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mrdax
Posted on: Jun 30 2020, 01:41 AM


Group: Member
Posts: 277

Some new employees on board with CUV

https://www.linkedin.com/in/aidan-mcevoy-84759634/
Mobile App Developer (Flutter) at CLINUVEL PHARMACEUTICALS LTD
June 2020 onwards

Mobile App Dev??? Flutter is a framework for mobile apps... maybe some sort of registration app or experience sharing within patient groups?!

https://www.linkedin.com/in/corissa-yee/
Financial Specialist
June 2020 onwards
In Palo Alto


https://www.linkedin.com/in/lauren-herbert-966633181/
Communications Associate at Clinuvel (UK) Limited
I think she was already in the team and also already mentioned.
But since May a new role.
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mrdax
Posted on: Jun 28 2020, 10:29 AM


Group: Member
Posts: 277

Interesting viewpoint.

QUOTE
No interest in being involved with protest shareholders, sp manipulators, shorters or anybody that slanders the CEO and company that I have invested in

So do you think it's better to stay in a heavily censored space/forum? if so, what do you think is the benefit? and why is it a protest or sp manipulation if we want to exchange information about "our" company freely?

furthermore...
as macgyver also pointed out:
Why exactly do you come here in the first place, if it's not influencing your decisions or your investment?
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mrdax
Posted on: Jun 9 2020, 04:03 PM


Group: Member
Posts: 277

Aint gotta have humour. Gotta sell.
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mrdax
Posted on: May 31 2020, 11:06 PM


Group: Member
Posts: 277

Try imgur.com.
Easy and convenient.
Upload a picture/screenshot, when done, hover over the image, click on the 3 dots on the top right hand side corner of the picture and click on the sharing options.

From there you'll directly find the bbcode to post here.
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mrdax
Posted on: May 27 2020, 07:41 AM


Group: Member
Posts: 277

If I recall correctly, tomorrow is the day of the HAS decision.
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mrdax
Posted on: May 21 2020, 05:38 PM


Group: Member
Posts: 277

Not seen it being posted before, just some inspiration.



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mrdax
Posted on: May 14 2020, 08:07 AM


Group: Member
Posts: 277

QUOTE
Corona week 11

In all clinics the treatment is continued! AND: in a conversation with

Dr. Karsten Weller from the Charité informed Elke from the board of directors that there are more treatment places available in Berlin - so get in touch if you are not yet being treated!


http://www.epp-deutschland.de/
Updated yesterday
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mrdax
Posted on: May 7 2020, 02:37 AM


Group: Member
Posts: 277

Chinese subtitles.
Awesome.
China market-entry.... keep moving forward wub.gif
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mrdax
Posted on: May 6 2020, 10:27 PM


Group: Member
Posts: 277

Not sure whether this was already posted in the past, can't remember right now:https://link.springer.com/content/pdf/10.1007/s40271-019-00399-2.pdf
"The Patient Perspective: A Matter of Minute" from Rocco Falchetto
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mrdax
Posted on: May 5 2020, 12:39 AM


Group: Member
Posts: 277

Do you have a list of hospitals in Italy which have approved the supply of Scenesse?
I mean, 390k€ only yields ~30 implants, which isn't much, but at least it adds up.
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mrdax
Posted on: May 2 2020, 10:24 PM


Group: Member
Posts: 277

Three posts about vitiligo on their Facebook page in the last few hours king.gif
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mrdax
Posted on: Apr 24 2020, 05:52 AM


Group: Member
Posts: 277

http://www.epp.care/
At least they have some sort of hospital / centres where the knowledge would be available:
Ireland
Spain
Finland
Norway (rejected it, right?)
Sweden
Belgium

Do we have information w.r.t reimbursement on these countries?
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mrdax
Posted on: Apr 24 2020, 04:26 AM


Group: Member
Posts: 277

QUOTE
Clinuvel is to make its phototoxicity product Scenesse (afamelanotide) available to patients in China under a named-patient program while it prepares a formal marketing approval dossier for submission to the regulator.

Scenesse, which treats the rare genetic metabolic disorder, erythropoietic protoporphyria (EPP), will be distributed by Clinuvel and the local pharmaceutical firm, Winhealth Pharma Group, under an exclusive collaboration agreement.

Clinuvel, which is headquartered in Melbourne, Australia, estimates that about 5,000 people in China have EPP, based on a prevalence of 1:75,000 to 1:211,000, and says that no therapy is yet approved there for the condition.

EPP causes incapacitating burns and internal damage to vessels whenever patients are exposed to visible light, particularly sunlight. “Patients are forced to live indoors, deprived from birth onwards of social contacts and a normal life,” the company said. It noted that afamelanotide acts as an anti-oxidative, strengthens blood vessels and reduces swelling, protecting patients against any light source and ultraviolet radiation.

Under the named-patient program, Clinuvel and Winhealth Pharma will distribute Scenesse to selected large Chinese medical centers and hospitals, and will also provide training and accreditation for medical staff in providing long-term care to patients. “Local subsidies are available to enable eligible EPP patients to receive treatment,” the company noted.

Clinical data on Scenesse generated in the US and the EU, as well as from the Chinese named-patient program, “will be filed to the National Medical Product Administration to obtain full registration of Scenesse,” it added. Scenesse was approved for marketing in the EU in 2014 and the US in 2019. (Also see "Clinuvel Completes Arduous Journey To US Approval Of Scenesse" - Scrip, 9 Oct, 2019.)

Clinuvel will remain responsible for the pharmacovigilance and safety monitoring of the product while Winhealth will be responsible for the selection and management of Chinese hospitals and health care professionals. The commercial terms of the collaboration have not been disclosed.

“In Winhealth Pharma we believe we have identified a trustworthy counterpart who will work towards the same goals as Clinuvel’s team,” said Lachlan Hay, the Australian firm’s director of global operations. “The long-term thinking of Winhealth’s management fits well within our horizon.”

The move is also seen as part of Cinuvel’s strategy to penetrate the Chinese and wider Asian marketplace. In February, it announced an investment in the further expansion of its R&D facilities in Singapore, including new state-of-the-art labs.

“With the expansion of our R&D facilities in Singapore, we progressively became focussed on China as part of our long-term entry to Asia,” Hay said. The period following the approval of Scenesse in the EU and the US was identified as “the optimum moment to enter China and start facilitating the first ever treatment for Chinese EPP patients,” he noted. Clinuvel is now establishing an office in Shanghai to coordinate its activities in the region, he added.


Elsewhere In The World

To date, more than a dozen European countries have made Scenesse available as standard of care to EPP patients, including Germany and the Netherlands, Hay said.

However, the company has hit problems with NICE, the health technology assessment body for England, which has so far not recommended the product’s use on the National Health Service. (Also see "UK Appeal Panel Tells NICE To Revisit Scenesse Rejection" - Pink Sheet, 12 Oct, 2018.) “We attended a meeting of NICE’s HST [highly specialized technologies] Committee on 14 March 2019 following the appeal hearing of 30 July 2018,” Hay told the Pink Sheet. “No further details have been published by NICE following the 2019 Committee meeting.”

In Scotland, where the drug is under assessment by the Scottish Medicines Consortium, Clinuvel is currently “engaging with the relevant stakeholders”, Hay said, adding that “it is expected that Scenesse fits the criteria for ultra-orphan disorders.”

An approval dossier for Scenesse is pending with the Australian regulator, the Therapeutic Goods Administration, “with an expected response in Q4,” Hay said. “Other submissions are planned for countries with recognised EPP patient populations (such as Japan).”
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mrdax
Posted on: Apr 23 2020, 06:15 PM


Group: Member
Posts: 277

Not sure whether it was posted before, I don't think so.
As was suspected already before... not so good news from the german epp-community:
http://www.epp-deutschland.de/index.html

QUOTE
First effects of the pandemic on the treatment of EPP patients!

We feared it, but hoped that we would not have to report such a story, but now it has happened - the effects of the current situation have hit Corinna, who is classified as a risk patient and is not being treated!

It is unimaginable to be forced back into the dark after years of treatment, during which a reasonably "normal" life was possible, and to have to fear unspeakable pain again!


->
http://www.epp-deutschland.de/mediapool/21..._Behandlung.pdf
(PDF document created in the evening of 21 of Apr, so pretty new)

QUOTE
Corona prevents treatment
Actually, I would almost be in Berlin to get my second Scenesse implant today at the Charité. Actually. But in fact I am at home and I am afraid (again) of every next fine weather day. The next pain, if I don't pay enough attention and get too much sunlight.
This is also a Covid-19 related situation.
I had heart problems seven years ago and was therefore classified by the doctors of the Charité as a risk patient worthy of protection. Thanks to the special conditions of admission of Scenesse, only the treatment centres in Berlin, Chemnitz, Düsseldorf and Mainz are allowed to carry out the treatment here in Germany. Simply send the prescription here and have my family doctor place the implant.
I am therefore "worthy of protection" - and therefore lose my protection from the light of the sun indefinitely


At least the Patient representative of NRW, Claudia Middendorf, has already written a statement:
QUOTE
"People with disabilities must not be discriminated against or treated unequally even in this situation. In particular, they must under no circumstances be deprived of health services or denied access to health care".


Whether it helps or not remains to be seen.
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mrdax
Posted on: Apr 23 2020, 06:08 PM


Group: Member
Posts: 277

Thanks for the link.
Small tipp for everybody not willing to signup:

If you watch the video in fullscreen, it will stop at 15sec. If you just click play in the middle of the videoframe without exiting fullscreen mode, you can watch it till the end without registering.
Just if you close the fullscreen, it says you need to register. graduated.gif
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mrdax
Posted on: Apr 22 2020, 10:32 PM


Group: Member
Posts: 277

Probably because no one ever got a response from Cuvs IR team weirdsmiley.gif
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mrdax
Posted on: Apr 22 2020, 07:45 PM


Group: Member
Posts: 277

QUOTE
There are currently 150 drugs out there right now trying to solve the COVID-19 problem ... obviously being fast-tracked for clinical trials so that hopefully in 6 months they might have something. WE HAVE SOMETHING RIGHT NOW!!!!


I suppose many of those are already approved drugs? Meaning: if they'd need to undergo clinical trials causing months of delay, wouldn't the same apply to Scenesse? that's why I don't quite understand " WE HAVE SOMETHING RIGHT NOW!!!!".

Thanks
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mrdax
Posted on: Apr 21 2020, 11:03 PM


Group: Member
Posts: 277

I always thought you'd be using Google Translate to do so graduated.gif If not, how happens you translate all those other websites *scratching my hea*.
Using Google Translation, I found this page:

http://www.urpl.gov.pl/pl/produkty-lecznic...B3w-leczniczych
where it says:
QUOTE
The Register of Medicinal Products Authorized for Marketing on the territory of the Republic of Poland is kept by the President of the Office pursuant to art. 28 of the Pharmaceutical Law.
The following are entered in the Register:
* medicinal products authorized by the President of the Office in national (NAR), mutual recognition (MRP) and decentralized (DCP) procedures;
* medicinal products authorized by the European Commission under the centralized procedure (CEN);
* medicinal products authorized for parallel import (IR).

