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schlitzo
Posted on: Jun 30 2019, 01:52 AM


Group: Member
Posts: 249

We're all in this for 2 reasons - to get rich and to give some very unfortunate folk a second chance in life. At this stage of affairs, there is no need to be at each other's throats. This board has been a very pleasant and informative place to be for some time now. Let's not spoil the show when we're almost at the main event.
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schlitzo
Posted on: Jun 26 2019, 11:17 AM


Group: Member
Posts: 249

Bloody hell, we have another 3 months of this! Bollocks!!!
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schlitzo
Posted on: Jun 20 2019, 09:19 AM


Group: Member
Posts: 249

Sorry Epi, I don't check the boards every day. If I had seen your post, I wouldn't have posted today. I don't think there are any 'elitist boys clubs' here. You may have posted on a 'big up' day and everyone was too busy counting their $$$.
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schlitzo
Posted on: Jun 19 2019, 11:40 PM


Group: Member
Posts: 249

https://www.theguardian.com/fashion/2019/ju...-harm-than-good

If they ban sunscreens, does anyone know of a product that will save your skin and the coral reefs of the world at the same time?
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schlitzo
Posted on: Jun 18 2019, 02:46 PM


Group: Member
Posts: 249

Doesn't look like it's going to happen today, Mac. You must be totally gutted!
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schlitzo
Posted on: Jun 13 2019, 11:13 PM


Group: Member
Posts: 249

I thought we'd get a bit of a run in if things looked positive, like just before we got into the ASX300. Surely there are many out there that can do the numbers. Anyway, hope WAZ is on the ball, we appreciate all the effort you put into that, well done!
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schlitzo
Posted on: Jun 8 2019, 03:00 PM


Group: Member
Posts: 249

Sure. I’d omit the frilly wording though. Maybe a CUV and Scenesse on the sleeves. Great job!
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schlitzo
Posted on: Jun 4 2019, 10:33 AM


Group: Member
Posts: 249

Shorters are going to have some fun over the next 4 months. Hello low 20's. Damn, we have not had one smooth ride so far with CUV. Hope things work out in October, but my gut tells me this time next year. Truly hope I'm wrong.
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schlitzo
Posted on: May 27 2019, 05:22 PM


Group: Member
Posts: 249

It's getting to the point that if I don't see a $1 rise in the SP, I feel robbed! Not sure how I'd feel if it was $20! Let's hope I'll find out soon!!!
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schlitzo
Posted on: May 22 2019, 02:40 PM


Group: Member
Posts: 249

Know idea of who Uhoh is. A few have asked but didn't get a reply, as far as I know. Very interesting and intelligent person though. Need to be up with all the terminology to understand his posts. I've alway appreciated all the effort he puts into them. Keep it up Uhoh, I'm sure it's not just me who appreciates your posts.
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schlitzo
Posted on: May 17 2019, 10:49 AM


Group: Member
Posts: 249

A friend called me last night to catch up, told him I had retired due to an investment working out. "Why didn't you tell me about it?" Actually I did, TWICE! I forget the number of family, friends I've told about Clinuvel, only a couple have listened. Probably the same mentality as a 'sure thing' in a horse race. I guess you all have similar stories. Makes me think if we can't pass the word on to friends and family, that there really aren't that many out there who are aware of this company at the moment. What's going to happen when all the planets line up, ASX200/100/50, FDA approval, Nazdaq, Australia, Japan, vitiligo, cosmetics, topical cream; when everyone is trying to jump on the band wagon? Really, really exciting times ahead...especially for us SCENESSIANS!
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schlitzo
Posted on: Apr 18 2019, 11:13 AM


Group: Member
Posts: 249

Surely we're seeing the last of this malarkey. WTF!
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schlitzo
Posted on: Mar 20 2019, 11:21 AM


Group: Member
Posts: 249

BLOODY HELL!
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schlitzo
Posted on: Mar 13 2019, 07:39 PM


Group: Member
Posts: 249

My guess is that the rise then large drop, then rise again in the SP today refers to a head fake in sports - to put the opponent off and in the wrong direction.
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schlitzo
Posted on: Mar 12 2019, 12:46 PM


Group: Member
Posts: 249

That pool looks like the perfect place to let your bowels release for the last time, JH! Good luck, hope you get it. Where is it (roughly)?
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schlitzo
Posted on: Mar 6 2019, 04:10 PM


Group: Member
Posts: 249

Piotroski’s F-Score in Focus For Clinuvel Pharmaceuticals Limited (ASX:CUV) as it Touches 6




https://augustareview.com/piotroskis-f-scor...s-it-touches-6/




Never heard of it, an interesting read.




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schlitzo
Posted on: Mar 6 2019, 09:57 AM


Group: Member
Posts: 249

This is all pretty amazing, even surreal after years of uncertainty (mind you, many of us kept the faith). I originally invested in Epital after I read an article in the Age about a 'Barbie Doll' drug. Having fair skin and living on the beach most of my youth, I was immediately interested, looked up the company and bought shares for 8 cents each. The rest is history, unfortunately, a rather long one. Now here we are, ASX200 a big chance on Friday, FDA approval hopefully on July 8, ASX100 then ASX50?, Nasdaq on the horrizon, along with all the other fruit in the basket. A lot has been said about management over the years but they have kept their course and resolve and now we are all reaping the rewards. I'm retiring on Friday week at 61, hopefully my wife soon after, but then again, she's only 23 and has many good years of work left in her. Our 11 year old son, whom I bought shares for in CUV, will be able to put himself through college and be set for a good start in life. Thank you CUV and management for putting us where we are now, and thank you to all the great contributors for all their time and effort they have put in to this board. Happy Times ahead!!!

BTW, my wife really isn't 23. Her age is close to what the SP will be on July 8.


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schlitzo
Posted on: Mar 4 2019, 11:45 AM


Group: Member
Posts: 249

Investor Briefing - https://www.asx.com.au/asxpdf/20190304/pdf/...641yqv1b0fw.pdf
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schlitzo
Posted on: Feb 28 2019, 12:14 PM


Group: Member
Posts: 249

Count me in for anywhere & everywhere!
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schlitzo
Posted on: Feb 28 2019, 11:54 AM


Group: Member
Posts: 249

A blood bath out there today. Nice just to sit back and watch the fun!
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schlitzo
Posted on: Feb 27 2019, 10:31 AM


Group: Member
Posts: 249

Is Svalbard northern enough? Has great beaches I hear!
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schlitzo
Posted on: Feb 27 2019, 09:35 AM


Group: Member
Posts: 249

Took us almost 20 yrs to get to $25, doubt it will take 20 months to get to $100. If things all go as planned, this is going to be one hell of a year! Can't complain about the last 6 months either!!! Time to start talking about us all meeting up on a tropical beach somewhere smile.gif
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schlitzo
Posted on: Feb 26 2019, 09:53 AM


Group: Member
Posts: 249

<h3 class="methodology-index-head"> </h3><h3 class="methodology-index-head">
QUOTE
S&P/ASX 200</h3>
Index Goal
To establish a highly liquid and tradable index with low turnover. This allows the index to be used as a benchmark for investment returns and for additional S&P/ASX indices to be constructed as benchmarks for varying investment classes and objectives.


Measuring Performance
The S&P/ASX 200 contains a fixed number of constituents. Its numerical value (or level) represents the total weighted market capitalisation of its 200 constituents, relative to a base period. Therefore, a move in the index from 5,000 to 5,500 would indicate the total weighted market capitalisation of its constituents had risen 10%.

Movements in the value (share price) of large companies will have a greater effect on the index level than movements in a small company as there a calculation (weighting) is applied according to a company’s market capitalisation.


Selection Criteria
A security must be listed on the ASX and be an ordinary or preferred equity stock (e.g. no bonds or warrants etc.). Its average daily market capitalisation for the previous six months must be considered institutionally investable and meet a minimum benchmark size. Liquidity must be adequate and its public float (shares not owned by company founders, directors, government agencies etc.) must also meet a minimum requirement.

Note: The above criteria are for inclusion into the index and not for continued membership. As low index turnover is important, a security in the index may on occasions violate one or more of the selection criteria without being removed.


Index Maintenance
Regular maintenance of the S&P/ASX 200 is required to accurately reflect changes in its constituent’s market capitalisation and liquidity.

Quarterly Rebalancing

Changes are implemented on the third Friday of March, June, September and December. One week notice is given on impending changes (excluding September where two weeks notice is given).

Intra-Quarterly Additions

Generally only occur when there is a vacancy in the index due to a deletion. Two to five business days notice is given.

Intra-Quarterly Deletions

Generally only occur due to mergers, acquisitions and suspensions. Two to five business days notice is given.
QUOTE





Yes, I'm sure the S&P calculations are proprietary.


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schlitzo
Posted on: Feb 26 2019, 09:25 AM


Group: Member
Posts: 249

If CUV is going to make the ASX 200, we should start seeing some sort of movement up pretty soon. I imagine there are some out there that know how to do the math. It is Friday, March 8, right?
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schlitzo
Posted on: Feb 25 2019, 02:24 PM


Group: Member
Posts: 249

What was the story with the 1.3 million volume July 2 last year?
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schlitzo
Posted on: Feb 13 2019, 07:42 PM


Group: Member
Posts: 249

Only 5,000 shares for one of those! I'm getting me one.

BTW, I'd put a CUV Frilly on there somewhere, just to let people know where you're coming from.
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schlitzo
Posted on: Feb 6 2019, 10:24 PM


Group: Member
Posts: 249

61! But mind of an uneducated 18 year old. For any of you who are thinking the same and like to ride, I’m doing the Lhasa - Kathmandu mtb tour early September. Johnny tech was suppose to join me but has bailed. Any takers???
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schlitzo
Posted on: Feb 6 2019, 08:48 PM


Group: Member
Posts: 249

Does anyone want to take a guess at what sort jump we'll get if added to the ASX200? A few seem to believe our last spike was from being added to the 300. Bloody hell! It's not that far off now. Would be nice to get a bit of a build up before hand.




BTW, I'm rolling with the dice and retiring in 37 days. If things don't work out on July 8th, I'll be applying for work again on July 9th.


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schlitzo
Posted on: Jan 10 2019, 09:32 AM


Group: Member
Posts: 249

FDA sets PDUFA date ....Whhhoooop!

https://www.asx.com.au/asxpdf/20190110/pdf/...sc3v3tm7xs5.pdf


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schlitzo
Posted on: Dec 10 2018, 09:08 AM


Group: Member
Posts: 249

15 mins before ASX opens - Offer - 16.92, Bid - 11.95. Bad news on the way?
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schlitzo
Posted on: Nov 30 2018, 08:55 AM


Group: Member
Posts: 249

No ann. this morning thumbdown.gif . Last chance for a Xmas pressie - Dec 21. What are our chances?
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schlitzo
Posted on: Nov 21 2018, 09:32 AM


Group: Member
Posts: 249

AGM presentation - https://www.asx.com.au/asxpdf/20181121/pdf/...hbj4p2nx7vc.pdf
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schlitzo
Posted on: Nov 21 2018, 09:31 AM


Group: Member
Posts: 249

Chair's address - https://www.asx.com.au/asxpdf/20181121/pdf/...h98gsp43yp0.pdf
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schlitzo
Posted on: Nov 12 2018, 02:18 PM


Group: Member
Posts: 249

$3 down on a Monday...can't wait to get home and tell the wife!
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schlitzo
Posted on: Nov 8 2018, 11:40 PM


Group: Member
Posts: 249

Good to read differences of opinion are kept civil these days. One year ago, this site was f...ing mess. It got to the point where I only read it once every couple of weeks, and only the posts of who I knew weren't involved with the bickering. Over the last 6 months there has been a wealth of informative info posted by many here, some of which must spend a good part of their free time writing, researching and posting. Truly appreciated by me and many others, whether SS members or not. Keep up the good work and high standards.
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schlitzo
Posted on: Oct 29 2018, 03:56 PM


Group: Member
Posts: 249

I nearly bought more on Friday thinking the blood bath was over, going to wait till this Friday now. Oh well, think of the brighter side of things...when/if things turn around, we get to go on the same ride again! I rather enjoyed it last time, no doubt I will again.
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schlitzo
Posted on: Oct 10 2018, 09:54 PM


Group: Member
Posts: 249

I wonder if the result would've been different if all the pricks at NICE were inflicted with EPP and couldn't join their mates in Majorca eating fish n chips and drinking Fosters during summer holidays.
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schlitzo
Posted on: Oct 9 2018, 09:59 AM


Group: Member
Posts: 249

Magnitude 7.5
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schlitzo
Posted on: Oct 1 2018, 09:47 AM


Group: Member
Posts: 249

II s it Labor Day in Oz today?
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schlitzo
Posted on: Sep 28 2018, 03:41 PM


Group: Member
Posts: 249

I ‘d almost be happy with that!
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schlitzo
Posted on: Sep 28 2018, 09:32 AM


Group: Member
Posts: 249

If everything falls into line with CUV's other goals, indications, etc - go ahead by NICE, other EU countries + patients growth, FDA approval, Japan, Australia (NZ?), Asia, other countries, Vit, Paediatrics, Photodermatoses, Melanogenesis, Organ transplant patients, cosmetics, others?...
I can't see why we can't reach AU$2,000, or even more! I imagine before we even get close to $2,000, there will be a 10 - 1 split to put more shares on the market as no one will want to sell any and will be to high for anyone to get in. I may not see those days, but I'm already envious of the options my 10 yr old son is going to have in the future.


