Cassiopea Announces First Patient To Be Enrolled In Phase Ii Trial For The Treatment Of Androgenetic

jamesbooker1975

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imagine being 44 and bullying people online. i bet an egg that you aren't even balding properly, nobody here seems to be(some exceptions of course but the vast majority i have seen are literally NW2 or some sh*t but still active everyday which is indicative of a high level of neuroticism)

You are an average Joe, so idiot that believe that having 44 years is a bad thing. First at all, even idiots like you get the 44 . Second, I have 26 years of experience on hair loss treatment and I am a pharmacy .

You are so ignorant, that believe that DHT is a wasted product on our organism that must be eliminated. You have no idea the role that DHT have in the boby, but even worst, finasteride block a lot of reactions, cause 5-alpha-reductase is part of many, many reaction in the body.

But, being an idiot should be hard enought, so take it easy Joe.
 

recedingdude123

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I am most excited for this product, as it seems like a real alternative to finasteride and has the potential to be released soon.

according to the press release quoted in this post, the Phase III trial for men will be 6 months long, and they have apparently already met with the FDA about it on November 13th. They said they hope to get it rolling in Q4 2019, but even Q1 2020 would mean it could be finished by summer/fall 2020.

The drug has already proven to be dose dependent in the Phase II trial which is very positive. Phase II showed 14.3 new hairs per square cm, and thickening of existing hair shafts by the way. That sounds pretty promising to me.

I am not sure how long FDA approval usually takes, but given that the acne treatment is already under review, that could help speed up the process. I just hope you Americans can help the rest of us out who live abroad and ship it to us if and when its released.
 

jamesbooker1975

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I am most excited for this product, as it seems like a real alternative to finasteride and has the potential to be released soon.

according to the press release quoted in this post, the Phase III trial for men will be 6 months long, and they have apparently already met with the FDA about it on November 13th. They said they hope to get it rolling in Q4 2019, but even Q1 2020 would mean it could be finished by summer/fall 2020.

The drug has already proven to be dose dependent in the Phase II trial which is very positive. Phase II showed 14.3 new hairs per square cm, and thickening of existing hair shafts by the way. That sounds pretty promising to me.

I am not sure how long FDA approval usually takes, but given that the acne treatment is already under review, that could help speed up the process. I just hope you Americans can help the rest of us out who live abroad and ship it to us if and when its released.

Once a Phase 3 started, if all goes well, it take around 2 years to hit the market. Specially for this kind of drugs, they are not hurry :(
 

hypetraintime

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NotInmywatch

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From their press release for Winlevi: "The FDA has set August 27, 2020 as the Prescription Drug User Fee Act (PDUFA) action date."

Once that is approved, you should be able to get it compounded, off label. with an appropriate vehicle for your scalp at 7.5%.

wait, this is interesting. the whole point about paying millions to the FDA for breezula approval is that is another vehicle and another concentration different from winlevi
and any pharmacy could bypass this just by compounding winlevi???
 

hypetraintime

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wait, this is interesting. the whole point about paying millions to the FDA for breezula approval is that is another vehicle and another concentration different from winlevi
and any pharmacy could bypass this just by compounding winlevi???

They want to get specific approval for Androgenetic Alopecia. But given that the FDA will approve the active ingredient Clascoterone in the winlevi application, anyone could just have it formulated to 7.5% in a topical solution as apposed to a cream. Off Label Breezula will be available in 2020.
 

HairSuit

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wait, this is interesting. the whole point about paying millions to the FDA for breezula approval is that is another vehicle and another concentration different from winlevi
and any pharmacy could bypass this just by compounding winlevi???
Not ANY pharmacy. You would still have to go to a compounding pharmacy, but yes.......
 
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