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Kalaz
Posted on: Dec 4 2019, 10:56 AM


Group: Member
Posts: 43

A lot of great debate here for sure, but I just smile and nod.
Steadfast and confident is where I stand...
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Kalaz
Posted on: Nov 29 2019, 08:23 AM


Group: Member
Posts: 43

https://youtu.be/elAijpmQYr0

Can anyone understand German? Interested in what he has to say.
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Kalaz
Posted on: Nov 25 2019, 07:08 AM


Group: Member
Posts: 43

Continue...Or does it just change the color of the spots of light skin. I have a white friend who has Vitiligo and she is excited to get a permanent tan.
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Kalaz
Posted on: Nov 25 2019, 06:55 AM


Group: Member
Posts: 43

Does mt-7117 tan the skin?
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Kalaz
Posted on: Nov 22 2019, 02:04 PM


Group: Member
Posts: 43

What the hell is with
you people? Have you all
forgotten where this company
has come from? Just yesterday
many of you were high on what the
future holds. If you're not long, get out
when the sp gets back to post approval.
I am absolutely solid on what the future
holds for this company and I am not
worried a bit. I don't care what pw got yesterday, his plan worked to get us
here. I agree that the agm wasnt awesome but going after skin cancer is
Fn exciting to me. Vitiligo is going to go forward and yes it should have been
a hot topic at the agm. There are huge
investors in this company and they are
steadfast. Do they know more than us? Hell yes!! There is no way they are accepting any offer, the runway is too damn long. Why would they take 100.00 when 500.00 is a short distance away. Chill out y'all!!!
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Kalaz
Posted on: Nov 21 2019, 09:35 AM


Group: Member
Posts: 43

If all goes according to plan
PW will be able to buy Real Madrid..
4.2 billion... no problem!
3 to 5 years yes?
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Kalaz
Posted on: Nov 16 2019, 03:41 PM


Group: Member
Posts: 43

WTF!!!!
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Kalaz
Posted on: Oct 31 2019, 02:23 AM


Group: Member
Posts: 43

Isnt it nice that we are discussing
PWs compensation and not looking for
A new horse to bet on?
My 30k investment 15 years ago is now
220k plus the 5k shares picked up along the way 100k. If not for PWs 2005 plan where would we be?
With my now 15k shares it is feasible
To see my account reach a possible 2 to 5mm I'm thinking this is a dream, just don't wake me up until 2027... Though I agree that the recession clause is rediculous, I approve the rest. 30 billion MC by 2027, and I hope I'm invited to the McG PW wedding. 🤘😎
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Kalaz
Posted on: Oct 28 2019, 07:43 AM


Group: Member
Posts: 43

If PW hits his goals of 7.5 billion, at what point do you think the share price will split? I would think they would want to keep it below 50.
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Kalaz
Posted on: Oct 27 2019, 03:31 PM


Group: Member
Posts: 43

NKTR-181 (loxicodegol) is a novel mu-opioid agonist molecule designed to have a slow rate of entry into the brain thus reducing abuse potential and CNS-mediated side effects. NKTR-181 is in development for the treatment of chronic low back pain in adult patients new to opioid therapy.
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Kalaz
Posted on: Oct 27 2019, 02:01 PM


Group: Member
Posts: 43

Nektar therapeutics already has this ready to go... pdufa was September but put on hold by fda for some reason.. I own some nktr, not happy about them at this point
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Kalaz
Posted on: Oct 26 2019, 01:02 AM


Group: Member
Posts: 43

I originally held epitan shares, when we switched to clinuvel I was converted to clvlf shares. My broker bought clvlf shares for me about 6 months ago. Why buy clvly adrs? I'm in USA
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Kalaz
Posted on: Oct 22 2019, 02:35 AM


Group: Member
Posts: 43

https://www.google.com/url?sa=t&source=...d=1571675678725
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Kalaz
Posted on: Oct 16 2019, 11:59 PM


Group: Member
Posts: 43

Ocular = eye drops .. uho posted about this yesterday on GG
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Kalaz
Posted on: Oct 16 2019, 11:33 AM


