Registered Members Login:
   
Forgotten Your Details? Click Here To Recover +
Welcome To The ShareCafe Community - Talk Shares And Take Stock With Smart Investors - New Here? Click To Register >

3 Pages (Click to Jump) V   1 2 3 >

NewToCli
Posted on: Feb 8 2019, 01:00 AM


Group: Member
Posts: 528

That a new financial system is required for Nasdaq listing and U.S. reporting standards is a very good catch and quite likely. Again, we need to read between the lines in the cuv newsletters... maybe Mr. Bull can help to make it more obvious.

see here: https://listingcenter.nasdaq.com/assets/Lis...First_North.pdf

"Therefore, prior to listing the company should enhance its accounting and control system in order to ensure that the company is able to comply with the requirements, and is able to deliver reliable information to executive management and the board of directors. In addition, once listed, the company will be required to promptly publish its financial reports."

"Prior to the listing, the company is expected to have introduced and maintained the requisite routines, policies and systems for information distribution, including financial reporting. This is required in order to supply the market with relevant, reliable, accurate and timely information pursuant to the rules of Nasdaq First North"
  Forum: By Share Code

NewToCli
Posted on: Feb 7 2019, 10:53 PM


Group: Member
Posts: 528

Good news !!!! Clinuvel hired a new IR Manager, Malcom Bull, he joined Cuv in January in Melbourne. He is a well experienced banker and IR Manager..
Look out for him in LinkedIn

Fingers crossed he brings in new transparency and guidance to attract more shareholders!! Clinuvel is preparing for something big!!
  Forum: By Share Code

NewToCli
Posted on: Feb 7 2019, 08:17 PM


Group: Member
Posts: 528

well, chart analysis is always just a best guess and most people dont give it any credentials. Predicting past prices for future movements can always be only a guess... but once the market startes behaving in those patterns, why not include them in an analysis... I think I once posted a similar chart as below... before the break out. Even the long-term trend has been tested from above and then now the break-out is quite a good and strong signal... (if you click the pic it opens in the right order)
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

NewToCli
Posted on: Feb 7 2019, 06:21 PM


Group: Member
Posts: 528

That’s what I posted some time ago.. we are in a new up move after the triangle consolidation with price target above 30 aud
  Forum: By Share Code

NewToCli
Posted on: Feb 6 2019, 10:40 PM


Group: Member
Posts: 528

Congrats!!! And wow what a nice trip!! Check by Kopan Monastery in Kathmandu if you like to meditate with the monks, my favorite spot there. Probably not around in September, but who knows.. smile.gif
  Forum: By Share Code

NewToCli
Posted on: Feb 6 2019, 09:53 PM


Group: Member
Posts: 528

Congrats to your retirement! Not knowing your age I hope it’s an early one and you can enjoy an independent free life style now aside the daily sheep life! If there is a benefit for us long term holders is that we can retire early now 🙏🏻 PW, don’t mess up the end game now!!
  Forum: By Share Code

NewToCli
Posted on: Feb 2 2019, 11:58 PM


Group: Member
Posts: 528

The info given below is just not accurate. They don’t even mention that treatment is available in Germany and Austria too and compassionate use in Spain (that was written once in a newsletter or yearly report). Also we have never heard from anywhere about a refusal from France..

Let’s see what happens in March with UK...
  Forum: By Share Code

NewToCli
Posted on: Feb 1 2019, 09:05 AM


Group: Member
Posts: 528

Open 21.50, now down 1% to 21.38. Not as bad as the sell off in germany
  Forum: By Share Code

NewToCli
Posted on: Feb 1 2019, 05:22 AM


Group: Member
Posts: 528

We will see who gets approval and who maybe not.. where as Clinuvel has a high probality of Approval now with priority, I wouldn’t be too sure with brema, as the fda already raised conecerns about safety.. better silently sneak to approval than big headlines and fail
  Forum: By Share Code

NewToCli
Posted on: Jan 31 2019, 09:32 AM


Group: Member
Posts: 528

😂 yes what else of course .. your Bs never stops does it? Iggy is back, actively and bashing.. what a strong buy signal!!!!

The market keeps stable, seems like you won’t get the shares much cheaper again
  Forum: By Share Code

NewToCli
Posted on: Jan 31 2019, 09:06 AM


Group: Member
Posts: 528

Order book Doesn’t look too bad.. similar to the other days

Open at 22.00, 21.95 now .. while writing down to 21.81 and up to 21.98.. als always just a few shares move the price... no panic, fda will be the key
  Forum: By Share Code

NewToCli
Posted on: Jan 31 2019, 08:42 AM


Group: Member
Posts: 528

Autch!
  Forum: By Share Code

NewToCli
Posted on: Jan 18 2019, 04:56 PM


Group: Member
Posts: 528

From the patient community it is recommend to administer 6 implants. In some centers I Europe they already do it. I all implants are reimbursed, no matter if 4 or 6. The Centre in Düsseldorf is at it capacity limit and they always plan treatment for the whole year. The patients are on a waiting list and they call them to arrange the appointments, but not all patients can be treated yet due to capacity and bureaucracy
  Forum: By Share Code

NewToCli
Posted on: Jan 18 2019, 01:05 AM


Group: Member
Posts: 528

Even applied in some centers already, no issues with health insurance. Would be nice to see that the SC roll out in the US will be directly with 6 implants a year
  Forum: By Share Code

NewToCli
Posted on: Jan 15 2019, 09:19 PM


Group: Member
Posts: 528

... whole Hollywood will queue up at the centers to get implanted
  Forum: By Share Code

NewToCli
Posted on: Jan 15 2019, 09:00 PM


Group: Member
Posts: 528

Usually the doctors in the USA are allowed to apply any fda approved drug to patients for off label if they think it makes sense. Just then the health insurance might not cover costs.
No matter what the drugs label says, a physician can legally prescribe the drug for any reason.
  Forum: By Share Code

NewToCli
Posted on: Jan 15 2019, 06:44 PM


Group: Member
Posts: 528

I think 10-20% is way too underestimated. FDA approval should lead to a new (fair) evaluation of the potential of Scenesse including vitiligo and Label extensions. Combined with better PR I expect quite a good run up and spike up on the day of the fda approval. There is always uncertainty until the approval is official. It also depends on the conditions of the approval, eg patient registry vs off label potential. We are talking about a single product company. The approval is almost make or break. Also there are lots of USA Fonds that will only Invest with approval. There have been studies conducted analyzing pre fda stock behavior and they found out an average increase by around 30-40% until the day of approval (which mostly spikes up another 20-50%). Maybe better to have low expectations.. but the current fair value with fda apporval is somewhere around 60-70 AUD considering probability weighted future cash flow for mentioned indications .. not even talking about skin care or billions of revenues from Vitiligo. Time to get some fantasy into this stock!
  Forum: By Share Code

NewToCli
Posted on: Jan 15 2019, 07:36 AM


Group: Member
Posts: 528

Good luck to the shorters ... better get back in the game and join the up run to new highs. German market leading now. What about the asx200 listing? Is this a done deal or can illiquidity become an issue?
  Forum: By Share Code

NewToCli
Posted on: Jan 12 2019, 02:45 AM


Group: Member
Posts: 528

Better be careful, there is no reason why the price should bounce back now.. we are in a strong break out with next price target 32 aud. Positive news flow is awaited and broader market interest .. we are just up 15% since priority review news and have been even 10% higher, even though the company is much more derisked now..

Can’t see any ground for those retractions you are talking about
  Forum: By Share Code

NewToCli
Posted on: Jan 11 2019, 09:04 AM


Group: Member
Posts: 528

good opening with 21.50 !! 1 minute later high of 23 AUD !!! the market is hot !! down to 22.65
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

NewToCli
Posted on: Jan 11 2019, 03:40 AM


Group: Member
Posts: 528

Tonight I will post the order book real time for cuv @ asx. Let’s celebrate the opening together wink.gif
  Forum: By Share Code

NewToCli
Posted on: Jan 10 2019, 10:48 AM


Group: Member
Posts: 528

And back down to 20.20 aud.. thin market as usual, a few shares push the price 5-8% up m down.. time for nasdaq.. please PW do us this present
  Forum: By Share Code

NewToCli
Posted on: Jan 10 2019, 10:33 AM


Group: Member
Posts: 528

Market depth attached. The last high around 21.60 is being sold
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

NewToCli
Posted on: Jan 10 2019, 09:45 AM


Group: Member
Posts: 528

Anyone access to real-time stock price?
  Forum: By Share Code

NewToCli
Posted on: Jan 3 2019, 11:40 PM


Group: Member
Posts: 528

thx macgyver

Here we go with the chart... smile.gif


Attached thumbnail(s)
Attached Image



 
  Forum: By Share Code

NewToCli
Posted on: Jan 3 2019, 09:20 PM


Group: Member
Posts: 528

Chart formation looks very bullish for Clinuvel. After the spike to 24 AUD the price consolidated in typical triangle formation. Usually this is set to be a very bullish formation. The break-out starting.. whats the next trigger points?
- priority review
-...
- Skin care....

just from the chart formation, next price target is around 30-31 AUD. fingers crossed.

