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blackm3
Posted on: Yesterday, 03:04 AM


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Posts: 309

We can also expect ( in time when clinuvel decides) for the delivery method of scenesse to be relaxed... the implant method should be short lived
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blackm3
Posted on: Oct 10 2019, 03:14 AM


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Posts: 309

Also expecting a jump in todays trading on the asx
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blackm3
Posted on: Oct 9 2019, 04:00 AM


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Wooooohooooo. Yeah booyyy
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blackm3
Posted on: Oct 8 2019, 05:42 AM


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Was a nervous wreck also cheers
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blackm3
Posted on: Oct 8 2019, 05:18 AM


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Haha johhny h .... just drink a few vodkas ... lose a few days sleep ( re me ) and go onto youtube ...
watch a horse named winx ... will make u believe in the extraordinary😉 Australian clinuvel/ winx
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blackm3
Posted on: Oct 8 2019, 02:46 AM


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Posts: 309

I used a rough but honest calculation of 1500 europe epp patients and 1500 usa patients.( should be much higher though)
3000 patients in total at 3.5 implants average per year .
3000 times 3.5 = 10500 implants at $25000 aud per implant
= $262 million for usa and europe .

The tax rate is 30% in Australia ( someone please correct me if im wrong ) .
So we have roughly $170 millon profit after tax .
48 million cuv shares listed at $170 million profit is a EPS of 3.
EPS of 3 with a low PE ratio of 30 is $90 a share.
I havent included Australia Japan etc etc etc epp sales only Europe and Usa.


I Havent slept well the past 48hrs and wont till the fda decision , any mistakes
I have made above in my calculations are due to 19 years of waiting
For this moment and lack of sleep

Goodluck to everyone



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blackm3
Posted on: Aug 31 2019, 03:11 AM


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Posts: 309

We are not 1000% fda approved ,
We would be $36-40 a share by now if so
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blackm3
Posted on: Aug 26 2019, 09:02 AM


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Posts: 309

Sharemarket today for cuv not looking good .
Tuesday may be much worse unfortunately .

Trump vs china
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blackm3
Posted on: Jul 22 2019, 01:17 AM


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Posts: 309

David j lewis is a long term cuv holder/ investor .. hes been around as long as me .. he’s also a sharescene member
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blackm3
Posted on: Jul 12 2019, 09:26 PM


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Posts: 309

https://www.fool.com.au/2019/07/12/why-the-...s-down-8-today/
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blackm3
Posted on: Jun 26 2019, 04:41 AM


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Posts: 309

Clinuvel shareprice now down more than 15% over the past few trading days .
I firmly believe cuv would have shot past the $40 mark if the Iran / usa fiasco didnt happen .
Hopefully a somewhat strong recovery today ( although i said that yesterday )
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blackm3
Posted on: Jun 25 2019, 03:56 AM


Group: Member
Posts: 309

Clinuvel shares down 6% over the past 3 trading days ... looking foward to a strong recovery in” the right direction “ over the coming days
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blackm3
Posted on: Jun 21 2019, 02:23 PM


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Posts: 309

$39.74 wow
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blackm3
Posted on: Jun 19 2019, 09:22 PM


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Posts: 309

Large volumes and price rise expected friday / monday ... got my popcorn
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blackm3
Posted on: May 28 2019, 05:12 PM


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Posts: 309

The shareprice run leading up to the asx200 announcement will be nice ( fingers crossed we are in )
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blackm3
Posted on: May 17 2019, 07:29 PM


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Posts: 309

Cooper energy asx code coe to replace healthscope in the asx 200 on the 27th may.Refer coe announcement
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blackm3
Posted on: Apr 24 2019, 03:00 AM


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Posts: 309

Ignoramus , stop it mate , we will report you again .
Regards trent
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blackm3
Posted on: Nov 14 2018, 01:16 PM


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https://youtu.be/CmZ0Ttv3D5U
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blackm3
Posted on: Nov 14 2018, 02:34 AM


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Posts: 309

Errors showing up .
Will find a way
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blackm3
Posted on: Nov 14 2018, 02:12 AM


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Posts: 309

Currently uploading the Pw interview to youtube . ...Its my first vid onto youtube .
Its titled “ pw cuv “
I hope it works ....im at 8% loaded so far
Cheers
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blackm3
Posted on: Oct 13 2018, 01:14 AM


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Posts: 309

Hi seeva , the falling aud $$ may be favourable to clinuvel based on overseas sales ?
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blackm3
Posted on: Oct 7 2018, 02:39 AM


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Posts: 309

Farma , have seen these patents/ideas come and go over the last 19 years whilst invested in epitan/cuv , ptpt barbara gilchrist, forskalin etc etc the list goes on and on ...clinuvel has won the race ... all other hopefuls are decades behind .
We have been through this before farma
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blackm3
Posted on: Sep 26 2018, 06:57 AM


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Posts: 309

Its best to take a step back and ignore the share price .
Our milestones are:
Nice/ clinuvel to reach an agreement
Fda nda filing completed
Japan and Aus application for epp
And so on
Slow and steady
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blackm3
Posted on: Aug 8 2018, 04:27 AM


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Posts: 309

Facebook post

From the APF website:
**For Mobile device use**

The APF is fighting hard for Scenesse to be granted Priority Review status at the FDA. This is the fastest possible review process for a new treatment through the FDA. Scenesse has proven to be an effective treatment with nearly 6,700 worldwide SAFE doses implanted for the treatment of EPP. There IS no current FDA-approved treatment available for this extremely painful phototoxic disease.

As a TEAM we are much more effective.

Please use this Facebook frame to show your support for our cause and to help gain attention to the much needed Priority Review and approval of the EPP treatment Scenesse!

#ApproveScenesse
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blackm3
Posted on: Jun 20 2018, 10:11 AM


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Posts: 309

Does clinuvel have to announce the nda is submitted?
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blackm3
Posted on: Jun 14 2018, 04:03 AM


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Posts: 309

Taking notice of the ramped up posts re instagram and facebook from clinuvel on vitiligo... hmmm looks good... really good
The recent shareprice volumes / movements seen in the past 48hrs from us old timers ...looks good 😉
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blackm3
Posted on: May 26 2018, 04:41 AM


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Posts: 309

Ignore the trolls please guys ... please ignore , your time is better spent elsewhere
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blackm3
Posted on: Apr 22 2018, 03:49 AM


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Posts: 309

Copied and pasted
Attached thumbnail(s)
Attached Image


 
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blackm3
Posted on: Mar 18 2018, 12:43 AM


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Posts: 309

Xray , think alot of humour is misunderstood , i had a giggle. Lots of cuv investors on this board from around the world
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blackm3
Posted on: Dec 20 2017, 10:06 PM


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Posts: 309

http://www.pharmatimes.com/news/nice_turns...implant_1214791
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blackm3
Posted on: Sep 13 2017, 12:55 AM


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Posts: 309


The video was posted 30 minutes ago , checkout the " fda please accelerate the approval of the life changing afamelanotide for epp " facebook page .


EPP and HOW AFAMELANOTIDE PROTECTS:
JT is holding a vial of protoporphyrin solution, the substance found in the blood of a person with EPP. For this experiment, Jasmin Barman, PhD, extracted the protoporphyrin from the blood of someone with EPP and put it into the solution. The entire blood of a person with EPP does also glow, but it is not visible without a special microscope because the red blood color (the heme) blocks the visible florencense. So, for a person with EPP, when they are exposed to visible light, their blood starts to glow and results in internal 2nd degree burns on the inside of their veins causing excruciating pain.

