Italian Hair Loss Lotion To Hit The Market In 2016

[rafiles]

Who needs the results, they should sell it I will buy it.

 

[The 7TH Sense]

@The 7TH Sense so they're saying they may not actually release the results? I don't understand. Also is this info from Beps given to the moderator for Ieson

Marlin says the trials are in reality carried with the purpose of getting the certainty it has really no sides. He says effectiveness is secondary.
I do not fully believe it; to reach the market, a cosmetic should have an effectiveness, if not, people won't buy and FIDIA does not hope to have wasted money buying the patent, financing the organization for the trials, and organizing the market plan. Also, it's a complex cosmetic, full of expensive molecules, they will be hard times for FIDIA if it reveals scam. If it will be marketed, there's no point to believe in its uneffectiveness.

 

[Xenithrising]

*will slap brotzus lotion on head without any efficacy reports crew*

Join me

 

[g.i joey]

there's 2 ways to perceive that message..

1) either they're trying to scam us and cover their asses on side effect cases and potential lawsuits on a cosmetic product that doesn't work.

2) Theyre so confident in its effectiveness that they just need to clear the side effects to be released as a cosmetic.

Either way studies on effectiveness would help market and sell the product much better.

 

[Drogedagh]

He says effectiveness is secondary.

did he get that from Beps or is it his own assumption?

 

[rafiles]

They need people and time to test the side effects.

I am ready to be a test person.

 

[DrizzyD]

Marlin says the trials are in reality carried with the purpose of getting the certainty it has really no sides. He says effectiveness is secondary.
I do not fully believe it; to reach the market, a cosmetic should have an effectiveness, if not, people won't buy and FIDIA does not hope to have wasted money buying the patent, financing the organization for the trials, and organizing the market plan. Also, it's a complex cosmetic, full of expensive molecules, they will be hard times for FIDIA if it reveals scam. If it will be marketed, there's no point to believe in its uneffectiveness.

That's kinda strange but perhaps they're double checking the side effects of the updated lotion they've created? Maybe the original lotion had good/decent results, and they believe they can improve upon them but at the risk of possible sides so that's the main thing they're looking at? Maybe that's also why they stated they may not show the results from this trial because if there are sides with the updates lotion they will instead stick with the original formula and not show the results of their enhanced one. That's about all I can think of in terms of why they would go this route. Any thoughts @That Guy ?

 

[The 7TH Sense]

That's kinda strange but perhaps they're double checking the side effects of the updated lotion they've created? Maybe the original lotion had good/decent results, and they believe they can improve upon them but at the risk of possible sides so that's the main thing they're looking at? Maybe that's also why they stated they may not show the results from this trial because if there are sides with the updates lotion they will instead stick with the original formula and not show the results of their enhanced one. That's about all I can think of in terms of why they would go this route. Any thoughts @That Guy ?

No no, I don't think so.
On IESON, many members are stating FIDIA enhanced the power of the lotion by doing something I do not remember right now; but I disagree. In the BC interview, Brotzu was asked if the lotion could be enpowered, but he firmly said: "Right now I don't think we can improve it, but things are constantly evolving".

Put in your mind that this is going to be a very powerful cosmetic, and by the time it will be used probably in many therapies, but NOT for a pathology, it belongs to the more specific cathegory of "cosmeceutic". Search on Google for it. Eventually, specific national associations periodically evolve some of them into proper drugs (even though is bit rare), and, if this will work, probably will be involved in such a solution, which is good: it would mean it has the right efficacy and the components are not fresh water and sugar. Maybe that would be even the best ending.

 

[rafiles]

What about to stop using it after gaining hair back, will they all fall again.

 

[Pavi]

I don't understand this at all. You're telling me that they don't even care about the efficacy and that the trials are only for safety? I don't believe that whatsoever

 

[MrJolly16]

there's 2 ways to perceive that message..

1) either they're trying to scam us and cover their asses on side effect cases and potential lawsuits on a cosmetic product that doesn't work.

2) Theyre so confident in its effectiveness that they just need to clear the side effects to be released as a cosmetic.

Either way studies on effectiveness would help market and sell the product much better.

Pretty sure it´s option 2. They bought Brotzu the patent (such an amount of money!) and @beps63 claimed he has the hair he had when he was 38 years old (now if I remember correctly is over 50), so it´s pretty obvious they are just checking the sides.

 

[shookones]

Well, for one thing the fda rehulations have completely changed, they're extremely lax in the trials to shelf like the Japanese (21st century act) so I wouldn't worry. Likely it would pass through, it's a cosmetic not ny classified drugs

 

[WMQ]

The fact that the trial is conducted by third party is already telling us the lotion will not be commercialized anytime soon.

 

[WMQ]

I'm not sure I see the logic there.

Will you prepare commercialization and industrial scaling up before gaining any test results?

 

[shookones]

You would absolutely prepare commercialization before pharmaceutical trials begin if there is proof of adequate gains from brotzus personal procedure and trials. It would mean pre-tampering and tweaking from fidia, brotzus original lotion was convincing enough for Androgenetic Alopecia.