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schlitzo
Posted on: Sep 24 2018, 04:08 PM


Group: Member
Posts: 249

Hope the time span between 20 - 30 is shorter than it was between 10 - $20!
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schlitzo
Posted on: Sep 18 2018, 10:24 PM


Group: Member
Posts: 249

They say there are 3 kinds of people in the world: Ones who are good with numbers and ones who aren't!
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schlitzo
Posted on: Sep 15 2018, 01:42 PM


Group: Member
Posts: 249

6 hot biotech stocks




http://www.thebull.com.au/premium/a/73920-...re-in-2018.html


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schlitzo
Posted on: Sep 14 2018, 01:06 PM


Group: Member
Posts: 249

Hope they come up with something new to keep him there 35 yrs instead of months. No doubt as soon as he gets out he'll be back to his old tricks. Should be more of his like in there with him.
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schlitzo
Posted on: Sep 11 2018, 09:10 AM


Group: Member
Posts: 249

Ann. out but no time to read it - https://www.asx.com.au/asxpdf/20180911/pdf/...6wb932sw7sl.pdf
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schlitzo
Posted on: Sep 10 2018, 09:44 PM


Group: Member
Posts: 249

What the hell will tomorrow bring? I've got friends left, right and center asking me what they should do. I usually just tell them 'I told you what to do 15 yrs ago'. All the grief I got from many for putting most of my eggs in the one basket are now sucking eggs. Definitely interesting times ahead. These kind of days are the ones we've all been dreaming of over the years. May there be many more! Can't wait to see what kind of one we'll get when/if FDA approval comes thru.
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schlitzo
Posted on: Sep 10 2018, 09:55 AM


Group: Member
Posts: 249

Here's the link - https://www.asx.com.au/asxpdf/20180910/pdf/...5v38mlzptnk.pdf
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schlitzo
Posted on: Sep 6 2018, 12:14 PM


Group: Member
Posts: 249

A lot of speculation going about here with the latest ann. Exactly what data is required, and how much of it is unclear. What is clear though, Clinuvel has never hurried themselves in these situations (though with time, they usually get the job done). Going on their past record, I'm not expecting this to be sorted out at a drop of hat (though will v. happy if it is). Was on quite the high last week and was expecting more gains this week. Just as well we're all very experienced with the 'waiting game'. Hope good news comes around soon; we all deserve it! Most of all, we all want to avoid the 'TMBRFTLT' scenario!!!
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schlitzo
Posted on: Sep 5 2018, 10:30 AM


Group: Member
Posts: 249

When FIL dumped all those shares the other day, I was wondering if sour news was headed our way. Oh well, gives me an opportunity to grab a few more at a better price.
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schlitzo
Posted on: Sep 5 2018, 09:23 AM


Group: Member
Posts: 249

Looks like another delay. Surprise, Surprise!

https://www.asx.com.au/asxpdf/20180905/pdf/...20xyhgtwn72.pdf


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schlitzo
Posted on: Jul 10 2018, 09:07 AM


Group: Member
Posts: 249

Japanese 'Ganguro' needs to come into fashion again. Mind you, I think I'd prefer to be poor than seeing that all around Asia.




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schlitzo
Posted on: May 20 2018, 08:11 AM


Group: Member
Posts: 249

You add another 300k+ from mine and a few others I've told about this stock and SS.
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schlitzo
Posted on: May 16 2018, 02:42 PM


Group: Member
Posts: 249

Acne, some research with was done some years back with afemelanotide, might be they have refined a topical cream for it, if so, could be a big one as a lot of young asians suffer big time from acne.




QUOTE
Background:
α-Melanocyte-stimulating hormone (α-MSH) is a melanocortin peptide that increases skin pigmentation during ultraviolet light-mediated tanning. As α-MSH has been shown to possess anti-inflammatory effects, we assessed the clinical potential of a superpotent α-MSH analogue, afamelanotide (Nle(4)-D-Phe(7)-α-MSH), in patients with acne vulgaris, the most common inflammatory skin disorder.

Methods:
Afamelanotide (16 mg) was given in a phase II open-label pilot study subcutaneously as a sustained-release resorbable implant formulation to 3 patients with mild-to-moderate facial acne vulgaris. Evaluation included lesion count, adverse effects and patient-reported outcome. Monitoring of laboratory parameters included differential blood counts, electrolytes, urine analysis, and liver and kidney function tests. Skin melanin density was measured by reflectance spectrophotometry.

Results:
The total number as well as the number of inflammatory acne lesions declined in all patients 56 days after the first injection of afamelanotide. Life quality as measured by Dermatology Life Quality Index likewise improved in all 3 patients 56 days after the first injection of afamelanotide. There were no adverse effects except mild and short-term fatigue in one patient. All patients experienced increased pigmentation especially on the face. Clinically relevant changes in laboratory parameters were not detected.

Conclusions:
Afamelanotide appears to have anti-inflammatory effects in patients with mild-to-moderate acne vulgaris. Future trials are needed to confirm the anti-inflammatory action of this melanocortin analogue in patients with acne vulgaris.
QUOTE





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schlitzo
Posted on: May 14 2018, 12:26 PM


Group: Member
Posts: 249

Serious tree shaking going on here!
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schlitzo
Posted on: May 14 2018, 08:49 AM


Group: Member
Posts: 249

QUOTE
Confirmation that no off-label use of SCENESSE® has taken place
QUOTE


For me, this is the big one that is going to get us passed by the FDA!

Happy Times!

For some reason my 'Thanks Button' doesn't work on this computer

Thanks Frogster! Great News!!!




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schlitzo
Posted on: May 11 2018, 02:50 PM


Group: Member
Posts: 249

We may get another delay like with the EMA, but it will eventually be passed. There are the other indications to take into account, what ever the cosmetic line is, receipts from Europe.... I think it would be far from over. At least management has “experience in rejections” and would take the appropriate course of action. Keep the faith!
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schlitzo
Posted on: May 11 2018, 09:42 AM


Group: Member
Posts: 249

It looks like the trend for now- 5 to 10c gains, till the next resistance level ( not sure what that is, but I'm guessing about $14). Charties, can you oblige? From there, we could stall before another substantial jump. Anyone want to take a guess at where we'll be by Dec 31?

I'm not getting my hopes up about FDA approval due to the fact that up to now I've been disappointed every single time, there has always been some further delay or hurdle. Mind you, if it is approved, I'll be more the merrier, and as Borat would say, 'Retard'


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schlitzo
Posted on: May 10 2018, 07:50 AM


Group: Member
Posts: 249

Clinuvel's TEMA trending higher - https://www.derbynewsjournal.com/2018/05/06...er-last-5-bars/
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schlitzo
Posted on: May 8 2018, 10:22 AM


Group: Member
Posts: 249

ASX shows CUV opening bid at $14 a few minutes before opening. Could be another good day!
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schlitzo
Posted on: Apr 23 2018, 01:38 PM


Group: Member
Posts: 249

Getting close to the all time high of AU$12.30 set back on April 13, 2007.




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schlitzo
Posted on: Apr 10 2018, 07:23 PM


Group: Member
Posts: 249

Nice little gain today - AU$10.22 at close. Hopefully a sign that something may have been submitted. Another $9.78 gain and Johnny Tech takes me heliboarding in Nepal!
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schlitzo
Posted on: Mar 31 2018, 10:44 AM


Group: Member
Posts: 249

Never heard of XP before, interesting stats for Japan. Japan has a very good health care system, the patient pays 30% of costs, the government 70%. I just got out of hospital after 17 days. I had a 4.5 hour op on my ankle with involved taking cartilage from my knee and soft bone from my knee and hip. Also had my big right toe fused with plates and screws. Was done by one of the leading doctors in his field in Japan on the date I requested. Also got a high end leg brace - usually US800. Total bill I paid was US700. If you pay more than US1000 you can claim it back on tax. The town I live in also reimburses some of the cost of my op. I've not heard of anyone being knocked back for any sort of treatment over here, so I doubt there will any of the hassles going on with many European countries at the moment.
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schlitzo
Posted on: Mar 28 2018, 11:36 PM


Group: Member
Posts: 249

Some here seem to think that PW and Co. are purposely delaying, sidestepping, f.....the dog and aren't really interested in getting this gem of a drug passed with the FDA asap. I can assure you that they are just as keen as we are to get rich, only, unlike us armchair critics, they know what they are doing; they are trying to get it right the first time and avoid what happened in Europe. I've been in this as long as anyone here, pretty much from the start of Epitan, and can't count the number of times I've been disappointed. It's easy to point the finger when that happens, I've done it myself. IMO, the management team is doing everything in their power to get this passed as soon as humanly possible, to be doing otherwise just doesn't make sense. I truly hope to retire when this gets passed by the FDA, if it's not this year, then 2019, or 2020 if need be. I'm still willing to wait...with the odd bitch here and there. Always a hoot to read everyones varied opinions and appreciate the effort some of the posters put in to keep us up to date with CUV news from near and afar.
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schlitzo
Posted on: Mar 1 2018, 09:23 AM


Group: Member
Posts: 249

I suggest you all write to Clinuvel voicing your objections to the new logo, I did as soon as I saw it. I also mentioned that they take a look here SS to get an idea of what their shareholders think about it all. To save time, copy and paste what you have written here, don't hold back. This is a real balls up and they need to know loud and clear that it is just not good enough. I agree with CUV88, I want the old logo back! PADerm, did you send in your logo? I thought it was pretty cool. Well done!
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schlitzo
Posted on: Feb 21 2018, 01:37 PM


Group: Member
Posts: 249

They could have at least given Artemis a decent set of knockers!
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schlitzo
Posted on: Feb 20 2018, 12:46 PM


Group: Member
Posts: 249

At least the SP has jumped up to AU$17.50 on news of the new website...oh, hang on. No it hasn't!

I'm starting to think the 'C' isn't for 'Clinuvel'. The mind boggles!


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schlitzo
Posted on: Jan 29 2018, 01:17 PM


Group: Member
Posts: 249

Hopefully his daughter will do her best to follow her father's legacy. She already has quite the resume.
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schlitzo
Posted on: Jan 29 2018, 10:49 AM


Group: Member
Posts: 249

Clinuvel appoints US based director. Interesting choice, Dr Agersborg's father cofounded this company.

https://www.asx.com.au/asxpdf/20180129/pdf/...33z9g837xfs.pdf

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schlitzo
Posted on: Dec 4 2017, 12:50 PM


Group: Member
Posts: 249

I very much doubt people would keep coming back for more if they felt like they were going to puke every day for 3 mths. It can't be right.
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schlitzo
Posted on: Nov 29 2017, 09:31 AM


Group: Member
Posts: 249

I have no idea what it could be. I thought any topical that might darken your skin was related to VLRX001, which is still in pre-clinical. If they indeed do have something that will, can they put that straight out on the market with out approval of any kind? Can anyone enlighten us on this? I have no idea what the process would be for a topical cream. I can't see why any approval would be needed. Damn, if it is something that will give you a tan, I'm queuing up to some! I have a wedding to go to in Bali in Oct and I could be the 'bell of the ball'. Last time I went there, my mate's feet broke out in a rash, which then started to work its way up. After a week it was getting close to his gonads, in which he commented, 'Bloody hell, if it reaches my bollocks, my wife isn't going to believe it started at my feet.' I was fine, till arrivied back in Japan and had a hot shower, I immediately broke out in the same rash on the arms and legs. Really itchy and unpleasant for a couple of weeks.
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schlitzo
Posted on: Nov 28 2017, 12:14 PM


Group: Member
Posts: 249

At least the Chairman's address was humorous -
QUOTE
It's not often one gets the chance to quote Lady Macbeth but response to her husband's doubts was "Screw your courage to the sticking place and we'll not fail" and I dare say we're well screwed!
QUOTE
There were a few more in there that got a chuckle out of me.

Then everything went down hill with Presentation. I got the biggest laugh on page 4 when they went on about their consistancy in their communication to shareholders. WTF!

Mind you, I agree with KRD with what he pointed out. Some interesting stuff there. Only wish I was 30 yrs younger. I can just imagine my son running into the hospital in 20 yrs time screaming 'Dad, we're rich!' just as my bowels release the last time.

Looking fwd to Xray's summary of the day (and of course anyone else that went).


  Forum: By Share Code

schlitzo
Posted on: Nov 20 2017, 02:17 PM


Group: Member
Posts: 249

AGM just over one week away. One would think there would be some movement in the SP by now if there was going to be any significant news... Unless the spike a month ago had something to do with it. I imagine it will be as per usual - disappointing. All the same, keeping a low profile till FDA approval is probably best for everyone concerned. Anyone here going to be attending?


  Forum: By Share Code

schlitzo
Posted on: Nov 16 2017, 02:10 PM


Group: Member
Posts: 249

QUOTE
By the way didn't you notice that the last few days nearly no comments are placed on this board!
QUOTE





Only the 100 by you.