I wanted to upload the picture, but I get only error message here, upload failed, upload directory not available... but anyone can see in the chart
  Forum: By Share Code

NewToCli
Posted on: Dec 21 2018, 05:55 PM


Group: Member
Posts: 528

Palatin has received additional requests from the FDA. They need to generate additional clinical data if not even another clinical trial. They most likely will postpone that PDUFA date and in my view I would highly doubt if the FDA approves a drug that is active in CNS without a clear safety profile. Just look at the stock price.. The safety track record for SC will stand for itself..

Still a good chance for cuv to have the first melanocortine approved by the FDA
  Forum: By Share Code

NewToCli
Posted on: Dec 19 2018, 09:14 AM


Group: Member
Posts: 528

Vitiligo phase 2 results published!!

“The results of the CUV102 and CUV103 studies are the foundation for the combination therapy with afamelanotide in vitiligo and our Institute is ready to engage in the next steps of this exciting and promising clinical program in the United States.

Clearly, we are positioning ourselves at the forefront of vitiligo treatment and are developing a number of scientific tools to accompany the technological innovation we wish to introduce,

The results of the pooled analysis of all patients (n=18) who received SCENESSE® (systemic treatment) plus narrowband ultraviolet B therapy (NB-UVB) showed that the combination therapy was clinically effective in achieving repigmentation in patients with vitiligo,
  Forum: By Share Code

NewToCli
Posted on: Dec 7 2018, 03:22 AM


Group: Member
Posts: 528

Great find. Shortly before Scenesse approval from te EMA, the EMA initiated a program to involve patients to drug evaluation. Now the FDA starts a project to acknowledge real world data. Coincident, or is our PW shaping and modernizing the authorities behind the scenes to get his baby through the processes.. let's see what will happen in japan and australia next eat :D I can imagine he will even learn to speak japanese to negotiate with local insurances.
  Forum: By Share Code

NewToCli
Posted on: Dec 3 2018, 07:53 AM


Group: Member
Posts: 528

good catch... the results from mouse studies (university muenster Germany) using Scenesse for MS treatment are public since 2016 and show significant improvements .. it's frustrating to see all those potentials for a safe well tolerated medicine, but not progressing on it by a company with the IP and drug for it and with 40 million cash on bank doing nothing for it being paralyzed by a bureaucratic process... sometimes i wish for a take over by big pharma to bring the products and benefits to patients
  Forum: By Share Code

NewToCli
Posted on: Dec 1 2018, 10:15 PM


Group: Member
Posts: 528

true Iggy, the anti-inflammatory effect of SC might even be the bigger benefit for EPP patients than the tanning effect. still the current market evaluation of cuv isn't appropriate for its potential and coming profit increase from EU roll out
  Forum: By Share Code

NewToCli
Posted on: Nov 30 2018, 11:00 PM


Group: Member
Posts: 528

yes, trades with 5 to 25 shares turn down the price by 5%.. volumes low, no one again interested to buy in
  Forum: By Share Code

NewToCli
Posted on: Nov 29 2018, 07:12 PM


Group: Member
Posts: 528

i think it will be delayed until spring and then standard review with approval in 2020. i also think nothing will be shared on skin care not vitiligo results. why should they? no fda progress no further actions for vitiligo. i'm wondering when they start to make the cash on bank work for shareholders..
  Forum: By Share Code

NewToCli
Posted on: Nov 26 2018, 08:04 AM


Group: Member
Posts: 528

91% of approved drugs reimbursed in France, sounds promising
  Forum: By Share Code

NewToCli
Posted on: Nov 19 2018, 04:37 AM


Group: Member
Posts: 528

unfortunately not this year.. but anyone who is going would ask about any plans for further MS studies?
  Forum: By Share Code

NewToCli
Posted on: Nov 14 2018, 07:26 AM


Group: Member
Posts: 528

Palatin out of the race... while Clinuvel submitted safety data from real life patient protocols...
  Forum: By Share Code

NewToCli
Posted on: Nov 12 2018, 08:32 AM


Group: Member
Posts: 528

thanks - great post explaining the concerns about brema... from a regulatory point of view, SC should be the much clearer case for approval smile.gif
  Forum: By Share Code

NewToCli
Posted on: Nov 12 2018, 12:39 AM


Group: Member
Posts: 528

we will see about the outcome of the NDA. Amag as ptns partner has done many NDAs so for sure they know better how to do it than cub doing all by themselves without the experience. But let's see about the outcome. Brema.. is effective in the CNS and not sure if anyone understands the mechanism happening there. The FDA should have some concerns about that drug and it's mechanism. there is no real world data as with cuv.. savefty is far less understood than from afamelanotide.
  Forum: By Share Code

NewToCli
Posted on: Nov 8 2018, 11:43 PM


Group: Member
Posts: 528

https://www.prnewswire.com/news-releases/pa...-300746297.html

Shitty Palatin doesn't sleep
  Forum: By Share Code

NewToCli
Posted on: Nov 7 2018, 08:28 PM


Group: Member
Posts: 528

maybe 800-1000? seems there are more and more countries supplied and in the existing markets more patients will be treated
  Forum: By Share Code

NewToCli
Posted on: Nov 7 2018, 01:57 AM


Group: Member
Posts: 528

currently treated around 500-600 i would say ... feasable in europe should be 2000-2500, same in the usa..
  Forum: By Share Code

NewToCli
Posted on: Nov 6 2018, 07:05 AM


Group: Member
Posts: 528

Batman pattern discovered in cuv chart!
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

NewToCli
Posted on: Nov 1 2018, 08:58 AM


Group: Member
Posts: 528

has someone the opening price real time? would be interesting to see if the asx price matches the european close.. thx!
  Forum: By Share Code

NewToCli
Posted on: Oct 31 2018, 08:17 AM


Group: Member
Posts: 528

Amazing achievement!!! new profitability high of 73.5% margin on net cash flow.
  Forum: By Share Code

NewToCli
Posted on: Oct 18 2018, 11:01 PM


Group: Member
Posts: 528

and the authorities are the earth inhabitants who try to fight until the latest possibility to stop the invasion 🤣
  Forum: By Share Code

NewToCli
Posted on: Oct 18 2018, 06:31 PM


Group: Member
Posts: 528

Smart move from the FDA. Letting 2 months pass for the NDA validation to come up with additional request with an open timeline. Which keeps cuv on hold as long as they wish... Actually a smart strategy, if you want to keep new companies out of business as long as possible...
  Forum: By Share Code

NewToCli
Posted on: Oct 18 2018, 06:02 PM


Group: Member
Posts: 528

What will await us in 2019? Interesting to see how much aligned 2018 is with 2016 and 2014... October seems to be the strong month.
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

NewToCli
Posted on: Oct 17 2018, 05:48 AM


Group: Member
Posts: 528

what an amazing lecture!! and he mentions clinuvel at the beginning. what insights how effective msh could help with MS ... why is cuv not starting any studies in this field? everyone who joins the AGM please put it on the table and make a pressure to the mgmt team to make this potential transparent...
  Forum: By Share Code

NewToCli
Posted on: Oct 7 2018, 10:52 PM


Group: Member
Posts: 528

Let's welcome Blackrock as a new shareholder as of 30.09 with 57k shares! (source barrons)
  Forum: By Share Code

NewToCli
Posted on: Oct 1 2018, 06:28 PM


Group: Member
Posts: 528

First it was just a big burden for Cuv to establish the EPP centers. But now it becomes more and more clear what an immense competitive advantage this will be. The centers will become a Hub for any treatment of porphyria with scenesee. Starting from clinical trials to final treatment.. and guess what? all systems for pharmacovigilance are set up and all patient data is owned by cuv. A matter of time until warren buffet comes across this huge moat.
  Forum: By Share Code

NewToCli
Posted on: Sep 26 2018, 11:46 PM


Group: Member
Posts: 528

Welcome back & thx for sharing. I have come across that thesis already, it's a good read! smile.gif Many factors accelerating the SP now
  Forum: By Share Code

NewToCli
Posted on: Sep 26 2018, 10:35 PM


Group: Member
Posts: 528

reported patients means, that there are around 1300 patients registered across the EPP patient centres in Europe... meaning, those number is known by name and could be treated immediately, once either Scenesse is available in more countries or e.g. like in germany more centres are established... Just getting these numbers into treatment should more than tripple our profits... to get to 1 EPS shouldnt be a big issue for our beloved management team
  Forum: By Share Code

NewToCli
Posted on: Sep 25 2018, 04:31 PM


Group: Member
Posts: 528

the price per dose has been updated in that published article from Informa...
  Forum: By Share Code

