formulation will then have to be developed industrially.
We are unable to forecast now the effectiveness and tolerability results, that will have to be supported by the same study, with statistically significant findings.
We are therefore conscious that it is premature to define a date for the product launch, we hope it will be in 2017 based on the study results.
We kindly ask you to be very careful in circulating this news and please refer always to us in case of any further request.
Best regards
xxxxxxxx
Responsabile Comunicazione
(details removed just now)
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I mean--that really pissed me off.
I think he is full of sh*t.
The guy has 4 pages of postings ALL just for this thread--skimming them all I saw were negatives.
Good repost of that e-mail! Forgot about this one. Probabely displaced this mail because that would mean around 6-12 months from now -.^ so around 3.-4. quartal 2017 until they release the lotion?
rafiles
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I swear you made me comprehend more in a 10 rows post than Marlin on 5 entire pages on IESON, with whom I am discussing in Italian, about the problems he's making about being the lotion a cosmetic.
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Hey I've been away for a while (left around page 260 if I remember correctly haha) and was wondering if I'm correct with catching up that:
1. Unconfirmed source says February the third party running the trials will send results to FIDIA.
2. Growing concern that it will be considered a drug and have many obstacles to become available even in Italy.
3. Concern that come February we won't hear any news for sure
Anything else that I missed? Has there been any good news?? Anything to make me optimistic?
1. Unconfirmed source says February the third party running the trials will send results to FIDIA.
2. Growing concern that it will be considered a drug and have many obstacles to become available even in Italy.
3. Concern that come February we won't hear any news for sure
Anything else that I missed? Has there been any good news?? Anything to make me optimistic?
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alexfighter was banned. Nothing else.
It can't be classified as a drug with no drug components or ingredients.. that's the entire point of brotzu switching out one of his ingredients. Avoid that law.
It's cosmetic product with cosmetic effects. Like eyelash thickeners man. Man I told myself I wouldn't come back to this site f*** some people are so hopeless
It's cosmetic product with cosmetic effects. Like eyelash thickeners man. Man I told myself I wouldn't come back to this site f*** some people are so hopeless
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I know you have problems comprehending my writing so the quote is from FIDIA
Please note following line.
It is fundamental now to implement the usual development path to ensure first that the efficacy and safety of the remedy are in compliance with the requirements of the latest regulations governing the production of products for the health of people, and then define the best solution to make it available to patients.
Fidea aims to start the clinical study in March 2016, according to a defined protocol and whose formulation will then have to be developed industrially.
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I do not assume that plus 1 year from any of the correspondences from FIDIA or DR Brotzu--where do you have that from?
Are you speculating?
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This is all speculation.
I dont know where people get this time table from.
The trials started in May--they were supposed to start in March...I do not know and no one knows from Fidia the length of the trials--this was all speculation on time table of the trials
The only thing confirmed by Fidia is that they hope to have product launch in 2017...They also confirmed in a website/article to publisher that they had indeed told Dr Brotzu they may have news at the end of 2017.
Everything else is speculation or rumor or internet posters who supposedly spoke to someone who knows someone blah blah blah.
I wonder why this liposome vehicle isnt being used with minoxidil? Is it hard to create? I wonder if a compounding pharmacy could create a 5% minoxidil liposome solution
Of course this are speculation, why should I know. This whole tread is 99.9% speculation. But like they said in their e-mail, they first do the trials and then look for a solution to release the product. So if they will get the results of the study in february (again rumors) they wont release the product right after that. It will take additional time for sales strategy, marketing, distribution, different national laws etc. So we can easily add 3-6 months after the they got the results. We don't even know if they are able to mass product the lotion at this point, if they aren't they will have to figure out and then buy and install the stuff they need to produce the lotion. Worst case they have to develope all the machines and order a special product which could add a lot of time until they are able to produce. So i don't expect this lotion before autumn 2017. I hope i'm very wrong about my claims!
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Correct it most likely will not be available until the end of 2017--this was pretty much discussed somewhere between page 1-25 of this thread.
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[QUOTE="Barbe a papa, post: 1404581, member: 128892"
As for Americans, the FDA is very much less likely to approve it, as I cited in a previous post. So there is a very good chance it will not be marketed in the USA in any way for a relatively substantial amount of time after it comes out in Europe. So expect to buy it online from Europe when it finally releases. I'm not trying to rain on your parade, I'm trying to get the facts straight rather than say random sh*t with no evidence.
The only chance the lotion has of being considered only a cosmetic in the USA is through branding loopholes by not labeling the product as a hair stimulant. However, this would make the manufacturer liable to litigation over effects that are not labeled. It will be a cosmetic, but it will also be classified a drug in the USA. But again, I beg you to prove me wrong.[/QUOTE]
It will most likely be an over the counter drug if this is an issue.