--> LINK --> Register of Medicinal Products


If you click the link you'll see again:

QUOTE
Register of Medicinal Products
- Medicinal products entered in the Register of Medicinal Products Authorized for Marketing on the territory of the Republic of Poland.
- Medicinal products entered in the Community Register of Medicinal Products


Entering Scenesse in the name field yields this page:
http://pub.rejestrymedyczne.csioz.gov.pl/P...y.aspx?id=33476





======================
Also listed in this PDF:

Title says:
"LIST OF MARKETING MEDICINAL PRODUCTS ON THE BASIS OF AUTHORIZATIONS ISSUED BY THE COUNCIL OF THE EUROPEAN UNION OR THE EUROPEAN COMMISSION"
http://bip.urpl.gov.pl/sites/default/files...acznik_nr_2.pdf

But not sure what it _really_ means.
Found another PDF from 2016 (filename says 2016 and also in the PDF meta-information itself), where it's also listed:
http://bip.urpl.gov.pl/sites/default/files...acznik_nr_2.pdf

So doesnt seem to be a very new update.
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mrdax
Posted on: Mar 26 2020, 10:18 PM


Group: Member
Posts: 277

Let us hope that no further political measures will make travel to the clinics difficult or impossible, or force clinics to second the capacities of medical staff to help corona patients who have fallen ill in the crisis situation. This is the current state of affairs in Zurich at the Triemli Hospital, which does not currently treat EPP patients. To make it quite clear: this pandemic is an extreme situation and human lives come first.
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mrdax
Posted on: Mar 5 2020, 12:56 AM


Group: Member
Posts: 277

What a bummer.

Cuv once wrote in a newsletter to keep most information shut behind a door to avoid leaking sensitive information to competitors bla.

We have a valid competitor, and it's not just since yesterday, and Cuv leaves all its shareholders in the dark. Please start leaking some information to us. We are legit owners of this company


Purely incredible management. Not in a positive sense.
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mrdax
Posted on: Feb 21 2020, 01:37 AM


Group: Member
Posts: 277

Lately, CUV is posting about some rare skin diseases...
Have those been seen before on the CUV and/or FB page?

Actinic Prurigo (AP)
https://www.clinuvel.com/photomedicine/scie...actinic-prurigo

Urticaria Pigmentosa (UP)
https://www.clinuvel.com/photomedicine/scie...a-pigmentosa-up

And lastly, Hydroa vacciniforme (HV), this post on FB:
QUOTE
"Hydroa vacciniforme (HV) is a rare, chronic photosensitivity disorder commonly occurring in children. The disease is characterised by the eruption of inflamed bumps and fluid-filled blisters (vesicles) on the skin following exposure to sunlight. Commonly presenting on the face, ears and hands, these vesicles heal over time as pox-like or “vacciniform” scars. Ultraviolet A (UVA) radiation (320-400nm) is the main wavelength of light which has been demonstrated to induce symptoms."

https://www.facebook.com/clinuvel/photos/a....57553541136311/
Which, unprofessional as they are, links to https://zcu.io/7OzC which basically is a dead link (at least for me).


Are those listings just for the sake of completeness to build awareness of rare skin diseases...?
Or is any of those a future target for the "photoprotective company"
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mrdax
Posted on: Feb 16 2020, 11:28 PM


Group: Member
Posts: 277

Interesting that a Mr Langsam, which translates to "slow" in German, speaks about PW 🤷🤣
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mrdax
Posted on: Feb 1 2020, 08:18 AM


Group: Member
Posts: 277

deepl.com has a pretty perfect translation algorithm ;-)
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mrdax
Posted on: Dec 20 2019, 01:53 AM


Group: Member
Posts: 277

Cuv quite active on FB as well.

About vitiligo and also about XP.

https://www.facebook.com/clinuvel/photos/a....57361372171311/

https://www.facebook.com/clinuvel/photos/a....57367103381311/

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mrdax
Posted on: Dec 10 2019, 08:10 PM


Group: Member
Posts: 277

Check the answer to the question @ 8:55
https://www.youtube.com/watch?v=39O8oxM1Cn8#t=8m54s
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mrdax
Posted on: Nov 26 2019, 08:14 PM


Group: Member
Posts: 277

Certainly not out of nowhere.It was mentioned already at least 1.5 years ago, somewhen in Mai or June 2018.
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mrdax
Posted on: Nov 20 2019, 09:32 PM


Group: Member
Posts: 277

Are you PW btw? weirdsmiley.gif
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mrdax
Posted on: Oct 18 2019, 06:21 PM


Group: Member
Posts: 277

Actually, it's even better (or worse, however you wanna call it):I guess even the shareholders with 10k-100k shares are kinda "locked up", which make up another 10% of the company.
So -> Nearly 93% are locked up. 7% of shares "freely" available for trading.No wonder we have such volatile days.
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mrdax
Posted on: Oct 18 2019, 04:37 PM


Group: Member
Posts: 277

Quite interesting to see the shareholder distribution this year.
2019 --> https://pasteboard.co/ICv6wAq.png
2018 --> https://pasteboard.co/IBt3Sku.jpg
Within the big players, it's 3 less then last year, but still the number of shares increased.
The biggest increase of nearly 50% (~1000 shareholders) is, as expected, in the category between 1-1000 shares.The other categories stayed quite the same.
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mrdax
Posted on: Oct 18 2019, 03:30 AM


Group: Member
Posts: 277

You cannot compare both stocks do easy.

Yes avita is burning money but they're addressing a much bigger market in future with the current approved treatment then clinuvel right now. Which might change with Nasdaq primary listing and more news towards vitiligo.
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mrdax
Posted on: Oct 17 2019, 12:44 AM


Group: Member
Posts: 277

That's true.

Actually the only downside I see on this board is that sometimes it's pretty difficult to find a specific old post because the keyword search is not always the best and the pagination only shows like 10 posts per page. So you gotta scroll back quite far.

I wrote a tiny script which fetches all the html-pages until a certain page and merges the posts together into one big html page which can than be converted to PDF. The script removes some elements like the list of "thanks" to squeeze more content into the document without wasting too much "space".

Resulting in one big document until a certain time (e.g. last 1 or 2 years) which is easily accessible and searchable.

If anyone is interested in it, I could share it.
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mrdax
Posted on: Oct 14 2019, 02:58 AM


Group: Member
Posts: 277

I just listened to the IR Call again and am very very curious to see whether we can finally trust the time schedules given by Dr Wolgen this time.

Especially when it comes to Vitiligo, he says: "The news will follow the next few weeks" (@14:17). I mean, 2 years are also a few weeks... But hopefully, he's aware to use the word "weeks" instead of "months" or "years" in this context, especially after the watergates have opened now.

http://www.clinuvel.com/IRteleconf20191009
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mrdax
Posted on: Oct 12 2019, 10:43 PM


Group: Member
Posts: 277

Nice find.
For everybody too lazy to google yourself -> BPA Festival 20th Anniversary is today:

http://www.porphyria.org.uk/event/bpa-20th...2-october-2019/
QUOTE
The first ever porphyria festival will take place on Saturday 12 October 2019 at the Science and Industry Museum in Manchester and has been designed especially for you. With three main stages hosting a variety of sessions and an exceptional line-up of speakers, you can design your personal agenda for the day! Whether that’s understanding strategies to help you gain control of your condition, listening to a wealth of personal stories and experiences or focusing on connecting with others, our 20th anniversary event is designed with you at the heart


Exactly two months back on 12th of August, one of the organizers posted on FB:
https://www.facebook.com/events/science-and...84384231600385/

QUOTE
Attendee numbers are already at the highest we've ever had to a BPA event. Tickets are limited, so please book early to avoid disappointment. Finalised set list coming soon. https://www.eventbrite.co.uk/e/bpa-20th-ann...sary-festiva…
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mrdax
Posted on: Oct 12 2019, 07:16 PM


Group: Member
Posts: 277

CUV is really serious right now about social media coverage.
10 posts on FB and 7 posts on instagram within the last 4 days (9th of Oct till today):

https://www.facebook.com/pg/clinuvel/posts/
https://www.instagram.com/clinuvel_pharmaceuticals/?hl=de
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mrdax
Posted on: Oct 10 2019, 07:43 PM


Group: Member
Posts: 277

Citing from Jan 2019 newsletter (January https://www.marketscreener.com/CLINUVEL-PHA...2019-27867125/), I just thought it's a good idea to share it here again after FDA-approval just opened the doors to a wider audience and further trials and indications:

QUOTE
"We are on track to unveil further work from the VALLAURIX team in late 2019, ever vigilant that other groups are seeking to claim advances in the same space. I fully support the notion that knowhow and expertise needs to remain inhouse. By necessity this sometimes means that our stakeholders cannot be made privy to exciting progress. As a public company we serve many interests, however in this tumultuous world of open communication the interests of patients and shareholders prevail and therefore CLINUVEL will only share meaningful progress when we have secured positions which cannot be compromised by our competitors in the space."

Exactly what was communicated by Wolgen in the IR-Telco -> Vallaurix as R&D centre for innovation; OTC-products identified; as much information as possible will be kept privately inhouse to build a competitive advantage, hence we will not hear too much about it which doesn't mean intense work in the background is not happening.

QUOTE
"CLINUVEL will need to fortify its position as a leading Australian drug developer for generations to come. Rather than isolated events, all our decisions to expand the Group are interconnected with each other through careful planning, choice of optimum timing to execute, these are some of the considerations needed to succeed."
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mrdax
Posted on: Oct 9 2019, 04:08 PM


Group: Member
Posts: 277

Priority review will be requested in Australia.
But FDA approval doesnt directly impact the australia review process.

But w.r.t. Japan:
They are right now developing a strategy to moving into Japan.
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mrdax
Posted on: Oct 9 2019, 03:57 PM


Group: Member
Posts: 277

Question about NICE
NICE has not yet responded after the appeals.
Wolgen is confident that the team with its ressources is able to combat NICE with a new review.

EDIT:
Now some question about topical formulations.
In OTC Range CUV has identified
Not revealing too much as of now, but the news flow will come soon.
Trilogy: Manufacturing, Registration, and one more, ... so it's important to not be too transparent so that competitors cannot easily re-engineer and re-build the products.
First product line to be made available within one year
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mrdax
Posted on: Sep 26 2019, 05:47 PM


Group: Member
Posts: 277

Double, see sherlock
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mrdax
Posted on: Aug 14 2019, 07:14 PM


Group: Member
Posts: 277

👍
Fine summary.
Bit outdated about asx200 inclusion though. Asx200 inclusion was already done and it's still mentioned as chance in the swot analysis.
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mrdax
Posted on: Aug 10 2019, 12:13 AM


Group: Member
Posts: 277

https://www.shortman.com.au/stock?q=CUV

What a steep incline of shorts.
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mrdax
Posted on: Jul 11 2019, 07:02 PM


Group: Member
Posts: 277

Newsletter July
https://www.clinuvel.com/wp-content/uploads...-11July2019.pdf
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mrdax
Posted on: Jun 22 2019, 09:14 AM


Group: Member
Posts: 277

Not annoying to be.
Otherwise couldn't have bought cuv only two years back at these prices 😁

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mrdax
Posted on: Jun 18 2019, 08:52 PM


Group: Member
Posts: 277

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mrdax
Posted on: May 23 2019, 12:44 AM


Group: Member
Posts: 277

Are we at 500 yet. Don't think so. Yet.
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mrdax
Posted on: May 22 2019, 07:25 PM


Group: Member
Posts: 277

Was wondering the same, too insane knowledge.
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mrdax
Posted on: May 21 2019, 04:13 PM


Group: Member
Posts: 277

Seems like they released a book w.r.t. EPP
http://www.epp-deutschland.de/
Seems like a very small edition which is not released to big book stores though.