  Forum: By Share Code

schlitzo
Posted on: Nov 11 2017, 09:27 AM


Group: Member
Posts: 249

Thanks Ajshare. Bloody hell, they have a lot! I doubt if the latest additions will be knocked back.
  Forum: By Share Code

schlitzo
Posted on: Nov 10 2017, 06:57 PM


Group: Member
Posts: 249

Investek, appreciate your posts and comments. My wording was incorrect as far the patents go, patents applications is correct. With EPP and Vitiligo being granted, can you think of any reason why these new ones shouldn't be? Does anyone know how many patents Clinuvel has, and if any have been knocked back at all? I thought they had a whack of them.
As for as anything reaching the market after EPP, it's all a big 'IF'. In our favor is the safety record, over how many years now? Over the years, drugs with side effects that can kill a horse have been passed, makes me think on the positive side.
  Forum: By Share Code

schlitzo
Posted on: Nov 10 2017, 04:12 PM


Group: Member
Posts: 249

You're right! It is from Oct 2016. Just spent time (I don't have) trying to find something from this month, with no luck. Oh well, worth the read all the same, I hadn't come across that one before. If anyone knows of the recent article, please post.
  Forum: By Share Code

schlitzo
Posted on: Nov 10 2017, 12:39 PM


Group: Member
Posts: 249

For those who haven't accessed Homm's newsletter...





QUOTE
By Florian Homm - For years I have been receiving regular inquiries about Clinuvel, in English and in German. Since I can not possibly answer these mails, I comment on this company at longer intervals. Certainly, I feel very much connected to this company. Clinuvel is one of the most sensible companies I have seen as a financier in my long history. My 1st update came in my best-selling autograph (head-hunting, Rogue Financier, Munich publishing group), in which I recommended Clinuvel at a rate of 1.20 Australian Dollars (AUD) to my readers. The 2nd update came after the failure of the Clinuvel takeover by Retrophin. At that time the price had fallen from about 5.20 AUD to 2.40 AUD. Many investors were extremely insecure. And that is why I decided to express my positive opinion on this pharmaceutical / biotech value. You can find these posts today in the most important forums on Clinuvel in English. For some time now I have received a lot of inquiries. "What should I do after the strong course development," is the most common question? Instead of answering these questions one by one, I share my personal opinion on this title about the board week. What is important is that you should know that neither I nor my family have Clinuvel shares. My employer holds 25,000 shares. However, since the spring of 2014 he has not bought or traded any further shares. In principle, I urgently recommend all alternatives, to consider alternative opinions and to make their own opinion. What follows is my purely personal assessment. This can, of course, be wrong. I do not currently benefit from a positive course development. It is important to me that this promising company will prosper and reduce the suffering of several million people suffering from various skin diseases (EPP, vitiligo, skin cancer). I hope that these updates will be superfluous in the coming years. It would be desirable if a sound research on this company were made by credible, professional and conflict-free analysts (Research Coverage). I am very grateful that I could be involved in the positive development of this company and thank you for your attention. Important note Although the stock market capitalization of Clinuvel has now exceeded the mark of 300 million Australian dollars, this value should be subject to limits on purchases. The daily trading volume fluctuates very strongly and is spread over exchanges in Australia, Germany and America. Background I have been intimate with this internationally active pharmaceutical company for more than a dozen years. Originally, I discovered this company. As she tried to bring a skin darkening against sunglasses to the market. At that time, Clinuvel was still called EpiTan Limited and was run by promoters. The company was almost broke, and we were then at about 0.30 AUD, far below market value. Then the company was relatively brutally, but very effectively restructured. Almost all leading employees and more than half the board took their leave. The current CEO, Philippe Wolgen, was recruited and thus began the actual success story. Instead of continuing to deal with the untrustworthy sunglasses and tanning work, Wolgen began to explore serious medical applications for Clinuvel. The combination of Homm as a successful investor and success as a talented and meticulous pharmaceutical manager was honored by the stock market. The stock price of the stock increased by a factor of forty in a very short time to 12 AUD. In order to implement the vision of Wolgen, we were collecting about 80 million AUD for Clinuvel at other institutional investors. After I went into exile in autumn 2007, many investors lost interest in Clinuvel and the stock fell below 1.00 AUD. For a long time, the stock valuation was below the present value of the company. In November 2012 I returned from my exile and recommended the stock Clinuvel in my bestselling bounty hunting at a rate of 1.20 AUD with the remark that the company would either scientifically and financially succeed or that another pharmaceutical company Clinuvel friendly or hostile Would take over. Exactly the latter happened. After my involuntary vacation in Italy (15 months of delivery in Pisa and Florence), the company Retrophin launched a hostile takeover offer under the aegis of its highly controversial CEO Martin Shkreli. The share rose by 430% to 5.20 AUD. I had hardly been released from the Italian custody, and this overwhelming battle had already begun. During this time, for the very first time in my life, I advised a company as a so-called White Knight against Shkreli and his friends. I got a lot of praise, but I did not earn a Eurocent. The result is known. Shkreli failed miserably and Clinuvel continued her research. In November 2014, the approval of the critical Clinuvel drug (SCENESSE®) was passed by the European authorities against extreme light sensitivity. The most important milestone in the company's history was achieved. Update Annual Report 2016 The latest research report on Clinuvel dates back several years. In an environment without any professional research, the market takes a relatively long time. To understand important data and interpret the messages between the lines correctly. Organic sales rose by an impressive 97% to AUD 6.42 million, while losses were reduced by 70% from 10.4 to 3.2 million AUD. Very smartly, we see the Clinuvel company strategy to implement a uniform price in Europe for the EPP treatment with SCENESSE®. The 30 per cent rise in prices in recent days does not adequately compensate for this good development. The solvency of Clinuvel also improved significantly. Cash rose from 0.6 million to 13.8 million AUD, or 30%. We are particularly aware of what CEO Philippe Wolgen has indirectly communicated in his CEO's Outlook. The Clinuvel CEO expressed confidence in the approval by FDA in the US of SCENESSE® in the EPP area. He also spoke positively about the developments and outlook of SCENESSE® in the treatment of vitiligo. Anyone who knows something better about Philippe Wolgen will know how to take that cautious optimism. Wolgen has always been a very reserved CEO. The Wolgen premise is still "underpromise and overdeliver" (little promise and much more deliver). It is precisely for this reason that we find the subtle expressions of Philippe Wolgen so direction-oriented. The Opportunity Although Clinuvel is now an index on the Sydney Stock Exchange, there is still no research on this title. Neither in Australia, Europe or the USA. The share also trades on various German exchanges and on the Nasdaq. The exchange turnover leaves something to be desired, but the shareholder is absolutely first class. Among other things, Fidelity, the Rockefellers, Philippe Wolgen as well as other brilliant investors in the share register can be found. SCENESSE® has several applications. Not only for extreme light sensitivity (EPP, also called vampire or Hannelore cabbage disease in the Volksmund), but also in the treatment of vitiligo (white spot disease). I would not like to mention other applications here in more detail, but in at least two other areas, I consider a long-term valuation potential of not less than US $ 1 billion realistic. We see the maximum valuation potential of vitiligo at almost fantastic 5 billion US dollars or more. But before we bring our motivation to this insane assessment, we would like to evaluate Clinuvel on the basis of EPP. Currently there are approximately 47 million Clinuvel shares. At a current exchange rate of 6.32 AUD, a stock market valuation of around AUD 300 million is generated. This corresponds to a valuation of around 205 million euros or less than 200 million dollars. According to various estimates, there are between 4,000 and 10,000 people who suffer extremely from EPP and other similar light-sensitivity disorders. The treatment costs are considerable. Although it suggests that Clinuvel's EPP treatment could cost over US $ 70,000 a year, we have estimated a much lower value of US $ 50,000 in our calculations. In addition, the approval of the American health authority (FDA) is still pending. We calculate the probability of SCENESSE® approval for the USA at over 80%. We categorically categorize the market as a whole with a maximum of 4,000 patients. Overall, we are confident that at least 2,000 patients will be treated with SCENESSE® by mid-2018. This results in a very conservative sales potential of US $ 100 million. In the case of a commodity use which is very small, a profit potential of US $ 80 million would be conceivable (US $ 60 million after tax). This would correspond to a P / E ratio of less than 3 for 2018 in the current stock market valuation. A company such as Clinuvel, however, should be valued at a P / E ratio of 20 to 30, giving a profit potential of 6 to 10 at the current price. The following link provides you with the Clinuvel stock chart and other useful company information: http://www.clinuvel.com/en/investors/investing-in-clinuvel/share-price However, the combination therapy for vitiligo is much more significant for Clinuvel. There are 50 million vitiligo patients worldwide. Every year there are at least 1.2 million Vitiligo treatments. The previous vitiligo treatment results from clinical phase 2 are promising. I advise every prospective buyer to deal more intensively with this topic. Especially by visiting the Clinuvel website. It is quite conceivable that the Clinuvel vitiligo combination therapy will be the "standard of choice" in treatments of vitiligo patients. With a 50% market penetration and a low treatment price of only 5,000 US dollars per treatment, a turnover potential of 3 billion US dollars is generated. This calculation is not based on insane assumptions, but has been confirmed by the world's leading dermatologists. We do not want to and will not start from any net profits, but a turnover rate of 3 times for a large pharmaceutical company would by no means be offset. This results in a potential valuation of US $ 9 billion against a current stock market value of less than US $ 200 million. The estimated cost of an extensive Vitiligo Phase 3 trial is approximately $ 60 million. Risks In general, the exchange risk applies. Since we consider the overall market to be very risky (see also my book Endspiel, Munich publishing group), a pearl like Clinuvel should not be spared in a stock market crash. In our view, the greatest short-term risks are that the FDA does not approve SCENESSE® as a treatment for EPP. We see this risk at a maximum of 15%. Vitiligo can not be automatically approved by an author. Here we see the chances at 50%. In addition, Clinuvel has to raise its treasure chest for this project. This could lead to a clear dilution of the number of shares. With today's share price, the number of shares would increase by about 20 to 25% in order to finance the upcoming vitiligo studies. Also, you can not assume without risk that Clinuvel will be able to translate the estimated annual turnover for the EPP treatment of 50,000 US dollars per patient across a broad corridor. It is also not certain whether this price level can be maintained. The biggest risk at Clinuvel is a takeover, which allows a quick profit, but the investor takes the chance to multiply his investment in the medium term. This is why Wolgen has been working feverishly on a shareholder structure since the retrophi- nate attack, which, through the participation of loyal and very knowledgeable shareholders, enables him to ward off a further takeover attempt. Several small capital increases have enabled Wolgen to mobilize highly professional and reliable shareholders who share his vision of Clinuvel as a future multi-billion dollar pharmaceutical company. This could mean that Wolgen is not interested in professional research coverage and close collaboration with investment banks. These defensive defensive measures partly explain the insufficient investor and public relations activities. It is questionable whether he can once again fight off a hostile takeover. With a takeover rate of 12 to 15 AUD, even strong hands could become weak. From our point of view and my experience as a long-term corporate raider, a high share price and a fair company assessment are the best defense against grasshoppers and corporate spies. On the other hand, Wolgen, without the slightest doubt, is a first-class manager and remarkably good chess player. Why should he not first consolidate his shareholder base at very low valuations, and only then, in accordance with very good company announcements, would the Clinuvel story be made public through various Wall Street banks? In all fairness, one has to admit that he leads his company transparently. The website is quite informative. Clinuvel is a trademarked title. Larger investors are advised to contact the company if they wish to acquire blocks. Since leaving the company as a Clinuvel investor, the company has always made it possible for very wealthy private investors and institutional investors to participate in smaller capital increases in millions. Conclusion Despite considerable risks, we do not know any other biotech or pharmaceutical investment, which could potentially increase tenfold over the next 3 to 5 years. Even more rare are promising pharmaceutical and biotech companies of this kind who already have an attractive, approved product and significantly increase their product sales every year. This means that the risk is limited, at least from a fundamental point of view. The undervaluation of the Clinuvel share, which is still absurd from our point of view, is based solely on a shortcoming of first-class investment research, non-existent IR activities and, consequently, a very low level of awareness of the company in the investor community. Nomura already rated the stock at 12 AUD per share about 9 years ago. At that time, there was neither an approved product nor sales, nor any credible vitiligo studies and data. Today you will find a positive entrepreneurial milestone after the other on the Clinuvel website. Clinuvel can hardly prevent the investment community from drawing attention to the company. An FDA decision on EPP will be issued no later than the next 10 months (as of October 2016). With other positive Vitiligo messages is to be expected in the same time window. Ultimately, we believe it is likely that a well-known and respected investment bank will publish research on Clinuvel over the next 12 months. I strongly urge you to read the 2016 Annual Report of Clinuvel meticulously. More importantly, what is between the lines. For me as a successor to the Wolgen, the cautious optimism of the CEO is a clearly positive announcement. Wolgen is known as an archconservative CEO and auditor. This is the reason why the price of the share has been following positive developments for almost a decade. Despite the recent price rise, there is no change in our medium-term positive assessment. Rather, we are inclined to raise our already unusual medium-term price target of 35 AUD. We will definitely stay on the ball and will closely monitor upcoming developments. Michael Uhlemann, the owner of "The Second Opinion" holds 25,000 shares in Clinuvel. These shares were acquired over several years. Last year in spring 2014. PS: Risk-averse investors may consider hedging a Clinuvel position with an inverse biotech ETF (for example, the ProShares Ultrashort Nasdaq Biotechnology ETF (BIS)), or by short-term positions on equity indices or overpriced individual values. Persistent investors can try to buy the stock in setbacks. The stock is quite volatile. In all investment decisions, we advise inexperienced investors to invest in their knowledge and to seek professional advice. Your Florian Homm www.florianhomm.org www.diezweitemeinung.eu Price: AUD 6.32 in October 2016 Stock market capitalization approx .: AUD 300 million Long-term target price: 35 AUD Long-term incentive (simple): 538% Risk (simple): 50% CUV Website: www.clinuvel.com Stock Exchanges Australia: Sydney Stock Exchange, Price AUD 6.50 Germany: Munich, Frankfurt, Berlin, Hamburg, Stuttgart USA: NASDAQ www.vorstandswoche.de Securities: Clinuvel Pharmaceuticals (Sponsor ADR), Clinuvel Pharmaceuticals