Group: Member
Posts: 43

Ok, let me try this again.
What do you all think Vitiligo is worth, low end, including revenue and sp?
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Kalaz
Posted on: Oct 16 2019, 09:46 AM


Group: Member
Posts: 43

Yep, sorry I meant 65 million, so that increases everything.. I saw a post some time ago regarding a Vitiligo estimate but cannot find it
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Kalaz
Posted on: Oct 16 2019, 09:24 AM


Group: Member
Posts: 43

Somebody help me out here please.
I understand there are approximately 6.5 million people worldwide affected by Vitiligo. If .03% of the population were to be treated that would be 195,000 patients. I assume the price per implant would drop dramatically, does anyone have a thought on price per implant as I am thinking 10% of current price??? 1700.00 per implant USS 2500.00 AUD. With 6 implants per year that's 1.3 billion USD ... what does that translate too in share price, and how do you arrive at your share price? Doing some homework for a friend who is now interested in investing. Thank you in advance.
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Kalaz
Posted on: Oct 16 2019, 03:31 AM


Group: Member
Posts: 43

I cannot get on Clinuvel website right now, it may be down.
Can anyone tell me when phase 4 was completed? Was it just before approval?
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Kalaz
Posted on: Oct 16 2019, 01:53 AM


Group: Member
Posts: 43

Farma, I was thinking the same thing 😎
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Kalaz
Posted on: Oct 14 2019, 04:20 AM


Group: Member
Posts: 43

With 190,000 new cases of skin cancer every year and Australia and New Zealand the leaders in these cases, I am holding until I see this is addressed. I live in Arizona and I am very familiar with melanoma as I have family and friends with the disease. When I bought this stock in 2003ish it was because I thought this could be a revolutionary breakthrough drug that will combat this cancer. I had my rollover 401k completely invest in this company on a gamble and watched closely through the years. We are free of all that held this company back and the runway is very very long. I am lucky enough to be retired the last 5 years and now 55 so I have time to watch this company grow and hopefully see this drug stop skin cancer and see my vision fulfilled. 500 USD by 2029!!!
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Kalaz
Posted on: Oct 11 2019, 08:38 AM


Group: Member
Posts: 43

I think most people have been thanked that deserve it..
I want to add one more... I am not sure if you are on this board under a different name but, Uhohinc, thank you for your incredible research on GG... you truly kept me in this stock over the years.. I think 800-1600 is very reachable and could go beyond with what you have written in your posts... Cheers Uho!!! and thank you so much!!
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Kalaz
Posted on: Oct 11 2019, 08:16 AM


Group: Member
Posts: 43

I like the way you think!!!
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Kalaz
Posted on: Oct 9 2019, 08:50 AM


Group: Member
Posts: 43

Can someone list all of the indications that this drug will help? I mean, the ones that have been brought up here. I wish I had kept track through the years.
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Kalaz
Posted on: Oct 9 2019, 06:09 AM


Group: Member
Posts: 43

Fidelity shows up 5.57 USD 30.22%
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Kalaz
Posted on: Oct 9 2019, 06:06 AM


Group: Member
Posts: 43

Has Dr Wally checked in yet?
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Kalaz
Posted on: Oct 9 2019, 03:20 AM


Group: Member
Posts: 43

Love me a whataburger!!! I think I will join you!!!
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Kalaz
Posted on: Oct 9 2019, 03:19 AM


Group: Member
Posts: 43

Been waiting since 2003 and it finally happened!!!!! Wooohoooo!!!! CONGRATULATIONS TO ALL!!!!
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Kalaz
Posted on: Oct 9 2019, 03:14 AM


Group: Member
Posts: 43

FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder
U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)
NEWS PROVIDED BY

U.S. Food and Drug Administration
Oct 08, 2019, 13:00 ET

SILVER SPRING, Md., Oct. 8, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria.

"For patients who are suffering from erythropoietic protoporphyria, a rare disorder, exposure to light may be extremely painful. Prior to today's approval, there were no FDA-approved treatments to help erythropoietic protoporphyria patients increase their light exposure," said Julie Beitz, M.D., director of FDA's Center for Drug Evaluation and Research Office of Drug Evaluation III. "Today's approval is one example of the FDA's ongoing commitment to encourage industry innovation of therapies to treat rare diseases, and work with drug developers to make promising new therapies available to patients as safely and efficiently as possible."