Horrific to even contemplate, imagine what it is like to experience every time you are exposed to visible light.

Gratefully, JT just received his 9th implant of Scenesse (afamleanotide 16mg). Because of Scenesse, JT has been able to live a relatively pain free life for the last 2 years. I asked Dr. Rocco Falchetto to explain how Afamelanotide protects a person with EPP. There are 3 mechanisms of Afamelanotide at work to protect a person with EPP:
1. In the experiment, when the yellow cellophane is placed between the blue light and the protoporphyrin solution, the solution stops glowing. This is because the yellow color absorbs light in the bluish light range and prevents it from reaching the protoporphyrin molecules. The same principle applies when we tan: exposure to UV light triggers the formation of melanin, our natural pigment which makes us look tan, and just like the yellow filter, melanin absorbs the bluish component of visible light, preventing it from reaching the protoporphyrin molecules and, consequently preventing them from becoming energized and releasing their destructive energy into the immediate environment (the veins carrying the blood). Afamelanotide triggers the production of protective light-absorbing melanin without having to expose a person with EPP to the sun (which results in pain).
2. Afamelanotide also has strong anti-inflammatory effects. Part of pain and suffering of a person with EPP is from the phototoxic events that are experienced after exposure to light. Afamelanotide's anti-inflammatory mechanics explains why EPP'ers can expose themselves to light for longer periods of time and if they are over-exposed, the symptoms resolve more rapidly than without afamelanotide. JT has experienced both of these benefits - able to tolerate much more time exposed to light and when he has had a reaction, the pain and swelling subside much more quickly.
3. Afamelanotide also has anti-oxidative effects, meaning it triggers natural biological mechanisms which scavenge noxious oxygen radicals and other reactive oxygen species which are generated when protoporphyrin is energized by visible light. When a person with EPP is exposed to visible light, the energy that is released into the immediate environment is transferred onto the oxygen in our blood vessels and cells, turning it into these noxious reactive species, one of the culprits in the phototoxic reactions EPP'ers experience. Afamelanotide's scavenger mechanism helps to alleviate this.

For EPP'ers, Afamelanotide is life changing and life giving, allowing them to live life as we all do - free from the fear of excruciating pain merely from being exposed to visible light. For those fortunate enough to have access to Scenesse, we will not stop the fight until ALL have access.
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blackm3
Posted on: Jul 24 2017, 09:11 PM


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Posts: 309

https://porphyriafoundation.blogspot.com.au...th-epp.html?m=1
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blackm3
Posted on: Jul 24 2017, 04:48 AM


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Posts: 309

From fb

JULY 22, 2017
EPPALIVE
I attended an EPP patient education meeting held by the American Porphyria Foundation at a place known as Camp Sundown.

Camp Sundown is a parent’s homage to their child who was diagnosed with Xeroderma Pigmentosa (XP for short), a condition where a person can die if they are exposed to even small amounts of ultraviolet light. This camp, founded by Dan and Caren Maher, has become a safe haven for children who experience photosensitivity.

I had never heard of this place until last year when I saw a special on it on Dateline (NBC Synopsis, Full Archived Episode), even though I had lived within a two-hour driving distance of it for many years as a kid.

The first thing I was struck by was the person at the door who, once I was inside, greeted me with, “Is this level of light ok for you?” I’ve never been asked that by a total stranger. She was talking about the Christmas tree lights hanging along the walls inside the building. I immediately felt a comfortability I had never felt anywhere else in my life, and never would I have imagined something like that coming on me so suddenly.

The few windows inside were heavily tinted and blocked off with shutters and curtains. The fully enclosed indoor pool had even been designed with a double door entrance so that potential swimmers could determine, through the heavily tinted windows of the second door, if the pool was being aired out for maintenance before exposing themselves to dangerous light through any open doors on the other side.

I was given a tour by some of the teenagers and children with EPP who had been attending for many years. I felt an instant connection to these children, as though I was looking at what could have been my younger self. I know what they go through on a daily basis, something that no amount of blog posts or TV specials will ever truly be able to convey. And yet here, with total strangers, was an understanding that depreciated words.

I met some of those who were interviewed on the Dateline episode. They admitted that it was far beyond their comfort zone to do the show, but they did it because they wanted to educate families and especially doctors trying to diagnose children. And I thought starting up a blog was far out of my comfort zone! I felt like they were championing me before ever meeting me.

The EPP patient meeting itself was very educational. I learned many new things about my condition and afterwards met some concerned parents of young children with EPP. All the parents there were inspiring champions for their children. Some of them had been searching for years for answers to their child’s pain until they finally found the diagnosis.

In attendance was a specialist EPP researching doctor who spoke and answered questions as though she actually knew what she was talking about! This is the very first doctor I have ever met who was familiar with EPP. Imagine going to a doctor for treatment of a broken who didn’t even know what a broken leg was. That’s how it has been for me for years until this EPP patient education meeting.

The education meeting was skyped from a porphyria specialist center in New York City. I didn’t even know such a thing existed in the United States. I thought that any work in the US was strictly research. I didn’t know they saw patients. I feel like I’ve been in the dark for years. (Get it? Nudge, nudge.)

I learned that there are only 500 known people in the United States who have EPP. I learned that the combination of genes to have a child with EPP is extremely rare, and that even in each pregnancy where the potential for EPP does exist there is only a 25% chance of producing a child with EPP. I learned that there is a psychologist in the US who actually specializes in treating people with EPP.

At this point I’m a little overwhelmed. I wonder what could have been had I known about this in my youth. But I’m glad that I met these amazing people now. They have created a community for themselves where none existed before and freely invited me to join them as though I had never been absent. There was no furtive social exam I had to pass in order to be dubbed as sane, as is the case with many who meet me for the first time. There was no explanations required, no interrogations, and, strangest of all, no ignorance. Just acceptance and understanding and welcoming arms.
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blackm3
Posted on: Jul 12 2017, 01:50 AM


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Posts: 309

Where is the announcement re your link from clinuvel ?
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blackm3
Posted on: Jun 22 2017, 03:04 AM


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Posts: 309

"we like to be aggressive in our targets"

Thats disgraceful / reckless and embarassing
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blackm3
Posted on: Jun 15 2017, 04:17 AM


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Hi heckekjohn
Epitans drug was all over the papers/ tv news 13 years ago led by the crooked ceo wayne millen .
It didnt do us any favours as you can understand .
Clinuvel remains silent until the the time is right😉


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blackm3
Posted on: Jun 15 2017, 03:34 AM


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Posts: 309

Over the past 16 years being invested in epitan / clinuvel , we have seen many threats in regards to sunless tanning drugs ... dr Barbara Gilchrest with her ptpt drug comes to mind and many many others.
At the end of the day ...they all failed ... todays news coverage of another hopefull sunless skin tanner adds to the list ...
the race has already been won by more than a decade .... slow and steady here we come
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blackm3
Posted on: Apr 28 2017, 11:58 PM


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Posts: 309

https://www.facebook.com/pg/CEPAwarenessSup...gJustinHamilton



Porphyria Awareness week! Let it be known! Be aware some of the photos in this videos can be disturbing. But this is real and this is some of what it looks like to have Porphyria and have a new struggle everyday! Justin has a rare porphyria called CEP, where he is allergic to uv rays. He gets blisters and sores which then turn into scars. He struggles everyday with this, but has the most positive, loving, and outgoing personality. You would never know anything is wrong, he is good at hiding the pain. But he is an incredible person and lives life to the fullest! EDIT: Feel free to share this post! To learn more about Justins fight and daily struggle you can visit https://www.facebook.com/pg/CEPAwarenessSup...gJustinHamilton
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blackm3
Posted on: Apr 4 2017, 05:51 PM