Will this share multiply again ?: Guest contribution by Florian Homm Wallstreet-online.de - Full article at:
http://www.wallstreet-online.de/nachricht/9003834-aktie-nochmals-vervielfachen-gastbeitrag-florian-homm://http://www.wallstreet-online.
QUOTE

I take a lot of what this guy says with a grain of salt, all the same, he's a very smart individual, though with a lot of different interests at stake. This stock has been under priced for years. It is still yet to take off but when it does, a lot will miss out unless you already hold shares. It's probably why most of us here have only bought shares in CUV, not that many (though I have no idea) trade it regularly to make profit. We're here on the firm belief that this stock will 'one day' make us rich enough to lead a comfortable life. Time is the only issue for some of us. I've probably held shares as long as anyone here and bought EPT when they first started out. If you have the time and patiance, this stock's long term potential is astronomical. EPP and Vitiligo (of which Homm gives a 50% chance of FDA approval) are just the foam of a nice glass of beer. The first huge reward will come from a topical cream that will promote tan. This was what the company was first about and they haven't forgetten about it. Recently with the PW's new neuro-degenerative patents granted, it has opened new multi billion dollar gate. If sucessful, in 10-20 yrs time Clinuvel will be a name as recognisable as Pfizer and Novatis. I may not ever be able to afford a Ferrari, though my son might end up having a different one for every day of the week, though I hope he will be more content with a Hi-ace van. Time will tell, some of us have plenty, others don't. Hey, what the f... do any of us know. The whole thing could come crashing down around us tomorrow. Let's hope not, this time next year we'll know for sure.
  Forum: By Share Code

schlitzo
Posted on: Sep 19 2017, 09:43 AM


Group: Member
Posts: 249

FDA update - http://www.asx.com.au/asxpdf/20170919/pdf/43mfqbgkwz3mp6.pdf
  Forum: By Share Code

schlitzo
Posted on: Aug 31 2017, 11:46 AM


Group: Member
Posts: 249

The mind boggles. Well, we're up 1 cent after the good news. Following this stock is like following Arsenal - the pain never stops.
  Forum: By Share Code

schlitzo
Posted on: Apr 12 2017, 11:36 AM


Group: Member
Posts: 249

What a brilliant page of info and good news. This what sharescene should look like instead of reading about 'plant' theories and bitching. Thanks ShareLooker, Royco, ValueFox, Cyprus, FarmaZutical, Odi01! I'm a happy boy! Soon to be a RICH boy!!!
  Forum: By Share Code

schlitzo
Posted on: Apr 12 2017, 10:33 AM


Group: Member
Posts: 249

Here is the Ann. from Clinuvel if anyone is interested. Cheers to Cyprus for giving us the good news early.

http://www.asx.com.au/asxpdf/20170412/pdf/43hgsl5g2z3zvn.pdf


  Forum: By Share Code

schlitzo
Posted on: Mar 8 2017, 11:21 PM


Group: Member
Posts: 249

It's not stop. No matter what you say to these idiots, they are hell bent on insulting each other and ruining this site. It truly is pathetic!
  Forum: By Share Code

schlitzo
Posted on: Mar 1 2017, 01:23 PM


Group: Member
Posts: 249

That would involve reading his posts! I have my own ignore button.
  Forum: By Share Code

schlitzo
Posted on: Mar 1 2017, 09:12 AM


Group: Member
Posts: 249

9Lives is just another alias to someone else on this board. You just don't arrive and start bollocking someone straight away. Too many are only here to play games and to annoy. Cheers to all those who have time to research and contribute sincerely. Much appreciated!
  Forum: By Share Code

schlitzo
Posted on: Feb 24 2017, 09:51 AM


Group: Member
Posts: 249

Half yearly Report

http://www.asx.com.au/asxpdf/20170224/pdf/43g94w4c94rs03.pdf


  Forum: By Share Code

schlitzo
Posted on: Feb 1 2017, 02:42 PM


Group: Member
Posts: 249

For me, any shares bought between $7 - $8 is an absolute bargain. The last quarter's results weren't stella, but what did anyone expect, it's winter in Europe. It turned out to be more than what I expected, so a bonus. Even so, it's not going to set the markets alive. I, for one, will take the next 3 mths to accumulate when I can, and in the lows. Anyone selling at this point in time could be taking a risk. I have absolutely no idea when CUV is going to really take off (and it will), but I have no intentions of being left on the fence when it does. 3 months wait till the next sales isn't so long when you consider how long many of us have already waited. Good luck to us all.
  Forum: By Share Code

schlitzo
Posted on: Jan 20 2017, 10:18 AM


Group: Member
Posts: 249

Let's hope the jump in the SP this morning means someone knows about the results coming in next week. If it's still up at the end of the day, I'll be happy.
  Forum: By Share Code

schlitzo
Posted on: Jan 10 2017, 09:48 AM


Group: Member
Posts: 249

Being winter in Europe, will there be any sales at all?
  Forum: By Share Code

schlitzo
Posted on: Jan 1 2017, 12:52 PM


Group: Member
Posts: 249

Happy New Year All. I'm sure I'm not the only one on SS that believes it is going to be a pretty special one. As Rabbit said,
QUOTE
I've been surprised at the turn this board has taken, who'da thunk bitterness and acrimony would increase so much after such a success as EMA approval?
Would be nice to keep this board at positive and informative as possible. For those who have their snide little PSs, please get ride of them for 2017, and those who don't get along, please just ignore each other. How many days can we go before the hate returns and who is it going to be who breaks first. Good luck to us all this year, then again... I don't think we need luck anymore.
  Forum: By Share Code

schlitzo
Posted on: Dec 1 2016, 11:36 AM


Group: Member
Posts: 249

There is a daily pattern of SP moving up and down about $0.30 (down in the morning/up again in the afternoon), if you had 50,000 shares, that's $15k a day you could be making day trading. Not sure how many days it's been like this so far, but quite a few. Someone is making easy money.
  Forum: By Share Code

schlitzo
Posted on: Nov 28 2016, 11:20 AM


Group: Member
Posts: 249

I don't know who accurate the Canadian Association for Porphyria's graph is, but a conservative number gives it around 350. Seems a lot for the population of Canada.

Back to the AGM...any mention of the CUV 9900 and what's ahapping in Singapore?


  Forum: By Share Code

schlitzo
Posted on: Nov 28 2016, 09:47 AM


Group: Member
Posts: 249

http://canadianassociationforporphyria.ca/page-18157




Sorry, donT have time to do the count at the mo.


  Forum: By Share Code

schlitzo
Posted on: Nov 26 2016, 12:15 PM


Group: Member
Posts: 249

Outstanding posts today, everyone. Please take your bitching somewhere else. Absolutely pathetic!
  Forum: By Share Code

schlitzo
Posted on: Nov 21 2016, 09:38 AM


Group: Member
Posts: 249

No one should have to be banned or ridiculed on this board!!! We also don't need ignore buttons. If someone is getting to you, don't read their posts. There are also a couple here that desperately seek attention, if you don't take their bait, they will eventually fade a way. It's pretty bloody simple. Don't be stupid enough to respond to a stupid post! There are some here that I totally ignore (unless there are a bunch of 'thanks', then I may have a read). All the bitching that is going on is more annoying than the posts they are bitching about. We're all here for the same reasons, though everyone reasons differently.

Chill..Ignore...Get Along...Share Good Info...and most importantly...ENJOY BECOMING RICH!


  Forum: By Share Code

schlitzo
Posted on: Nov 15 2016, 09:33 AM


Group: Member
Posts: 249

I'd be surprised if it not that by the end of 2017. Will depend when FDA approval is though.
  Forum: By Share Code

schlitzo
Posted on: Oct 17 2016, 10:48 AM


Group: Member
Posts: 249

I thought you only rinsed with scotch before bed!
  Forum: By Share Code

schlitzo
Posted on: Oct 10 2016, 03:23 PM


Group: Member
Posts: 249

AU$19.57
  Forum: By Share Code

schlitzo
Posted on: Sep 19 2016, 12:18 PM


Group: Member
Posts: 249

I've held since the beginning of the Epitan days and have had years of friends calling me mad etc, now they are all calling me up asking me a million questions - 'When is a good time to get in?' , 'Where do I buy CUV?', 'Can I buy them in Japan/Belgium/Sweden/S.Africa?' I've always believed in this company, especially management. PW has done an amazing job getting us where we are now. I trust he will stay true and not sell us out. I would be absolutely gutted if that happened at this point. Years back on this board, we all use to talk about meeting up at some tropical beach, even Uhoh! Maybe we should start doing that again as this company is going to make us all incredibly wealthy (as long as they don't sell out...I can't think of one reason why they would). This is just the start of wonderful things to come.
  Forum: By Share Code

schlitzo
Posted on: Sep 17 2016, 07:27 PM


Group: Member
Posts: 249

Basically, I ended up getting double of the what the stock was worth to that time. I wasn't very happy with that outcome. Here are some details of the take over -

LEO Pharma to Acquire Peplin for US$287.5m

3 September 2009

Peplin, Inc. today announced a definitive merger agreement whereby LEO Pharma A/S (LEO), a privately-held, leading global pharmaceutical company within Dermatology and Critical Care, will acquire all outstanding securities of Peplin for approximately US$287.5 million (currently A$348.4 million) in cash. This represents a purchase price of US$16.99 per common share of Peplin stock or A$1.03 per Peplin CHESS Depositary Interest (CDI). US/AUS exchange rate of 1.21 as at 2 September 2009.

In addition, LEO will provide Peplin with access to a loan facility to fund ongoing operations until the transaction closes, which is expected to occur by the end of the calendar year. The Board of Directors of both companies unanimously approved the transaction. MPM Capital and GBS Venture Partners, two of Peplin’s largest stockholders, along with Peplin’s directors and executive officers have also agreed to vote in favour of the transaction.

The transaction is subject to approval of Peplin’s stockholders and other customary closing conditions. Stockholder proxy materials will be distributed, and a stockholder meeting scheduled to approve the transaction, following any US Securities and Exchange Commission review of the proxy materials.

"We are especially delighted to enter into this agreement with LEO, a globally recognised dermatology leader. We are very proud of the accomplishments of the entire Peplin team over the past several years to advance our lead candidate PEP005 Gel for actinic keratosis through to near completion of Phase 3 clinical trials. We are pleased LEO recognises the potential of PEP005 Gel as an innovative product for the treatment of actinic keratoses and other skin diseases," said Peplin Chairman and CEO Tom Wiggans.
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schlitzo
Posted on: Sep 17 2016, 04:58 PM


Group: Member
Posts: 249

I was a stock holder of Peplin (an Australian biotech), they sold out to Leopharma. I just got a pay out, no shares in Leo.
  Forum: By Share Code

schlitzo
Posted on: Aug 25 2016, 02:20 PM


Group: Member
Posts: 249

I doubt if they are going to sell out at this point in time when they are just about to bring in some profits. I expect they will make a deal with a big pharma at some stage, but not giving too much away. It's unique they have gotten this far by themselves. Excellent management and product are the only reasons. I'm sure all of management and most of the investors realize the more of the company they keep, the more profit for themselves. Any deal struck will be to Clinuvel's advantage. Looking fwd to good times ahead. Well done to all those who have stuck this one out.
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schlitzo
Posted on: Jul 20 2016, 07:06 PM


Group: Member
Posts: 249

I told you I couldn't find my glasses. I am from OZ, but haven't lived there for 35 odd yrs, been in Japan fro the last 20. Appypollylogies to all, especially, Landrews & MJS. Cheers for clearing it up.
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schlitzo
Posted on: Jul 20 2016, 06:45 PM