If they DIDN'T prepare for immediate commercialization after trials I would wonder if it was weak results and only a pump and dump ploy to inflate company share prices due to ineffectivness

So the reality is that it is the former we are waiting for.

 

[ironix]

Quote from Fidias old Mails:

"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."

They are stupid if they wouldn't test safty and effectivness aswell in the same study, so i'm pretty sure they will give us results about both.

In my opinion the good thing about those news (rumors) is, that they are probabely sure about the effectivness after brotzu showed them some results and now they just focus on safety.

1) either they're trying to scam us and cover their asses on side effect cases and potential lawsuits on a cosmetic product that doesn't work.

Why would they take the time and effort for a big study and spend thousands of euro for testing a cosmetical lotion? I don't think they even have to test this lotion. If they want to scam they could just release it and say: look a well known doctor found a new lotion and you will regrowth all your hair, buy it! But no fidia takes their time and spend some money to see if the lotion is safe so they wont get an image damage and to see what they really have on this patent. For me that's a big plus for fidia even though we have to wait longer.

 

[WMQ]

It seems perfectly reasonable to outsource the trials to a more equipped organization. It happens all the time, for basically everything. I don't see how it would impede the process whatsoever. Do you think the organization Fidia is having do the trials is not communicating with Fidia? Because that would be really weird to believe. I genuinely don't understand what you think is happening.

So the moderator on Ieson just posted this

Posted - December 17 2016: 22:38:29
In February, the report will be ready for these tests (as he said Beps), it is said to be made public, for sure will be delivered to Phidias.

And in the meantime, let us continue to talk (even) of the microcirculation, it is not forbidden to non-experts ... Hello MA - rlin

and then this

The trials are made by third parties on behalf of Phidias (so he told me Beps) and then the report is presented to Phidias February.

Hello

MA - rlin

Guess its just waiting time for the next couple of months so put on your hats for now and enjoy what is left of your bald life

New post from Marlin:

It should be noted that trials have been made in the first place to establish the safety of use of the preparation with these "new" substances, the efficacy is not required for a cosmetic, it is sufficient that does not do damage. Sorge also no doubt that if it was too effectively perhaps might have problems to be classified as a cosmetic. Fidia is waiting for the end of the test, but not so much to know if the product is effective, but to finally proceed to production and marketing, we say that removing an obligation imposed by law and can proceed.

So all this anxiously awaiting the outcome of the trials is another big mistake that some are taking misunderstanding about the real meaning of these trials.

Hello

MA - rlin

Hope you get it.

 

[wilfred]

You would absolutely prepare commercialization before pharmaceutical trials begin if there is proof of adequate gains from brotzus personal procedure and trials. It would mean pre-tampering and tweaking from fidia, brotzus original lotion was convincing enough for Androgenetic Alopecia.

If they DIDN'T prepare for immediate commercialization after trials I would wonder if it was weak results and only a pump and dump ploy to inflate company share prices due to ineffectivness

So the reality is that it is the former we are waiting for.

And it's a private company.

 

[hairblues]

I am quite worried about how the FDA will classify this lotion. It technically qualifies as a cosmetic, but can easily be argued as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals. If by some miracle this is out in Europe in 2017, I'm not sure if it will be out in the US for potentially much longer, if ever. Unless there's some insane public outcry and heavy lobbying. I could be wrong though, and I hope to god I am.

As I look more closely at FDA regulations, I'm now very convinced that this lotion will be considered both a cosmetic and a drug and will not be FDA approved for a very long time. But I still could be wrong.

If someone knows about any regulations regarding importing an FDA unapproved product from overseas, could you share your knowledge.

This page http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194904.htm seems to say that it is illegal to import drugs, but there are circumstances where it's fine including:

"-There is no commercialization or promotion of the drug to U.S. residents;
-The drug is considered not to represent an unreasonable risk;"

So that gives me some hope. Also, wasn't Nizoral not FDA approved until very recently? But people have easily had access to that for years. So yeah, hopefully everything will be fine.

Im pretty sure this was discussed earlier and that the drugs used in the formula are already approved by FDA

You can probably easily research this yourself on internet.

If all ingredient are already approved by FDA its all a moot point.

 

[hairblues]

Well the whole point is that there are no drugs used in the formula. PGE1 being the one drug, which was replaced with DGLA being an amino acid. However, just because there are no drugs in it doesn't rule it out from being classified as a drug itself. This excerpt from FDA site:

"Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth."

So unless I'm super mistaken, that essentially guarantees that the lotion will 100% be considered a drug in the USA. However, because it won't be sold in the US, it is fully legal to import it, if I understood what I read about importing FDA unapproved drugs.

Doubt it matters the ingredients are approved (pretty sure you can google that yourself if you want to verify)

If ingredients are pre approved drugs used in a new formula--they are not going to have to go through trials etc.

I dont really know what you are worried about. them selling it as medication vs cosmetic? does not matter if its pre approved ingredients even if they sell it as a medication its going to be available.