Erythropoietic protoporphyria is a rare disorder caused by mutations leading to impaired activity of ferrochelatase, an enzyme involved in heme production. Heme is an important component in hemoglobin, the oxygen carrying molecule in red blood cells. The decrease in ferrochelatase activity leads to an accumulation of protoporphyrin IX (PPIX) in the body. Light reaching the skin can react with PPIX causing intense skin pain and skin changes, such as redness and thickening. Scenesse (afamelanotide), a melanocortin-1 receptor (MC1-R) agonist, increases the production of eumelanin in the skin independent of exposure to sunlight or artificial light sources. It is an implant that is administered subcutaneously (inserted under the skin).

The efficacy of Scenesse was established in two parallel group clinical trials in patients with erythropoietic protoporphyria who received Scenesse or a placebo form of the implant subcutaneously every two months. The first clinical trial enrolled 93 subjects, of whom 48 received Scenesse, and were followed for 180 days. The primary endpoint was the total number of hours over 180 days spent in direct sunlight between 10 a.m. and 6 p.m. on days with no pain. The median total number of hours over 180 days spent in direct sunlight between 10 a.m. and 6 p.m. on days with no pain was 64 hours for patients receiving Scenesse and 41 hours for patients taking placebo.

The second clinical trial enrolled 74 patients, of whom 38 received Scenesse, and were followed for 270 days. The primary endpoint was the total number of hours over 270 days spent outdoors between 10 a.m. and 3 p.m. on days with no pain for which "most of the day" was spent in direct sunlight. The analysis did not include sun exposure on days patients reported spending time in a combination of both direct sunlight and shade. The median total number of hours over 270 days spent outdoors between 10 a.m. and 3 p.m. on days with no pain for which "most of the day" was spent in direct sunlight was six hours for patients receiving Scenesse and 0.75 hours for patients receiving placebo.

Scenesse's most common side effects are implant site reaction, nausea, oropharyngeal (part of the throat just behind the mouth, where the oral cavity starts) pain, cough, fatigue, skin hyperpigmentation, dizziness, melanocytic nevus (moles), respiratory tract infection, somnolence (feeling drowsy), non-acute porphyria (build-up of normally occurring molecules created during heme production) and skin irritation. Scenesse should be administered by a health care professional who is proficient in the subcutaneous implantation procedure and has completed the applicant-provided training. Scenesse may induce skin darkening, and a full body skin examination is recommended for patients twice a year. In addition, patients are encouraged to maintain sun protection measures during treatment with Scenesse to prevent phototoxic reactions related to erythropoietic protoporphyria.

The FDA granted this application Priority Review designation. Scenesse also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. The approval of Scenesse was granted to Clinuvel.

For more information:

NIH: Erythropoietic protoporphyria
FDA: Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Amanda Turney, 301-796-2969, amanda.turney@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration


Related Links
http://www.fda.gov

You just read:

FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder
NEWS PROVIDED BY

U.S. Food and Drug Administration
Oct 08, 2019, 13:00 ET

https://www.prnewswire.com/news-
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Kalaz
Posted on: Oct 1 2019, 12:46 PM


Group: Member
Posts: 43

No! And holding til 2026 minimum.
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Kalaz
Posted on: Sep 24 2019, 11:13 AM


Group: Member
Posts: 43

30 - 40 AUD or USD.. I vote for USD
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Kalaz
Posted on: Sep 24 2019, 03:58 AM


Group: Member
Posts: 43

Someone posted a Monte Carlo Valuation on this board not to far back, can you repost it or tell me how to get to the old post. I'm trying to convince my wife to invest a chunk of cash we have available before the 6th.
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Kalaz
Posted on: Sep 7 2019, 04:15 PM


Group: Member
Posts: 43

Its surreal that we are finally approaching pdufa. I bought this stock about 15 years ago on a tip from a friend here in Arizona. I always thought it had medical value and I have held on steadfast. Time went on and the more I learned, the more I felt this truly could be a life changing drug for so many people. Uhohinc taught me a whole new vocabulary and I think I can now pass a med school exam.. but then again I did stay at a holiday inn last night! Good luck to all who put there savings on the line and good luck to all who this drug will help in the future.. Cheers!
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Kalaz
Posted on: Aug 31 2019, 04:55 PM


Group: Member
Posts: 43

Nektar Therapeutics disclosed earlier this morning that as of this morning, the company has not received an action letter from the FDA regarding its new drug application for NKTR-181, thereby resulting in the FDA not meeting the PDUFA goal date of August 29.