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Posts: 309

Hi farleap ,
Fda gives clinuvel " 7 years " market exclusivity starting when approved.
Clinuvels drug being a "new chemical entity " falls under the
Hatch- Waxman Act giving us another 3 ( or 5 cant remember ) years protection.... so we will have at least 10 years market exclusivity in the usa for epp.
Cheers
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blackm3
Posted on: Mar 30 2017, 01:45 AM


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Posts: 309

Posted a few hours ago .
Looking foward to fda approval this year whether you are a epp patient/ investor ,cheers

http://www.porphyriafoundation.com/about-t...es/irina-jacobs
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blackm3
Posted on: Mar 23 2017, 10:58 AM


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Posts: 309

Posted on eppfacebook page today


Dear FDA,
Just completed our 7th trip to Zurich for the life altering treatment with Scenesse. Your experts may still be debating how effective the treatment is based on no personal knowledge of the pain, suffering and anxiety brought on by the cruel effects of EPP.
My son's personal experience tells me and all others with EPP that it is worth the 7 hours of driving to and from the airport from college, 19 hours of flight time to and from Zurich, 26 hours in Zurich (so he only has to miss one day of classes) to get 2 months of precious protection from the horrible effects of visible light.
#ApproveScenesseNow #DrKendallMarcus @FDA_Drug_Info
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blackm3
Posted on: Mar 2 2017, 09:36 PM


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Posts: 309

Moderate uv exposure is fine / recommended( vitamin d etc )
Those who are predisposed to skin cancer cant go out in the sun ... i know this ... i can assure you theres nothing to be excited about watching my dad going into day surgery every 6-8 months getting skin cancers cut out ... the worst part is the follow up /scans to see if the skin cancer has spread to the organs
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blackm3
Posted on: Mar 1 2017, 11:00 PM


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Posts: 309

Dated march 1st 2017

The German patient organisation «Selbsthilfe EPP e.V. » therefore requests an investigation by the appointed member of the German parliament for patient relations of the Ministry of Health, Karl-Josef Laumann, to clarify the reasons for the continued delays and with the aim to make the treatment available by next spring – the most challenging time for EPP patients. In order to make our voice count, representatives of «Selbsthilfe EPP e.V.» should be actively involved as equal stakeholder in every step of the investigation.
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blackm3
Posted on: Feb 16 2017, 02:59 PM


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Posts: 309

Was thinking the same thing Wally .... 2020 lines up close to Vitiligo fda approval
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blackm3
Posted on: Feb 2 2017, 11:32 PM


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The expert epp centres / doctors training clinuvel has setup / paid for in europe , makes me think does / or can a generic mob enter into clinuvels domaine........if not $$$ we are $$$
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blackm3
Posted on: Feb 2 2017, 09:13 PM


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Will be interesting to see if clinuvel follow up the 1-2 years lost of "market exclusivity" due to ema red tape/delays
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blackm3
Posted on: Jan 24 2017, 02:20 AM


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Posts: 309

I did try to buy cuv today on the asx ( only 500 shares ) ... once i put my bid in , within an instant the bots placed orders above my buy order. The whole bot / asx / trading is as crook as rookwood ( aussie slang)
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blackm3
Posted on: Jan 21 2017, 08:56 PM


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Posts: 309

3 years tops for Scenesse to hit the vitiligo market.


Hit the nail on the head kiwi .
Shareprice will move up as expected and continue doing so
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blackm3
Posted on: Jan 15 2017, 03:54 AM


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Posts: 309

Fda epp approval this year may contradict your last post johnnytech
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blackm3
Posted on: Jan 8 2017, 02:50 PM


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Posts: 309

I will have a go to ... $17.50 aud by june .
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blackm3
Posted on: Jan 7 2017, 02:13 AM


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Posts: 309

By june / july 2017 clinuvel should have 10 or so ( give or take )countrys online in europe.
Roughly thats 12million or so per quarter .
Im not going to do the calculations now , let the smarter guys do that .
Anticipation of fda approval ( likely ) will throw us into speculation ontop of that. Speculation ,always will drive the sp higher than what is fair value .
Mid 2017 its going to be a wild ride... the day traders and speculators will show up on our forum posting etc etc
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blackm3
Posted on: Dec 21 2016, 02:38 AM


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Posts: 309

The below pics rc is what us australian comsec users see only .
Would be happy to see anything comsec doesnt show me ( seeing i pay them enough $$)
Cheers mate
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blackm3
Posted on: Dec 21 2016, 02:18 AM


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Posts: 309

Apologies for two identical pics , my first time using sharescene ( uploading pics rc)
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blackm3
Posted on: Dec 21 2016, 01:57 AM


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Posts: 309

Attached Image


Attached thumbnail(s)
Attached Image


 
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blackm3
Posted on: Dec 13 2016, 03:09 AM


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Posts: 309

Hi reality check ,
Every year eofy usa ( december ) clinuvel has been sold " down "and we are seeing the same as of now ... i have watched this for the past 16 years since the ipo ept.
In january the shareprice moves up as it does like clockwork .
I dont understand how or why but can only comment from my experience .
Cheers
Blackm3
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blackm3
Posted on: Nov 29 2016, 02:32 AM


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Posts: 309

Seeva that is perfect thanks... if ss doesnt want to clean up the rubbish then we can
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blackm3
Posted on: Nov 28 2016, 11:48 PM


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Posts: 309

Same here seeva
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blackm3
Posted on: Nov 18 2016, 11:07 PM


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Posts: 309

I believe the idea is if you want to accumulate shares, you buy slowly / small parcels throughout day .. and at the end of the day.. if you can sell only a small amount of what was accumulated to bring the shareprice back to where it started or lower , repeat the next day .
There will always be people selling ( not because they want to) but due to family hardship , bills to pay or other opportunities elsewhere as the shareprice isnt going up.
Not paying individual brokerage fees per trade ie selling 3 shares unlike you and me is a big advantage to them .
I may be wrong though
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blackm3
Posted on: Nov 18 2016, 12:28 AM


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Posts: 309

Desiree lyon also cannot invest in cuv , although she wished she could .
Thats what she said to me at the agm
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blackm3
Posted on: Nov 2 2016, 12:07 AM


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Posts: 309

I hope your right frank , a takeover is our worst nightmare .
Pw wont let that happen 😉
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blackm3
Posted on: Oct 29 2016, 10:52 PM


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.
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blackm3
Posted on: Oct 28 2016, 03:54 PM


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Copy and pasted from gg

https://www.facebook.com/groups/AmericanPor...03834572976045/
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blackm3
Posted on: Oct 12 2016, 03:10 AM


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Posts: 309

$9.00
I have lowered my sp estimate by a few dollars due to the eofy usa where we see a selloff by our usa investors / friends .
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blackm3
Posted on: Aug 11 2016, 10:38 PM


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Posts: 309

In regards to iggys earlier post .
Our phase 1 trials in 2001 consisted of daily injections , we didnt have the slow release tech ( implant ) back then .
I cant imagine any pharma being involved or showing any interest nor could i .
I hope this clears up why /how clinuvel (epitan ) were lucky to hold the mcr1 rights..drug and how lucky we are...hindsight
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blackm3
Posted on: Jul 11 2016, 09:04 PM


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Impreza was my old username from many years ago lol
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blackm3
Posted on: Jul 9 2016, 03:34 AM


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Germany has a poulation of 82 million
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blackm3
Posted on: Jul 9 2016, 03:29 AM