Group: Member
Posts: 249

Mr JS, please give me one example of me degrading this board. BTW, where are my f...ing glasses????
  Forum: By Share Code

schlitzo
Posted on: Jul 20 2016, 06:41 PM


Group: Member
Posts: 249

God my eye sight is terrible, sorry, my last post was meant for Mr JS.
  Forum: By Share Code

schlitzo
Posted on: Jul 20 2016, 06:40 PM


Group: Member
Posts: 249

If you are referring to me, then you are very wrong. I don't have time to play these games. I have the same name on the all the sights (here HC and Uhohs), I've no need to change my name as many here do. Please don't add my name to any bitching sessions. I've been on this board for longer than most, but too busy to contribute any more. Like to read every now and then, but the bitching on this sight gets a little too much at times. Mainly read Uhoh's posts.
  Forum: By Share Code

schlitzo
Posted on: Jul 13 2016, 09:53 AM


Group: Member
Posts: 249

MSS!
  Forum: By Share Code

schlitzo
Posted on: Jul 12 2016, 08:43 PM


Group: Member
Posts: 249

Who exactly were you way back when? Just out of interest...
  Forum: By Share Code

schlitzo
Posted on: May 18 2016, 01:52 PM


Group: Member
Posts: 249

$5. biggrin.gif biggrin.gif
  Forum: By Share Code

schlitzo
Posted on: Apr 12 2016, 03:11 PM


Group: Member
Posts: 249

Only a couple of cents (Aust) off a 52 week high. Would like to see that broken soon... like today!
  Forum: By Share Code

schlitzo
Posted on: Apr 11 2016, 10:05 AM


Group: Member
Posts: 249

Lagoda has been buying up shares again...do they know something we don't?
  Forum: By Share Code

schlitzo
Posted on: Mar 23 2016, 09:07 PM


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Posts: 249

Don't stop at 2 PM!
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schlitzo
Posted on: Mar 23 2016, 06:30 PM


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Posts: 249

One would think we are billionaires on this site. There are no plants, never have been, never will be. This is CUV, hardly anyone has heard of it (though this could be changing:-). The best way to really squeeze someone's balls and get them going is to IGNORE them. It's easy, remember who the bullshit artists are and don't read what they write. At the same time, I truly appreciate those who have genuinely contributed to this board, don't know where some of you get the time, obviously, you don't have young children. I've forgotten how long I've been a holder, I read something about a company called Epitan in the newspaper years back, having sun damaged skin myself, I immediately thought it was a winner and bought a whack of shares for 10c. Had no idea of what was ahead, wish I did and would have saved me years of torment. Looks as though, at last, things are starting to change. Afamelanotide really could end up a wonder drug that is going to make some lucky people very rich, and make many unfortunate folk feel normal again. I think this is just the beginning of a very long and good run up. Unlike most of you, I have always though PW was the man for job and still do. Someone in his place would still be jumping through the same hoops and having to tick the same boxes. Once CUV is in a safer position with a few more indications under its belt, I think you'll find him a different man. Anyway, I still dream of being rich from this stock, time to dream again. Best of luck to you all, especially the long-termers.
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schlitzo
Posted on: Mar 14 2016, 10:25 PM


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Posts: 249

Does anyone here know who snapped up most of the shares issued? Was there any one significant buyer? Or were they spread out all over the shop? Cheers in advance:-)
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schlitzo
Posted on: Mar 9 2016, 11:34 AM


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Posts: 249

WTF! The never ending nightmare of holding this stock continues. I'm sure it is going to get there in the end but talk about pushing the boundries of tolerance. Surely we aren't going to see $3 again...are we?
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schlitzo
Posted on: Feb 16 2016, 09:47 AM


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Posts: 249

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced an update on the commercialisation of its novel drug SCENESSE® (afamelanotide 16mg) in adult patients with erythropoietic protoporphyria (EPP) in Europe.1

Clinuvel has been working towards finalising distribution infrastructure, with a focus on a Risk Management Plan (RMP) and pharmacovigilance in accordance to EU legislation to undertake the long term follow up of EPP patients receiving SCENESSE®.2 Patients will be treated in accordance with a Post-Authorisation Safety (PASS) Protocol.

EUROPEAN PRICING AND REIMBURSEMENT

Payors across Europe acknowledge the need to treat EPP, a rare genetic disorder which is regarded as the most extreme form of phototoxicity, an anaphylactoid reaction to light and UV. SCENESSE® is the first treatment for EPP, falling under the category of highly specialised technology.

Advisory bodies and healthcare organisations in a number of European countries are currently inviting patient representatives and expert physicians to closed workshops to assess the burden of EPP and the proposed access to SCENESSE® as part of the process of determining a reimbursement price under current national healthcare provisions.

Factors such as development, manufacturing and distribution costs, as well as specific expenditures related to the long term follow up of patients determine the pricing of the product in Europe and other regions. Discussions are ongoing and final pricing is not yet established.

Clinuvel expects the first patients to receive treatment with SCENESSE® pending regulatory requirements and pricing agreements in individual European countries. It is anticipated that, in the coming weeks, various European authorities will publish details relevant to market access and distribution.

“We are aware of the recurring risks EPP patients are exposed to during months of higher light intensity,” Clinuvel’s CEO, Dr Philippe Wolgen said. “Our first concern is to ensure long term patient safety. We very much look forward to these patients receiving the product under the EU marketing authorisation.”

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schlitzo
Posted on: Sep 15 2015, 04:35 PM


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We just had a 0.37 jump in the SP on the ASX before closing.
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schlitzo
Posted on: Jul 27 2015, 12:47 PM


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Posts: 249

Like most of you, I'm definitely not happy with the share price where it is, but do you think changing the CEO, or getting him to communicate more openly is going to change things at all? Sure the SP might be a little higher (or not). CUV is still a very speculative buy, and that is what is keeping people out. Even if we were at, let's say $7, how many of you would sell before vitiligo has been passed? The process of getting a new drug passed is agonizingly slow. I only wish I had just found out about CUV now and not way back in the Epitan days. Still, I'm not hanging about to double or triple my money. I'm hoping, praying (I don't know who to) and trying not to let my bollocks shrivel up at the chance of actually retiring and being comfortable. Put in another CEO, you still have the same wait for appoval. PW has been ticking most of the boxes so far, I for one, would like to see him stay.
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schlitzo
Posted on: Oct 24 2014, 08:14 AM


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Champagne for a positive... Shotgun for a negative.
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schlitzo
Posted on: Sep 15 2014, 07:32 AM


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Posts: 249

Not too many days in my life have I looked fwd to Monday morning. Is there enough pressure to break $4 today?

Someone mentioned a week or so ago about the reverse split reverting back to what it was. Is there any truth or reason for Clinuvel to do that sometime in the future?



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schlitzo
Posted on: Sep 9 2014, 02:57 AM


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Posts: 249

Should we receive approval in a few weeks by the EMA, and the SP continues in its present direction, at what point would we be looking at any kind of dividend? For someone who has been in this from the beginning, I wish I had only just heard about Clinuvel. It's been such an incredibly long wait (most of it with a knife held close to my wrists) that it is hard to believe that we are coming to the end game. Even so, how many times have we been here before? Like many of you, I haven't sold a share, and hopefully will wish I had bought many more come 2 weeks. Good luck to us all, especially me! Followed by Uhoh, that guy deserves to by very rich from Clinuvel.
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schlitzo
Posted on: Feb 21 2013, 09:20 AM


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Posts: 249

The dodgy looking chap driving the Aston Martin of course!
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schlitzo
Posted on: Feb 5 2013, 06:56 PM


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Posts: 249

CUV had ZERO action on the ASX today. We wait...
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schlitzo
Posted on: Feb 3 2013, 11:27 PM


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It's the first time in a long time that I'm actually looking fwd to Monday.
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schlitzo
Posted on: Jan 25 2013, 06:22 PM


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Posts: 249

Hey, what happened to the champers? Please don't go back to the manky soup?
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schlitzo
Posted on: Jan 21 2013, 08:37 AM


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Move to Australia, Mate!
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schlitzo
Posted on: Jan 18 2013, 09:45 AM


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Charties, do we still have resistance at $2.30, or are we going to break thru it? What is the next point after 2.3?
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schlitzo
Posted on: Dec 19 2012, 10:37 AM


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Posts: 249

Some good news for Xmas...

Successful Ph lla Vitiligo results -



QUOTE
Combination of novel drug with NB-UVB achieves better, faster repigmentation in vitiligo patients


  • The primary study objective achieved: extent of repigmentation (VASI/VETF scores: p=0.025/p=0.023)
  • Patients with darker skin types (Fitzpatrick IV-VI) responded best to the SCENESSE® combination treatment (VASI scores: p=0.037)
  • The secondary study objective: time to repigmentation showed a strong favourable trend towards SCENESSE® treatment (p=0.086)
  • Overall the combination therapy was well tolerated, no significant safety issues reported.
Melbourne, Australia and Baar, Switzerland, December 19 2012
QUOTE



Well...at least we know that something WILL happen in 2013 with EPP. Hopefully, it will put a smile on our miserable faces.

MX&HNY to all the Die Hards.

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schlitzo
Posted on: Nov 30 2012, 11:55 AM


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Posts: 249

I emailed CUV and asked if they had any comment about these 1 share trades, especially the one at the end of the trading day. No reply as yet...
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schlitzo
Posted on: Nov 28 2012, 02:38 PM


Group: Member
Posts: 249

From Uhoh's post...

QUOTE
The present invention provides for a hexapeptide, namely CUV 9900, which is an alpha-MSH analogue capable
of stimulating the melanocytes and consequently, the synthesis of melanin. Furthermore, it has been shown that CUV9900
is a potent skin protectant and has prolonged activity in the repair of cellular DNA of dermal (skin) cells following UV
irradiation. CUV 9900 is superior to the physiological molecule alpha-MSH and can be beneficial in many disorders, for
example in disorders where the melanogenic response is deficient in its activity due to insufficient signalling following
alpha-MSH release, or in disorders where melanogenesis is deficient due to metabolic, immunogenic, genetic or mechanical
factors affecting the biological signalling of the melanocyte.
QUOTE


It also seems the delivery of CUV 9900 can be done by just about any method, including a topical cream.

QUOTE
Advantageously, CUV9900 may be also administered topically using a transdermal delivery system as described
in International Patent Application No. PCT/AU2005/001552 (published as WO 2006/037188). The topical transdermal
delivery system includes (1) a peptide, (2) a solvent system in which the peptide is soluble, (3) optionally, a substance
capable of in vivo stimulation of adenosine 3’,5’-cyclic monophosphate (cAMP) or cyclic guanosine 3’,5’-monophosphate
(cGMP), and (4) optionally, a skin stabilizer.
QUOTE


If they get this one passed, look at the SP heading higher than you ever imagined. The EMA & FDA don't like the idea of implants, but different story with creams.

Only hope I live long enough to benefit from this one, should it come about.
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schlitzo
Posted on: Nov 14 2012, 07:12 PM


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Posts: 249

I fully understand what your concerns are, Hotty, I felt like I was totally F....d over when the split happened. Then I thought if CUV was worth $20b and I had a 0.3% stake in the company would I lose out with the reverse split, basically no. I would have $6,000,000 what ever it was. If the SP can reach $20 on the old scale, it can reach $200 after the split because that's what's the company would be worth. I'm probably completely wrong and would be very happy indeed with your math in your initial post, should it come about.

Anyway, enough of having $6,000,000 bucks in our pockets, still a long way to go, if it ever happens. Wish I had more to add than the odd ramblings but I know nothing about the markets. However, I truly do appreciate the hard-corers here who continually keep us up to date with the latest; I often wonder where and how you get your info. All I hope is that you keep it up, I'm sure it's not just me on the sidelines appreciating it.

Surely has been one hell of a roller coaster ride for me emotionally, and still is. I read something positive and start thinking about buying more shares, then the following post is the opposite and I feel like selling (but I never do). Hopefully, there will be talk of beach parties again one of these days.
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schlitzo
Posted on: Nov 14 2012, 04:21 PM


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Posts: 249

You are giving two different examples. All I'm saying is that no matter how many times you split, you'll end up with the same amount of money as our stake in CUV doesn't change.

30,000 shares x 10 = 300,000 shares @ $1 =$300 000 then x $20 = $6,000,000

and if the 10 to 1 split doesn't occure, how much do we have?

30,000 shares @ $200 = $6,000,000

or after another reverse split

3,000 shares @ $2,000 = $6,000,000

Look at the share price now

30,000 shares @ $1.90 = $57,000

If the split hadn't occured

300,000 shares @ 0.19 = $57,000


I'd be very happy whatever way. I'd even be happy to make up the difference with you with the splits.





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schlitzo
Posted on: Nov 14 2012, 10:34 AM


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Posts: 249

You still own the same amount of the company:

30,000 shares @ $10 = 300,000 shares @ $1 x $20 = $6,000,000
or
30,000 shares @ $10 x $200 = $6,000,000

More shares look better but we end up with the same in the end - Same, same, onry diffelent!

Just hope we end up around the $1,000 mark.

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schlitzo
Posted on: Nov 8 2012, 06:56 PM


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Posts: 249

Hope this is the start of good things to come, F... knows how long some of us have been waiting. I remember a nice elderly gentleman some years back being concerned as to when the sp was going north due to his health, age and family issues. I don't know if he is still with us, I sincerely hope so. Unfortunately, I am starting to get up there now, along with some health problems. I am beginning to worry this long drawn-out process of getting a drug passed is going to outlast me. Would hate to be able to buy the Ferrari only to fail the driving test.
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schlitzo
Posted on: Oct 22 2012, 04:12 PM


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Posts: 249

QUOTE
Patients with rare conditions face postcode lottery.
Research shows that patients with rare conditions have less chance of accessing 'orphan' medication if they live in England.
QUOTE


http://www.guardian.co.uk/society/2012/oct...ostcode-lottery

I think the UK probably one of the best health care systems in the world, but this sounds a little unfair and needs to be seriously looked at again.
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schlitzo
Posted on: Oct 2 2012, 06:40 PM


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Posts: 249

AGM set. Anyone planning/able to go?