NewToCli
Posted on: Sep 24 2018, 06:59 AM


Group: Member
Posts: 528

why you think it's strange?
  Forum: By Share Code

NewToCli
Posted on: Sep 24 2018, 06:39 AM


Group: Member
Posts: 528

it's amazing, a huge awareness building!
Yes they explain it quite well..

the dialogue is like this:
Better? yes thank you. We have analyzed your blood and.. you suffer from a disease called Ery... short EPP... please give her something for the pain. EPP is a rare genetic defect in the blood, it goes along with a painful strong light sensitivity which impacts the liver and can lead to gallstone. "Does it mean Alena is not able to face any light?". Unprotected not - yes. and it doesn't matter if it is sun light or artificial light. "Why never someone recognized that?" Not all patients have observable symptoms and maybe it wasn't sooo strong with you. "I was always careful with the sun - i dont understand.. at home in brazil the sun is much stronger isn't it?" well it's difficult to compare with here, the light is very different in Europe. "Maybe a sun screen could help?" Unfortunately not, they mostly only filter UV B. "Does my wife need to live in the dark now forever?" Until a few years ago it was really the case. But in the meantime fortunately there is a medicine - afamelanotide. It will be administered via an implantat that helps the body to build up a self protection. There is only one little problem. the health insurances might not cover it. "Then i will cover it for her, no matter how much it is"

end of scene
  Forum: By Share Code

NewToCli
Posted on: Sep 24 2018, 04:15 AM


Group: Member
Posts: 528

Guys, for everyone who understands German:

https://www.ardmediathek.de/tv/In-aller-Fre...mentId=56201404

This is a German TV Show "Junge Ärzte" (like a German version of Dr. House), running daily at 19.15h in one of the major german public programs. This Episode was on TV just last Thursday 20.09. -> watch from Minute 18:22. There is a patient diagnosed with EPP and she gets a treatment with "Afamelanotide" ... amazing job done from the EPP community to get EPP on a TV show to increase awareness!!!

  Forum: By Share Code

NewToCli
Posted on: Sep 23 2018, 07:40 AM


Group: Member
Posts: 528

So maybe JJ brings not only an award for cuv but also a take over bid wink.gif
  Forum: By Share Code

NewToCli
Posted on: Sep 22 2018, 09:56 PM


Group: Member
Posts: 528

totally support this idea! how would we do it?
  Forum: By Share Code

NewToCli
Posted on: Sep 22 2018, 07:01 PM


Group: Member
Posts: 528

wrote her too... a fatal mistake that should be corrected immediately
  Forum: By Share Code

NewToCli
Posted on: Sep 21 2018, 03:50 AM


Group: Member
Posts: 528

Anyone from here in Basel on 4.10 for the next conference with Cuv?
  Forum: By Share Code

NewToCli
Posted on: Sep 21 2018, 12:14 AM


Group: Member
Posts: 528

how likely would that be that the fda takes the nda and just approves a few weeks later or immediate?
  Forum: By Share Code

NewToCli
Posted on: Sep 10 2018, 10:41 PM


Group: Member
Posts: 528

it's tempting to take cash out but be patient... there is no logical reason now... the baby is just starting to draw attention..
  Forum: By Share Code

NewToCli
Posted on: Sep 10 2018, 08:57 PM


Group: Member
Posts: 528

The only thing you will regret about Clinuvel is, that you didn't buy more stocks ... lmaosmiley.gif
  Forum: By Share Code

NewToCli
Posted on: Sep 10 2018, 07:45 AM


Group: Member
Posts: 528

Does anyone know what is the senevth country that is selling Scenesse?

I got so far:
- NL, DE, CH, ITA, AT, ES

Spain has been mentioned in some half or full year report. in the current annual cuv mentioned a another country which has established access schemes with full reimbursement..
anyone an idea which one? or do we need to call all epp centers to ask which one turned online?
  Forum: By Share Code

NewToCli
Posted on: Sep 2 2018, 11:36 PM


Group: Member
Posts: 528

2021 .... or by end of 2018?
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

NewToCli
Posted on: Sep 2 2018, 07:11 PM


Group: Member
Posts: 528

amazing find! nasdaq listing is immanent! end game is starting! WB knew exactly why he missed out on an already 10 bagger and started investing just now... the game is on
  Forum: By Share Code

NewToCli
Posted on: Sep 2 2018, 07:07 PM


Group: Member
Posts: 528

i would disagree here. fda approval means rest of the world too and a real probability for vitiligo treatment and other indications. vitiligo is mostly not factored in neither is any epp sales in the US.. all those should be a real potential with fda approval approaching. that's why i think much of the potential is not factored in... just EPP values 1bn and look, not even that is in the SP.. fda progress and approval will put clinuvel on the spotlight of many many more investors and those can't ignore the potential anymore...
  Forum: By Share Code

NewToCli
Posted on: Aug 1 2018, 09:25 PM


Group: Member
Posts: 528

https://stockhead.com.au/health/us-roadbloc...velopments/amp/

One local biotech which has suffered at the hands of regulators in Europe and the US is Clinuvel (ASX:CUV) which has product for treating severe cases of skin pigmentation. Even though it has been approved for sale in Europe, the UK has refused to provide reimbursement. In the US, Clinuvel has been working with the FDA for more than a decade to gain access, and has only recently filed its formal application to gain access.
  Forum: By Share Code

NewToCli
Posted on: Jul 29 2018, 10:55 PM


Group: Member
Posts: 528

2020 would be a bad joke.

but as we see here, like always, after PWs newsletter there is more confusion than ever before.
  Forum: By Share Code

NewToCli
Posted on: Jul 28 2018, 02:08 AM


Group: Member
Posts: 528

to me the newsletter was 4 pages of text but saying nothing. just another confirmation that management is not able to keep timelines. Before they spoke about skin care product line, now it's a test pilot product which suddenly needs regulatory clearance.. and why is he mentioning fda can take up to 24 months? and who cares why they choose the implant formulation.. it's 4 years after approval... and ema in amsterdam should be a good thing, maybe mr billionaire can have a better lobby work then ...

what about further eu roll out? what about label extension? what about partnerships? etc
  Forum: By Share Code

NewToCli
Posted on: Jul 1 2018, 05:31 AM


Group: Member
Posts: 528

well... the market in europe for epp is 180-300mn aud alone.. and the drug is approved since 3.5 years now and rolled out since two years and the company is just able to materialize 10-15% of the market by now... that is also how you can look at it .. nothing very impressive here...
  Forum: By Share Code

NewToCli
Posted on: Jun 5 2018, 01:22 AM


Group: Member
Posts: 528

very sad yes... clinuvel can only surpass with priority review ... at least we have a solid drug for a serious condition smile.gif
  Forum: By Share Code

NewToCli
Posted on: Apr 21 2018, 01:48 AM


Group: Member
Posts: 528

end of year at least 12 eur. the arrows are the same just logarithmic scale
Attached thumbnail(s)
Attached Image



 
  Forum: By Share Code

NewToCli
Posted on: Apr 8 2018, 02:02 AM


Group: Member
Posts: 528

Iggy is back!!!!! :-D with last attempts to talk out some weak hands for the big guys last accumulation! it seems big things will happen soon smile.gif
  Forum: By Share Code

NewToCli
Posted on: Mar 19 2018, 10:47 PM


Group: Member
Posts: 528

come to switzerland my friend, it's tax free!
  Forum: By Share Code

NewToCli
Posted on: Dec 21 2017, 05:30 AM


Group: Member
Posts: 528

It's a crime, not a regulation!
  Forum: By Share Code

NewToCli
Posted on: Dec 2 2017, 02:50 AM


Group: Member
Posts: 528

Seriously, are you getting paranoid all of a sudden or what is happening? I hope you are selling off your shares with that assumptions.. I'm sure Lagoda are happy to take them
  Forum: By Share Code

NewToCli
Posted on: Dec 2 2017, 02:47 AM


Group: Member
Posts: 528

Why does VRX has no IP? What about the patents? they are in development of the topicals with anticipated launch late 2018 in Asia as in the AGM (assuming it's correct). They are building the future product pipeline for Clinuvel. Of course there is intrinsic value... with the idea of the IPO i guess Homm just wants to express that in case you would just valuate vrx itself you would come around 300-500mn, independent of its owner structure etc.
If they really bring out an effective topical it's huge... there are lots of biotechs with just some IP and product ideas valuated more...

