CLINUVEL PHARMACEUTICALS LTD (Seite 1887)
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Antwort auf Beitrag Nr.: 57.327.881 von ODI01 am 20.03.18 10:46:31
Die FDA Sorge um "off label" usage würde durch eine Kosmetikserie mit @-msh jedenfalls kräftig befeuert. Insofern bin ich gespannt wie und was Clinuvel an Skincareprodukten anbieten will.
Zitat von ODI01: Day At The FDA
. They explained that there is concern that the drug would be
used for “off label” usage and that it would take time and effort to
weigh the risks and benefits of a drug such as Afamelanotide.
http://www.porphyriafoundation.com
Die FDA Sorge um "off label" usage würde durch eine Kosmetikserie mit @-msh jedenfalls kräftig befeuert. Insofern bin ich gespannt wie und was Clinuvel an Skincareprodukten anbieten will.
Ich hoffe das scenesse im Laufe des Jahres in den USA endlich zugelassen wird
Antwort auf Beitrag Nr.: 57.327.881 von ODI01 am 20.03.18 10:46:31sehr eindrücklich.
Day At The FDA
I was part of the Afamelanotide trial last summer and was fortunate
enough to have received the real thing. Unless you have EPP, I cannot
explain what a miracle that was. But I did get the chance recently to
do just that at the FDA Office of Orphan Diseases. Another fellow
EPPer, Matt Johnson, joined me. In my 62 years I had never met anyone
with EPP outside of my family (I have two cousins with EPP). That was
an experience in itself. Those of us with EPP know that we can never
explain to someone without EPP what it is like, but listening to Matt
Johnson was like reading my own thoughts. Matt and I spoke a couple of
times during telephone conferences before we actually met at the FDA
in Silver Spring, Maryland. Although our session was scheduled for
10:30am, we were asked to come early to meet with Dr.Timothy Cote, the
head of the Office of Orphan Diseases. I arrived just before 9am and
Matt was close behind. Dr. Cote had just returned from Israel two day
prior and was sick the day before, so he was not in good spirits, but
after a few minutes listening to Matt and me, he was beaming. He told
us that his staff, like all bureaucratd, tends to lose site of their
mission and was delighted that we were there to remind them that we
are out there.
Dr. Bob Desnick, a member of the APF Advisory Board, was also to
attend, but his flight from New York delayed him an hour. By the time
we were ushered into the conference room over 30 doctors and health
professionals were waiting to hear what we had to say. For an hour
Matt and I regaled them with the inexplicable world of EPP and the
miracle of Afamelanotide during which time we were videotaped. We
tried to tell them of the unrelenting pain, the isolation and self-
doubt, and ultimate despair. Then we told them about our experience
Last Summer and how it had changed our lives. We weren't supposed to
directly discuss this, but it just couldn't stay untold - so we did.
Dr. Desnick translated what we had to say into meaningful medical
speak, but I believe that our words had more impact.
Like most families, we have gone to the beach almost every summer, and
every summer after 15 minutes, I am banished to the house and sit with
my feet in a lobster pot of ice water for the next 5 days “sipping”
copious amounts of adult beverages. Needless to say this is hardly
endearing to my wife and makes everyone wonder. But last summer, I
spent hours on the beach with virtually no pain – a certified miracle
if ever there was one. Like most EPPers, I have never told anyone
outside of my immediate family about my condition. My colleagues at
the office began referring to me as Mr. Tan without ever knowing why.
But the most compelling thing that day at FDA was a video that Matt
had brought. It was a video of the episode that led to his diagnosis.
He was 11 at the time and had gone skiing with his family. The video
showed the progress of the effect of EPP over the period of about 10
days. As most of EPPers know, even though the pain has past, we are
not a pretty site after 10 days. It had a profound effect on our
audience.
Drs. Cote and Mueller thanked us for our time and promised that they
would advocate our case to the extent they could, but could promise
nothing. They explained that there is concern that the drug would be
used for “off label” usage and that it would take time and effort to
weigh the risks and benefits of a drug such as Afamelanotide. Dr.
Mueller told us that she would share the video of our session with the
FDA Center for Drug Evaluation and Research. I believe that this was a
first and significant step in getting approval for the use of
Afamelanotide, but I am not sure that the end is in sight. I live 45
minutes from the FDA campus and with the help of APF will continue to
do whatever it takes to gain approval for use of Afamelanotide.
Posted by American Porphyria Foundation at 9:26 AM
http://www.porphyriafoundation.com
I was part of the Afamelanotide trial last summer and was fortunate
enough to have received the real thing. Unless you have EPP, I cannot
explain what a miracle that was. But I did get the chance recently to
do just that at the FDA Office of Orphan Diseases. Another fellow
EPPer, Matt Johnson, joined me. In my 62 years I had never met anyone
with EPP outside of my family (I have two cousins with EPP). That was
an experience in itself. Those of us with EPP know that we can never
explain to someone without EPP what it is like, but listening to Matt
Johnson was like reading my own thoughts. Matt and I spoke a couple of
times during telephone conferences before we actually met at the FDA
in Silver Spring, Maryland. Although our session was scheduled for
10:30am, we were asked to come early to meet with Dr.Timothy Cote, the
head of the Office of Orphan Diseases. I arrived just before 9am and
Matt was close behind. Dr. Cote had just returned from Israel two day
prior and was sick the day before, so he was not in good spirits, but
after a few minutes listening to Matt and me, he was beaming. He told
us that his staff, like all bureaucratd, tends to lose site of their
mission and was delighted that we were there to remind them that we
are out there.