QUOTE
Summer without Sun...

....this was the title given to their book by the children and young people at the writing workshop held at the last annual meeting in November 2018. Now it has been published. We are happy that the participants expressed themselves so differentiated about their lives. We would like to thank the writer Eva Segeber, who ran the writing workshop, and the graphic designer Saskia Behrens for the graphic design.

The writing workshop, the production and the printing of the book were only made possible by the generous donation on the occasion of the 50th birthday of the father of a daughter with EPP.

If you would like to know more or read the book, please contact the board by e-mail.


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mrdax
Posted on: May 5 2019, 05:33 PM


Group: Member
Posts: 277

Unpleasant chart
https://finance.yahoo.com/quote/ACPH.BR?p=A...;.tsrc=fin-srch
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mrdax
Posted on: Apr 24 2019, 05:44 PM


Group: Member
Posts: 277

QUOTE
Projecting along a straight line, there is a confidence that the Company will attract much more interest from a larger pool
of superannuation funds



We eye expansion as the next stage of the Company’s organic and inorganic growth. There are inherent dangers
coming with mergers and acquisitions. Within the organisation we are aligned on the need for a structure
which allows growth and minimises risk. Infrastructure, systems, and procedures have been put in place by
senior management prior to embarking on an expansion strategy and integration. It could be said we are
nearing the moment where CLINUVEL is ready to expand beyond its core activities while maintaining its focus
on afamelanotide and melanocortins
. In our chief executive we identify an experienced individual who
recognises the importance of building functional teams and remains aware of the dangers of ill-planned and ill-
timed expansions.
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mrdax
Posted on: Apr 17 2019, 10:10 PM


Group: Member
Posts: 277

https://mobile.twitter.com/Filapek/status/1...438665045172226
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mrdax
Posted on: Apr 3 2019, 05:16 AM


Group: Member
Posts: 277

Dont think it means anything.
We had the same search result in the past already; guess it was posted here on the forum as well. It's just due to the fact how the search-algorithm works I guess.
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mrdax
Posted on: Apr 2 2019, 04:59 AM


Group: Member
Posts: 277

There's one point I didnt quite understand.
He says CUV has a change/risk ration of about ~5:1.

5:1 equals 2.5:0.5.

And that would mean:
chance = 2.5x (+150%)
risk = 0.5 (-50%)

Maybe I didnt quite understand some basic maths, then please enlighten me :D
Or it was just a miscalculation of Homm :D
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mrdax
Posted on: Mar 26 2019, 06:49 PM


Group: Member
Posts: 277

Hopefully some progress can be made w.r.t. perception of vitiligo in the future:

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mrdax
Posted on: Mar 20 2019, 10:11 PM


Group: Member
Posts: 277

nice to see some investor events scheduled in the near future:

Attached Image
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mrdax
Posted on: Mar 19 2019, 09:36 PM


Group: Member
Posts: 277

Let's hope they'll offer a IR contact form to order some merchandising products like cups, pens etc as a way to promote themselves 🤣
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mrdax
Posted on: Mar 17 2019, 02:50 AM


Group: Member
Posts: 277

Sure, and ps=per share.
Xray is constantly talking about a takeover, he seems obsessed with the idea ☺️
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mrdax
Posted on: Feb 12 2019, 12:21 AM


Group: Member
Posts: 277

Dunno which data is right or wrong, but it seems there are a few different data providers.

Bloomberg also lists a Vol of 108k

https://www.bloomberg.com/quote/CUV:AU
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mrdax
Posted on: Jan 27 2019, 05:30 AM


Group: Member
Posts: 277

Invite me. Or join our Cuv WhatsApp group 😎
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mrdax
Posted on: Jan 25 2019, 06:35 AM


Group: Member
Posts: 277

Why and how?
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mrdax
Posted on: Jan 25 2019, 01:07 AM


Group: Member
Posts: 277

Why are you insisting so much on people showing off their tan or whatever?

Why shouldn't it be enough for them to promote their new abilities to go outside, doing outdoor activities etc etc?
This is way more important than the tan, isnt it?

And there are plenty of reviews & people telling that they can now participate in "normal" daily-life activites to an extent that they can't even imagine living a live without SC anymore.
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mrdax
Posted on: Jan 24 2019, 08:33 PM


Group: Member
Posts: 277

What exactly do you want to tell us?

QUOTE
The woman in this article was managing ok until the age of 50 years. So EPP is not a disease commencing in early childhood, according to this story.

So from one example you are drawing a generic conclusion?
Sorry to say, but I thought you'd be a bit more rational.

QUOTE
This story also says; “Approval would be a relief to the 600-some patients with the condition in the United States”. The Caucasians in America are mainly of European heritage. Yet the numbers are far smaller than in Europe.

So? There are so many things unclear when it comes to statistical "distribution" of patients with EPP, which I guess, are highly likely to never be understood.
Apart from that -> Who knows, where they go this number (600) from. PTH from SpheneCapital has listed the USA with a prevalence of 4.3k patients.
So decider on your own, which number is more pleasing to you.

QUOTE
Why would Clinuvel get mixed up with this weird story? Haven’t they got something more factual?

You mean to say, a small company based in Australia, should and/or could control every press-article released in the www?
Sure, that's why there's not ONE single weird story about trump on the internet. weirdsmiley.gif
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mrdax
Posted on: Jan 24 2019, 04:03 PM


Group: Member
Posts: 277

Iggy/cobi no tan?
https://youtu.be/SVQvXZB4ToI
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mrdax
Posted on: Jan 24 2019, 06:37 AM


Group: Member
Posts: 277

Sorry to say but you missed one important factor:
https://edge.media-server.com/m6/p/34dvbwgm

Nasdaq conference call on 20th of sept.
Hence the run-up certainly wasn't only due to asx300
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mrdax
Posted on: Jan 20 2019, 09:05 AM


Group: Member
Posts: 277

What's all that bs talking about?

Be it an injectable drug or pill to swallow, fact is: no one knows what ppl at the FDA think/want and whether being injectable is a prerequisite or not.

Btw, Please post your source for that 'high' dropout rate.
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mrdax
Posted on: Jan 18 2019, 12:53 AM


Group: Member
Posts: 277

http://www.epp-deutschland.de/mediapool/21...Januar_2019.pdf

They are already fighting for label extension for 6 implants instead of 4.

The doubt written in the linked letter about delayed/paused treatment has been rejected in the meantime and a continuation of treatment was committed, as can be read on the homepage of the German EPP association.

Translation from the EPP homepage:

QUOTE
Treatment of patients in Düsseldorf

Last week we received news from anxious patients that there are no new appointments for treatment at the University Hospital Düsseldorf at the moment, because the continuation of treatment with Scenesse was discussed at a higher level. This was first confirmed to us upon request, so that we wrote the following letter to the UKD on behalf of the patients concerned:

Letter self-help EPP to UKD

In the meantime, the answer has been given that it was probably a misunderstanding and that further action is planned. We therefore hope that all patients treated in the UKD will continue to receive reliable treatment! At this point we would like to thank the Board of the UKD for their prompt response.
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mrdax
Posted on: Jan 16 2019, 06:01 PM


Group: Member
Posts: 277

Just use https://imgur.com/upload instead -> Drag/Drop image to Imgur and paste the links here.
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mrdax
Posted on: Jan 16 2019, 04:09 AM


Group: Member
Posts: 277

https://www.marketindex.com.au/rebalance-announcements

When do rebalances occur?
• After the market closes on the third Friday of March, June, September and December.

How much notice is given?
• The market is notified one to two weeks prior to all upcoming constituent changes.
March, June & December - one week notice is given

15th of March would be the possible rebalance date.
Notice would be given by 8th of March if we were to be included (in 7 weeks already, yaay) graduated.gif
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mrdax
Posted on: Jan 15 2019, 05:06 AM


Group: Member
Posts: 277

It's quite tough to say and heavily depends on macro-economics, on lobbying, on possible competition, on future trial-results, on politics etc.
So many factors which can't be neither predicted nor modeled.

Personally, I'd be very happy with 60 aud in 5 years.
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mrdax
Posted on: Jan 10 2019, 01:07 AM


Group: Member
Posts: 277

Wow, CUV is serious about VP tongue.gif

Attached Image

https://www.clinuvel.com/photomedicine/scie...egate-porphyria
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mrdax
Posted on: Jan 8 2019, 11:54 PM


Group: Member
Posts: 277

Just a hint graduated.gif

There are various ways to automatically "watch / monitor" a website or some pre-defined part of it (e.g. only the main div) for changes, just to list very few:

Android:
Web Alert -> https://play.google.com/store/apps/details?...alert&hl=de
Very powerful, used it quite often in the past.

IPhone
Distill.io for paid customers
Probably also some more free alternatives, but I dont own an iphone to check it.

Online services
https://visualping.io/
https://www.wachete.com/
partially free if you only watch a few websites

Software for Windows
https://www.aignes.com/
any probably many more...

Firefox Extensions / Chrome Extensions
UpdateScanner -> https://sneakypete81.github.io/updatescanner/
Distill -> https://addons.mozilla.org/de/firefox/addon...src=recommended -> Also offers Android / iOS Apps and a partially free online service

Just to name a few :-)
So no more need to constantly keep pressing F5 wub.gif
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mrdax
Posted on: Dec 14 2018, 04:39 AM


Group: Member
Posts: 277

Very enlightening as always.
Joy to read.
[Sarcasm off]
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mrdax
Posted on: Nov 23 2018, 02:19 AM


Group: Member
Posts: 277

QUOTE
"The Photobiology team at Salford Royal Hospital are seeking adults with EPP to take part in a study examining the relationship between daylight exposure and occurrence of symptoms throughout the year. The study, funded by the British Skin Foundation, is recruiting now. Participants will complete a diary for up to 4 weeks in each season to record their time spent outdoors, weather conditions, clothing and sunscreen worn, and occurrence of symptoms. Attendance at the hospital is not required. For further information, please contact Joanne Osman, Senior Research Nurse on 0161 206 0457; E-mail: joanne.osman@manchester.ac.uk"


Some more studies going on in the UK about EPP.
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mrdax
Posted on: Nov 19 2018, 09:34 PM


Group: Member
Posts: 277

AGM yet to come

QUOTE
CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced it will hold its 2018 Annual General Meeting of shareholders on Wednesday 21 November 2018 at 10.00am AEDT at The Events Centre at Collins Square, Tower 2, Level 6, 727 Collins Street, Melbourne, VIC 3008 Australia.
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mrdax
Posted on: Nov 14 2018, 04:04 AM


Group: Member
Posts: 277

You could upload it to Google Drive, Dropbox or something like this. Maybe easier, if you've got it.
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mrdax
Posted on: Nov 8 2018, 05:41 AM


Group: Member
Posts: 277

Probably a buddy of Dr Thomas Luger. They know their stuff. king.gif
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mrdax
Posted on: Oct 19 2018, 07:22 PM


Group: Member
Posts: 277

QUOTE
This year we have seen our staff presenting more at international conferences,
giving more interviews and seeking a broader audience for the CLINUVEL
story. I predict the activities surrounding media and communication will
increase in 2019 as the interest in the Company grows. Our communications
and investor relations team is expanding for the wide variety of stakeholders
to obtain first-hand communication from the Company.