The only critical point is that the management needs to deliver now, which as we know is always uncertain...
  Forum: By Share Code

NewToCli
Posted on: Nov 7 2017, 04:13 AM


Group: Member
Posts: 528

New high 6.25 eur = 9.45 aud in Germany ... Volume almost 150k shares!!!! Is there a take over coming???!
  Forum: By Share Code

NewToCli
Posted on: Nov 6 2017, 06:27 AM


Group: Member
Posts: 528

And? It was highly profitable to him... he also invested in night clubs... established jdate dating portal etc... when he smells business and profits he just does it!
  Forum: By Share Code

NewToCli
Posted on: Nov 2 2017, 09:35 PM


Group: Member
Posts: 528

You have to pay for it it's a monthly abo... he said Clinuvel is the most undervalued biotech ... but his predictions are a bit bullish in my view ...
  Forum: By Share Code

NewToCli
Posted on: Nov 2 2017, 02:52 AM


Group: Member
Posts: 528

85k shares traded !!!! Price up to 5.16eur
  Forum: By Share Code

NewToCli
Posted on: Nov 2 2017, 12:04 AM


Group: Member
Posts: 528

Germany is out of control once more!!! 67.4k volume pushing the buy side up to 5eur = 7.56 AUD !!!! It's time the asx follows!
  Forum: By Share Code

NewToCli
Posted on: Oct 30 2017, 09:07 AM


Group: Member
Posts: 528

Wow this is highly disappointed should it have been the best quarter?!?!
  Forum: By Share Code

NewToCli
Posted on: Oct 26 2017, 10:41 PM


Group: Member
Posts: 528

The only thing that that report shows is that they have absolutely no idea of the business of Clinuvel.
  Forum: By Share Code

NewToCli
Posted on: Oct 25 2017, 05:25 AM


Group: Member
Posts: 528

Wow german price up to 4.95e which is around 7.43 aud! Let's see if that will be matched tomorrow! Who is greedy enough to buy over 6% above value ????
  Forum: By Share Code

NewToCli
Posted on: Oct 25 2017, 03:12 AM


Group: Member
Posts: 528

Let's hope now he will pump it up to 20! With fda approval a billion market cap would be a fair thing for Pw and the Rockefellers
  Forum: By Share Code

NewToCli
Posted on: Oct 25 2017, 02:48 AM


Group: Member
Posts: 528

Homm and his followers getting positioned before he publishes his first newsletter next week... maybe he is already picking up shares for his investment fund
  Forum: By Share Code

NewToCli
Posted on: Oct 25 2017, 02:15 AM


Group: Member
Posts: 528

In Deutschland drehen schon wieder alle durch, 34k Volume, preis von 4.70 auf 4.90
  Forum: By Share Code

NewToCli
Posted on: Oct 9 2017, 10:09 PM


Group: Member
Posts: 528

Patterns like to repeat at the stock market. Lagoda knows it...

What will happen 2018? You all guess...

IT IS TIME FOR THE NEXT UPMOVE !!!
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

NewToCli
Posted on: Sep 28 2017, 10:08 PM


Group: Member
Posts: 528

Lagoda is still accumulating. They won't let the SP skyrocket as long as they are buying. They will not let someone get their shares. Maybe PW is doing them a favor in not Communicating until there pockets are fully loaded and Nasdaq listing is arranged.
  Forum: By Share Code

NewToCli
Posted on: Sep 11 2017, 05:06 AM


Group: Member
Posts: 528

Yes and that is what patients report in Germany ... almost a hole day in the hospital for the first treatment to get all the tests done and signed off
  Forum: By Share Code

NewToCli
Posted on: Sep 3 2017, 07:12 AM


Group: Member
Posts: 528

So the article scientifically proves that SC is a cost effective treatment. And it's EMA approved... and yet local authorities try everything to deny the benefits and the proposed price (e.g. Wales)... how can that be?
  Forum: By Share Code

NewToCli
Posted on: Aug 11 2017, 08:07 PM


Group: Member
Posts: 528

Dilution for what reason? To let some investors in cheap? For what? Pw wants to finance the company itself.. now 24mn on Bank increasing every months ..
  Forum: By Share Code

NewToCli
Posted on: Aug 11 2017, 07:23 PM


Group: Member
Posts: 528

Sorry I don't have more info at hand what happened back then with epitan and fda... would be worth to do some research
  Forum: By Share Code

NewToCli
Posted on: Aug 10 2017, 08:29 PM


Group: Member
Posts: 528

Hi Mr. Dax, Hallo Mr. Müller smile.gif Nice to have you onboard.

To your first point:
Before Clinuvel the company was "Epitan" and they left behind burnt earth with the FDA, trying to promote Scenesse as a tanning agent with lots of promotion. I assume, PW wants to keep quite until all regulatory things are cleared. He does not want to gain attraction to speculative investors (at the moment). At least we all hope, that this will change, once regulatory hurdles are cleared. Also he is now evaluating NASDAQ listing, which means more publicity to the company, and increased attention. I also guess the main two investors Lagoda (still accumulating) and Fidelity will push PW towards this. A real nasdaq listing with FDA approval would be a big jump for our little baby Clinuvel.

To your second point:
Mr. Homm kind of created Clinuvel, putting PW as CEO in place, renaming the company after the Epitan disaster and putting in some funds. Also he considers Clinuvel as his most ethical investment. He sees a huge potential. I'm convinced his interest in the company is real and not for pushing. He just wants to make aware of this value opportunity (which it is!). Not sure if he has not still stocks of the company, somewhere locked away in his Swiss accounts. Also he continuously supported Clinuvel in the background, e.g. when Skhreli put his bid on the table, Homm helped to create Vallaurix... (while he was in prison...).. I also trust him and his way of wanting to help the small investors.. he wants to help people... he understood his former life style didnt bring him much happiness.. nevertheless he always is a good self-marketing person wink.gif

All just my humble opinion... I hope that helps?!
  Forum: By Share Code

NewToCli
Posted on: Aug 7 2017, 11:08 PM


Group: Member
Posts: 528

Maybe they wanted to review the product and vial today in the meeting and Lachlan forgot to take it with him or he couldnt resist to inject himself? LOL :-D .... but also, how can a product be available there if its not approved?
  Forum: By Share Code

NewToCli
Posted on: Aug 7 2017, 11:06 PM


Group: Member
Posts: 528

Scenesse approved in Aserbaidschan
https://apa.az/xeber-az/sosial_xeberler/nad...lenib-5722.html

List of drugs for rare and specific diseases has been approved

The list of rare and specific haematics for growth has been confirmed. The Collegium of the Ministry of Health has made a decision on "Approval of the list of medicines intended for the treatment of illnesses requiring rare and specific treatment."
 
According to APA, 101 medicines were included in the list.... number 32: Scenesse
  Forum: By Share Code

NewToCli
Posted on: Aug 3 2017, 05:14 AM


Group: Member
Posts: 528

https://www.amazon.de/Erfolg-Crash-konkrete...rian+Homm+Crash

Only in German... 1000% within a few years
  Forum: By Share Code

NewToCli
Posted on: Aug 3 2017, 03:18 AM


Group: Member
Posts: 528

Mr Florian Homm published a new book, on his phrases about clinuvel he suggests a dramatic undervaluation of the core business and he estimates a potential of 1000% in the stock. Yes, 1000%!! He assumes fda approval and Nasdaq listing within 12 months.

I will leave here for a while. That's all to say, no value here... sometimes there is good content here, but I'm tired to read all this massive bullshit before...

Clinuvel has a massiv potential, it's under the radar currently. PW knows what he does and he will Bring up his baby when appropriate. Haters hate, plants continue their games.. others stay long and profit
  Forum: By Share Code

NewToCli
Posted on: Aug 2 2017, 07:56 PM


Group: Member
Posts: 528

US patients still travel to Zurich and send letters to the FDA. And why should anyone fire PW? Any solid arguments? Let me think... no ... so why do you talk about that here?
  Forum: By Share Code

NewToCli
Posted on: Aug 2 2017, 07:41 PM


Group: Member
Posts: 528

For me the only thing that counts is C-O-N-T-E-N-T and F-A-C-T-S, relevant facts. So why don't you share knowledgable and relevant facts here? Instead you are comparing apples with oranges and posting far irrelevant facts, trying to build a false opinion here... Scenesse targets at the moment an ultra orphan market, and not a mass oncology market..

Scenesse is far too expensive? Sure it is NOT, it is even well fairly priced, actually I guess its underpriced.

Why? -> look at these relevant facts:

http://info.evaluategroup.com/rs/607-YGS-3...ages/EPOD17.pdf --> page 9
--> Average cost per patient in the USA for an orphan drug: 140k USD / year (see screenshot)

For Germany:
https://www.ecker-ecker.de/pdf/Poster-Price...ugs20161018.pdf
-->
• 14 first reimbursement negotiations have been completed so far for Orphan Drugs outside oncology.
• Negotiated reimbursements range between 34,343 € and 497,874 €.
• Negotiated reimbursements are inverse to epidemiology, i.e. reimbursement per patient increases with the rarity of the disease. This is confirmed by a coefficient of determination
of R2 = 0.60.
- If you look at the graph you will see that prices for orphan drugs below even 1000 patients are well above 100k, mostly between 200-300k / year even....
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

NewToCli
Posted on: Aug 1 2017, 03:11 AM


Group: Member
Posts: 528

Seriously??????

What's this attitude against Pw suddenly? He achieved what not much would have been able to... we know nothing how he is running the company internally and motivating his team.. he has selected a super loyal team with people who are in for the long run and are super persistant against any hurdles coming... we have no idea if any other CEO would have come so far... I'm sure most would have marketed the company and jump off with a nice premium...