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Germany has 1000 epp patients and austria 120 epp patients using the 1/75000 rule
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blackm3
Posted on: Jul 9 2016, 01:20 AM


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Posts: 309

Copy and pasted from clinuvels last ann:

(FDA) has granted SCENESSE® (afamelanotide 16 mg) Fast Track designation for the treatment of erythropoietic protoporphyria (EPP). This designation recognises the severity of EPP and the unmet medical need of the disorder in the US. SCENESSE® is commercially available for EPP patients in Europe.3

Looking at the last sentence the "3" indicates to me that not only the netherlands are receiving the drug but swiss and italy also have access even though they are disputing the fair price.
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blackm3
Posted on: Jul 8 2016, 12:47 AM


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Posts: 309

A quick look at holland shows a population of around 17 million ppl . Using the 1/75000 rule it gives us around 220 epp patients .
Would be good to have holland on board soon.
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blackm3
Posted on: Jul 7 2016, 01:48 AM


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Posts: 309

A take over attempt if it did happen wont be sucessfull , i can assure you us top 20 or even 25 shareholders will laugh it off.
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blackm3
Posted on: Jul 4 2016, 10:33 PM


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Posts: 309

Hi frogster ,
Having read over your detailed post on costs and earnings and potential sp , the figures are in usd correct ?
cheers
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blackm3
Posted on: Jun 17 2016, 09:15 PM


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Posts: 309

reimburser will cover full cost to 3 implants per year as we understand now . $33500aud.
The unfortunate epp severe sufferers who require 6 treatments can be treated at a lower cost after 3 implants . .. Some type of agreement has to be reached .
After all , the regulators worldwide have decided on orphan drug incentives which is in our favour re clinuvel.
One point which hasnt been discussed is the falling / weak aud and will continue over the coming years... All $$ earned is overseas ... Something to think about
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blackm3
Posted on: Jun 9 2016, 10:36 PM


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Posts: 309

I have noticed over the years in december ( end of financial year in the usa ) selling pressure of cuv .
Cuv hits lows in december.
Here in Australia our financial end of year is end of june ... Can account for the recent sell down ..
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blackm3
Posted on: Jun 7 2016, 11:34 PM


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Posts: 309

I disagree , the suicide rates and liver organ failures more than justify clinuvels drug to be priced in at the lower 20% of orphan drugs /pricing
The added cost of safety guidlines placed upon clinuvel places more risk /cost to both sides of the party
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blackm3
Posted on: Jun 3 2016, 07:24 PM


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Posts: 309

Copy and pasted from the other cuv board





kar18na said:
I like your numbers but $100m revenue won't be achieved in 1-2 years IMO.

To reach that will take some time but if revenues increase substantially each quarter, the market will take notice and revalue this accordingly.

If they can get to $10-$20m revenue for 2017, they will be doing well IMO.

Take a look at Pharmaxis with its EMA approval for Bronchitol. Revenues aren't impressive.

Obv FDA approval will be huge if Clinuvel are successful in Europe.Click to expand...
I acknowledge your point re Pharmaxis. Their EU experience was exceptionally disappointing having only successfully negotiated pricing in a handful of countries - Germany and UK among them. They seemed to have learnt from their mistake and have now done a distribution deal. The usage of Bronchial was also too sporadic. Clinuvel have elected to go it alone, having reportedly rejected an offer from Pfizer for EU distribution. IMO Scenesse differs from Bronchitol in that there is no alternate treatment for EPP, it is an ultra orphan indication and long term usage data is available and extremely supportive.

I acknowledge slow takeup by payors is a risk to my earlier assumptions. The first 18 months since approval has been fairly slow.

Time will tell
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blackm3
Posted on: Jun 3 2016, 12:10 AM


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I find it interesting Pfizer approaching clinuvel to distribute scenesse throughout europe and clinuvel knocking them back . Shows pharma wanting a peice of the action . Dont know the details if someone knows more
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blackm3
Posted on: May 27 2016, 08:35 PM


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http://www.livestrong.com/article/509405-d...ing-l-cysteine/
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blackm3
Posted on: May 24 2016, 01:16 AM


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Dr wolgren did say at the 2014 agm vitiligo / scenesse will be availiable in 3 to worst case 5 years time . I also made the mistake of quoting him saying epp pricing will be $15,000 per dose which is not correct.
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blackm3
Posted on: May 18 2016, 11:21 PM


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Thats correct clinhope , the idea for vitiligo is to darken the skin on the " white patches only " .... The implant does well but local / topical cream is much better as the surrounding skin does not darken re implant
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blackm3
Posted on: May 18 2016, 11:05 PM


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The topical is not systemic
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blackm3
Posted on: May 18 2016, 01:22 AM


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I keep reading asx biotechs run at average 18.5 pe ratio . ( i have to do research to confirm )
If that is the case then im sure we know orphan drug status will sit higher .. Need to research more though
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blackm3
Posted on: May 17 2016, 10:59 PM


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I dont have the figures but from what i read , epp is diagnosed in most cases in adulthood .. With the unfortunate few children , so we can assume 99% of the epp patients ( quoted) are adults .
Note , sorry iggy i accidently thanked your negative post , fat fingers and iphone ....
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blackm3
Posted on: May 16 2016, 12:51 AM


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I believe some epp patients will require 2 implants per year and some will need it 6 times a year.. Depending on the severity of the disease.
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blackm3
Posted on: May 14 2016, 09:59 PM


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Norways population is 5.2 million .
30 patients at 3 times a year ( 40k aud ) is $3.6 million
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blackm3
Posted on: May 7 2016, 01:22 AM


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Aussie biotechs run at ave 18.5 pe ratio ... Clinuvel with orphan drug status ( 10 yrs ) in specialised centres will be ALOT higher
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blackm3
Posted on: May 6 2016, 10:43 PM


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Clinuvel will seek /apply for the 2 years lost in sales due to the unecessary restrictions placed on them by the emea, so 10 years exclusivity will stand . The emea will not argue that.
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blackm3
Posted on: May 6 2016, 02:26 AM


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Clvly leads the aussie cuv ( $3.30 = $4.40 aus)?
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blackm3
Posted on: Apr 30 2016, 11:33 PM


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Could be worse , could be on the disability pension
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blackm3
Posted on: Apr 26 2016, 12:19 AM


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Does anyone know if there are more epp or Xt porphyria sufferers ? Clinuvel was recently given fda Orphan drug status for Xp and im sure the numbers were quoted but i cant find it.
Also , a biotech forum on the other message board quoted aussie biotechs run at average 18.5 p/e ratio ... I believe clinuvel will be much higher .
Epp is ranked 3rd ( population wise ) of porphyrias
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blackm3
Posted on: Apr 24 2016, 10:56 PM


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Thinking the ball is in the fda's court re clinuvels awaiting fda response whether or not they are happy with the data and get the go ahead for the nda
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blackm3
Posted on: Apr 5 2016, 03:18 AM


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Do the fda regulators feel the same way ? Remembering they (fda)rejected clinuvels drug in 2005 for skin cancer..
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blackm3
Posted on: Mar 31 2016, 10:17 PM


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Thanks to uhol gg

News from the EPP - front : Start treatment with SCENESSE in Dusseldorf in mid-April 2016 - if EMA and BfArM play ! Dear members of self-help EPP ! As we have just heard , our porphyria center in Dusseldorf is now fully prepared to start the treatment of EPP patients with SCENESSE ! In mid-April it could go!
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blackm3
Posted on: Mar 24 2016, 09:40 PM


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Correct, before the split
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blackm3
Posted on: Mar 24 2016, 07:50 PM


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The highest shareprice we reached was in march 2007 where we hit Just over $14.80 during early morning trading , ( the start of ph3 epp trials announced )
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blackm3
Posted on: Mar 22 2016, 12:41 AM


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Was trying to dig up my old notes from 10 years ago in regards to high does of carotenoids , from memory the fda warned about permanent eye damage and advised against it .
I tried to google it but all i found was shady companys promoting their magic pills
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blackm3
Posted on: Mar 18 2016, 10:15 PM


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That could possibly be the last ever CR clinuvel has to make since the ipo , its been a long 15 years invested but good things come to those who wait ...
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blackm3
Posted on: Mar 15 2016, 10:13 PM


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Dont think the top 20-25 shareholders would allow that including myself
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blackm3
Posted on: Mar 1 2016, 01:30 AM


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I am not a epp sufferer but my co-worker was , he resigned ( having a position in the company to be proud of ) . Reason for resignation not disclosed.
I sent an email ( more indepth detail) today to the fda regarding my co-worker ..