Even though it was too be expected, still I like the mentioning of expansion of IR work by PW himself
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mrdax
Posted on: Oct 17 2018, 05:01 PM


Group: Member
Posts: 277

Sorry man, should have clarified better. I was taking the piss.

In this interview, he's being asked how he can make so many phone calls a day (few hundred), hence he goes on and shows a good and a bad phone call. These were the ones I linked.

And I added, out of the blue as a joke, that I was imagining that these were examples of times when he called PW (bad phone call @10:04) and WB (good phone call) devilsmiley.gif
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mrdax
Posted on: Oct 16 2018, 10:55 PM


Group: Member
Posts: 277

Country-wise position-split: Australia listed with 5.69 %
Within the Top10 Stock-positions, there's only one stock from Australia (Amaysin) with 3,8%.

That means:
CUV <= 1,89%.
But still awesome find, thanks Sharelooker smile.gif
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mrdax
Posted on: Oct 16 2018, 06:54 PM


Group: Member
Posts: 277

Homm's phone call with PW recorded @10:04:
https://www.youtube.com/watch?v=Zrhz9MouvpA&t=10m03s

And this the call with WB after his 13mio-AUD purchase back in August:
https://www.youtube.com/watch?v=Zrhz9MouvpA&t=10m12s
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mrdax
Posted on: Oct 13 2018, 07:22 PM


Group: Member
Posts: 277

Check for yourself :-)

"UK Appeal Panel Tells NICE To Revisit Scenesse Rejection @ Pink Sheet"
Attached File  file.pdf ( 254.29K ) Number of downloads: 136


QUOTE
“The committee has been asked to make reasonable adjustments,” Wolgen said. “Clinuvel’s position is to wait, but not too long, to see if NICE takes the initiative. If not, then our path is still open for applying to the High Court for a Judicial Review. In fairness, we could wait a couple of weeks, but certainly not months.”

He said the company “could apply for judicial review tomorrow but we should give them a just chance to come back to us. We have three months to appeal – I don’t think we should wait that long, but I am open to their phone call.”
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mrdax
Posted on: Oct 13 2018, 07:10 AM


Group: Member
Posts: 277

I was wondering whether this is done by a working student who needs some working experience for his CV and does this kind of writing for free.

Main intention being to fill some more pages on the website 🤣
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mrdax
Posted on: Oct 13 2018, 02:56 AM


Group: Member
Posts: 277

https://www.clinuvel.com/social-media/subq/...omic-challenges
Does anybody see any use in these SubQ posts?
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mrdax
Posted on: Oct 12 2018, 07:31 AM


Group: Member
Posts: 277

You gonna attend the AGM?
Can you sign up for this event just as "regular" shareholder (even though you probably own a pretty decent amount of shares :D).
Have you yet attended one AGM in the past?
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mrdax
Posted on: Oct 10 2018, 02:32 AM


Group: Member
Posts: 277

https://www.instagram.com/p/BnJWhRID-fo/
Wow, CUV is pushing hard for vitiligo treatment.
Pretty decent amount of likes.
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mrdax
Posted on: Sep 28 2018, 10:10 PM


Group: Member
Posts: 277

Why smartest guy?
If he's reading here for more than 10 years and still didn't invest even though he could see the uptrend (as you've told, you've got 1000% with this stock), it wasn't so smart :-)

I rather bet he's Iggy who finally bought some shares at the same time Willem Blijdorp did so (at around ~10$ that was). It got quite quiet around Iggy, so probably he wanted to reinvent himself :-)
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mrdax
Posted on: Sep 27 2018, 12:49 AM


Group: Member
Posts: 277

Next event is knocking on the door:

18TH ANNUAL BIOTECH IN EUROPE FORUM
Tomorrow in a week (4TH-5TH OCTOBER 2018).

One of the biggest (or the biggest?) biotech conference in europe.

Just for reference, this is the list of attendees and investors last year:
http://www.sachsforum.com/17bef-attendees.html
http://www.sachsforum.com/17bef-investors.html

I guess the company is better known in europe than in the US b/c of the approved drug being rolled out so I do not expect such a hike like after the Newsmakers conference in the US. But hoping for a new push for new investors :-)
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mrdax
Posted on: Sep 26 2018, 04:10 PM


Group: Member
Posts: 277

Wake up!
It's been mentioned 6 years ago already:

Attached Image



I do like in fact they are driving such a "small" car with little fuel consumption.
Explains why the savings in the bank are so huge devilsmiley.gif
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mrdax
Posted on: Sep 26 2018, 05:57 AM


Group: Member
Posts: 277

https://en.wikipedia.org/wiki/Midnight_Sun_(2018_film)
I know, was posted before. But just to recap, it's also about xeroderma pigmentosum.
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mrdax
Posted on: Sep 26 2018, 02:08 AM


Group: Member
Posts: 277

Anybody got some information about the Japanese health care system enter whether it's good or bad.

It was mentioned already it's looking at FDA for orientation, so I hope they gave a big interest in giving lifes to their xp patients, and not trying to back away from paying like the UK does
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mrdax
Posted on: Sep 22 2018, 05:45 PM


Group: Member
Posts: 277

QUOTE
The company also expects to price the drug the same as the price in Europe, part of a strategy to be
transparent on pricing. The drug is priced in Europe at €1,400 per dose and is dosed every 60 days, though
the company said most patients receive three to four doses per year.


laugh.gif laugh.gif

Edit: should have reloaded the page before posting
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mrdax
Posted on: Sep 21 2018, 02:58 AM


Group: Member
Posts: 277

Since 1 week, there was no new signer at all.
I think the petition is kind of satured, and most likely not gonna hit the req threshold for futher review.

But nvm, was only the drop in the ocean anyway.
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mrdax
Posted on: Sep 12 2018, 05:42 PM


Group: Member
Posts: 277

Sure, why should he sell before FDA approval (probability ~85-90%), at least a doubling of the EPP patients treated, vitiligo treatment, etc ...? he once said he gotta be mature enough to hold CUV for at least several years (somewhere said something between 5-10years as far as I remember). would be pretty embarassing for his reputation to change his mind by 180° degree and give a sell recommendation.
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mrdax
Posted on: Sep 11 2018, 07:20 PM


Group: Member
Posts: 277

Thanks @ Uho for this find:

QUOTE
EUROPEAN SOCIETY FOR PHOTODERMATOLOGY

Scientific Programme, 19th Annual Photodermatology Day
Paris, France
Palais des congrès de Paris 2 Place de la Porte Maillot
Room 241
Wednesday 12th September 2018, 13.30 to 17.30

Dermoscopic modifications of melanocytic nevi during therapy with Afamelanotide
Rossi MT, Arisi M, Calzavara-Pinton PG (Brescia, Italy)


so there's another conference where they're talking about but not limited to Afamelanotide.
There's one session about DNA repair, one about vitiligo and one about XP (Unexpected phenotypes in Xeroderma Pigmentosum and relationship to molecular defects).

Attached File  201809_ESPDProgramme_Paris.pdf ( 207.88K ) Number of downloads: 101


====================================================

To all who are interested in the details of XP, here's a pretty long thesis about the subject:

"Xeroderma pigmentosum
A disease model for clinical, cellular and molecular consequences of ultraviolet
radiation-induced damage"


https://core.ac.uk/download/pdf/141245053.pdf
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mrdax
Posted on: Sep 9 2018, 06:42 PM


Group: Member
Posts: 277

IMHO, what is even more interesting is the fact how the growth of interest is splitted between germany and the rest of the world.
I mean it's clear where it's coming from, because Homm advertises CUV and also the research from sphenecapital probably rather hits the german market than anything else.

Germany:
Attached Image



USA:
Attached Image



Switzerland, netherlands, italy all look the same as the USA. Even in australia, there's no uptrend at all.

So the rising interest in germany is the main driver for the overall chart.
Now imagine there'll be further independent research in another country, e.g. in the USA, and especially imagine the growing interest in the USA with FDA PR and/or approval. It'll make booooooooooooooom wub.gif
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mrdax
Posted on: Sep 7 2018, 11:43 PM


Group: Member
Posts: 277

Just having posted this in the morning, there's yet another update from just right now:
http://www.more-ir.de/d/16925.pdf

:-)
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mrdax
Posted on: Sep 7 2018, 07:01 PM


Group: Member
Posts: 277

Hi new Investors.
The file posted by Farma is only an update (from mid of 2018) to the original full report (from start of 2018).

If you want the full story including in-depth analysis and models, please refer to the initial research done by SpheneCapital:
Includes Business profile, EPP-case, financial forecasts, Basics of the human skin, SWOT-analysis, Shareholder-structure, timelines, DCF-model and much much more:

Attached File  16065.pdf ( 892.79K ) Number of downloads: 217
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mrdax
Posted on: Sep 7 2018, 04:59 PM


Group: Member
Posts: 277

Yes for sure. Here it is Attached File  Will_NICE_Change_Its_Mind_On_Scenesse_After_UK_Public_Hearing_____Pink_Sheet.pdf ( 219.55K ) Number of downloads: 153
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mrdax
Posted on: Sep 7 2018, 03:44 PM


Group: Member
Posts: 277

As I have a free acc now on pinksheet, I was browsing through some older articles and came across this one (which I think was posted before):
https://pink.pharmaintelligence.informa.com...nce-From-Europe

It says:
QUOTE
CEO Philippe Wolgen said the company had taken advantage of the FDA’s increasing openness to real world evidence (RWE) by including data from EU patient experiences in the US filing, and that it planned to apply a single price policy across the US, as it has done in Europe.

[...]

The US drug development program has been under way for more than a decade, with Clinuvel having been in “regular and frequent” communication with the FDA. The product was granted orphan drug designation in the US in 2008 and fast-track designation in July 2016. In November 2016, the FDA concluded that the scientific data were ready to be filed as part of a rolling review. The NDA dossier includes data and analyses from five EPP clinical studies (two of them in the US), as well as compassionate-use and special access scheme data. The data set consists of almost 6,700 doses in more than 800 patients, and the package also includes a post-authorization plan to monitor US patients.

[...]

A key factor in the US filing was the growing openness of the FDA to the provision of real world evidence. The new FDA Commissioner, Scott Gottlieb, who was appointed in May 2017, “came out quite early in his tenure on ‘real world data’, meaning he wanted patients to have a say in drug approvals – in other words, the real life experience of patients would be a factor in the drug evaluation process,” Wolgen said.

