Cassiopeia Release Full Year Results To 2018 Including Update On Breezula

Francesco17

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This
what I'm more concerned about right now is availability on markets outside of the US like Europe since in their presentation they are only talking about application to FDA but not their european counterparts which it would also need to go through tho. so if things turn out sh*t, this might be on the market in the US in 2022 but for Europeans it is still up for testing for maybe years which is a time frame that would completely ruin my hair. f*****g bullshit. same with winlevi, they don't even talk about european approval

FDA is often considered as a world standard though. I may be wrong
 

luen12

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Found this on their website:
http://www.cassiopea.com/company/strategy.aspx9E313478-DC04-4F56-8491-3EB57361DE69.jpeg
So, it seems like they intend to focus on the US market at first :( It definitely is a bit weird to me considering they are an European company and do their trial in Germany, but they are a small company and it seems like they don‘t have enough capabilities to enter more than one market at a time. And for them the US market is the most homogeneous market to enter.
So probably they are looking for a bigger European pharma company as partner after their Winlevi launch in the US, that takes care of the EMA approval. Maybe it‘s going to be cosmo, their parent company. And maybe once they have their partner after Winlevi, that partner intends to launch Breezula at the same time as in the US. I dont think they will lose too much time, as the European market is the potentially bigger market.
 

luen12

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FDA is often considered as a world standard though. I may be wrong

Yes you are right, but they still need an EMA approval to market it in the EU, and that takes as long as the FDA approval process.
But if everything goes wrong, 2022 seems like a good year to spend the holidays in the United States.
 
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Tom4362

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Found this on their website:
http://www.cassiopea.com/company/strategy.aspxView attachment 111992
So, it seems like they intend to focus on the US market at first :( It definitely is a bit weird to me considering they are an European company and do their trial in Germany, but they are a small company and it seems like they don‘t have enough capabilities to enter more than one market at a time. And for them the US market is the most homogeneous market to enter.
So probably they are looking for a bigger European pharma company as partner after their Winlevi launch in the US, that takes care of the EMA approval. Maybe it‘s going to be cosmo, their parent company. And maybe once they have their partner after Winlevi, that partner intends to launch Breezula at the same time as in the US. I dont think they will lose too much time, as the European market is the potentially bigger market.
Would it be difficult to get it to Europe when only approved in US?
 

luen12

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Would it be difficult to get it to Europe when only approved in US?

Not really sure. I guess it could be difficult to order, just like it's difficult to order it from China right now, as it has to go through customs. Plus you would need a prescription. But I can't imagine that it would be a huge problem if you got a prescription from a US doctor and bring it to Europe in your own luggage.
 

Francesco17

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Yes you are right, but they still need an EMA approval to market it in the EU, and that takes as long as the FDA approval process.
But if everything goes wrong, 2022 seems like a good year to spend the holidays in the United States.

Since this is a purportedly side effects free drug, hopefully it could be approved without controversy.

I believe we should look at how and when Propecia and Rogaine were approved by EU regulators to have an idea of what might happen with Breezula, actually, hold on - isn't Cassiopea an Italian company?
I'm confused now
 

Vinc2097

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None of this pricing stuff has been decided
The acne cream Will be out next year so we can use this until breezula and in many countries acne products are subsidized by health insurances so maybe it's time to befriend some young kids with acne

putting cream in our hair.. my hair are already so greasy i cant imagine putting cream on it and go outsite
 

Phatalis

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putting cream in our hair.. my hair are already so greasy i cant imagine putting cream on it and go outsite

Well..could put it on early. Like 3am. Takes minoxidil 4 hrs for maximum application time. Then you can take a shower.

Then put it on before bed. No one would even know and you'd have a full day with normal hair
 

Phatalis

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Since this is a purportedly side effects free drug, hopefully it could be approved without controversy.

I believe we should look at how and when Propecia and Rogaine were approved by EU regulators to have an idea of what might happen with Breezula, actually, hold on - isn't Cassiopea an Italian company?
I'm confused now

They're using the funding from marketing and selling in the U.S. for their penetration into the EU as the U.S. market has more potential from what it says in their financial report.

You could just have cool guys who have access to it in the u.s. and they could mail it to you haha.

We can work together on this forum
 

ZP31

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Or maybe you are a student, you have another disease have lost your job, live in a poor country or are in situations beyond your control - just like male pattern baldness. I believe none of us would like to be called a loser for something whoch is beyond our control

If any of the above are true, treating your hairloss should be the least of your conerns lmao. Life ain’t a f*****g charity. Get your priorities in line, do what you have to in order to gain the financial ability to treat your hair.
 

fuDHTck

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Guys chill...
If you run trials for the FDA then you don't need to redo them for EMA. Usually most companies apply for approval at the same time for both the FDA and EMA and approval comes more or less at the same time on average. So don't worry about that.

Also did someone by chance listen to their call?

The stock going down is probably because there was basically no news at all in the annual report... I am sure it will go up when they announce results of trials...
 

Phatalis

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their stock is doing very badly. probably because they mentioned how they require much more money from investors in the future... but -7% is pretty bad. hopefully they won't run out of money. also in their presentation they didn't mention anymore how the expect to be the 12 month data to be even more effective than what they saw after 6 months-they did mention this in their presentation last year. not a good idea to interpret too much into this but I wouldn't be surprised-with the luck that we normally have since decades- if 12 month results are actually less effective than 6 month data, that people started to lose hair again

I'm not trying to be TOO optimistic but I would find that extremely hard to be true.

The results at 6 months were big. Why would it suddenly reverse?

I think basing the effectiveness of the product off the stock isn't really a good way to go.

Wait until we see the results to make judgement.

I get where you're coming from though.
 

Phatalis

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Guys chill...
If you run trials for the FDA then you don't need to redo them for EMA. Usually most companies apply for approval at the same time for both the FDA and EMA and approval comes more or less at the same time on average. So don't worry about that.

Also did someone by chance listen to their call?

The stock going down is probably because there was basically no news at all in the annual report... I am sure it will go up when they announce results of trials...

This.

No one has any real incentive yet to dump money into it.

Wait until the results and let's see.

It's a tricky situation because money's involved. They can't just go throwing around stuff. If you are how this stuff works topline results is different from full results for very specific reasons.

They have to release stuff carefully andword it carefully.
 

Phatalis

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I just hope this sh*t works so I don't have to nuke myself with dutasteride or finasteride.

Seti looks promising...

But really other than that idk.. brotzu looks like a load of horseshit to me. I can't think of anything else we have to work with. Don't wanna get depressed.
 

Phatalis

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I don't know.. maybe because it works from a different angle directly at the receptor, maybe the receptor gets more sensitive when it finds out it is being inhibited. but by that logic finasteride would have to lose efficiency very quickly as well.. also then this probably would have happened with winlevi as well but there 12 months was great. so the principle of it obviously works for a longer time. I don't know, I just thought we would find out some really good sh*t today but I guess it's not that grim at this point

Yeah dude I don't think it's grim. They're still slated to show the results march-june. Topline. And the way this stuff works is it gets complicated when investment gets involved.

Wait for the actual topline results before you get scared. THis is just money and business right now.
 

WheeljackG1

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I think this is the first I'm hearing of this. Do we know what the sides could be like?
 

Badbald

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Anybody in the UK or London that knows how to get CB from Kane shop? Willing to do a group buy

I am also looking at doing this as im in the UK, ive heard Kane isnt the best source though alot of people on here calling him a scammer. The main thing to look for is somewhere to get the batch tested, we could buy from a Chinese suplier for a good price and get it tested here
 
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