Study the book "good to great" by Jim Collins, and the characteristics of a level 5 manager... there are lots of analogies to PW imho.

Let's don't judge what we don't know about.
  Forum: By Share Code

NewToCli
Posted on: Jul 31 2017, 06:55 PM


Group: Member
Posts: 528

If this is not a success story, then what is??? Place it well, PW, and attract new investors with your equity story!

Could we hit the 20mn in Revenues in the Annual Report? I remember last year the annual report figures were also around 3mn higher compared to the sum of the receipts from the quarterlies
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

NewToCli
Posted on: Jul 28 2017, 04:49 AM


Group: Member
Posts: 528

Thx for sharing your experience, this is really interesting! smile.gif
  Forum: By Share Code

NewToCli
Posted on: Jul 28 2017, 03:28 AM


Group: Member
Posts: 528

Thanks! What is the purpose of a wash in the middle of the year of 250k eur? What wonders me is that the german market is totally illiquide and then these things happen with 20k shares in a single transaction... I can't imagine this happens spontaneous? Maybe it was an arranged trade? All the volume of 58k shares went through within 7 minutes at the same price level. The price has been brought down before with just a trade of 700 shares... I assume there is no one waiting to suddenly pick up a 20k Bock of unknown Ur9 shares. And the market maker would continuously drop the price ... mhhhhh
  Forum: By Share Code

NewToCli
Posted on: Jul 28 2017, 01:41 AM


Group: Member
Posts: 528

Another 5k dropped.... someone seems in panic ?!
  Forum: By Share Code

NewToCli
Posted on: Jul 28 2017, 12:50 AM


Group: Member
Posts: 528

Holy!!!! Someone just dropped 13.5k , 23k and 20k shares along only 3 trades in Germany! This is a very unusual pattern.. also it was transacted to the bid price, pushing the price down from 4.75 to 4.40 eur.... seems like someone selling off before numbers?!?!
  Forum: By Share Code

NewToCli
Posted on: Jul 27 2017, 10:03 PM


Group: Member
Posts: 528

I guess FIL and Lagoda are pushing cuv for these steps. Get on the Nasdaq, get where the money and volume is, get a strategy published, get diversified... then you have a great story to tell...
What you guys think?

Quarterly tomorrow or on Monday?
  Forum: By Share Code

NewToCli
Posted on: Jul 26 2017, 07:46 PM


Group: Member
Posts: 528

Obvisouly someone reported him and he got banned for a month ...
  Forum: By Share Code

NewToCli
Posted on: Jul 26 2017, 07:36 PM


Group: Member
Posts: 528

My dear friends, shareloooker has been banned. So don't ask for him after pushing him away
  Forum: By Share Code

NewToCli
Posted on: Jul 23 2017, 07:48 AM


Group: Member
Posts: 528

Yes agreement in Germany has been reached and all insurances have to pay...
  Forum: By Share Code

NewToCli
Posted on: Jul 23 2017, 07:46 AM


Group: Member
Posts: 528

If someone of you goes to the AGM, there is only one question i would ask:

Ther are around 1000 registered, therefore well known, patients in the core EU countries. You set a price of 18k eur per implant and a treatment circle of 4 implants per year. This together sums up to around 100mn AUd in revenues, why is this not showing up in your P&L after over 3 years of approval?!

  Forum: By Share Code

NewToCli
Posted on: Jul 20 2017, 01:46 AM


Group: Member
Posts: 528

Sharelooker wrote me a PM that he had a vision that tomorrow really(!!) is the day of the newsletter ... this is just FYI.... please don't Block me, I will not quote him again
  Forum: By Share Code

NewToCli
Posted on: Jul 19 2017, 07:34 PM


Group: Member
Posts: 528

It seems Sharelooker has been banned. I think this is overreacted... Whoever reported him, come on guys, he never blamed anyone like others do here... such a joke
  Forum: By Share Code

NewToCli
Posted on: Jul 19 2017, 05:15 PM


Group: Member
Posts: 528

Also depend it on market cap development / stock price targets ... or shareholder value if you like... it's time we profit from progress too, not only PW
  Forum: By Share Code

NewToCli
Posted on: Jul 18 2017, 07:14 AM


Group: Member
Posts: 528

I guess ASX webpage has some serious bugs not showing up the long posted recent all awaited newsletter stun.gif
  Forum: By Share Code

NewToCli
Posted on: Jul 17 2017, 10:35 PM


Group: Member
Posts: 528

Sounds like Shkreli is back on board and making some fun of us ....
  Forum: By Share Code

NewToCli
Posted on: Jul 17 2017, 09:42 PM


Group: Member
Posts: 528

Thx for reminding the community on my findings from last week wink.gif
  Forum: By Share Code

NewToCli
Posted on: Jul 16 2017, 02:25 AM


Group: Member
Posts: 528

Well if authorities and systems are not working properly and are not trying to understand patients disease and in the opposite trying to put companies with effective and save drugs out of the game a CEO should by all means create awareness of the BS going on in these processes... apart from that I agree to your points of no-newsletter
  Forum: By Share Code

NewToCli
Posted on: Jul 16 2017, 02:22 AM


Group: Member
Posts: 528

Sharelooker is one of the rare ones here who posts extreme valuable information and insights. He is very driven by solid content sharing.. and he is not getting involved in any blaming or bullshiting game like what has become the fundament of this board lately.... I'm sure he is not dumping shares for this hilarious price now... i guess just his patients and emotions got a bit out of control lately... but let's forgive him
  Forum: By Share Code

NewToCli
Posted on: Jul 14 2017, 07:45 PM


Group: Member
Posts: 528

Sharelooker, where is the newsletter? Did you eat it from the asx page? wink.gif we are waiting for it!!!
  Forum: By Share Code

NewToCli
Posted on: Jul 13 2017, 04:57 AM


Group: Member
Posts: 528

Clinuvel is still a risk for most institutionals because they only have one product and are not diversified. Once new new strategy is out and new products are in pipe this valuation will change! Also we finally need strong EPS and better quarterly profit growths! As long as revenues just cover costs no one understands the dramatic profitability of scenesse.

Take your seat on the rocket ! Starting soon!
  Forum: By Share Code

NewToCli
Posted on: Jul 12 2017, 06:53 AM


Group: Member
Posts: 528

I regularly screen the registry of the European patent office with the search term clinuvel ... so suddenly I saw this new brand registration... they also registered "Scynesse" some years ago together with scenesse ...
  Forum: By Share Code

NewToCli
Posted on: Jul 12 2017, 06:33 AM


Group: Member
Posts: 528

RC, you wanna have more shares? You can have mine, for 25 usd I would consider an off market trade.. :-D
  Forum: By Share Code

NewToCli
Posted on: Jul 12 2017, 06:28 AM


Group: Member
Posts: 528

Who knows, we will see what happens! I think they just put anything possible in the name rights to protect any application field for potential later use... but that they file for a name now means definitely that they make a progress with the topical!!!! Wow, if the market understands this correctly we should see new all time highs soon!!
  Forum: By Share Code

NewToCli
Posted on: Jul 12 2017, 04:37 AM


Group: Member
Posts: 528

To file for another market authorization they need to have a registered product name... maybe it's all steps being planned... to me it sounds that's how they want to all the topical formulation...
  Forum: By Share Code

NewToCli
Posted on: Jul 12 2017, 01:59 AM


Group: Member
Posts: 528

There is no announcement, but the fact of brand name registration can be seen in the european patent registry. So I guess from clinuvel viewpoint it is not shareholder relevant... I assume they will unveal everything in the strategy update or maybe annual report...
  Forum: By Share Code

NewToCli
Posted on: Jul 12 2017, 12:47 AM


Group: Member
Posts: 528

@Sharelooker: Can you hear the train coming? :-D
  Forum: By Share Code

NewToCli
Posted on: Jul 12 2017, 12:27 AM


Group: Member
Posts: 528

CLINUVEL HAS REGISTERED A NEW BRAND IN EUROPE !!! This is awesome news and adds dramatic intrinsic value to the company! Once there is the official Strategy update, the broad investor base will acknowledge the progress that has been made! Look at the application fields they have registered for!!!!