“That discussion began in 2017, when the FDA started looking at real world evidence,” the Clinuvel CEO noted. “So we paused and put our pens down briefly during our submission and discussed internally and with the FDA, saying that is very much what happened in the EU where the EMA [European Medicines Agency] used the company as a test case by including physicians and patients in the formal decision making process” by the agency's drug evaluation committee, the CHMP.

[...]

The RWE data were included in the dossier for the FDA as part of the NDA submission. “It makes sense to include real world experience – this has been done sporadically before but not systematically,” Wolgen observed. “A company reporting a European PSUR [periodic safety update report] and data from the annual [safety] report as part of a US submission is pretty rare, but it fits this drug in protoporphyria patients, it fits our profile. It also makes sense as you want to learn on both sides of the table how physicians and patients are behaving under real life conditions." It could be a model for other rare diseases, Wolgen suggested.


And from the latest announcement we know:
"This additional information covers product manufacturing information and details from the European post-authorisation use of SCENESSE®."

First part is more or less clear, but we are left in the dark w.r.t. second part of the dossier.
So as the discussions were ongoing w.r.t RWE-data since a long time (see article above), somehow I cannot imagine that the second part of the announcement is asking for more RWE-data weirdsmiley.gif
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mrdax
Posted on: Sep 7 2018, 03:30 PM


Group: Member
Posts: 277

Interesting article, as I was also wondering a few days back why we still havent heard back from NICE.
I made a free acc to share the article with you guys: [attachment=50444:Will_NIC...nk_Sheet.pdf]

QUOTE
Asked what Clinuvel would do if the appeals were rejected, the company's UK general manager, Lachlan Hay,
said: “Certainly we will look more closely at the next legal avenue.”

High Court?

QUOTE
Explaining the company’s position, Hay said NICE’s approach to evaluating Scenesse had been
“unreasonable both in terms of its insistence on using a metric or health economic tool that is inadequate to
value this product in this particular disease.”

The EMA, “by its own admission,” had “realized that its own tools are inadequate to value Scenesse in EPP,”
yet NICE was still insisting on “arriving at an ICER [incremental cost-effectiveness ratio] and relying on their
own inadequate methodology. The one size 􀃦ts all approach that NICE is taking is completely inappropriate
and unfair.”

[...]

Asked whether Clinuvel’s policy of having a single price and no hidden discounts for Scenesse could have
caused problems in negotiating a managed access deal, he said he thought there was “a level of expectation
by NICE/NHS that you conduct commercial discussion behind closed doors. I don’t see that 􀃦tting our
approach of being transparent and equitable in maintaining a uniform price for all the European insurers,
payors, governments, patients and physicians. Clinuvel does not do deals behind closed doors.”

[...]

For its part, the IPPN, which represents the interests of EPP patients at the international level, says NICE
failed to act fairly, for example by not acknowledging the evidence provided in patient testimonies and by
expert physicians “on the overwhelming clinical bene􀃦t” of Scenesse.

[...]

One problem is that the average values used by the EMA when assessing the clinical trial results suggested
that patients were able to spend an additional eight minutes per day exposed to light, which makes it seem
less effective than it really is, Barman-Aksösen said in an interview. In fact, patients can be outside “for
hours” and “that is a real bene􀃦t.
”

Not sure where from which mathematical metric this "8 minutes" is derived from...

QUOTE
According to Barman-Aksösen, the appeal panel listened carefully to the arguments put forward by the
network. “They didn’t say whether they agreed with us or the committee, but it seemed they really got the
points,” she said.
Falchetto said that judging by NICE’s “very complex decision 􀃧ow chart, we estimate that probably we will
not hear anything back before mid-September, at the latest the end of September.”
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mrdax
Posted on: Sep 5 2018, 02:47 AM


Group: Member
Posts: 277

Still not heard anything from the NICE Appeal!?
Should be rejected as of now IMHO, but the case is still open on their website (Status: In Progress)
https://www.nice.org.uk/guidance/indevelopment/gid-hst10009

weirdsmiley.gif
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mrdax
Posted on: Sep 4 2018, 06:32 PM


Group: Member
Posts: 277

https://www.asx.com.au/asx/statistics/displ...;idsId=02018932

, Change in substantial holding
  Forum: By Share Code

mrdax
Posted on: Sep 2 2018, 03:49 AM


Group: Member
Posts: 277

Edith: my post was sh*t, Can be removed
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mrdax
Posted on: Aug 31 2018, 07:44 PM


Group: Member
Posts: 277

Are you sure the 74-day deadline includes the non-working days?
Or is it up to 14 working days (excluding saturdays possibly?), that would mean ~3 weeks starting from 22th of August.
  Forum: By Share Code

mrdax
Posted on: Aug 29 2018, 11:16 PM


Group: Member
Posts: 277

End Game 2021.
Sound like the title of a good movie :D But if it's gonna be reality, hope I'll be able to cash out in 3 years from now and retire early.

Thanks WB.
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mrdax
Posted on: Aug 29 2018, 03:52 PM


Group: Member
Posts: 277

https://translate.google.com/translate?hl=e...roteccion-solar
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mrdax
Posted on: Aug 25 2018, 09:53 PM


Group: Member
Posts: 277

Just don't read it anymore! Only a few idiots remained there which either don't have a life, think it's funny to keep in trolling there, or who are desperate after investing all their savings because Homm said it could potentially be a 30 bagger and the SP hasn't yet doubled in the last month's.

After most of the people including me went to a private WhatsApp group the amount of good content shared on the wallstreet online board has reduced to nearly 0.

So forget about everything being posted there, it's a waste of time and you'll not gather any information from there anyways.
  Forum: By Share Code

mrdax
Posted on: Aug 22 2018, 06:07 PM


Group: Member
Posts: 277

Sorry to say, but there simply MUST be something wrong with these numbers.

Date Doses Source
21.08.2018 7900 https://www.asx.com.au/asxpdf/20180821/pdf/...hsyj916m1lc.pdf
25.06.2018 6700 CLINUVEL completes SCENESSE FDA Filing
14.05.2018 5100 CLINUVEL Regulatory Update

Leave alone the difference of 2800, just focus on 14th of Mai to 25th of June...

The difference is 1600 implants (may to june) which would already yield revenues far above 10mio AUD. And that's only 6 weeks out of 4th quarter which consists of 13 full weeks. But we know the 4th quarter figures already and it was something around 10mio AUD of revenue of receipts received.

So we can conclude, these numbers must be nonsense (i.e. maybe different "reporting" rules, e.g. testing-doses etc).
  Forum: By Share Code

mrdax
Posted on: Aug 21 2018, 04:12 AM


Group: Member
Posts: 277

More awareness for EPP in the UK
https://www.facebook.com/ManxRadio/videos/410433519483597/

From today, was live on Manx Radio (UK). On FB this radio station has ~30k followers on their FB page, aint bad.
Told her in advance to spread the word about the online petition, now gotta listen to it whether she mentioned or not. graduated.gif

She's saying to have fought hard the last 6 months to get this drug approved and will keep no fighting, spreading the word, going to a 10mile run in Plymouth in October to make aware of EPP. really like how she's going about it.
  Forum: By Share Code

mrdax
Posted on: Aug 17 2018, 09:34 PM


Group: Member
Posts: 277

They try their best, understandably...
https://petition.parliament.uk/petitions/226495

Fund afamelanotide on the NHS to treat erythropoietic protoporphyria
Erythropoietic Protoporphyria is a life changing genetic condition, your body has a reaction when exposed to UV and visible light. You can't go out without covering head to toe, just to be able to leave the house. Inside all blinds must be closed, also lights to be checked. No prevention or cure.

At 10,000 signatures...
At 10,000 signatures, government will respond to this petition

At 100,000 signatures...
At 100,000 signatures, this petition will be considered for debate in Parliament

Hard to see those milestones being met.
  Forum: By Share Code

mrdax
Posted on: Aug 15 2018, 10:33 PM


Group: Member
Posts: 277

https://endpts.com/biogens-big-breakthrough...-reimbursement/

QUOTE
Once again, UK regulators have proven that they are unwilling to pay a heavy price for the breakthrough drugs that the FDA enjoys hustling through to quick approvals.

In this case, the UK's NICE is at least temporarily closing the door on Spinraza, Biogen's landmark new therapy for rare cases of SMA, despite discounting the $750,000 US list price for the first year of therapy.

But without a better idea of the longterm impact of the drug on patients, some of whom face a death sentence at the age of 2, it wasn't possible to conclude that the price was justified.

[...] but the very high cost of nusinersen meant it could not recommend the drug as a cost effective use of NHS resources," noted Meindert Boysen, director of the centre for health technology evaluation at NICE.
  Forum: By Share Code

mrdax
Posted on: Aug 15 2018, 04:36 PM


Group: Member
Posts: 277

Thanks, good find.
Doesn't look good than wrt PR

Have you seen a similar statistic about drug-domain vs chance for fast track designation?

Would be handy to see whether it looks similarly bad and still we've made it with Scenesse. So I'd still have some hope that Scenesse simply is an outsider drug 😎
  Forum: By Share Code

mrdax
Posted on: Aug 15 2018, 01:49 AM


Group: Member
Posts: 277

I think it's quite funny to see that they bought likes on the picture about the NICE quote and about FDA approvals.
😂
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mrdax
Posted on: Aug 14 2018, 01:16 AM


Group: Member
Posts: 277

In which way do you think was it different beforehand?
  Forum: By Share Code

mrdax
Posted on: Aug 11 2018, 10:52 PM


Group: Member
Posts: 277

Is there anything unclear wrt this part:

QUOTE
Due to the current situation / August 2018 of the lack of supply concepts for people with EPP and the insufficient treatment options, we, the self-help EPP e.V. , *wrote our demands to:

· The health policy in NRW for the benefit of Claudia Middendorf and Karl-Josef Laumann

· Federal Health Minister Jens Spahn

· The patient representative of the Federal Government Ralf Brauksiepe

to put the life situation of people with EPP and also all other people with rare diseases in the focus of politics.


Just to increase publicity and awareness and maybe get some better (ie faster and/or increased number of slots) rollout going..
  Forum: By Share Code

mrdax
Posted on: Aug 11 2018, 04:04 PM


Group: Member
Posts: 277

QUOTE
August 2018

On 09.08.2018 Ulla and Elke were from the board of self-help EPP e.V. Jürgen Grebe / UK Münster for a personal conversation with Ms Claudia Middendorf, Commissioner of the Government of North Rhine-Westphalia for people with disabilities as well as patients in the Ministry of Labor, Social Affairs and Health.

Due to the current situation / August 2018 of the lack of supply concepts for people with EPP and the insufficient treatment options, we, the self-help EPP e.V. after the interview written demands

· The health policy in NRW for the benefit of Claudia Middendorf and Karl-Josef Laumann

· Federal Health Minister Jens Spahn

· The patient representative of the Federal Government Ralf Brauksiepe

to put the life situation of people with EPP and also all other people with rare diseases in the focus of politics.