Fb today

RARE DISEASE DAY IS TODAY!

Don't forget to have email their letter to Dr. Kendall Marcus demanding approval of Scenesse TODAY!

Her email is kendall.marcus@fda.hhs.gov. We will not stop until we get approval!

Also please follow @MarthaWithEPP on Twitter. Please be sure to share her Tweets!

#SuccessWithScenesse #DrKendallMarcus U.S. Food and Drug Administration Scenesse - afamelanotide 16mg
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blackm3
Posted on: Feb 29 2016, 01:33 AM


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Posted on fb

URGENT: Tomorrow is Rare Disease Day and we are asking that EVERYONE email their a letter to Dr. Kendall Marcus directly on this day. It is very important that this be done on Monday, February 29, 2016.

Do not copy a template, please make it your own. Feel free to use template as guide. Get your friends and family to also email letters. All letters must be different. Please do this regardless if you have already sent in a letter. Again it is very important that this be done tomorrow. Let her know we want Scenesse - afamelanotide 16mg approved now to help all those with EPP!

Dr. Marcus' email is:
kendall.marcus@fda.hhs.gov

Let's make her inbox explode so she knows we mean business. Rare diseases cannot be overlooked and when there is a safe treatment available it should be approved!

Please let us know you emailed her and don't forget to send a copy to the APF. Thank you all for your help. As they say it takes a village and we will get this approved!

#SuccessWithScenesse #FDADrKendallMarcus #ScenesseIsSafe
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blackm3
Posted on: Feb 28 2016, 12:52 AM


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Hi farma ,
My memorys not too good but mesoblast asx code msb is the bio Pw was watching re nasdaq listing .
I ran through some recent msb announcements and a heart trial was restricted to a lower patient trial which had a neg / shareprice fall.
Could be wrong but i did put msb on my watchlist and i think thats what Pw is watching.
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blackm3
Posted on: Feb 27 2016, 01:10 AM


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Good post farma ... As to the question who is selling right now at these prices .. Theres probably alot of people who dont involve themselves or bother to read sharescene ,hc or google groups.
The idea that Pw may achieve 35k per implant as suggested lately on the forums brings the short term shareprice up 4-5 fold .
I feel a bit guilty repeating on Ss Pw's words at the 2014 agm where he was indicating 15k per implant... We will know soon enough
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blackm3
Posted on: Feb 26 2016, 02:23 AM


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The post below shows scenesse is not seasonal.. Its needed all year round



One of the symptoms of Erythropoietic Protoporphyria is thin skin which causes us to scratch and scar easily. In the winter comes dry skin and my hands are constantly in and out of water from washing or doing normal everyday tasks like the dishes. I find regardless of how much moisturizer is used my hands and arms scratch more easily and my thumbs crack and peel like a snake sheds it skin. Although it may not be during a reaction, because the skin cracks more easily, it can still be painful especially around the knuckles. Just scratching an itch no matter what time of year can cause ripping of the skin. I did find that during the trials, having received Scenesse, my skin did not tear as quickly as it would without. Maybe this too can be avoided with approval.
#SuccessWithScenesse #DrKendallMarcuss #FDAApproveScenesseNow
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blackm3
Posted on: Feb 22 2016, 11:15 PM


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One of my earlier posts i mentioned dmp ( dominoes pizzas ) which is a aussie asx listed company .
Dmp was trading at around $3.00 a share a few years ago and today sits at $60.00/ share
I did a rough bit of research and did some numbers/ calcs.
Dmp has 88million shares listed ( double cuv at 44 mill)
Dmp posted a 57 million $ profit which has pushed the sp to $60
Im a bit confused as to how a company earning 57mill can reach $60 /share with twice the amount of shares as cuv.. My thoughts are what if clinuvel could earn the same profit through epp sales ?
Would appreciated to be corrected btw
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blackm3
Posted on: Feb 11 2016, 11:02 PM


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Looking foward to the implant pricing / agreement ... How close did Pw get to his $15,000 target per treatment.
Good find royco btw , maybe you can take over LH 's job
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blackm3
Posted on: Feb 5 2016, 02:18 AM


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Have to agree with you zero t .. He has more worries than Salim Mehajer here in oz
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blackm3
Posted on: Feb 5 2016, 12:49 AM


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Off topic for now but martin may have another go at clinuvel in the future


Martin Shkreli invokes the Fifth Amendment, declines to answer Congressional questions
Updated Moments Ago

Former pharmaceutical CEO Martin Shkreli appeared as a witness before a congressional committee on Thursday, but chose to invoke his Fifth Amendment right not to testify.
Shkreli, who raised the price of a lifesaving medicine by 5,000 percent, was not expected to answer price spike questions from lawmakers on the House Committee on Oversight and Government Reform.
Former drug executive Martin Shkreli ® exits with his lawyer Benjamin Brafman at the U.S. Federal Courthouse in Brooklyn, New York February 3, 2016.
Shkreli attorney: I told him to stop talking
Shkreli, 32, sparked outrage last year among patients, medical societies and Democratic presidential front-runner Hillary Clinton after his former company Turing Pharmaceuticals raised the price of 62-year-old Daraprim to $750 a pill from $13.50.
The medicine, used to treat a parasitic infection, once sold for $1 a pill.
In December, Shkreli was arrested and charged with running his investment funds and companies almost like a Ponzi scheme. He has pleaded not guilty, stepped down from Turing and was fired from KaloBios Pharmaceuticals. He is also a former head of Retrophin, which sued him, alleging mismanagement.
Behind the questions about drug pricing and the Ponzi allegations, Shkreli is something of a controversial figure for his social media presence, which often appears to make light of the criticism against him
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blackm3
Posted on: Feb 4 2016, 11:10 PM


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Completing ph3 usa epp trials years ago without submitting fda nda comes to mind landrews
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blackm3
Posted on: Jan 31 2016, 06:35 PM


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A copy and paste from fb


Rocco Falchetto
I have helped Gayle connect to Dr. Minder, so that JT could get the Scenesse implant. Since then it's like we've become family. We met during both of their visits to Zurich back in August 2015 and in January a couple of weeks ago. I was very impressed with JT's transformation between the two visits - During the first visit in August, I perceived him as reserved, quiet and he somehow looked sad to me; very different person during his second visit this January, where I perceived him as more open, self-confident and happy, I just didn't sense the sadness I sensed in August - Amazing what Scenesse has done! Another great story of its life-changing effect on EPP sufferers and their families, an effect I have experienced first hand for the last 10 years under the Scenesse treatment and that I could see in many other patients fortunate enough to receive the implant in Switzerland. FDA, please approve Scenesse as soon as possible. By doing so you will give a new life to many EPP patients and their families in the US and end their struggle and suffering with the disease. Thank you!
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blackm3
Posted on: Jan 28 2016, 08:44 PM