Brand name: Chivére
Application date: 07.02.2017
Day of registration: 02.06.2017

Classification:
Skin care preparations; cosmetic preparations for skin care; cosmetic preparations for skin care, based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide; cosmetic oils; skin creams (cosmetic); skin care creams (cosmetic), lotions (cosmetic) and oils (cosmetic); wrinkle removing skin care preparations; sunscreens, waterproof sunscreen; sunscreen preparations, sunscreen creams and lotions; cosmetics for protecting the skin from sunburn; sunblock; sun barriers (cosmetics); sun creams; cosmetic preparations for protecting the skin from the sun's rays; sun care lotions; compounds for skin care after exposure to the sun's rays; after-sun milks, creams, lotions and moisturizers; sun bronzers; sun-tanning preparations; cosmetics for tanning the skin including preparations for tanning without sunlight, all based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide; self-tanning preparations (cosmetic)

Details see here:
https://register.dpma.de/DPMAregister/marke...67&CURSOR=3

http://trademark.markify.com/trademarks/ct...%A9re/016323867
  Forum: By Share Code

NewToCli
Posted on: Jul 11 2017, 11:12 PM


Group: Member
Posts: 528

Scenesse has been successfully patented as a brand name in Europe for the treatment of Vitiligo! its coming!!!!!
  Forum: By Share Code

NewToCli
Posted on: Jul 11 2017, 07:39 PM


Group: Member
Posts: 528

Ok so if there is no news tomorrow you gonna call PW and ask for it, deal?wink.gif
  Forum: By Share Code

NewToCli
Posted on: Jul 10 2017, 10:59 PM


Group: Member
Posts: 528

Yes something is in the air... some investors preparing for the Big Bang... we will see much more countries online soon... Scandinavia, Scotland, Germany roll out expansion... and a lot of good news waiting.... the bomb has been filled, when will it explode?
  Forum: By Share Code

NewToCli
Posted on: Jul 9 2017, 07:24 PM


Group: Member
Posts: 528

3 weeks left to record sales and first profitable annual report! Last chance to pick cheap shares
  Forum: By Share Code

NewToCli
Posted on: Jun 27 2017, 03:46 PM


Group: Member
Posts: 528

For Swiss it's always an individual decision... I assume some will cover also 5 or more ... usually in Swiss the patient has to pay 10% of drugs himself
  Forum: By Share Code

NewToCli
Posted on: Jun 27 2017, 06:44 AM


Group: Member
Posts: 528

Sounds like Clinuvel is taking that costs? So we should deduct that from the income? Wtf ?
  Forum: By Share Code

NewToCli
Posted on: Jun 27 2017, 01:23 AM


Group: Member
Posts: 528

THE FIRST PROFITABLE FISCAL YEAR EVER IN CLINUVELS COMPANY HISTORY !!!!
  Forum: By Share Code

NewToCli
Posted on: Jun 27 2017, 01:10 AM


Group: Member
Posts: 528

from the article:

Sun protection on prescription

For patients with very sensitive skin, a uniform, loss-free and, above all, reliable protection of the entire body is of the greatest interest. Afamelanotide - an analogue of the alpha-melanocyte-stimulating hormone - was the focus of science in recent years. Phase II and III studies on lightning urticaria, vitiligo, erythropoietic protoporphyria, polymorphous light dermatosis (PLD) and the prevention of actinic keratosis in organ transplants have been concluded [11, 12]. Since 2012, Clinuvel AG has been selling the product under the name SCENESSE® (16 mg afamelanotide implant) in Baar for prophylactic treatment in patients with rare, genetically determined disease erythropoietic protoporphyria, which leads to an absolute light incompatibility of the skin of the affected patients. The product has the orphan drug status and is partly taken over by health insurance companies.

The conceptual advantages of systemic sun protection are undisputed. The use of afamelanotide is certainly a great advance for certain patient groups.
  Forum: By Share Code

NewToCli
Posted on: Jun 27 2017, 12:51 AM


Group: Member
Posts: 528

We will see... I dont believe in it. The german healthcare system is run by cost, not by helping people. they cut cost in any possible way... how should they extend? more centres? more doctors? both costs money and time for the involved stakeholders... I think no doctor in germany will be keen to help out, because its just more work, more administrative hurdles, more regulations... etc..
  Forum: By Share Code

NewToCli
Posted on: Jun 26 2017, 06:32 AM


Group: Member
Posts: 528

So, no other countries in 2018? wink.gif Austria is 15, 20.... Swiss is 65, 70..... Germany forget it ... 25, 30
  Forum: By Share Code

NewToCli
Posted on: Jun 22 2017, 08:57 PM


Group: Member
Posts: 528

Thanks for your thoughts, I agree! I assume the following: in Swiss Dr Minder is very committed to the patients and has got herself enough time to make the treatment part of her job. Same in Netherlands, they prepared well, they maybe hired a new doctor who s focus is EPP treatment.. in Germany the doctors are fully busy already and EPP is on top, with additional hurdles... while they want to help they just don't have enough time... why they don't get additional doctors? Because it costs something to the hospital and they are not willing to invest. Should cuv have anticipated that? I guess so! When they train and introduce the registry it should become clear to the centers how much efforts it would be so they could discuss their capacity with cuv... and define measures how to speed up.. or, they didn't understand the hurdles correctly and thought no prob we do it and then they find out how complicated it is... one example: to get treatment the patient has to do a skin screening first with a specialized dermatologist... and in one Centre there is only one person in the hospital.. she has only time one day a month to look st the patients.. so this is an obvious bottleneck... can't they go to another dermatologist before? I don't know...
  Forum: By Share Code

NewToCli
Posted on: Jun 22 2017, 05:44 PM


Group: Member
Posts: 528

I strongly assume Mr Bjildrops has been brought in for Europe distribution and I think he was key for a smooth and fast access in the Netherlands. Apart from that it's a valid question what he does for cuv ?! :-D
  Forum: By Share Code

NewToCli
Posted on: Jun 22 2017, 05:42 PM


Group: Member
Posts: 528

Sorry but that is just not true... the capacity is not a matter of the price of the drug... it's a matter of the hurdles the Ema out on the drug. The price for an ultra orphan is still in a normal rane
  Forum: By Share Code

NewToCli
Posted on: Jun 22 2017, 08:49 AM


Group: Member
Posts: 528

I think what it means is that they also want to have a phase 4 study and patient follow up...
  Forum: By Share Code

NewToCli
Posted on: Jun 21 2017, 10:52 PM


Group: Member
Posts: 528

certainly by end of year ---> could also be earlier isnt it... wink.gif lets be patient... the current SP decline indicates slow progress (again)...
  Forum: By Share Code

NewToCli
Posted on: Jun 21 2017, 10:51 PM


Group: Member
Posts: 528

well, yes.. but as mentioned, its a worst case estimate for the health insurers to calculate maximal costs... the number from patient organization in germany is around 400, and in UK around 300...
  Forum: By Share Code

NewToCli
Posted on: Jun 21 2017, 10:32 PM


Group: Member
Posts: 528

well I think the deadlines - as usual with cuv - are vague and not very fixed.. we will see when they finish the rolling submission. Regarding Germany centres I think it was somewhere in the change.org update for EPP patients... they are in close contact with german health politics and patient representative... he said he talked to the centres, and they are afraid of taking all the costs for the patient registry, while the health insurances do not reimburse that (only the medicine)... the centres are still overwhelmed by the additional requirements for the treatment.. (dear centres, go to Zurich or Rotterdam and watch them how they can treat 65-100 patients)... also the patient representative talked directly to cuv to find a way to establish more centres (cuv is saying they are trying there best)....

good luck to all...
  Forum: By Share Code

NewToCli
Posted on: Jun 21 2017, 08:44 PM


Group: Member
Posts: 528

Update on German EPP centres:
- 1 centre seems to have stopped treatment
- 1 centre is full for this year (ca. 20 patients max) -> building more capacity for next year
- 1 centre also only treating very little patients
  Forum: By Share Code

NewToCli
Posted on: Jun 21 2017, 08:41 PM


Group: Member
Posts: 528

full article of an interview with Mr. Hay.
- FDA NDA submission by end of first half of 2017 "maybe too aggressiv" -> more likely end of 2017
- Additional tracking of patients in the US -> most likely
- Other countries in EU: In talks with scandinavic countries
- Pediatric version for EPP: first trials in maybe 2-3 years

Attached File(s)
Attached File  Interview__Clinuvel.pdf ( 180.32K ) Number of downloads: 146

 
  Forum: By Share Code

NewToCli
Posted on: Jun 10 2017, 01:01 AM


Group: Member
Posts: 528

Thx, since long time a really valuable article describing finally the reality of the pricing (average in terms of orphans). Thx Dr Minder! Keep on fighting the ignorance and false understanding of SC
  Forum: By Share Code

NewToCli
Posted on: Jun 4 2017, 04:11 AM


Group: Member
Posts: 528

It's systematic in the german system. The centers in Germany are part of public hospitals. Public hospitals have very limited resources because there is no money for them. The docs are fully utilized already and additionally now the EPP patients come and ask for treatment, with all the requirements of skin scan etc.. which requires additional specialist doctors... so they say well we don't have time and capacity to treat you guys all at once...so in the end they treat 10 people or so per Centre...they are just not prepared for this! They are going to train new doctors for the administration but it takes time ... don't ask me why it obvisouly was not a problem in NL and CH...they welcomed the treatment and to help patients while Germany tried anything to end it... so far for the "german social system".

Maybe cuv should hire its own medical team and open own centers.. and ramp up the market immediately...shouldn't be such a big investment..put 4-5 docs there in 2-3 centers... i just hope this BS won't repeat in other countries that will come online soon..