At this point we would like once again to thank you in the name of the board and all people with EPP for the friendly welcome, the open ears and the empathy of Mrs. Middendorf.


Translated by Google.
http://www.epp-deutschland.de
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mrdax
Posted on: Aug 10 2018, 02:23 AM


Group: Member
Posts: 277

Sorry, here's one more, just put online on CUV insta channel.
They've probably seen my posts about approval-rates, haha

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mrdax
Posted on: Aug 10 2018, 01:51 AM


Group: Member
Posts: 277

How to combine the elusive ingredients for successful innovation
The sixth, 'Sub Q: Under the Skin' column is up on CLINUVEL's website.
In this edition, Giles Delaney shares six elusive ingredients for successful innovation.

http://clinuvel.com/social-media/subq/ingr...sful-innovation
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mrdax
Posted on: Aug 10 2018, 12:00 AM


Group: Member
Posts: 277

Is there anyone who has really had the belief that Scenesse would be approved in the UK?
Come on, they are even denying life-saving drugs like cancer-drugs or similar.
The more people die, the less becomes the countries pension problem (aging society..) rolleyes.gif
https://www.telegraph.co.uk/news/health/new...ble-on-NHS.html

QUOTE
Many cancer medicines which are widely available in Europe, such as [...] are not available in the United Kingdom.

France gives out on average 1,600 mg of Bevacizumab per bowel cancer case, compared to virtually none in the UK.

[...]

Patients are 20 per cent more likely to be given the breast cancer drug Herceptin on average in Europe than in the UK; 50 per cent more likely if they live in France or Spain.

Andrew Lansley, the shadow health secretary, said: “It is unforgivable that thousands of cancer sufferers in England die each year because they are not given the drugs that they need when we spend over a hundred billion pounds a year on the NHS.


I know a few people who lived there for a while and they told, their health system is just a joke.
It's just a f%$&cked up system.
  Forum: By Share Code

mrdax
Posted on: Aug 9 2018, 04:27 PM


Group: Member
Posts: 277

Hope one day we can achieve a good market penetration in germany alone to reach such revenue-heights



(old source: https://www.g-ba.de/informationen/nutzenbew...tab/beschluesse -> module 1)
  Forum: By Share Code

mrdax
Posted on: Aug 7 2018, 02:55 AM


Group: Member
Posts: 277

Yeah and it was a pretty new user who gained very little attraction with his post.
Made me wonder where he got it from and/or why it wasnt discussed at all here
  Forum: By Share Code

mrdax
Posted on: Aug 4 2018, 12:30 AM


Group: Member
Posts: 277

It may be complete bullsh*t, but just want to raise that point.
Not to confuse or irritate (no Im not xray or iggy), just to make 100% sure we have the same understanding.

Looking at page 13 (https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM591976.pdf), I see that ALL drugs with either Fast Track // Breakthrough Therapy // Priority Review were approved.

BUT: In the whole document I don't find the non-approvd drugs; especially because I was also searching the total number of drug filings in 2017 earlier, to calculate the approval rate. But couldn't find it. No information given at all about non-approved ones. (I hope I have just missed it?)

So for me it raises the question: Are you sure that the Fast Track // Breakthrough Therapy // Priority Review drugs listed on p13 is the complete list? Im not so sure. For me it looks like these are only the drugs which got approved afterwards. So MAYBE there are more drugs which had FastTrack status which didnt get approved, but just that non-approved drugs are nowhere mentioned in this PDF file ...

This also kind of confirms my view:
QUOTE
Fast Track designated drugs have the potential to address unmet medical needs. Eighteen of the 46 2017 novel drugs
(39%) were designated by CDER as Fast Track.


46 was the total number of approved drugs, let alone the total number of filings.
So they just give the rate of approved fast-track drugs to the total number of approved drugs and than list the drugs one by one. But they dont note e.g. the total number of fast-track drugs (approved+non-approved).

So for me, the sentence is quite clear that it doesn't try to say anything about total rate, total filings, total number of fasttrack drugs or anything like it.

Hence, I'd say the assumptions were wrong.

Please let me know whenever you have a diff. opinion. I hope I'm wrong.
  Forum: By Share Code

mrdax
Posted on: Aug 3 2018, 11:09 PM


Group: Member
Posts: 277

QUOTE
A REPORT OF THE APPEAL HEARING – READ ABOUT NICE’S SHOCKING DISREGARD OF EPP
(posted on behalf of Jasmin B.-Ak.)

Dear All

As most of you are aware of, on Monday 30 July 2018 an Appeal Hearing was held against NICE’s Final Evaluation Determination (FED) for the Highly Specialised Technology (HST) evaluation, which recommended against routine funding of afamelanotide for the treatment of erythropoietic protoporphyria (EPP) in the National Health Service (NHS) in England.

I would like to thank all of those who provided me with their moving testimonies and personal insights, and it was very nice meeting some of you in London during the weekend! Your input helped me focus on the task and do my best to enable access to the afamelanotide treatment and end this incredible suffering. I am absolutely convinced that withholding access to the only treatment for EPP is inhumane, inexcusable and unjust and that all British suffers are entitled to this treatment.

Concerning the appeal hearing, I think I can speak for all the appellants that we came out with rather mixed feelings. On the one hand, we were impressed by the quality and fairness of the appeal panel, which consisted of two physicians, one working in the NHS and one retired, a lay member, an industry representative and one person of the team of non-executive directors at NICE. We had the impression that the appeal panel had a reasonable understanding of the condition and the points raised by us, especially the aspect about EPP being such a rare and complex condition that standard techniques to measure effectiveness and benefit of a treatment are not sufficient to show the real-world effects of afamelanotide. They were impressed by the consistency of the patient testimonies and the experience reported by the expert physicians, who all report life changing effects of the therapy. In addition, they questioned the NICE committee rather critically on aspects raised in the appeals, for example on the validity to use a generic Quality of Life measure, which knowingly, and I want to stress knowingly here, underestimates the positive effects of the treatment instead of the proposed EPP specific Quality of Life instrument, which is significantly more appropriate.

On the other hand, though, we were very concerned and even shocked by comments made by the NICE committee members, who were responsible for the negative FED recommendation. Throughout the hearing, they maintained their interpretation of limited clinical trial outcomes, in spite of our explanations that when measuring the time spent in direct sunlight, an average value calculated over the entire trial period including all rainy days and working hours spent indoors in an office (and not outdoors in sunlight) will dilute the effect, i.e. the actual measured time spent outdoors in direct sunlight, and make it look smaller than it actually is. Patients under treatment report that they can be outside for hours in sunlight but, of course, this is only possible if the sun is shining and we do have the time to be outdoors. In addition, the clinical trial outcomes clearly show that EPP patients under treatment on average can spend roughly the same amount of time outdoors as normal individuals, as explained at the meeting by Dr Lesley Rhodes, a world renowned photodermatologist, who performed such studies herself. Therefore, the argument of the NICE committee that the trial results represent a limited effectiveness is woefully incorrect.

Regrettably, the NICE committee did not really accept the explanations put forward by the appellants and maintained that the trial results show only small benefits, without however providing any explanation for their negative assessment. We also learned during the meeting that the NICE committee did not invite either expert physicians or patient organisations – the two stakeholders with the best insights – to elaborate on the terms of a so-called Managed Access Agreement (MAA), which would allow access to the afamelanotide treatment while more data of real-world effectiveness is gathered. In the end, NICE simply dismissed a possible MAA arguing it would not provide any additional evidence on effectiveness. A terrible missed opportunity that in itself effectively prevents reducing the NICE committee’s uncertainty on whether afamelanotide has an effect in a real-world setting. We regard this as completely unreasonable and unfair!

Now brace yourselves, the worst has yet to come: The committee also showed a very cold attitude towards EPP sufferers at the meeting. Repeatedly, they described EPP as being “unpleasant”, even after we strongly disagreed, pointing out that this wording hardly describes the severe pain and second-degree burns caused by the phototoxic reactions, and that we felt offended by this description! To top it all off, the debilitating and disabling consequences of EPP were shockingly dismissed: Dr Peter Jackson, the chair of the NICE committee, stated that EPP does not qualify as a disability because disabilities would be visible… (!) This, after we explained in the introduction that EPP is largely invisible but extremely painful, disabling and debilitating, and that having to cover up to be protected from light is a significant burden, especially for children. Needless to say, we were shocked, enraged and very concerned that an individual stating such beliefs presides over a body tasked to decide on treatment access for EPP sufferers. Personally, I think it is utterly scandalous!

Now, the fate of EPP suffers in England lays in the hands of the appeal panel. They will decide on whether or not NICE acted fairly, abused its power and / or did not sufficiently consider the evidence. I have hope, especially since the panel seemed to be honestly moved by the patients’ and expert physicians’ testimonies on the burden of the disease and seemed convinced by our description of the real-world evidence of the benefit of afamelanotide, which is the most important thing! I can assure you, all appellants did an excellent job in making the committee and the appeal panel aware of the life-changing effects of the treatment and the urgency to enable access in England.

Now, let`s keep our fingers crossed and hope that EPP patients in England and the UK will soon be able to enjoy the warmth of the sunrays and the almost normal life made possible by the afamelanotide treatment.

Let the sun shine for everyone! Geronimo!

Jasmin

More information regarding the treatment can be found on NICE’s website, including the original appeal papers which have been published on 30 July 2018:

Four stakeholders submitted appeals against the negative “Final Evaluation Determination” and were heard before the appeal panel, the British Porphyria Association (BPA), the British Association of Dermatologists (BAD), the International Porphyria Patient Network (IPPN) and the Company. The appeals and correspondence with the authorities can be viewed under: https://www.nice.org.uk/guidance/indevelopm...10009/documents

IPPN was represented by a British patient, James, a lawyer from a British law firm, Emily, and myself.
  Forum: By Share Code

mrdax
Posted on: Aug 2 2018, 08:09 PM


Group: Member
Posts: 277

Leave alone Fast Track and Priority Review stats, just looking at the total approval rate:



I left 2017 out because I didnt find the total number of filings in 2017.
Not so sure what happened in 2015 and 2016, maybe deadlines were missed and hence filing/approvals were shifted back and forth, but that's just an assumption.

So an average approval rate of 80%, pretty decent I'd say. Trend seems to be going uphill slightly.
This article from "independend" research seems to confirm it, even though it's from Aug2015:
https://www.forbes.com/sites/gradsoflife/20...s/#154ad9dd6f5f
Let's hope the inclusion of "real-world data" which came up lately will eben better the rate, especially for drugs already in use in different countries.

And furthermore if you take into consideration the safety profile of Scenesse and the duration of research done on this new drug.

EDIT
From Dec2017:
https://www.raps.org/regulatory-focus%E2%84...ts-21-year-high

QUOTE
Frank David, MD, PhD, managing director of the consulting firm Pharmagellan, explained to Focus: "Over 90% of drugs that are submitted to FDA get approved, so the NME count mainly a reflection of the number of applications - which, in turn, reflects the registration trials that were funded 2-3 years ago.