I thought the fda had to give a crl or approval.
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Kalaz
Posted on: Aug 7 2019, 01:48 AM


Group: Member
Posts: 43

I have held this stock for about 15 years and I plan to hold for another 8 years.. this stock has a long way to go. Up!
Your account name is appropriate Level, very level headed
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Kalaz
Posted on: Jul 23 2019, 09:23 AM


Group: Member
Posts: 43

I was recently looking at some posts on GG and came across uho's age related macular degeneration piece. Holy cow that would be a life changer for a lot of people... including us
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Kalaz
Posted on: May 30 2019, 08:39 AM


Group: Member
Posts: 43

I too retired early. I sold my business at 48 and retired at 50, now 55 years young. I bought 10k shares about 12ish years ago and have been patiently waiting for approval. After approval I will be loading up on this fantastic company stock so that I can eventually help family and finally contribute to those in need of a hand up. For now, I am raising my grandson and life is amazing.
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Kalaz
Posted on: May 24 2019, 01:57 AM


Group: Member
Posts: 43

Albert king played his guitar upside down, crazy good.. music isn't a competition so its impossible to say who's best.

Are we at 1000. Yet?
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Kalaz
Posted on: May 23 2019, 08:03 AM


Group: Member
Posts: 43

I am a huge Stevie Ray Vaughan fan, between him Jimi and Clapton theres none better.. george111 you are a very lucky man
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Kalaz
Posted on: May 22 2019, 01:46 PM


Group: Member
Posts: 43

Long long time holder here... I have watched G Groups for years and years.. uho is the only one that comments anymore.. is he a doctor or scientist or? I have always been intrigued by what he/she post. If half of what he discovers comes to pass this stock will be worth hundreds per share. Thoughts? Glta!
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Kalaz
Posted on: May 1 2019, 01:32 AM


Group: Member
Posts: 43

Sounds like something you would read in a motley tool ad
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Kalaz
Posted on: Jan 15 2019, 03:38 AM


Group: Member
Posts: 43

I bought this stock so long ago that I don't remember how I learned about it. I live in Arizona so I am sure it got to me through University of Arizona friends as of course that is where it all started. I have watched all of the posts thru Google groups and here and I somehow knew this drug was way more than a tanning product, although I feel sun protection is so needed for those of us that live in the desert. I bought at .60 pre reverse split so 6.00 and I have never sold a single share in fact bought more when I could afford it, still only at 10k shares. I would like to know what you all feel is a realistic 5 year share price? I have felt 250 someday is realistic , am I dreaming. Thanks to all of you that have contributed, you have made me laugh and kept me informed. CHEERS!
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Kalaz
Posted on: Jan 15 2019, 03:38 AM


Group: Member
Posts: 43

I bought this stock so long ago that I don't remember how I learned about it. I live in Arizona so I am sure it got to me through University of Arizona friends as of course that is where it all started. I have watched all of the posts thru Google groups and here and I somehow knew this drug was way more than a tanning product, although I feel sun protection is so needed for those of us that live in the desert. I bought at .60 pre reverse split so 6.00 and I have never sold a single share in fact bought more when I could afford it, still only at 10k shares. I would like to know what you all feel is a realistic 5 year share price? I have felt 250 someday is realistic , am I dreaming. Thanks to all of you that have contributed, you have made me laugh and kept me informed. CHEERS!
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Kalaz
Posted on: Sep 22 2018, 03:03 AM


Group: Member
Posts: 43

I haven't seen anyone comment on yesterdays announcement on Nasdaq presentation. What was it about?
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