There are over 200mn AUD on the streets in Europe for cuv to capture with EPP, it can't be that this takes ages to materialize while having the monopoly!!!
  Forum: By Share Code

NewToCli
Posted on: May 29 2017, 03:22 PM


Group: Member
Posts: 528

So what is your issue here again? 97% of patients can live a normal life they could not do before. 92% of patients are retained (see last newsletter). The german GKV agreed on the uniform pricing of ca 18k EUR per implant. With gkv there is no excuse for other countries not to pay or hold back. there is no excuse anymore for the centers not to treat patients (they are building up capacity). There are at least 2-3k treatable patients in Europe in the mid term.. that is around 18k x 3.5 x 2k = 126mn EUR Sales... with a margin of over 70%.

Please don't waste your time again here bringing quality posts down the pages with your Blabla.
  Forum: By Share Code

NewToCli
Posted on: May 10 2017, 09:23 PM


Group: Member
Posts: 528

The price tag is well in line for an ultra orphan with such patient population... usual prices are out to 100k per year... it is not the case that the price tag is way too high... and you are right, the hurdle is not over because EPP centers in Germany still cannot handle the patient run up...that is independent from pricing too... it's just a systemic fight against innovative scenesse ...with GKV now paying there cannot be any showstopper for other countries... PW will fight and win it! In 5 years who cares about Europe anyway, he will expand the US and take a foot in the door in Asia...
  Forum: By Share Code

NewToCli
Posted on: May 5 2017, 07:16 AM


Group: Member
Posts: 528

Maybe PW himself... he is a Dr and from Singapore smile.gif) maybe he checked by the Swiss Office in Zug and said hello to Ms Minder...
  Forum: By Share Code

NewToCli
Posted on: May 3 2017, 03:37 AM


Group: Member
Posts: 528

Well I hope not... because there's lots of poison approved in the US which you shall be glad is not on the market (or in the food) in Europe. But I agree, it it's approved in EU the FDA can directly follow wink.gif haha ...

Anyway, another year of patient waiting for something to happen.
  Forum: By Share Code

NewToCli
Posted on: May 3 2017, 01:39 AM


Group: Member
Posts: 528

No it's a different pathway... fast track vs accelerated approval vs breakthrough treatment.... so if decided for fast track... can't get accelerated then
  Forum: By Share Code

NewToCli
Posted on: May 3 2017, 01:37 AM


Group: Member
Posts: 528

I remember that NICE quoted a study on the prevalence of EPP in the U.K. Being a couple of thousand patients. Based on that prevalence they decided scenesse is not a specialized treatment but a standard treatment... I have to look it up, but the study they referenced seemed out of any number from statistical prevelance. I assume Clinuvel fought it many times and now the NICE acknowledged it's error in false assumptions...
  Forum: By Share Code

NewToCli
Posted on: May 3 2017, 01:08 AM


Group: Member
Posts: 528

Does anyone understand the FDA approval process in detail? What I understand with doing research is that the NDA will be files rolling until end of June 2017. Then the FDA has 60 days for feedback to accept the nda as final. Then via PDUFA process the clock will start for the approval process, which is 10 months for standard and 6 months for priority review. So, assuming this is the correct process approval would be due 10months after august 2017, which is June 2018... God beware I hope I'm wrong
  Forum: By Share Code

NewToCli
Posted on: May 2 2017, 01:34 AM


Group: Member
Posts: 528

All patients in Europe would be at least 2000 people and above. That's at least 140mn aud revenues and EPS of at least 2. That should trigger a valuation far beyond 10aud....
  Forum: By Share Code

NewToCli
Posted on: Apr 28 2017, 07:51 PM


Group: Member
Posts: 528

Very accurate thoughts. I assume they over-estimated the update in Germany. Even though they stated in the last AGM that Germany is "online", not much patients have been treated yet. Maybe they thought, well we set up 3-4-5 centres now so every day there should be patients flying in. But reality is, that centres only treat a couple of patients once a months and that physician capacity is just not available by now. I don't think PW travels around Europe and checks how the centres are doing... Also even though GKV has giving green light, patients need to bring confirmations that insurance is paying the costs.. I don't think that patients need to be more convinced of the treatment (marketing costs), or that many patients would stop the treatment. I think the root cause is still bureaucratic hurdles and lack of capacity from the centres (they promised a lot already one year ago, but not much happened). Patients demand the treatment, they cue up, but treatment is rare... and from the reaction of the SP we see that the market didn't expect much more...
  Forum: By Share Code

NewToCli
Posted on: Apr 19 2017, 11:39 PM


Group: Member
Posts: 528

For all newbies here:

1) Scenesse is the only approved drug for treating EPP - first in line, gold standard, nothing else works; neither cimetidine nor beta carotene (cime even can be dangourous); there is enough scientific proof you can find
2) Scenesse has a track record of over 10 years being save and effective
3) Scenesse is a life changer for EPP patients! It has enormous benefits and enables them to have a normal life they could never have without it! You can find dozens of patient reports all over and all report that first time in life they are normal!!!
4) Scenesse will be a Platform that can also treat many other skin related disease and has anti inflammatory benefits
5) Clinuvel is now in its fourth profitable quarter and will report its first ever profitable year, end of July

--> Decide for yourself on the potential of the drug and company!
--> Make your own research!
--> Don't get f** up here in this non fact based emotional discussions

That's all to say!
  Forum: By Share Code

NewToCli
Posted on: Apr 18 2017, 05:13 PM


Group: Member
Posts: 528

No worries my friend, Switzerland is paying the new price for most patients.. they need to, there is no alternative
  Forum: By Share Code

NewToCli
Posted on: Apr 15 2017, 02:05 AM


Group: Member
Posts: 528

Price action follows volume action! And what we see right now is volume action smile.gif accumulation still going on
  Forum: By Share Code

NewToCli
Posted on: Apr 15 2017, 01:36 AM


Group: Member
Posts: 528

Thanks for sharing!!! Wow, rarely seen such a poor report/analysis about cuv.... and that for a premium member access... shame on that Mr. M
  Forum: By Share Code

NewToCli
Posted on: Apr 14 2017, 10:03 PM


Group: Member
Posts: 528

It really seems very suspicious ... suddenly the volume ramps up dramatically in Germany and shortly after such article ... this could be a typical script playing out for pushing up own interest ...
  Forum: By Share Code

NewToCli
Posted on: Apr 14 2017, 09:59 PM


Group: Member
Posts: 528

Also in recession the patients will be treated and cash will flow in
  Forum: By Share Code

NewToCli
Posted on: Apr 14 2017, 06:07 AM


Group: Member
Posts: 528

Take it slowly with Germany... the centers still don't have much capacity and will only slowly ramp up! But the GKV decision should be an opener for the other countries now and give more confidence for FDA approval ...
  Forum: By Share Code

NewToCli
Posted on: Apr 11 2017, 01:27 AM


Group: Member
Posts: 528

may I ask why you assume 12-15k? Considering uniform pricing it should be around 18k like in Netherlands and Switzerland (20k CHF). Also, considering usual discount of 20-30% from original price (around 22k net, it is ca 27k incl. tax) it would level down to 18k... so the data points are more likely for 18k... arent they???
  Forum: By Share Code

NewToCli
Posted on: Apr 10 2017, 11:56 PM


Group: Member
Posts: 528

Last chance to buy cheap!! Proof of concept is done now, and cuv is a serious player in the Pharma industry!! PW is getting closer to his dreams of buying a soccer club
  Forum: By Share Code

NewToCli
Posted on: Apr 8 2017, 09:40 PM


Group: Member
Posts: 528

well, Germany cant afford more, they need to finance all the refugees... and in their reasoning.. what is EPP, just cover up
  Forum: By Share Code

NewToCli
Posted on: Apr 8 2017, 08:38 PM


Group: Member
Posts: 528

In theory but it will take more time as the centers are not capable of treating all the patients...they don't have the capacities and resources... and they are overwhelmed by the bureaucratic hurdles... better expect very slow uptake in Germany ... even though the patients are cuing up and can't live without SC anymore once they had it
  Forum: By Share Code

NewToCli
Posted on: Mar 31 2017, 05:21 AM


Group: Member
Posts: 528

5-7mn revenues .... not much increse awaited ... don't think 2-3 fold... why? Because not much more happened in the roll out ... that winter sales is lower is well known and well observed in last report... we can only hope for a good ramp up in next quarter and summer quarter .. adding some more countries
  Forum: By Share Code

NewToCli
Posted on: Mar 29 2017, 03:05 PM


Group: Member
Posts: 528

One side note my friend - nothing has ever been obvious with cuv ... even we many times thought so :-D
  Forum: By Share Code

NewToCli
Posted on: Mar 29 2017, 06:52 AM


Group: Member
Posts: 528

It's just a pain to see the potential and all patients waiting for it... it's all there but the health system and bureaucracy is holding it away from patients.. a save and life changing drugs for a minimal patient population... it's a joke of 20th Century ...