QUOTE
"Over the long term," David said, "It's interesting that more drugs seem to get approved per year now than a decade ago. I think one big reason for this trend relates to the therapeutic areas in which development is most active. Cancer and rare diseases have gotten much more 'hot' over that period, mainly because those are areas with accelerated and perhaps lower-risk approval pathways and sustained premium pricing - and those are also areas with typically faster and cheaper R&D (compared with, say, hypertension and depression)."


If anybody could just find out the number of approved/rejected drugs only for the drugs with priority review and/or fast track designation, that would be awesome.
  Forum: By Share Code

mrdax
Posted on: Aug 2 2018, 07:28 PM


Group: Member
Posts: 277

In 2016 "only" 7 of the 8 drugs with FastTrack got Priority Review.

Fast Track:
"Anthim Defitelio Epclusa Exondys 51 Lartruvo Ocaliva Spinraza Zinplava"

Priority Review:
"Axumin Defitelio Epclusa Exondys 51 Lartruvo Netspot Nuplazid Ocaliva
Rubraca Spinraza Tecentriq Venclexta Xiidra Zepatier Zinplava"


So Anthim didnt get Priority Review even though it had FastTrack Designation.
So 7 of the 8 drugs with FastTrack got Priority Review.

https://www.fda.gov/downloads/Drugs/Develop...n/UCM536693.pdf

This slide is also pretty interesting:


Unfortunately there are no detailled statistics / slides about the rejected drug filings (or I missed it).
I'd be interested in the ratio of drug-rejections in relation to drugs with Priority Review, over the past few years.


EDIT:
Stats for 2015:
https://www.fda.gov/downloads/drugs/develop...n/ucm481709.pdf

Fast Track: (14 drugs)
Avycaz Corlanor Cotellic Daklinza
Darzalex Entresto Genvoya Kanuma
Lonsurf Orkambi Portrazza Strensiq
Tagrisso Viberzi

Priority Review: (24 drugs):
Alecensa Avycaz Bridion Cholbam Corlanor Cotellic
Cresemba Daklinza Darzalex Empliciti Entresto Farydak
Ibrance Kanuma Lenvima Ninlaro Orkambi Praxbind
Strensiq Tagrisso Unituxin Viberzi Xuriden Yondelis

Drugs with Fast Track which didnt get Priority Review:
Genvoya
Lonsurf
Portrazza

Darzalex Tagrisso
3 out of 14 didnt get Prio Rev


2014 I didnt find.
But 2013is here:
https://www.fda.gov/downloads/drugs/develop...n/ucm381803.pdf
  Forum: By Share Code

mrdax
Posted on: Jul 31 2018, 05:41 PM


Group: Member
Posts: 277

Havent you been the pussy who sold all his shares? graduated.gif
  Forum: By Share Code

mrdax
Posted on: Jul 29 2018, 11:01 PM


Group: Member
Posts: 277

Can we open a petition to stop PW from writing any more newsletters? It's just a nonsense investment of time if all you intend to do is confuse.

Either be clear, concise and reliable or invest your time somewhere else, eg in getting core business running
  Forum: By Share Code

mrdax
Posted on: Jul 29 2018, 06:27 PM


Group: Member
Posts: 277

Good summary.
But if it's asking too much to do a two-month forecast at the start of April about three articles, which imho, completely lays in their hands (just need to write them?), I'm asking: how should they forecast a full year or even further ahead?

They missed June and more probably Juli. So out of a two-month timeframe they made more than four months.

What will they do out of half a year (time until end of 2018)?

Guess is, end of autumn they'll say they'll release the products after FDA approval. Hence it's gonna be in 2020.

🤣😎
  Forum: By Share Code

mrdax
Posted on: Jul 28 2018, 10:43 PM


Group: Member
Posts: 277

Secondly, IIRC the molecules size was said to be too big to penetrate the skin.
  Forum: By Share Code

mrdax
Posted on: Jul 24 2018, 04:01 AM


Group: Member
Posts: 277

All this vitiligo talking just for fun? Must admit I doubt it.
Attached Image



Hope there's some real good news coming soon w.r.t to Vitiligo.
The timing of Willem buying 1.3M shares would fit perfectly, just right before such an announcement.
  Forum: By Share Code

mrdax
Posted on: Jul 23 2018, 11:25 PM


Group: Member
Posts: 277

FDA committed to easing approval path for biosimilars
https://seekingalpha.com/news/3371185-fda-c...ath-biosimilars
  Forum: By Share Code

mrdax
Posted on: Jul 22 2018, 02:37 AM


Group: Member
Posts: 277

QUOTE
On a related subject Clinuvel seems to be positioning to ‘own’ the photo protection space, note the following:
Photoprotection URL redirects to Clinuvel.com
http://photoprotection.com


Good find.
This domain is framing "http://www.clinuvel.com/en/science-of-skin"
Page not yet created, or again taken offline until the event starts?
This is an old page of "science of skin", but without content: http://www.clinuvel.com/investor/news/item...science-of-skin

But to use an iframe is again so bloody amateurish, this is so 2000 king.gif

EDIT:
Just because I find it funny:
While googling for this "science of skin" thing, I saw their blog is stil up and running with the old design:
http://www.clinuvel.com/blog/lightandhealt...nce-of-sunburn/
Damn, what a company. Nothing important, but just hilarious. weirdsmiley.gif
  Forum: By Share Code

mrdax
Posted on: Jul 22 2018, 02:30 AM


Group: Member
Posts: 277

QUOTE
We will present all of the letters at once to the FDA!
Right now we have 478 letters.
Let's get to 500! Please send letters today!
Time is of the Essence!


Attached Image



QUOTE
A letter from Senator Blumenthal about my request that
he contact the FDA for priority review of Scenesse


Attached Image



I hope so much that they get this medi approved to finally help all those sufferers.
FDA should go on and help decreasing suicide rate!!
  Forum: By Share Code

mrdax
Posted on: Jul 21 2018, 01:22 AM


Group: Member
Posts: 277

"I really do worry about unpredictable consequences of what else it's doing in the body," Linden said.
If people like this "expert" sit in the FDA-board, then EPP-patients are f*#&cked

(Dr. Kenneth Linden, a professor of dermatology at the University of California, Irvine School of Medicine and the co-director of its Melanoma Center)
  Forum: By Share Code

mrdax
Posted on: Jul 20 2018, 07:51 PM


Group: Member
Posts: 277

FDA rejection=75% drop of SP?
🤔🤔 weirdsmiley.gif

Aren't they profitable and growing quite massively in Europe?
Haven't they a few more useful products we're all looking for?
  Forum: By Share Code

mrdax
Posted on: Jul 19 2018, 03:43 PM


Group: Member
Posts: 277

They published the change of institutional holders today with fresh data:
https://www.barrons.com/quote/stock/au/xasx/cuv

QUOTE
FIL Investment Management (Singapore) Ltd. 53.43K 0.11% -414.74K 0.01% 07/13/18
FIL Investment Management (Hong Kong) Ltd. 3.03M 6.34% -108.29K 0.11% 07/13/18


FIL Investment Management (Singapore) Ltd. is completely out of the game now. And FIL Singapore still holding 3M of shares.
  Forum: By Share Code

mrdax
Posted on: Jul 19 2018, 03:20 AM


Group: Member
Posts: 277

Dont worry man. wub.gif

Attached Image

  Forum: By Share Code

mrdax
Posted on: Jul 18 2018, 11:27 PM


Group: Member
Posts: 277

So glad there are still some EPP patients you don't give up their lifes and trying to cope as good as possible.
Just rest 10sec and imagine you'd have to live their life...

  Forum: By Share Code

mrdax
Posted on: Jul 17 2018, 04:31 PM


Group: Member
Posts: 277

So the Selling-Phase from FIL, which my previous post from below (link to https://www.barrons.com/quote/stock/au/xasx/cuv) has indicated up to and including the month May, is still continuing. Doesn't seem to matter to them whether they sell at 10AUD or at 12.5 AUD, they keep on selling. No wonder the SP is stagnating.

This time no "trading" pattern, so IMHO no SP-manipulation can be concluded.
  Forum: By Share Code

mrdax
Posted on: Jul 17 2018, 01:53 PM


Group: Member
Posts: 277

QUOTE
TO ALL UK EPP PATIENTS - YOUR SUPPORT IS NEEDED FOR THE UPCOMING APPEAL HEARING AT NICE - WRITE TO SCIENCE@PORPHYRIA.CH

Dear All

My name is Jasmin, I am an EPP patient working as molecular biologist in the Swiss reference laboratory for EPP and related disorders in Zurich. As I am not a member of Facebook, I asked Rocco to post my message to your group on my behalf.

In 2014, during the approval process of afamelanotide (Scenesse®) for the treatment of adult patients affected by EPP, I was invited by the European Medicines Agency (EMA) to share my experience about living with the condition and the effects of the afamelanotide treatment. In addition, I contributed a scientific statement during the German access negotiations and was part of an oral hearing, which successfully led to reimbursement of the afamelanotide therapy for EPP by the German Health System. I myself receive the afamelanotide treatment since 7 years now and know first-hand about the therapy‘s transformative effects and find it outrageous that many other EPP patients, such as yourselves in the UK, are denied access to it!

Access discussions with NICE are now ongoing since more than two years. Although several UK EPP sufferers contributed to the discussions as patient representatives by sharing their first-hand experiences with the condition and the treatment, which were confirmed by an overwhelming feedback in the online comments of the international EPP community and statements from the expert physicians and patient organizations, NICE still maintains their initial opinion of a, I quote, „small benefit which does not provide sufficient value for money“. Regrettably, the evaluation of NICE is based on an inconsistent and unfair use of the clinical trial data. In addition, patient input has largely been ignored by NICE and their assessment contradicts the results of the evaluation by the EMA.

Therefore, the International Porphyria Patient Network (IPPN), which Rocco and I have co-founded, submitted an appeal against the unfair discrimination of UK sufferers compared to EPP patients in other countries, in which afamelanotide is currently available. NICE has arranged a hearing for our appeal against their evaluation and the appeals of three other stakeholders. The appeal panel will convene on Monday 30 July 2018 at NICE, 10 Spring Gardens, London, SW1A 2BU to hear oral representations from us and the other appellants. IPPN will be represented by myself, an EPP patient from the UK and a legal advisor. We will do our best to enable access for English and, hopefully, all UK patients.

In order to represent UK patients in the best way possible, we would like to hear from you: Share your thoughts on the matter sending me an e-mail to science@porphyria.ch

And if you happen to be in London on the weekend prior to the hearing, I would be able see you there on Saturday night, 28 July! Drop me a note and we can arrange to meet.

Hope to see you in London!

Best wishes,

Jasmin
  Forum: By Share Code

mrdax
Posted on: Jul 13 2018, 03:41 PM


Group: Member
Posts: 277

https://www.barrons.com/quote/stock/au/xasx/cuv

As per end of April, Fidelity Funds SICAV - Asian Smaller Companies Fund -200k shares.

And from May:
FIL Investment Management (Hong Kong) Ltd.
FIL Investment Management (Singapore) Ltd.

sum = -500k Shares

blink.gif
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mrdax
Posted on: Jul 7 2018, 07:23 PM


Group: Member
Posts: 277

Has anybody yet thought about whether blijdorps investment could attract new investors, be it retail or regular people?