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced it will hold its 2012 Annual General Meeting of shareholders on Tuesday November 20, 2012 at 10.00am AEST at Grant Thornton Audit (Vic) Pty Ltd, Level 2, 215 Spring Street, Melbourne, Australia.

A formal Notice of Meeting and the company’s Annual Report will be lodged with the ASX no later than October 19, 2012.

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schlitzo
Posted on: Sep 12 2012, 12:57 PM


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Posts: 249

Why it takes forever for this lot to decide to pass a drug is to basically cover their own sorry asses. They don't want another thalidomide on their hands, even if the safety record of afamelanotide has been exceptional for over 10 yrs. The last thing on their mind is to help those who are crying out for it.

I have bronchietasis and have been waiting for a drug called Broncitol (from Pharmaxis - another Australian company) to hit the shelves. It was knocked back by the EMA once (I have no idea why), and is now going thru the process again after appeal. Another totally safe drug (made from monitol - the sugary coating on stick chewing gum). It's the first new drug in 20 yrs for bronchiectasis, it helps rehydrate the lungs so it's easier to cough up the gunk which helps stop infections. I've been waiting for this for years. Bastards!

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schlitzo
Posted on: Sep 6 2012, 01:46 PM


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Posts: 249

I wonder if in time, Scenesse could actually stimulate the hair folicule enough to make it grow. Add androgenic alopecia to the list and we'll all be buying football teams. I did read somewhere on one of the M2 sites that someone claimed there was some regrowth on there head (could have just been the darker hair making it look thicker). I haven't read anything anywhere else about it. Best to ask Uhoh.
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schlitzo
Posted on: Sep 1 2012, 12:08 PM


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Posts: 249

Rather disturbing post by Uhoh... I don't like the way they highlighted 'CURE'

QUOTE
If you live within driving distance of any of the following five Porphyria Centers, you are needed to participate in this important research:

University of Texas Medical Branch, Galveston, TX
University of Alabama, Birmingham, AL
University of Utah, Salt Lake City, UT
University of California San Francisco, CA
Mount Sinai Hospital, New York, NY
The researchers will be studying the use of ISONIAZIDE , which is a drug currently used for Tuberculosis, but in this case will be used for EPP. Patient volunteers will return to the center every two weeks for monitoring. All EPP patients are eligible for the study except those who are currently in the present Phase III clinical trials with Scenesse. SinceRESEARCH IS THE KEY TO OUR CURE, everyone who participates in research as a patient volunteer is extremely valuable to the future of all of us. If you are interested in participating, please contact the APF--- 866 APF 3635
QUOTE



Though if they have to go thru the same process to get their drug passed as CUV did, we should be safe for a while.
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schlitzo
Posted on: Aug 15 2012, 05:21 PM


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For those of you who have yet to watch the interview, Mr Thomas is winner of four Emmy Awards, anchor and producer, entertainment reporter at WJBK Fox 2 Detroit.
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schlitzo
Posted on: Aug 15 2012, 04:43 PM


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Posts: 249

Just watched the webcast with Lee Thomas and PW. I was very much encouraged by the interviews and am most keen to see parts 3 & 4. I don't know if Mr Thomas (who is also afflicted with vitiligo) contacted Clinuvel for the interview or vice versa. If the later, then it was a very smart move by PW and Co. Get Mr Thomas on your side and you have the spokesperson for the vitiligo community rooting for you and promoting you (for free), I'm sure with the enthusiasm he showed in the interview, most of them are already aware. If the trials continue in the same positive manner, we could all be sitting pretty in 5 yrs (don't know how many times I've thought/said this before).

What I'd like to see is Mr Thomas approach CUV for a 'Morgan Spurlock-esque' documentary with him being treated for his vitiligo over a year or so. Then air the doc with a fully cured (we hope) Mr Thomas prior to the public release of the drug (if it ever is).
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schlitzo
Posted on: May 25 2012, 07:21 PM


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Why do you think that, Go4it? Is it because you think vitiligo is a vitilinogo?
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schlitzo
Posted on: May 25 2012, 12:23 PM


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Posts: 249

You're not alone thinking that way, Hotty, there are plenty of out there. At least there is hope ahead with EU acceptance (I can't see them knocking it back) later this year, making many of us, who have been in this for years, a little happier. I mentioned about 4 yrs ago that I thought I would be sitting pretty by now just with divis, had no idea how long it really took to get a drug passed. Hopefully, in another 4 yrs there might be more chance of getting by on divis.

It's a pity there is such a stigma about the word 'Tan' with the FDA etc. Makes no sense to me when there are thousands apon thousands out there with some sort of skin cancer, with thousands more lying on the beaches now getting ready to join the ranks. I, for one, would not have the problems I do now if scenesse was availble to me from my teens when the pressure to have a good tan was a must. Anyway, exciting times ahead. We may not be the multi millionaires we once dreamed of, but at least we'll be able to have more comfortable lifestyle.
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schlitzo
Posted on: Feb 7 2012, 11:30 AM


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Posts: 249

At last! Management might drive us crazy with delays and silence, but in the end they are ticking all of the boxes.

Just had a 3rd year English class here in Japan. They had to write rhyming poems, so jotted this one down during their 10 min planning time. It's crap, but the students liked it, and made me explain what it was all about. Now they all want to buy CUV shares.

CUV Dreaming….



2012 is the year we’ve all been dreaming of,

And we all truly hope that there is a God.

Some of us have been in right from the start,

After 12 years of stress it’s even hard to fart.

Yes, that’s a long time to keep hold of your sanity,

Many have bailed screaming profanities.

Now the wait is over, at least that’s what we hope,

But if it turns out a dud we’ll all look like dopes.

If I do lose the lot, I’ll have to face my wife,

I’d better run fast to get away with my life.

With EU acceptance just 9 months ahead,

We all dream of millions at home in our beds.

Rabbitrun sleeps best with a scotch on his chest,

Contemplating which Escort Agency he thinks is best.

Some dream of numbers which can’t be compared,

With Uhoh stretching the limits to $2,000 a share.

Even P.W. has a dream of his own,

Like buying Man U. without taking a loan.

Still, some have doubts that the results will come thru,

Yes, Rosewood, we’re talking about you.

Now, now, keep your cool, I’m really not rotten,

Hey, stop right there, don’t hit that ignore button!

…..Now it’s 3 years later and we’re all out of reach,

As we’re all drinking champers on a tropical beach.

Even if you look for us, you won’t find us ‘round,

You see, we’ll all look different when we’re totally brown.

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schlitzo
Posted on: Jan 12 2012, 03:03 PM


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Posts: 249

ad0304s

Everyone is in shock and are unable to post. Hope we get plenty more of this over the next few months, definitely is a change to the usual - Good News = SP heading south.
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schlitzo
Posted on: Dec 24 2011, 09:14 AM


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Posts: 249

Silly Me! I forgot PW was single and a Party Boy. Of course he is going to favour New Year over Xmas as a date to file. So looks like Fri the 30th.
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schlitzo
Posted on: Dec 23 2011, 11:03 AM


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Posts: 249

Just put the champagne in the fridge. Gotta be an hour before closing today, right? PW's a European, they are big into Xmas over there. Mind you, I did put vintage champers in the fridge this time just in case it's longer than another 6mths. Been in this almost from the very beginning, and can't remember how many false summits we've climbed, not even sure if we are going to hit the heights we all dreamed of years back, but there is a summit ahead, the question is if it's going to be an Everest or Kosciuszko. I think we are all going to feel much better about our investments this time next year (I've also said this before).

Merry Xmas to you all, especially the ones who contribute most to this site. I think 2012 is going to be one to remember. Years back, we all use to talk about meeting up on a tropical beach once we were rich, hope that kind of talk is seen again here one day. Good luck to us all.
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schlitzo
Posted on: Dec 15 2011, 11:04 AM


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Posts: 249

They gave us some good news (I forget what is was) on Dec 23rd some years ago, keep your fingers x-ed they give us another Xmas pressie this year too.

Found it...

"Sydney - Tuesday - December 23, 2008: (RWE Aust Business News) -
Clinuvel Pharmaceuticals (ASX:CUV) reports the filing of its
Investigational New Drug (IND) application with the US Food and Drug
Administration (FDA) for its photoprotective first-in-class compound,
afamelanotide."
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schlitzo
Posted on: Sep 22 2011, 10:51 PM


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Posts: 249

General meeting Wed, Oct 9 at 10am. Anyone on this board going?

http://www.clinuvel.com/resources/cmsfiles...0922AGMDate.pdf
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schlitzo
Posted on: Sep 20 2011, 07:13 PM


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Posts: 249

Good ol Jack (Wood) does it again and buys 60,000 shares for around 100k. He's the only one in the CUV team who gives me faith! Had that feeling in my gut this morn that all wasn't right, feel much better about things now.

http://www.clinuvel.com/resources/cmsfiles...ndix3YJWood.pdf
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schlitzo
Posted on: Sep 14 2011, 10:16 AM


Group: Member
Posts: 249

That's the first thing I looked for when the results for EPP came in from Italy, there was no increase at all in the number of patients. I agree that it will be closely controlled and regulated from dermatologists, CUV and the regulators. Though I think this will be only be the case for a year or 2. Once the safety issue is established with doctor and patient word will spread, especially when there is money involved. I wouldn't be surprised if the number of EPP sufferers increases dramatically in 2013 (and they will all be wealthy).
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schlitzo
Posted on: Aug 31 2011, 06:29 PM


Group: Member
Posts: 249

I'll believe it when it happens, but would be nice to see them file for marketing authorisation with the EMA before the end of the year, meaning this time next year the sp might look a little brighter than it is now. Been a long, long f....... wait for many of us. Hang in there!

Company Announcement
Wednesday 31st August 2011
Baar, Switzerland and Melbourne, Australia
Clinuvel completes pre-clinical program for SCENESSE®
(afamelanotide)
Regulatory pre-clinical requirements met as toxicology, pre-clinical program concludes
Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it had
completed its pre-clinical program for its first-in-class drug SCENESSE® (afamelanotide). The completion of
this program is an important regulatory milestone for Clinuvel as it works towards filing SCENESSE® for
marketing authorisation with the European Medicines Agency (EMA) for the orphan disease erythropoietic
protoporphyria (EPP). The data, from four pre-clinical studies, confirm results from earlier trials.
The studies investigated the chronic effects of afamelanotide and the effects of the drug in reproductive
toxicology models. All four studies used significantly higher and more frequent levels of drug exposure
compared to those used in patients. Following a review of earlier pre-clinical studies conducted by the
company, the EMA agreed with Clinuvel that carcinogenicity studies of afamelanotide were not required.
Toxicology studies
Chronic exposure studies over 10 months showed that afamelanotide implants activated pigmentation as
expected but had no adverse or unexpected effects on tissue toxicity, the neurological or cardiovascular
systems. A placebo-controlled six month high dose study similarly showed no adverse effects of the drug and
confirmed the reversal of pigmentation within a 28 day recovery period.
Previous single and repeat dose toxicology studies of afamelanotide, ranging from 21-90 days, had shown the
drug to be safe and well tolerated in a number of pre-clinical models. Across these studies no clinically
relevant histopathological changes were observed. In studies using subcutaneous controlled-release drug
formulations, no evidence of drug accumulation in the system has been observed.
Reproductive studies
Earlier pre-clinical reproductive studies of afamelanotide in male and female models had shown the drug to
have no adverse effects on reproduction at significantly elevated exposure levels compared to those used in
humans. This latest data confirm the drug had no effect on body weight or weight gain, food consumption or
reproductive parameters. No abnormalities were seen in first generation off-spring. A no-observed-effect-level
(NOEL) of afamelanotide was seen at significantly higher dose levels than the dose used in patients.
“These pre-clinical results confirm once again the long-standing safety profile of afamelanotide and we are
satisfied that the results are sufficient for our first filing of the drug with European regulators,” Clinuvel’s Chief
Scientific Officer Dr Hank Agersborg said.
All pre-clinical results will form part of Clinuvel’s final dossier in its marketing authorisation application (MAA)
for SCENESSE® with the EMA for the orphan disease erythropoietic protoporphyria (EPP). Pending clinical
results from a US Phase II study (CUV030) and a European Phase III study (CUV029) the company expects to
file with the EMA before the end of 2011.

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schlitzo
Posted on: Aug 30 2011, 11:00 PM


Group: Member
Posts: 249

Nomura Analyst Report

Action: FY11 loss below forecasts
CUV’s FY11 normalised NPAT was -A$12.6mn (vs. Nomura at
-A$13.8mn). We forecast CUV will undertake a A$20mn capital raising in
FY12F in order to further fund its capital programme, particularly Vitiligo.
Catalyst: CUV moving into Vitiligo market
CUV aims to show that its lead compound, afamelanotide, has efficacy
against several sun-related diseases. CUV has previously announced that
it is to begin investigating the effectiveness of afamelanotide in Non-
Segmental Vitiligo, a condition that affects up to 45mn people globally.
This is a new medical indication for afamelanotide. CUV plans to use
afamelanotide as an adjunct to the current mainstay of treatment, narrow
band UVB (NB-UVB), as well as testing afamelanotide as a single
treatment option.

FY12 – should be a big year
Apart from further investigating the NSV opportunity, in FY12 CUV should
receive results of an EMEA marketing authorisation for afamelanotide for
EPP. This would be the final regulatory step before the start of EU sales.
Marketing authorisation is usually granted three to nine months after filing
in the US and EU.