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Seems borderline atm , how close we are to sales only Pw knows . 7.5 mill will last 8-10 months or so but i havent seen clinuvel let the bank drop below 5-6 mill.
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blackm3
Posted on: Jan 21 2016, 12:14 AM


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The same mindset can be applied to allergen in its early /medium stages of development.
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blackm3
Posted on: Jan 10 2016, 03:26 AM


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injecting drugs bought off the internet from unknown chinese suppliers.. The general public / genuine epp sufferers deserve better than that.
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blackm3
Posted on: Dec 28 2015, 01:27 AM


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Hi ignoramus ,
One of my co workers (20 years my senior) describes himself as a pessamist

- Define pessimistic: having or showing a lack of hope for the future : expecting bad things to happen—

My co worker always said being pessimistic was a way of never being let down or disappointed ( very low expectations in life)
He described waking up in the morning as a win ... That he had not passed away overnight .
I would be very interested how many successful people ( financially and or happy ) that are pessamists .
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blackm3
Posted on: Dec 16 2015, 06:08 PM


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Dec 2013 ,we also had a selloff of cuv pushing us under the $1.00 mark before it quickly recovered . Odd
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blackm3
Posted on: Dec 11 2015, 12:04 AM


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Posts: 309

Hi kiwi1 , sorry for the off topic cuv post .
I agree commodities are done and dusted . In regards to the aus banks , the australian housing market is in the biggest housing bubble the world has seen .. By a long shot.
The banks have leveraged themselves soo much that any downturn in the property market will bring a turn of events that will be remembered unfortunately for decades.
Today , the housing market is falling to pieces ..by the week ( after week)and its only been 1 month since the property investors were dreaming of neverending wealth. It turned so quick .
Back on topic , the fda filing for epp will be our next milestone and not too far away ( my belief ) .
Ignoramus , i recall u mentioned something earlier in your posts about campaigning / letters for epp fda approval and your thoughts / discrepancy with this approach ... I spoke to d . lyon face to face and she was proud of her achievements over the past 15 -20 years ( cant remember the years exactly lol ) with the campaign/ patient voice . We are lucky to have her onsIde.
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blackm3
Posted on: Dec 8 2015, 09:49 PM


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Ignoramus , i think mt2 users use saline as the vehicle ( eyewash ) found in any first aid cabinet . Will have the words " not for injection " on the bottle , otherwise it would the have to be prescribed by a doctor.
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blackm3
Posted on: Dec 2 2015, 10:58 PM


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I guess its a little frustating being invested in clinuvel . (Atm)
Example , my friend at work who doesnt understand shares / the market , done his research and set up a share trading account.
He invested in asx code dmp ( dominos pizzas ) 3-4 years ago at $3.50 from memory .
I think many here would laugh investing in pizzas ( i did )
He wouldnt understand what a pe ratio is or what market cap means.
Last time i checked dmp was $50 a share.
Makes you think money follows certain people no matter how hard you research / study.
Ok , no more negative posts from me 😜
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blackm3
Posted on: Oct 7 2015, 12:57 AM


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Is it possible RPape the buyer is also selling shares to themselves ? This may also create doubt to retail holders a large cuv holder is unloading .
Just thinking one of many tricks the experts have
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blackm3
Posted on: Sep 25 2015, 01:25 AM


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The last vitiligo timeline from PW quoted 3 to worse case 5 years, that was 12 months ago (2-4 now)
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blackm3
Posted on: Sep 19 2015, 11:07 PM


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I make the confident guess, that in real dollar terms I have invested more as a percentage of my total wealth in Clinuvel, than any Person on this board.

Dont be to confident ignoramus 😉
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blackm3
Posted on: Sep 10 2015, 01:49 AM


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50 days of leave unused ( days in lieu )
Lines up with brendas comments PW works tirelessly but he did cash those days in.
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blackm3
Posted on: Sep 4 2015, 11:44 PM


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The italian epp patients have been using the drug for 4-5 years now, no discrepancy reported as of yet
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blackm3
Posted on: Aug 25 2015, 10:55 PM


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The seller is using algo trades.. Not one of us
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blackm3
Posted on: Aug 22 2015, 12:42 AM


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I suspected royco retro were still selling based on the algo trades shuffling , ive soaked up a few but i believe they are almost done
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blackm3
Posted on: Jul 29 2015, 01:25 AM


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Commsec doesnt show this cross trade either
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blackm3
Posted on: Jul 15 2015, 11:36 PM


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Ljs is in the top 20 shareholders if im not mistaken, wont mention any names!
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blackm3
Posted on: Jul 7 2015, 11:07 PM


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Lol , your drunk ignoramus
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blackm3
Posted on: Jul 1 2015, 11:47 PM


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Hi Snaffew , i think once the drug is approved worldwide and the numbers ( people ) using the drug increase dramatically , we will see the implant price drop also .
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blackm3
Posted on: Jul 1 2015, 12:20 AM


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Hi royco ,
Clinuvels recent ( 2 weeks ago ) letter to the epp community quoted fda filing once eu rollout is complete.
This statement would be very misleading if another ph3 trial is req
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blackm3
Posted on: Jun 26 2015, 01:46 AM


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Hi snaffew,
I read your last post many times and i still cannot understand it.
Do you mean the black market is offering a slow release ( either mt1 or 2 ) ?
If not , you can forget about comparing a drug released in suspension vs implant .
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blackm3
Posted on: Jun 26 2015, 01:29 AM


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Makes you wonder what retro would be trading at if it was listed on the asx only ... Probably $2 -$4 or so.
When retro was mentioned at the 2014 agm there was laughter from the clinuvel directors re their debt
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blackm3
Posted on: Jun 25 2015, 01:45 AM


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What do you mean smart/not buying royco, im grabbing 500 shares every forthnight with my horrible wage lol
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blackm3
Posted on: Jun 20 2015, 08:23 PM


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How many votes do we need ignoramus lol joke
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blackm3
Posted on: Jun 20 2015, 12:47 AM


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PW's target of 12-15,000k aus per implant is set in concrete in my mind for the eu rollout.
Wont be too long before we find out ..if this hand picked well paid ceo is true to his word
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blackm3
Posted on: Jun 18 2015, 12:40 AM


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My thoughts ignoramus my friend is there are alot of unanswered questions , some input on your behalf would be greatly appreciated by the members here.
No i dont have the answer in regards to my question although uv light unfortunately wasnt the answer ( no tricks)
Uhol may direct me towards more hair follicles present in the upper half of the body but thats a terrible guess on my part
Thanks
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blackm3
Posted on: Jun 17 2015, 11:36 PM


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Hi ignoramus ,
With many questions / concerns you have in regards to mcr1 .
Maybe you can answer one of my questions
Why is the melanacotin drug more effective on the upper torso compared to the lower half of the body ?
Regards
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blackm3
Posted on: Jun 17 2015, 09:45 PM


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Landrews
, it does make you wonder how those tanning beds were ever allowed in the first place.. Glad they were banned in oz anyways
Off label may happen one day though
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blackm3
Posted on: Jun 16 2015, 03:08 AM


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Clinuvel are now posting links to the dateline program via their fb page for those in the usa
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blackm3
Posted on: Jun 13 2015, 11:31 PM


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To clarify , 10,000 people est suffer epp worldwide, 6-800 in europe , 500 in the usa , that leaves nearly 8500 elsewhere
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blackm3
Posted on: Jun 13 2015, 10:34 PM