Dr. Bob Desnick, a member of the APF Advisory Board, was also to
attend, but his flight from New York delayed him an hour. By the time
we were ushered into the conference room over 30 doctors and health
professionals were waiting to hear what we had to say. For an hour
Matt and I regaled them with the inexplicable world of EPP and the
miracle of Afamelanotide during which time we were videotaped. We
tried to tell them of the unrelenting pain, the isolation and self-
doubt, and ultimate despair. Then we told them about our experience
Last Summer and how it had changed our lives. We weren't supposed to
directly discuss this, but it just couldn't stay untold - so we did.
Dr. Desnick translated what we had to say into meaningful medical
speak, but I believe that our words had more impact.
Like most families, we have gone to the beach almost every summer, and
every summer after 15 minutes, I am banished to the house and sit with
my feet in a lobster pot of ice water for the next 5 days “sipping”
copious amounts of adult beverages. Needless to say this is hardly
endearing to my wife and makes everyone wonder. But last summer, I
spent hours on the beach with virtually no pain – a certified miracle
if ever there was one. Like most EPPers, I have never told anyone
outside of my immediate family about my condition. My colleagues at
the office began referring to me as Mr. Tan without ever knowing why.
But the most compelling thing that day at FDA was a video that Matt
had brought. It was a video of the episode that led to his diagnosis.
He was 11 at the time and had gone skiing with his family. The video
showed the progress of the effect of EPP over the period of about 10
days. As most of EPPers know, even though the pain has past, we are
not a pretty site after 10 days. It had a profound effect on our
audience.
Drs. Cote and Mueller thanked us for our time and promised that they
would advocate our case to the extent they could, but could promise
nothing. They explained that there is concern that the drug would be
used for “off label” usage and that it would take time and effort to
weigh the risks and benefits of a drug such as Afamelanotide. Dr.
Mueller told us that she would share the video of our session with the
FDA Center for Drug Evaluation and Research. I believe that this was a
first and significant step in getting approval for the use of
Afamelanotide, but I am not sure that the end is in sight. I live 45
minutes from the FDA campus and with the help of APF will continue to
do whatever it takes to gain approval for use of Afamelanotide.
Posted by American Porphyria Foundation at 9:26 AM
http://www.porphyriafoundation.com
Trading Spotlight
Was wird denn hier wieder fürn Müll gelabert?!
Das Ding zieht jetzt weiter bis 10 und 15-20 euro. Erst dann wird eine leichte Korrektur kommen.
In genau 2 Monaten (60 Tagen) wird das Ding kreuz und quer in die Luft fliegen. Da werden die neuen Produktlinien aufgetischt. Das wird eine richtig große Sache, wenn der CEO extra ein Interview zu dem Thema "skincare"gibt. Daneben wird eine neue Kommunikation aufgebaut die ebenfalls am 20. Mai aktiv wird.
Wir befinden uns jetzt bis Oktober in Rekordmonaten, was die Verschreibungen von den Implantaten angeht. Fast 100% "continuation rate" bei den Patienten, also keiner verzichtet auf das Implantat. Die Patienten bekommen ein ganz neues Leben.
Das Ding zieht jetzt weiter bis 10 und 15-20 euro. Erst dann wird eine leichte Korrektur kommen.
In genau 2 Monaten (60 Tagen) wird das Ding kreuz und quer in die Luft fliegen. Da werden die neuen Produktlinien aufgetischt. Das wird eine richtig große Sache, wenn der CEO extra ein Interview zu dem Thema "skincare"gibt. Daneben wird eine neue Kommunikation aufgebaut die ebenfalls am 20. Mai aktiv wird.
Wir befinden uns jetzt bis Oktober in Rekordmonaten, was die Verschreibungen von den Implantaten angeht. Fast 100% "continuation rate" bei den Patienten, also keiner verzichtet auf das Implantat. Die Patienten bekommen ein ganz neues Leben.
die richtige rally startet erst, wenn die quartahlszahlen wieder steigende umsätze und gewinne zeigen.
Heute leichte Verstopfung in Triebwerk eins, bitte bleiben Sie ruhig.
Antwort auf Beitrag Nr.: 57.325.535 von printguru am 20.03.18 07:21:28Hast du diese Zahl gewürfelt?
Nein ernsthaft, das kannst du vergesse. Die Aktie ist aktuell so was von überkauft, wir können froh sein, wenn sie sich bei 6.40 - 6.50 einpendelt. Die 7 kommen heute wohl noch nicht.
Nein ernsthaft, das kannst du vergesse. Die Aktie ist aktuell so was von überkauft, wir können froh sein, wenn sie sich bei 6.40 - 6.50 einpendelt. Die 7 kommen heute wohl noch nicht.
wird ein super Handelstag ich denke bis 7,2€ könnten wir heute zulegen
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