Valuation: TP A$3.62 (from A$4.26), BUY maintained
We make no changes to our model assumptions in terms of the take-up of
afamelanotide in its major markets, but have revised future operating
expenses in line with the FY11 result. As a result, our DCF-based
valuation and price target declines to A$3.62 (from A$4.26).
  Forum: By Share Code

schlitzo
Posted on: Mar 14 2011, 09:34 AM


Group: Member
Posts: 249

Need CUV to start moving North. I need to be moving further South, only 300km away from Fukushima and possible meltdown. It's a nightmare over here at the moment.
  Forum: By Share Code

schlitzo
Posted on: Mar 3 2011, 10:20 AM


Group: Member
Posts: 249

I agree, this is great news. If EPP gets passed, and I'm sure it will, Vitiligo will be a no brainer to me. The drugs safety record will already be established (as if it isn't now), also a lot of the ground work (data) will have already be done with EPP. As you said, KRD, CUV have to keep their head above water to be in a good bargaining position when a big pharma comes knocking at the door. The way they have handled things so far makes me think they are in for the long run. This has been such a long f...... wait for us long timers, going to be another challenging 3 yrs, but I will definitely be there at the end, one way or the other.

  Forum: By Share Code

schlitzo
Posted on: Nov 19 2010, 10:02 AM


Group: Member
Posts: 249

RR, I wasn't too happy when I first heard the news about the reverse split, had already made out my chart and what I was going to make from $0.50 up to $300. Thing is, if things go as we all hope, by the time we reach $100 ($10 before the reverse split), they will probably do a 10-1 split the other way. You'll be back at 100,000 shares again. If things continue on in a Uho-type curve, they will have to split again giving you 1 million shares! If CUV can pull this one off, you'll be rich enough, one way or another.

Mind you, given the choice, I was happier back before the change.
  Forum: By Share Code

schlitzo
Posted on: Nov 11 2010, 09:52 AM


Group: Member
Posts: 249

One noticable thing in slide 19 was the sexier 'bou langerie' the young lady was wearing after the implant. Once Scenesse takes off, I'm buying shares in Victoria Secret as well!

Thought they might have offered more at the AGM, we virtually know as much now as we did this time yesterday.

Does anyone know of a link to PW's presentation? Would like to watch him perform.
  Forum: By Share Code

schlitzo
Posted on: Nov 4 2010, 01:07 PM


Group: Member
Posts: 249

Spoke to a guy from finance in Suisse yesterday, didn't find out too much. Will know about data from Italy within the next 3 mths. There are no receipts in their books yet, so can't announce anything. Nothing out of the ordinary happening, as far as he knows, because of the low number of patients. Obviously half of Europe hasn't poured into Italy for a implant.

Asked about the waiver thing Uho posted. He knew nothing about that at all. Said he would look into it and email me any info he finds.

Was curious if anyone at CUV read SS, HC or YF, they said they did, but not that often.

Also questioned them about delays, said it was mainly due to the huge amounts of data that is needed to get anything passed these days. Because this is a shiny new drug, there is no other data out there, so they have to start from scratch, and it is taking up an awful lot of their time. BTW, my sister-in-law is working for a company here in Japan which is trying to get its heart pump passed by the fda and ema, and I know first hand at how much data is needed - I'm talking about a shit load - I've seen it!

If anyone else has questions, I suggest they give the Suisse office a call. Obviously the guy was very busy but was willing to give me time and was very friendly about it all.
  Forum: By Share Code

schlitzo
Posted on: Nov 1 2010, 07:45 PM


Group: Member
Posts: 249

Public holiday in Suisse today (don't know why they couldn't have told me that last Fri), will try calling again tomorrow. Did try a rangle some info out of a tech guy in there on phone duty but he had obviously been told to keep his mouth shut.

My heart skipped a beat when I noticed the SP at 17.5 today, nice recovery though - back to a staggering 19 cents!
  Forum: By Share Code

schlitzo
Posted on: Oct 30 2010, 10:21 AM


Group: Member
Posts: 249

RR, good to know you're still with us.

Well, more like a 'Benny Hill' Confucius quote; was referring to Blckman3's frustration with the SP being so low. Let's see if it get's the chop here -

Confucius say - "Man who wants to be with pretty nurse must be patient."

PS. Know that I live in Japan, which has a serious 'lack of crack' (the humorous kind).
  Forum: By Share Code

schlitzo
Posted on: Oct 29 2010, 06:20 PM


Group: Member
Posts: 249

The world has got far too sensitive. I'm sure if Mr Bigby were to read Uho's post he'd have a chuckle as well. Of course it was written tongue in cheek. Loosen up, it's Friday! Damn, I even had a Confucius moderated on HC the other day.

Rabbitrun, are you still with us?
  Forum: By Share Code

schlitzo
Posted on: Oct 29 2010, 03:03 PM


Group: Member
Posts: 249

He is the one who has at least 5 positive posts a day and is endlessly searching for more positive info on CUV (and finding it). If all of on SS, HC and YF posted as much as he did, we'd be reading all day long. Best you go over to YF and have a read.
  Forum: By Share Code

schlitzo
Posted on: Oct 29 2010, 12:04 PM


Group: Member
Posts: 249

From Uhohinc...

QUOTE
Before you click to go to this link ,,,,,take a deep breath, and be prepared, for when you see the FDA chairman whom has the power of making your stock value go ............

http://messages.finance.yahoo.com/Business...935&mid=935


  Forum: By Share Code

schlitzo
Posted on: Oct 29 2010, 09:40 AM


Group: Member
Posts: 249

Called their Suisse office, everyone was in Blighty on business (Man U vs Tott no doubt). Will be back on Mon so will call again.

They need to sort out their phone system there. Sounded like a backyard business. The woman who answered was very nice but must of had her hand half over the mouth piece so could hear most of the conv. will the other woman in the office, along with the noise of the mouthpiece against her hand. I mentioned they needed to sort that out.
  Forum: By Share Code

schlitzo
Posted on: Oct 28 2010, 11:29 AM


Group: Member
Posts: 249

I, for one, am very interested in seeing the data from Italy. Have no idea as to why we haven't heard anything yet, if I get home early enough today, I'll give CUV a call. Hopefully it is because the numbers are well above 60 and they are reluctant to let the info out. If they are, it either means the Italians are treating not just EPP-ers (hard to imagine that), or EPP-ers are heading across to Italy from other EU countries to get treated. When they do let us in on the data, it will give us a good idea if the good word is getting around or not. Would be nice to hear the numbers are up around 6,000 instead of 60.
  Forum: By Share Code

schlitzo
Posted on: Oct 12 2010, 03:45 PM


Group: Member
Posts: 249

Excuse my ignorance, but could someone please elaborate on these 'reverse 10 -1 splits a little more? I can see the benefits in the short term, but let's take the best case scenerio and CUV heads way north in 3 or 4 yrs to say '$100' (Hey, you have to believe). With a reverse 10 - 1 it would be $1,000 a share. Before it got to that would they do a 10 - 1 the other way?



  Forum: By Share Code

schlitzo
Posted on: Sep 22 2010, 11:31 AM


Group: Member
Posts: 249

Damn! So what rate did everyone get at the bank?
  Forum: By Share Code

schlitzo
Posted on: Sep 19 2010, 11:27 AM


Group: Member
Posts: 249

If management were to agree to a take over at anything under 500 million then we are riding a dud and we should be thankful for a buck. The way things are presenting themselves now, makes me believe they have much grander plans. We can rant and rave as much as we want but they have their own agenda and it is a long drawn out process. Best to take out a loan from the bank, go on 3 yr vacation somewhere (without checking the markets), then arrive home to riches (or the loaded gun you have under your pillow).
  Forum: By Share Code

schlitzo
Posted on: Sep 9 2010, 11:54 PM


Group: Member
Posts: 249

BTW, I'd be sooooooo tempted with 'A', but the thought of missing out on possible 10x would be too much for me, so 'B'.

  Forum: By Share Code

schlitzo
Posted on: Sep 9 2010, 04:11 PM


Group: Member
Posts: 249

As a matter of interest, please answer A or B. Would like get the general feel of SS posters on this one.

A. I would settle for $9.75 a share today?

B. I am prepared to ride this one out (for as long as it takes) for possible larger gains.
  Forum: By Share Code

schlitzo
Posted on: Sep 1 2010, 11:38 AM


Group: Member
Posts: 249

KRD, if/when CUV get EU EPP approval, would the cash flows coming in from that, along with the reserves they have now, be enough to get them thru the more expensive vitiligo trials? PW seems to have the patience of a saint, from what I've seen of his style so far, I'm sure he's in it for the long run. Deals are on the cards, but I don't think a sell out is. I know most of us would be gutted if they did get taken out by a big pharma. As for PW going back to Europe, now that he's been topped up with Australia's rich culture I'm sure he would be keen to get back to impress his mates. He'll be the envy on Zug!

  Forum: By Share Code

schlitzo
Posted on: Aug 25 2010, 09:48 AM


Group: Member
Posts: 249

QUOTE
There really is no other company in the ASX that offers the growth potential that SLA offers in the short to medium and long term. Most 'breakthrough' companies that I know of in the ASX (e.g. PRR) are still at least 3 years away from commercialisation.. and we all know that a lot can go wrong in between.


There is one, should all the bits fall into place over the next 3 yrs, and that's CUV - Clinuvel. Like SLA (I hold both SLA & CUV), it has huge potential, even more than SLA in my opinion, but the process of getting it to where you want it to be can just about kill you. Both companies are so close now you can almost smell it. Hopefully to all the faithful here and there (CUV) your time is almost at hand.

Sorry I have no time to contribute to posts here, but do get to read occasionally. Cheers to all the regulars who keep us all informed.
  Forum: By Share Code

schlitzo
Posted on: Aug 20 2010, 12:04 PM


Group: Member
Posts: 249

Don't know if this has been posted before, been on hols...

Successful Drug Trial Results for Light Intolerant 'Shadow Jumpers'

http://finance.yahoo.com/news/Successful-D...ml?x=0&.v=1
  Forum: By Share Code

schlitzo
Posted on: Aug 3 2010, 09:52 AM


Group: Member
Posts: 249

Had our excitey time in July, everyone needs to go into hybernation for 3 mths (bar uhohinc - he's still pumping out 10 posts a day, most worth a read, on the yahoo finance forum) before anything else of importance happens. Next year should be a different story though... I hope!
  Forum: By Share Code

schlitzo
Posted on: Jul 14 2010, 11:01 PM


Group: Member
Posts: 249

After this weeks ann. and feedback from CUV, I am very happy with our present situation. There has been a lot of bitching over the last year (make that 8 yrs), a lot of it justified, a lot of it not. When I first got into this stock way back in the early Ept days, I knew little to nothing about what it took to get a drug to the consumer. It has been a long lesson, but I now know what a drawn out, complicated and difficult process it is (the average length from discovery to market via FDA is over 14 yrs). We have been very lucky to have the present management team get us to where we are, as frustrating as it's been for many of us. For those of you who have just got into this stock and are looking for a quick buck, good luck!!! Mind you, if you are willing to sit this one out over the next 2 - 5 yrs, I'm sure you'll be generously rewarded by PW and co. Seems CUV has a few surprises up their sleeve as well. My hope is to be making enough from divi's within the next 5 yrs to live very comfortably and just sit back and watch to SP head north for years to come. I'd be willing to eat my zimmer frame if CUV isn't over $100 per share in 10 yrs time. As it is, I'll also be dancing in the streets with RR and Clinumaniac if we're over just "$1" by the end of the year. Exciting times ahead (accompanied by the usual delays and disappointments).

  Forum: By Share Code

schlitzo
Posted on: Jul 8 2010, 07:13 PM


Group: Member
Posts: 249


From '


Patient-recorded outcome to assess therapeutic efficacy in protoporphyria-induced dermal phototoxicity: a proposal

Elisabeth I Minder , Xiaoye Schneider-Yin and Christoph E Minder

Health and Quality of Life Outcomes 2010, 8:60doi:10.1186/1477-7525-8-60

Published:21 June 2010
Abstract (provisional)



Background
Protoporphyria (PP) resulting from two rare, inherited diseases of heme biosynthesis leads to dermal phototoxicity by accumulation of the heme precursor protoporphyrin IX. No standardized tools to quantify the degree of PP-related phototoxicity and its change by medical intervention have been published.


Methods
Results from a questionnaire completed by 17 affected individuals were used to determine the relative importance of two main components of PP-related phototoxicity, skin pain and sunlight exposure time, with respect to the effectiveness of any particular medical treatment.


Results
Inter-rater reliability was 0.71 (n=490), repeated estimates by four identical individuals showed high reproducibility (Slope=1, intercept = 0, n=136, Passing-Bablock). Six different models were developed, three of them showed good correlation with effectiveness estimates. Data from an unpublished trial indicated that the model with highest potential of responsiveness was the so called "Exposure times [multiplied by] Freedom from Pain" (ETFP). The minimal clinically important difference (MID) was 15 (10.2-20.4) ETFP scores, representing 28% of the standard deviation of the clinical trial data and 2.9% of its total range.