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The usa has a population of 319 million people and only 500 suffer from epp ..
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blackm3
Posted on: Jun 13 2015, 10:30 PM


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"500 people in the usa suffer from epp"
I would assume this includes children.
Would be interested where this data was communicated.
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blackm3
Posted on: Jun 12 2015, 12:00 AM


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This melanacortin produced in italy would be patented ?
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blackm3
Posted on: Jun 11 2015, 11:23 PM


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Thx madman , wow
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blackm3
Posted on: Jun 8 2015, 03:00 AM


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Clinuvel management ( not sure who quoted it ) said at the agm fda approval for epp will require " a bit of campaigning"
This to me indicates no further trials Are planned/ required.
For what its worth ...
I want to make it clear that cuv is focused on fda approval for epp / sufferers and that jumping to vitiglo for fda approval is NOT an option management or shareholders want.
Theres no doubt what this drug has to offer
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blackm3
Posted on: May 16 2015, 11:53 PM


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As eagle mentioned with psoriasis, eczema is also a genetic defect, my friend with eczema was asian with dark skin so its not dependant on type 1 and 2 skintypes
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blackm3
Posted on: May 16 2015, 11:44 PM


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I made a post some months back regarding the skin condition eczema . My best friend suffered from this unpleasant condition ( especially when the weather was warmer).
My basic understanding is inflammation of the skin causing uncontrollable itching ... Bleeding / scarring results due to scratching constantly.
A large % of people both white asian etc suffer from this from mild to severe
My thoughts are if the usa can prescibe off label .. It may be used to help eczema sufferers$$
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blackm3
Posted on: May 16 2015, 05:18 AM


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Recent patents by PW as talked about on google groups in the last few hours are interesting
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blackm3
Posted on: May 12 2015, 11:22 PM


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A Few spelling mistakes in my last post
M3
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blackm3
Posted on: May 12 2015, 11:19 PM


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Scenesse emea approval was granted not due to managements expertise, i think we all can agree on that .
It does however show how great this melanacotin is
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blackm3
Posted on: May 12 2015, 12:37 AM


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Hi royco ,
presentations / speeches etc at the agm pointed towards epp fda filing moving foward as planned.
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blackm3
Posted on: May 9 2015, 01:31 AM


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Think ive posted the same link . Thx royco
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blackm3
Posted on: May 9 2015, 01:29 AM


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A link clinuvel posted hours ago
Hope it works


http://blogs.nature.com/tradesecrets/2015/...ch-in-australia
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blackm3
Posted on: May 9 2015, 01:05 AM


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Well thats something i didnt know royco , good one mate
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blackm3
Posted on: May 6 2015, 12:25 AM


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Good point madman, i cant recall any % of ownership between the singapore / clinuvel partnership.
Does it indicate the setup/ partnership is purely for protection from takeover ?
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blackm3
Posted on: May 6 2015, 12:10 AM


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From memory a successful topical mcr1 was developed by ept/ cuv and a USa co but the challenge of approval was at higher risk ... So PW canned it .
Once the drug is approved and rolled out worldwide as an implant , cuv investors can take some comfort knowing the topical with patents extending beyond 2030 will carry on.
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blackm3
Posted on: May 4 2015, 01:00 AM


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Hi ignoramus ,
In regards to " you cannot force epp patients outdoors "
I may be wrong but im sure i read the lighting from the house/ lights inside also cause burning .
Another question i have is when clinuvel apply for fda approval , is it clinuvels option to apply for fast track?
Speculating now , maybe clinuvel had two options, file for fda approval 3-4 months ago and cross fingers or option 2 , supplement 6 months data which costs valuable time and $$ but take the option of fda fast track which may result in approval( or reject) in the same amount of time as option 1 ?? Could be way off with my thoughts though
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blackm3
Posted on: Apr 28 2015, 02:05 AM


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Posts: 309

I agree, we dont want the current management replaced or anything like that, maybe just a little bit more feedback .
Wayne millen still has alot to answer for ... For what he did back in september 2004, its all in the past i guess for some.
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blackm3
Posted on: Apr 25 2015, 07:26 PM


Group: Member
Posts: 309

To all australians nz
Remembering anzac day 100 years , lest we forget
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blackm3
Posted on: Apr 15 2015, 02:05 AM


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Posts: 309

I "had" a work colleague who suffered from epp ( in australia ) he has youtube vids re epp btw ( name withheld )
The effects of this condition are unfortunately more than skin deep ignoramus.
His position within the airline industry are what many australians would dream of .
I cant comment any further as i would only be making assumptions but he no longer works for the best airline in the world ... Who would give that up ignoramus....
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blackm3
Posted on: Apr 14 2015, 11:52 PM


Group: Member
Posts: 309

Try looking/ searching through google at the epp sufferers who have commited suicide and see if this would have any complications in negotiating pricing /costs.
Uhol posts neg and pos posts ... Perfect example was when uhol believed epp in the eu may not be approved... Uhol is not one sided/
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blackm3
Posted on: Apr 5 2015, 10:44 PM


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Posts: 309

Thanks that makes more sense
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blackm3
Posted on: Apr 5 2015, 10:25 PM


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Posts: 309

Looking at google groups , im having trouble understanding helenes post ... It indicates orphan drug pricing / cost with clinuvels drug costing $10000 pound ??
Im not sure , if someone here can translate pls
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blackm3
Posted on: Mar 16 2015, 12:03 AM


Group: Member
Posts: 309

From memory , Martin was twittering cuv a screaming buy at anything under $10 per share after ema approval , now its confirmed retro selling after ema approval .. Martin sounds like a genuine type of guy
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blackm3
Posted on: Mar 10 2015, 12:21 AM


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Posts: 309

Pw's pricing at the agm was around the 15k mark per implant ... He made that very clear.
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blackm3
Posted on: Mar 5 2015, 11:08 PM


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Posts: 309

Pw quoted 3-5 years for vitiglo approval at the agm ( best - worst case )
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blackm3
Posted on: Feb 26 2015, 01:18 AM


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Posts: 309

Hi royco ,
The cost / price of the implant " may " be much higher than first thought ... ( my take / thoughts from PW at the agm regarding the cost of orphan drugs)
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blackm3
Posted on: Feb 21 2015, 12:04 AM


Group: Member
Posts: 309

is it even possible for clinuvel to go it alone and treat vitiglo sufferers which effects nearly 50 million people worldwide? Unlikely...

Funding the trials for vitiglo "may" be possible if epp sales are good which puts clinuvel in a stronger position when partnering for distribution/sales...


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blackm3
Posted on: Feb 14 2015, 11:40 PM


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Posts: 309

Orphan indications ( epp) is 10 years starting once its approved ( till 2025 ).
Vitiglo is not orphan , so will rely on patent protection
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blackm3
Posted on: Jan 23 2015, 08:28 PM


Group: Member
Posts: 309

At the agm PW was talking about increasing the price of the implant , he showed orphan drugs and their cost and clinuvels drug was at the bottom of the list ( cheapest) . I think at the top of the list there was a drug for 1.5 million.
I cant remember if 10-15k per implant was the figure PW was looking at.
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blackm3
Posted on: Jan 19 2015, 10:01 PM


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Posts: 309

affects 1 in 6000-10,000 patients
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blackm3
Posted on: Jan 12 2015, 10:18 PM


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Posts: 309

In response to boys question re central nervous system ... It seems that if a drug passes through the brain barrier it creates all sorts of side effects .. Like u said boy , i believe palatin have / or are attempting to compete with viagra , the high blood press is a problem .
Thats why clinuvels melanacortin drug is considered the rolls royce
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blackm3
Posted on: Jan 12 2015, 09:58 PM


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Posts: 309

Royco , the jv may have also been setup for protection / takeover from large pharmas?
The terms of the jv have not yet been released and im guessing clinuvel is in no hurry to do so ...
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blackm3
Posted on: Jan 12 2015, 09:10 PM


Group: Member
Posts: 309

Boy ,
Answer is no it doesnt cross the brain barrier, whilst palatins drug does..
Which somehow raises blood pressure . Someone correct my post if it is misleading.

