-Finalize Special Protocol Assessment for Phase 3 Program with FDA
-Initiate Activities for Breezula Phase 3 trials in males – 4Q 2020/1Q 2021
And we have a delay :/
Please consider that Cassiopea HQ is near Milano in one of the worst affected areas by COVID-19 so that might be a factor...
Sorry to ask but could you simply give an explanation of what the protocol is for someone who has been out of the forum for some time? Also how to achieve it with a dermapen?
A quick update about topical finasteride from Polichem since I saw it mentioned.
There was an update in their latest presentation:: "Finasteride (androgenic alopecia) submitted to EMA in September;".
So it looks like we are getting it next year at least in Europe. Nothing amazing but at least...
So many new informations here. Everyone should read it.
Probably not super up to date but still.
Also interesting that they seem to be seeking European approval too at the same time.
I wouldn't say Cassiopea (CB) is weak per se. After one year results said you would still be above baseline and 6 months results were very good. The big question is what caused the drop and does it continue or kind of stabilize?
If it stabilize then it would still be a huge win to have something...
Phase III already finished. They are applying for approval with the FDA & EMA (or only EMA initially) very soon (Q4/19 or Q1/20).
So we should have in the next 2-3 years:
Cassiopea with Breezula
Samumed with SM04554
Follica with their device
Polichem with P3074
Honestly it would be already a...
They redesigned and updated the website ( https://www.cassiopea.com/ ). Nothing really new but few information:
PH3 in man still starting in Q1 2020
PH2 in women starting before end of the year
7.5% concentration chose for PH3
Yeah it might not be perfect but honestly I still hope it gets...
Dude calm your tits.
They will post the results when they are available. There is no hidden secret or conspiracy.
And you complaining on a forum won't make it faster.
Conference call transcript got published here: http://www.cassiopea.com/~/media/Files/C/Cassiopea/financial-reports/CassiopeaSpa_20190208_1500_CET_FullRG.PDF
Nothing too interesting...
I guess the summary is
"Concerning the Breezula program, we complete in this... in the last weeks the...
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...
"Follica expects to initiate the pivotal study in androgenetic alopecia following completion of an ongoing optimization study in the first half of 2019."
Not sure if this is new or not but it is on PureTech Health site...
@bridgeburn what's your view on topical estrogen at a not so high dose? Do you still think it would do something good? Even if small?
I am also on oral AA, just not confident risking it with bigger doses of estrogen even if topical...
Also second question: do you still see some shedding from...