Conclusions
Among the six models proposed to assess the effectiveness of therapeutic interventions in PP the ETFP model demonstrates the highest sensitivity using the existing data from a clinical trial of afamelanotide in PP. The results of this study have provided sufficient validation of the ETFP model that is likely to prove useful in future clinical trials.

  Forum: By Share Code

schlitzo
Posted on: Jul 8 2010, 11:32 AM


Group: Member
Posts: 249

Everyone is busy snapping up bargain shares at 0.23 cents. Wish I had a bit more extra cash, but I keep reminding myself that if this really takes off you won't need half a million shares to be rich. This month is shaping up to be very interesting indeed.
  Forum: By Share Code

schlitzo
Posted on: Jun 29 2010, 10:49 AM


Group: Member
Posts: 249

With these appointments only just going thru, I doubt if we'll get what we're waiting for by the end of the month (tomorrow). Mind you, I've heard from a couple of different sources that we will get the final ph 3 results by the end of June, would be nice to be surprised for a change. Everyone kill a chicken, pour blood over yourselves and dance around naked tonight, see if that helps.

  Forum: By Share Code

schlitzo
Posted on: Jun 22 2010, 06:32 PM


Group: Member
Posts: 249

BTW, thanks for the 3 points in the second match in South Africa ;-)

  Forum: By Share Code

schlitzo
Posted on: Jun 14 2010, 08:12 PM


Group: Member
Posts: 249

odi01

Because of the time differences, not everyone gets to watch the games live. I doubt very much if you like to be told the scores of games you haven't yet watched. Please keep scores to yourself, at least for a couple of days.

Cheers (& congratulations)
  Forum: By Share Code

schlitzo
Posted on: Jun 11 2010, 01:08 PM


Group: Member
Posts: 249

RR, just passed on to HC what Hopefull said here a week or so ago.

Surely something has to give soon. This has been such long journey for us long term holders, don't think I could take another year of nothing. People have even stopped talking about Island Parties etc, everyone ( bar Uhohinc) has been worn down. I envy the folks who have just jumped on board at such a low price considering where we are now in developement. Been 10 yrs of hell for some of us.

Hopefully nothing big will happen while the World Cup is on, don't want any big distractions for a month.
  Forum: By Share Code

schlitzo
Posted on: May 30 2010, 12:21 AM


Group: Member
Posts: 249

I've asked Uho a few times as to where he was from... but no answer, how come you are in on it? Like RR, I'm rather intrigued as he seems like a very intelligent and interesting chap. Happy to know he is still about, have no idea as to why he was booted from here??? Really do miss his posts.

BTW, been in contact with CUV of late and they are interested to know what kind of gripes I have with them, thought it would be a good idea for each of you out there with a bone to pick with CUV to write down what pisses you off the most about them and I'll add it to the list in my next mail. I know many of you will have a long list but just try to keep it to one gooden.
  Forum: By Share Code

schlitzo
Posted on: May 20 2010, 10:03 PM


Group: Member
Posts: 249

I think we have to have some faith in the management team at this point of affairs. They may be slow but they are ticking all the boxes as they waddle along. I think we all stand to make money out of this, the big question is, HOW MUCH??? Keep all the calculations coming in lads, those high numbers make my biffin tingle!

What happened to Uho? I think he still holds the record - $180 a share if I remember correctly.

Check it out, a first for Sharescene...I've set my avatar up on 'live poolside cam', everytime the SP goes up the pool boy gives me a wave and I reach down and take another sip of beer.
  Forum: By Share Code

schlitzo
Posted on: May 20 2010, 11:25 AM


Group: Member
Posts: 249

All we need now is for the SP to gain $150.94 and we're there!
  Forum: By Share Code

schlitzo
Posted on: May 19 2010, 09:23 AM


Group: Member
Posts: 249

Now I see where they are coming from. Still surprises me that they went for a very cosmetic 'sounding' name. Really thought it would be the other way around. Just goes to show what their long term intentions are.

  Forum: By Share Code

schlitzo
Posted on: May 18 2010, 11:18 AM


Group: Member
Posts: 249

Do a google search with Scenesse and Clinuvel is top of the list. The rest are porn sites!
  Forum: By Share Code

schlitzo
Posted on: May 18 2010, 11:00 AM


Group: Member
Posts: 249

Clinuvel unveils "SCENESSE" following European brand approval. Would have prefered "SCENASSE" myself. Thank goodness it wasn't "SCENESHERRE!

2 big anns. in 2 days, would be good to get another one by the end of the week. At long last the ball is rolling again. Hopefully this is the year things go our way, and we can all kick ourselves for not buying more at 0.18.
  Forum: By Share Code

schlitzo
Posted on: Mar 3 2010, 01:40 PM


Group: Member
Posts: 249

We've got to the point in time when every time I go the ASX I expect to see the ann. we've all been waiting for, namely the FDA approving IND to start Phase III trials. Even if it is, we still have a long wait before we are all filthy rich. Looking at the numbers of patients and the 3 yr time span (see below), CUV is going to have to be approved in Europe and OZ and start making money to finance the trial. If we are knocked back and have to start with Ph II it will be at least 5 yrs! That's a lot of cash they are going have to come up with.

CUV said the full results for PH III will be out before the end of March (and they have never missed a deadline), well, it's before the end of March now, so expect the ann. at any time.

BTW, does anyone know why the number of patients required for Ph's I, II & III have been much lower in CUV trials? (or haven't they?)



QUOTE
B. Phase I (after approval of the IND)
1. Clinical pharmacology studies
2. Done in 20 - 80 patients
3. Last an average of 6 months to 1 year
4. Purpose: Determine basic safety and pharmacological information
C. Phase II
1. Controlled studies in patients having the specific disease or condition that the drug is supposed to treat.
2. Involve 100 -200 patients
3. Average 2 years in duration
4. Purpose: Determine efficacy
D. Phase III
1. Multicenter, controlled and open trials
2. Involve 600-1000 patients
3. Average of 3 years in duration
4. “Pivotal studies” are usually Phase III trials that get the drug approved by the FDA
5. Purpose: Establishes safety and efficacy
  Forum: By Share Code

schlitzo
Posted on: Feb 24 2010, 10:42 AM


Group: Member
Posts: 249

Like wise, I've only purchased since 2003. Don't know enough about the ups and downs to take advantage of it, if I did, I'd have 2,000,000 instead of 200,000. The one thing that would kill me more than losing the lot with CUV going down the tube and that's to miss out if it really takes off. People keep telling me not to put all my eggs in one basket, but I'm seriously thinking of selling most of my other investments and doing just that. It's been a real rollercoaster ride with this stock but I've never felt more confident than over the last week or so. Kinda kicking myself I didn't buy more at 0.22, if there's another dip in the market in a months time, I am definitely going to buy more. As someone said some posts ago, "There are 2 outcomes to all this, we either stand to make a lot of money, or a shit load of money." This time next month, we should have a better idea as to where we stand and confidence in this stock can only grow from now on. Of course, the big hurdle is the US market, but if it is passed in Europe and Australia (which almost seems to be a definite) it has a good chance with the FDA. I don't think it will be knocked back because it tans, but passed because it is safe and will improve lives. Then again some have their suspicions...

Found this recently about Europe being concerned about the FDA approval rate -http://pharmtech.findpharma.com/pharmtech/News/News/ArticleStandard/Article/detail/500445

Royco, Rabbit, KRD and any others in the same boat, it might still be another 2 or 3 yrs before we think about retiring but it will be a far smoother ride getting there than what it has been. Good luck to us all.
  Forum: By Share Code

schlitzo
Posted on: Feb 8 2010, 09:33 AM


Group: Member
Posts: 249

Rpape

You can see for yourself at Melanotan.org.

Here is a direct link to some snaps of a type 1 - http://melanotan.org/cgi-bin/yabb/YaBB.pl?num=1184162868

Your guess is as good as ours as to when afamelanotide will be available to the public. The tingling in my biffin tells me some good news is just around the corner though. Better get in and by some CUV shares now so you can afford the implant!



  Forum: By Share Code

schlitzo
Posted on: Jan 26 2010, 10:34 AM


Group: Member
Posts: 249

Damn, we're diving. Mind you, got to look on the bright side of all this, if we get down to single figures it will be a perfect op. to stock up again for those of us who a bit skint sad.gif Don't you wish you'd just come across this stock now and not 7 yrs ago?
  Forum: By Share Code

schlitzo
Posted on: Jan 23 2010, 09:39 AM


Group: Member
Posts: 249

Seems our worries are over, the big news Uho mentioned has arrived - http://en.tackfilm.se/?id=1264203056824RA59
  Forum: By Share Code

schlitzo
Posted on: Jan 20 2010, 05:03 PM


Group: Member
Posts: 249

Here is the basic proceedure of approving a new drug at the FDA -

[/size]<H1 class=head1_body>[size="2"]"What is the approval process for a new prescription drug?</H1>Drug companies seeking FDA approval to sell a new prescription drug in the United States must test it in various ways. First are laboratory and animal tests. Next are tests in humans to see if the drug is safe and effective when used to treat or diagnose a disease.

After testing the drug, the company then sends FDA an application called a New Drug Application (NDA). Some drugs are made out of biologic materials. Instead of an NDA, new biologic drugs are approved using a Biologics License Application (BLA). Whether an NDA or a BLA, the application includes


  • the drug's test results
  • manufacturing information to demonstrate the company can properly manufacture the drug
  • the company's proposed label for the drug. The label provides necessary information about the drug, including uses for which it has been shown to be effective, possible risks, and how to use it.
If a review by FDA physicians and scientists shows the drug's benefits outweigh its known risks and the drug can be manufactured in a way that ensures a quality product, the drug is approved and can be marketed in the United States."


Unlike this forum where everyone has a different opinion or angle on our CUV, the FDA has a set rules to abide to, if they don't, there is another regulating body watching every move and can step in if they think something smells. The chances of having a Dr Wally involved is very remote. There are over 2100 scientists, including 900 chemists and 300 microbiologists working for the FDA. I'm sure it is a fair review process which must help in our case - CUV has an excellent safety record, (if you go thru the 26 new drugs approved last year you'll find they all have side effects far more severe than afamelanotide), the main issue is how much do EPP-ers benefit from afamelanotide. To me this still seems to be a grey area, or should that be 'brown area'? Time will tell, you won't get the exact answer here, look back over the posts from scratch to now, few have predicted correctly. Us CUV holders are like cats and this forum is the hand that strokes us, sometimes it's the right way and we purr, the other way and hair stands on end. I still have faith, and like Rabbitrun, I'm in this till the bitter end.

  Forum: By Share Code

schlitzo
Posted on: Jan 20 2010, 11:36 AM


Group: Member
Posts: 249

Down to 0.25.5, now that sucks...unless you have nerves of steel and want to top up. The ideal thing to happen now would be for PW to jump in and buy a million shares. Any chartists there? What's going on???
  Forum: By Share Code

schlitzo
Posted on: Jan 20 2010, 09:35 AM


Group: Member
Posts: 249

I think it's just someone who wanted to liven up the forum, most likely a regular poster on the drink at a mate's place.

  Forum: By Share Code

schlitzo
Posted on: Jan 18 2010, 06:41 PM


Group: Member
Posts: 249

DW

You should make a few posts at HC, the lot there are in need of some comic relief. More than appreciated here, though you gave yourself away with the extra pair of sunnies. But by all means, hit us with another one, nothing else happening with CUV to get us going. Try a few quotes from the bible about the dangers of UV, that should do it.
  Forum: By Share Code

schlitzo
Posted on: Jan 18 2010, 02:58 PM


Group: Member
Posts: 249

Wally Dr

You forgot Rule #6 - "God will strike you down if you fail to abide to rules 1 - 5."

Thanks for your insight, I'm selling all my CUV shares today and buying into any company that sells wide brimmed (at least 50cms) hats and MST.

Can't wait for your next post!



  Forum: By Share Code

schlitzo
Posted on: Jan 14 2010, 01:48 PM


Group: Member
Posts: 249

royco, sorry I didn't notice your post was a "quote" when you posted it on Oct 27, you sent the same quote as panguna. And all this time I thought you actually knew what you were talking about! wink.gif
  Forum: By Share Code

schlitzo
Posted on: Jan 13 2010, 11:39 PM


Group: Member
Posts: 249

"Glad to see there are others as enthusiastic about clinuvel as I am. I was lucky and recently bought about 160,000 stocks at a very very discounted price. Although the stock value has increased substantially since I bought in, I have no intention of selling. I'm on my way to becoming a doctor and have an excellent understanding of the clinical trials data that has been published. An important point that is not heavily emphasized is the fact that for these patients, there is NO treatment. Phase 3 clinical trials are designd to compare the new drug to the current "standard of care" but in clinuvel's case there is no treatment. Basically, the phase 2 trials may as well have qualified clinuvel for approval. It is extremely rare for a drug to go into phase 3 trial for disorder to which there is no treatment-one of the many unique aspects about clinuvel. This is why I have so much faith that the drug will get approved (not to mention that there are 12 swiss patients who continue to take the drug, even after the trial was over. It would be extremely unusual for the regulatory agencies to take away the only treatment these patients have)."



panguna, this looks like one of Royco's posts from last year.
  Forum: By Share Code

schlitzo
Posted on: Dec 23 2009, 01:56 PM


Group: Member
Posts: 249

Arty

That's got to be the prettiest graph I've ever seen. Surely things are going to change for us next week.
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