Reading / researching Eczema which effects quite a large population , especially infants .. The condition results in imflammation of the skin , wouldnt it be good if cuv had a topical anti imflammatory drug😜$$$$
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blackm3
Posted on: Jan 12 2015, 08:57 PM


Group: Member
Posts: 309

My thoughts also royco , hopefully not referring to 2005?
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blackm3
Posted on: Jan 4 2015, 01:19 AM


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Posts: 309

Ignoramus,
Reading through your latest posts , you should /may be aware there are cuv investors who have been involved with clinuvel +14 years or so ( research of the drug )
Please research / learn before you continue any more of these posts.
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blackm3
Posted on: Dec 11 2014, 01:51 AM


Group: Member
Posts: 309

Our goals in the next 12 months are ema ratification, fda epp approval and positive vitiglo ph2 results... That will more than please the shareholders..
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blackm3
Posted on: Nov 28 2014, 08:33 PM


Group: Member
Posts: 309

Yes royco she did for about 10 minutes and received an applause after her speech .
I also spoke to her before the agm started
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blackm3
Posted on: Nov 26 2014, 05:29 AM


Group: Member
Posts: 309

Epp and vitiglo approval ( emea fda ) is all we need, how rich do you guys want to be .
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blackm3
Posted on: Nov 19 2014, 11:27 PM


Group: Member
Posts: 309

Thanks royco
Nasdaq listing means one thing for the shareprice ...
Florian indicated / recommended nasdaq listing as well on Google groups , the ties between PW and florian may be alot closer than we think
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blackm3
Posted on: Nov 18 2014, 08:53 PM


Group: Member
Posts: 309

Thanx guys
Just random clinhope thx mate
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blackm3
Posted on: Nov 18 2014, 08:17 PM


Group: Member
Posts: 309

Is the clinuvel google groups site down ?
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blackm3
Posted on: Nov 15 2014, 09:54 PM


Group: Member
Posts: 309

With the agm less than 2 weeks away , maybe we should organize a list of questions / concerns to be put foward at the meeting.
It has been about 5 years or so since i last attended and from memory only 3 or so questions were asked ( including myself)
Looking foward to travelling down to melbourne in 10 days time , i expect the turnout to be alot bigger than the 45 or so ppl years ago.
Im wondering if a list of q can be put foward to management beforehand instead of me asking 30 questions ?
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blackm3
Posted on: Nov 4 2014, 01:04 AM


Group: Member
Posts: 309

Reminds me of palatin, high blood pressure etc , is it safe to assume the 6 billion M/c Acthar is Valued at is in trouble if we are fda approved ?
I need to read a bit more on it .. Thx madman
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blackm3
Posted on: Nov 3 2014, 11:38 PM


Group: Member
Posts: 309

How Acthar was approved by the fda with its numerous / dangerous side effects is interesting.
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blackm3
Posted on: Nov 2 2014, 03:08 AM


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Posts: 309

Our biggest concern is being taken over, people like klomp who has been around for many years like myself who fully understand what ema approval last week means
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blackm3
Posted on: Nov 2 2014, 03:00 AM


Group: Member
Posts: 309

I couldnt sell my large holding at $10 , surely you guys have done your sums.
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blackm3
Posted on: Nov 1 2014, 06:26 AM


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Posts: 309

Klomp , how can clinuvel protect itself from this?
The jv announced weeks ago? My thinking is that PW knew this would happen if ema approval?
Your thoughts klomp much appreciated, you have been around many years mate
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blackm3
Posted on: Nov 1 2014, 03:12 AM


Group: Member
Posts: 309

The comment by florian re off label usage for vitiglo sufferers never entered my mind.
Its a big win for both patients / investors in the short term.
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blackm3
Posted on: Oct 31 2014, 01:34 AM


Group: Member
Posts: 309

Martin could be one of those people who either go bankrupt or be billionaires, he took a small ( lol ) risk on cuv and it paid off .. But its never enough
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blackm3
Posted on: Oct 31 2014, 01:28 AM


Group: Member
Posts: 309

Martin has invested millions of $ into cuv and now that he has doubled his investment he may be able to borrow alot more $$
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blackm3
Posted on: Oct 31 2014, 01:08 AM


Group: Member
Posts: 309

If martin from retro had a takeover offer on clinuvel of $2.15 or so before the ema decision ( having done his homework beforehand on cuv).. Im sure he will be doing the numbers right now ... Didnt he have a 90 million $ loan ? If he played his cards right he would put another offer in / takeover bid which will not only push us up to his offer but also double or triple his current shares which he already owns in value, its a win win situation for him.... He either gets the company for a bargain price or worst case his shares go up 2-3 fold .thoughts?
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blackm3
Posted on: Oct 31 2014, 12:29 AM


Group: Member
Posts: 309

Intersuisse had a valuation of from memory $15 per share if phase 3 trials were granted/ started ... That was before the 10-1 split lol ...
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blackm3
Posted on: Oct 28 2014, 10:42 PM


Group: Member
Posts: 309

Looking at the clinuvel website tonight re vitiglo , dated september 2013 , it says vitiglo approval if effective and safe (best case )should be availiable within 2-3 years time , being just over 13 months since that was written means vitiglo approval is 12 months - 24 months away ? I would be leaning closer to 24 months away .
Clinuvel would have to organise distribution plans etc well before ( pharma partnership is the most likely and only option imho )
The next 6 months are certainly going to be exciting with fda approval ,possibly a vitiglo partner announced just to name a few that we are aware of.
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blackm3
Posted on: Oct 26 2014, 10:10 PM


Group: Member
Posts: 309

Ema approval has still not hit me yet ... Im still in shock.
Now looking foward to fda fast track approval .....which seems not too far away.
Reading here the sp predictions for tomorrow or possibly tuesday , it seems a range of $5 to $10 per share. ( providing the unexpected is not announced ).
Even at $5-10 per share, i dont see any value added for vitiglo if approved
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blackm3
Posted on: Oct 24 2014, 11:23 PM


Group: Member
Posts: 309

Best day of my life
Thanks to the guys on google groups .. farma and all the usual suspects well done
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blackm3
Posted on: Oct 24 2014, 10:05 PM


Group: Member
Posts: 309

Couldnt have said it better xray
Thanks to everyone here
Sad hank and jack missed the dream they worked so hard for
Uhol , i hope you didnt sell too many shares over the past few weeks , u have my respect mate
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blackm3
Posted on: Oct 24 2014, 09:25 PM


Group: Member
Posts: 309

After 13 years it still hasnt hit me, im numb
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blackm3
Posted on: Oct 24 2014, 09:02 PM


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Posts: 309

Are you guys serious?
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blackm3
Posted on: Oct 24 2014, 08:24 AM


Group: Member
Posts: 309

Trading halt
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blackm3
Posted on: Oct 24 2014, 08:14 AM


Group: Member
Posts: 309

If it was going to be $4.50 with a positive ann i would have sold weeks ago at $5.00 with no risk
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blackm3
Posted on: Oct 24 2014, 08:01 AM


Group: Member
Posts: 309

I need to hide this bottle of vodka ive been smashing for the past 4 hours
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