(which i doubt it will be)
I dont see anything for a cosmetic that is a problem
Do over-the-counter (OTC) medications go through the same approval process as prescription drugs?
A: No. Because there are over 300,000 marketed OTC drug products, instead of individual drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example analgesics or antacids. For each class, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients. New products that conform to a final monograph may be marketed without further FDA review. Those that do not conform must be reviewed by the New Drug Application process. A drug company may also petition to change a final monograph to include additional ingredients or to modify label
How FDA Evaluates Regulated Products: Cosmetics
As for Americans, the FDA is very much less likely to approve it, as I cited in a previous post. So there is a very good chance it will not be marketed in the USA in any way for a relatively substantial amount of time after it comes out in Europe. So expect to buy it online from Europe when it finally releases. I'm not trying to rain on your parade, I'm trying to get the facts straight rather than say random sh*t with no evidence.
The only chance the lotion has of being considered only a cosmetic in the USA is through branding loopholes by not labeling the product as a hair stimulant. However, this would make the manufacturer liable to litigation over effects that are not labeled. It will be a cosmetic, but it will also be classified a drug in the USA. But again, I beg you to prove me wrong.[/QUOTE]
It will most likely be an over the counter drug if this is an issue.
(which i doubt it will be)
I dont see anything for a cosmetic that is a problem
Do over-the-counter (OTC) medications go through the same approval process as prescription drugs?
A: No. Because there are over 300,000 marketed OTC drug products, instead of individual drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example analgesics or antacids. For each class, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients. New products that conform to a final monograph may be marketed without further FDA review. Those that do not conform must be reviewed by the New Drug Application process. A drug company may also petition to change a final monograph to include additional ingredients or to modify label
How FDA Evaluates Regulated Products: Cosmetics
Safety Data and Its Limitations
FDA monitors the safety of cosmetic products that are being marketed and acts on products that are established to be harmful to consumers when used as intended. The agency has a number of ways to monitor these products but often the available safety information is limited:
- Voluntary Cosmetic Registration Program: FDA encourages cosmetic firms to report product formulations through the VCRP. The VCRP database provides important information on these cosmetics. However, the companies are not legally required to tell FDA about their products and safety data.
- Inspections: FDA can inspect manufacturing facilities to determine if proper controls and practices are being followed. FDA also works with U.S. Customs and Border Protection to examine imported cosmetics. But because resources are limited, only a few establishments are inspected each year, and just a fraction of imports are physically examined.
- Surveys of products: FDA periodically buys cosmetics and analyzes them, especially if aware of a potential problem. The information obtained can be used to alert consumers, support regulatory actions, or issue guidance for industry. FDA does not have the resources to sample and analyze all cosmetics on the market.
- Cosmetic Ingredient Review (CIR) expert panel: The CIR is an independent, industry-funded panel of medical and scientific experts that meets quarterly to assess the safety of cosmetic ingredients based on data in the published literature as well as some that is voluntarily provided by the cosmetic industry. The industry data may or may not be complete. FDA takes the results of CIR reviews into consideration when evaluating safety, but the results of FDA safety assessments may differ from those of CIR.
- Reports from consumers and health care providers: Because the law does not require that bad reactions to cosmetics be reported to FDA, we may be unaware of problems. That's why FDA is trying to increase consumer awareness about the importance of reporting cosmetic-related problems. (See Bad Reaction to Cosmetics? Tell FDA.) If you experience a bad reaction to a cosmetic, please contact FDA’s problem-reporting program, MedWatch, on the Web or at 1-800-332-1088; or contact the consumer complaint coordinator in your area.
FDA conducts research on cosmetic products and ingredients to address safety concerns or to provide information to support regulatory actions or guidance. For example, the agency has conducted research on skin absorption of cosmetic ingredients, tattoo inks, and potential contaminants.
In considering the safety of a product, a number of factors are considered, such as:
- whether a cosmetic is likely to be inhaled, swallowed, or absorbed through the skin
- how often it is generally used
- how long it stays in contact with the body (for example, leave-on or wash-off)
- whether some people, such as children, the elderly, or people with compromised immune systems, might be more vulnerable than others
To prevent further shipment of a cosmetic that does not comply with the law, FDA may
- ask a federal court to issue an injunction
- request that U.S. marshals seize the products
- initiate criminal action
- refuse entry of an imported cosmetic
- request that a company recall a product
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Omg 2016 become 2017? then 2017 comes we wait until 2018...it would be better to wait other treatments aiming for 2018 like histogen