Let's see what happens this summer
  Forum: By Share Code

NewToCli
Posted on: Mar 29 2017, 06:25 AM


Group: Member
Posts: 528

Germany didn't move much so don't consider so much there.. where as NL is fully running... my estimate:
- Germany 20-30
- Swiss: 50
- NL: 80-120 (around 200 patients total, but I read several times that around 80 in treatment c urrently)
- Italy: 50-60 I guess (no transparency here where they stand w the insurances)
- Austria: no idea.. but max 25 patients as far as I know and also insurance issues

So what is it in total: 200-280 ... which shall be around 5-7mn AUD... might be a new record quarter but slow uptake...
  Forum: By Share Code

NewToCli
Posted on: Mar 29 2017, 05:05 AM


Group: Member
Posts: 528

Far away from real numbers
  Forum: By Share Code

NewToCli
Posted on: Mar 19 2017, 11:17 PM


Group: Member
Posts: 528

Can you find anywhere on the agenda that cuv giving a presentation? I can only find an 30min update from the Dr from Netherlands Centre.
"12h00 – 12h30 PL9 : Janneke LANGENDONK (Netherlands) : Afamelanotide (Scenesse, CLINUVEL) for the treatment of protoporphyria-induced phototoxicity, where are we ?"

There are also other presentations for alternative therapies and e.g. how Crispr gen modification could help EPP patients in the future..
  Forum: By Share Code

NewToCli
Posted on: Mar 18 2017, 01:04 AM


Group: Member
Posts: 528

It seems we need to shake out more weak hands before the big guys steam up the stock price towards the next record quarter and fda decision...
  Forum: By Share Code

NewToCli
Posted on: Mar 18 2017, 12:50 AM


Group: Member
Posts: 528

Next week the final sell off will start
  Forum: By Share Code

NewToCli
Posted on: Mar 16 2017, 04:40 AM


Group: Member
Posts: 528

I was trying to bring in some content again in this once valueable forum, but it's swamped over by the BS bingo here... so I will stop again..
  Forum: By Share Code

NewToCli
Posted on: Mar 15 2017, 09:56 PM


Group: Member
Posts: 528

Some assumptions, what you guys think:

In 2020:
- Peak Sales of 250mn USD for EPP (3-4K patients)
- EPS of 4 alone from EPP
- Fair value >30 USD / share for EPP
- Vitiligo on track
- Multiple additional indications on the way
- First glimpse of effectiveness in Neuro-disease

So don't let yourself draw in negativity and sell too cheap
  Forum: By Share Code

NewToCli
Posted on: Mar 14 2017, 07:18 PM


Group: Member
Posts: 528

Good arguments and mostly agree... but you need to know that it's not in PWs power what the german insurance union will be ready to pay. If they dislike his price they can say well we pay 10k that's it.If they neglect his price his only chance is to withdraw scenesse from the german market to keep uniform pricing...

Edit:
And the guideline for the german insurance union is not the well of the patient but an economic benefit/cost case..
  Forum: By Share Code

NewToCli
Posted on: Mar 14 2017, 08:06 AM


Group: Member
Posts: 528

Often Germany is seen for reference price within EU.. so it's just an assumption with France.. if Germany confirms the price then PW has much better negotiation power in other EU countries. And the authorities didn't set anything yet, PW set a price, the formal local approval process has been done by mid august last year. Now the union of the insurance companies evaluate the price and agree or disagree (this takes 6-9 months). If they disagree, PW can argue with them and they find a middle way.. (and Pw can think about how to handle it) as there has not yet been any official confirmation from the insurer union (GKV) I assume they still in the process.. that's why the patients don't get treated because the centers await the final confirmation from the insurance union.. otherwise the insurance could claim back costs from the centers... I really hope once that is done it will accelerate other countries... or as you say we will have a long snooze again...
  Forum: By Share Code

NewToCli
Posted on: Mar 14 2017, 02:13 AM


Group: Member
Posts: 528

French is just waiting for Germany. Once Germany is all set, it acts as a role model for the other countries.. so usually things will move faster then.. wait and see
  Forum: By Share Code

NewToCli
Posted on: Mar 10 2017, 09:55 PM


Group: Member
Posts: 528

Does it matter if cuv would be asx300? Where do you think the more patients are coming from? Apart from Netherlands and usual base in Swiss nothing will be added this quarter... neither Germany nor Austria are reimbursing yet consistently nor do they have capacity in the centers... let's see in 2018... the SP reflects reality I guess.. it's just that we lost track of how reality looks with this company
  Forum: By Share Code

NewToCli
Posted on: Mar 10 2017, 04:52 AM


Group: Member
Posts: 528

If if if ... fda and vitiligo program, give it some speculation and you can hit the sell button for >30usd/ share
  Forum: By Share Code

NewToCli
Posted on: Mar 10 2017, 04:14 AM


Group: Member
Posts: 528

We have seen from EMA approval that just having the approval is not worth much ...
  Forum: By Share Code

NewToCli
Posted on: Mar 9 2017, 10:10 PM


Group: Member
Posts: 528

Germany has lots of issues and is far from running fully ... in other neighbour countries not even the processes have been started.. the SP is exactly there where it is supposed to be... the market is smarter than we all think
  Forum: By Share Code

NewToCli
Posted on: Feb 28 2017, 02:34 AM


Group: Member
Posts: 528

You can change health insurance company every year in Switzerland.... so if some still refuse to pay even after the new law is effective after mach 1, I would assume that all patients will shift to a different insurance company latest end of this year. So Swiss will be fully running soon.
  Forum: By Share Code

NewToCli
Posted on: Feb 21 2017, 01:54 AM


Group: Member
Posts: 528

No big insights, I just think he knows very well all the rugalations and markets and that's why he approaches uniform pricing across the countries. If he would have applied for Swiss approval the swissmed would have had some negotiation power, with this constellation they don't and he can ask the price (which is still not that high for an ultra orphan)... and he knows patients demand the drug so he patiently just lets things unfold .. anyway, we will see if he will also one day start communicating more
  Forum: By Share Code

NewToCli
Posted on: Feb 21 2017, 01:32 AM


Group: Member
Posts: 528

PW knows exactly what he is doing with the pricing and reimbursement negiotiations and why he did not apply for Swiss approval.. he is a long term thinker with all the persistence needed to keep his curse! He is a genius manager
  Forum: By Share Code

NewToCli
Posted on: Feb 15 2017, 01:55 AM


Group: Member
Posts: 528

Tell me a moment when cuv was ever fairly valued since approval?
  Forum: By Share Code

NewToCli
Posted on: Feb 14 2017, 03:44 AM


Group: Member
Posts: 528

Also totally disagree! The price is well set for an ultra orphan drug with that small patient population.. 100k/year is a well medium price point... there are enough papers out there with data.. a lower price wouldn't lower the buerocratic BS. Patients demand it, patients will get, insurances will pay..
  Forum: By Share Code

NewToCli
Posted on: Feb 12 2017, 10:22 AM


Group: Member
Posts: 528

thx for sharing RC,
Nothing new here: "Insufficient Evidence of Cimetidine Benefit in Protoporphyria"
  Forum: By Share Code

NewToCli
Posted on: Feb 12 2017, 04:14 AM


Group: Member
Posts: 528

From this article: there are only three centers in Germany and they can each only treat 2 patients a week... 2 patients a week!!! What is wrong in Germany??
  Forum: By Share Code

NewToCli
Posted on: Feb 11 2017, 08:50 PM


Group: Member
Posts: 528

It's still the same stock and cuv is the main market, no matter what.. neither ur9 nor clvly is leading, they are both just mirroring cuv and the respective spread
  Forum: By Share Code

NewToCli
Posted on: Feb 3 2017, 02:52 AM


Group: Member
Posts: 528

So what is the market waiting for? Stock markets are trading the future... and all you list is what is already known now...is there so much doubt about cuv? Is the market just not seeing the company? Are there maybe other things blocking us we don't know about?
  Forum: By Share Code

NewToCli
Posted on: Feb 2 2017, 11:55 PM


Group: Member
Posts: 528

I totally agree.. what Cuv is building up is a very closed system which would not be easy to enter for any competitor... they have the technology, the IP, the data(!!!), the network..
  Forum: By Share Code

NewToCli
Posted on: Feb 2 2017, 09:40 PM


Group: Member
Posts: 528

just the question if we are still alive then.. :-D
  Forum: By Share Code

NewToCli
Posted on: Jan 31 2017, 08:31 AM


Group: Member
Posts: 528

Compared to last winter quarter +900% increase in receipts !!!!
  Forum: By Share Code

3 Pages (Click to Jump) V   1 2 3 >

Cant find what you are looking for? Show all active topics from the last 3 months


New Posts  New Replies
No New Posts  No New Replies
Hot topic  Hot Topic (New)
No new  Hot Topic (No New)



TERMS OF USE  -  CONTACT ADMIN  -  ADVERTISING