I guess this guy is pretty famous , so IMHO his activity could be monitored by a lot of people.

Let's hope it'll help awaking this sleeping beauty
  Forum: By Share Code

mrdax
Posted on: Jul 7 2018, 12:47 AM


Group: Member
Posts: 277

Why odd? I heard that CUV was just too big of a position in lagodas portfolio, that's why they had to reduce. Just a matter of funds-regulations, nothing else.
So in this case it doesnt matter, probably they were glad to be able to sell such a big position at once outside the market.

So I'd bet in case we'll see a further run of the SP, lagoda will be further decreasing the position because it'll be overweighted in their funds once more.
  Forum: By Share Code

mrdax
Posted on: Jul 6 2018, 05:03 PM


Group: Member
Posts: 277

Awesome news.
I hope this'll turn out to be as good as when the CEO of wirecard invested 40mio € in 2016 when some hedge funds attacked the stock. In the end he knew his business the best. So let's hope the same can be assumed about Blijdorp
  Forum: By Share Code

mrdax
Posted on: Jul 4 2018, 04:23 PM


Group: Member
Posts: 277

But still wondering why they sell 1.3M shares at 10AUD, if the current market price was ~11AUD.

Why not take the time, sell slowly on market and try to get higher prices? Giving 10% discount gives the impression they absolutely wanted to make sure to get those shares sold fast, otherwise they could've just sold other weeks at higher prices. or it's just another small market manipulation while transfering some stocks to another insto.
  Forum: By Share Code

mrdax
Posted on: Jul 4 2018, 03:00 PM


Group: Member
Posts: 277

ID of the link missing. Here's the correct link:
https://www.asx.com.au/asx/statistics/displ...;idsId=01996781

  Forum: By Share Code

mrdax
Posted on: Jul 3 2018, 04:37 AM


Group: Member
Posts: 277

This is only 7 weeks old, so I guess they'll meet their scheduled deadline here as well as the NDA deadline, of which the delay was also announced at that time and was also met in the end. Let's hope the best for the next few weeks,

hopefully a promising newsletter, the product announcement and the company's best quarterlys coming in July.
  Forum: By Share Code

mrdax
Posted on: Jun 29 2018, 07:24 PM


Group: Member
Posts: 277

Finding from message-board wallstreetonline:

QUOTE
Announcement on 22.06.18:
Nearly 6,700 afamelanotide doses administered to more than 800 patients

Announcement on 14.05.18:
SCENESSE implants administered globally to date : >5,100 (>4,000 to EPP patients)



6700-5100= 1600 Implants within 6 weeks?
Even with increasing number of patients getting treated, I highly doubt that number.
So probably again lapse of concentration while writing the announcements?

Would be very strange to get these basic numbers wrong, which are effectively the KPI of the core-business. lol
  Forum: By Share Code

mrdax
Posted on: Jun 29 2018, 05:01 PM


Group: Member
Posts: 277

Pretty decent visualization of how Scenesse works:
https://www.facebook.com/AccelerateApproval...65821466801219/

EDIT seems to be a repost from an older FB-post from end of 2017. But nevermind, still good to watch

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

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

Gratefully, JT just received his 9th implant of Scenesse (afamleanotide 16mg). Because of Scenesse, JT has been able to live a relatively pain free life for the last 2 years. I asked Dr. Rocco Falchetto to explain how Afamelanotide protects a person with EPP. There are 3 mechanisms of Afamelanotide at work to protect a person with EPP:

1. In the experiment, when the yellow cellophane is placed between the blue light and the protoporphyrin solution, the solution stops glowing. This is because the yellow color absorbs light in the bluish light range and prevents it from reaching the protoporphyrin molecules. The same principle applies when we tan: exposure to UV light triggers the formation of melanin, our natural pigment which makes us look tan, and just like the yellow filter, melanin absorbs the bluish component of visible light, preventing it from reaching the protoporphyrin molecules and, consequently preventing them from becoming energized and releasing their destructive energy into the immediate environment (the veins carrying the blood). Afamelanotide triggers the production of protective light-absorbing melanin without having to expose a person with EPP to the sun (which results in pain).

2. Afamelanotide also has strong anti-inflammatory effects. Part of pain and suffering of a person with EPP is from the phototoxic events that are experienced after exposure to light. Afamelanotide's anti-inflammatory mechanics explains why EPP'ers can expose themselves to light for longer periods of time and if they are over-exposed, the symptoms resolve more rapidly than without afamelanotide. JT has experienced both of these benefits - able to tolerate much more time exposed to light and when he has had a reaction, the pain and swelling subside much more quickly.

3. Afamelanotide also has anti-oxidative effects, meaning it triggers natural biological mechanisms which scavenge noxious oxygen radicals and other reactive oxygen species which are generated when protoporphyrin is energized by visible light. When a person with EPP is exposed to visible light, the energy that is released into the immediate environment is transferred onto the oxygen in our blood vessels and cells, turning it into these noxious reactive species, one of the culprits in the phototoxic reactions EPP'ers experience. Afamelanotide's scavenger mechanism helps to alleviate this.

For EPP'ers, Afamelanotide is life changing and life giving, allowing them to live life as we all do - free from the fear of excruciating pain merely from being exposed to visible light. For those fortunate enough to have access to Scenesse, we will not stop the fight until ALL have access.
  Forum: By Share Code

mrdax
Posted on: Jun 26 2018, 04:32 PM


Group: Member
Posts: 277

Looks like you forgot to take your drugs lately, you seem to be very confused and dizzy.

You're telling you sold all your shares, than you're telling this company is shit, than you're telling you need to buy "more" shares (more? how can you buy more if you don't own anymore), then next phrase you say the SP will drop down again. It's just annoying having to read trash all day long

"I think we will see $15 or more by end of July."

"Personally would like to see the SP back down to $10 to pick up more.
Pretty sure the FDA will issue a rejection soon, so that will be nice."

"Anyone else buying more?
I am."

"I sold all my shares once I discovered that the FDA will not approve Clinuvels drug.
Primarily because it does not work (except in Europe) and has too many side effects...including flatulence, painful erections and possible spontaneous combustion."

"Go back to the glue." <<<< You talking about yourself?

"Looks like Ignoramus is right.
Time to Panic.
Time to sell.
$2 tomorrow."

"I remember selling all my shares that day.
Started buying again 2010 and havent sold one share since."
  Forum: By Share Code

mrdax
Posted on: Jun 26 2018, 01:39 PM


Group: Member
Posts: 277

Best post of the day. Now only need to get Iggy banned from SS.
Please guys help reporting him
  Forum: By Share Code

mrdax
Posted on: Jun 25 2018, 06:34 PM


Group: Member
Posts: 277

@Royco, this is the post from Frogster:

http://www.sharescene.com/index.php?showto...mp;#entry883403

QUOTE
Performance Condition 1 was met on 28/11/14, and the 3B (New issuance) and 3Y (Change in Directors interest) notices were issued on 4/12/14 i.e. 6 days

Performance Condition 2 was announced as met on 23/12/14 and the 3B and 3Y notices were issued on 23/1/15 i.e. 31 days

Performance Condition 3 was announced as met on 22/6/16 and the 3B and 3Y notices were issued on 4/8/16 and 5/8/16, i.e. 47/48 days

If history is any kind of guide, when Performance Condition 4 is met, it might be 1 to 7 weeks before the statutory ASX announcement is made.
  Forum: By Share Code

mrdax
Posted on: Jun 25 2018, 02:05 AM


Group: Member
Posts: 277

" [...] trading be halted until after the expected announcement is made OR until the commencement of trade on 26th June, WHICHEVER IS EARLIER".

What could be the reason they do not yet seem to know which one is earler, or when they'll trigger the announcement?`
Probably just a verbalization which should not leave any room for speculation, is it!? I mean, in case they'd give a fixed schedule/time for the announcement, maybe it could be got in touch with Worldvitiligo day, hence this phrase?

Any opinions?

EDIT Maybe they havent finished writing it, hence they do not know the exact time their working student will finish the glory design with embedded logo in the PDF announcement :D
  Forum: By Share Code

mrdax
Posted on: Jun 23 2018, 06:49 PM


Group: Member
Posts: 277

QUOTE
Still begs the question why does it take two trading days to make simple announcement presumable about a regulatory submission.

I guess this is the core question we're all wondering about since 1.5 days, 'ignoramus'. Why instead of build the worst type of speculation without any indication, why not just wait for 2 more days?


If there were any bad news, why not just release it? Were any previous news announced only after a TH?

If NDA-submission is further delayed, why not just announce it, as it was done mid/end of mai already? We didnt see any TH there neither.

If NDA-submission is completed, why do a TH; as the market expects it anyway.

If FDA approved and/or rejected the NDA, we should all be wondering about why the NDA-submission was delayed 5 weeks ago. Even if it is on rolling basis, I don't see how the FDA could reject/approve an non-submitted NDA.

EMA withdrawing permissions for scenesse? Why should they, after 12 years of safety profiling and the latest announced safety-profiles in March or April this year, where it was just confirmed that 99% of people want to continue the treatment with scenesse?
  Forum: By Share Code

mrdax
Posted on: Jun 23 2018, 05:57 PM


Group: Member
Posts: 277

QUOTE
For instance what would be the reaction if an EPP patient in Germany being treated with Scenesse was diagnosed with a melanoma or a brain tumour? A two day trading halt may be required for the professionals to ascertain if there is any connection to the prescribed drug

Wouldn't they write "announcement w.r.t. regulatory permission/license" instead of "announcement w.r.t. regulatory submission"?
  Forum: By Share Code

mrdax
Posted on: Jun 22 2018, 04:53 PM


Group: Member
Posts: 277

1. checking the notice period of my working contract devilsmiley.gif
  Forum: By Share Code

mrdax
Posted on: Jun 21 2018, 10:16 PM


Group: Member
Posts: 277

Thanks, nice find.
Anyone knows whether such appeals have been successfull in the past? Or is it rather a formal act to not let the impression come into existence that the rejection wouldn't bother the patient association, i.e. to show some resistance, even if known to be in wayne?

"There are twenty five places available for this appeal hearing."
Let's all sign up for some seats and make a SS-meeting over there in London :D Looking forward to getting to know u guys hypocrite.gif
  Forum: By Share Code

mrdax
Posted on: Jun 21 2018, 01:44 AM


Group: Member
Posts: 277

Taking the piss again, or however it is called in ur aussie slang?
have to admit, genius at work. So funny. thumbdown.gif
  Forum: By Share Code

mrdax
Posted on: Jun 20 2018, 09:46 PM


Group: Member
Posts: 277

If that's true, than I'm really wondering how one can hold such a big position in CUV-shares (wasnt that you owning 50k+ shares?) while having such high doubts/fears. weirdsmiley.gif
  Forum: By Share Code

mrdax
Posted on: Jun 20 2018, 05:40 AM


Group: Member
Posts: 277

Hope we will see at least one of these things until end of June, which is effectively less than 10 working days:

*NDA update, possibly official announcement
*Bimonthly newsletter
*At least any update on vitiligo on the world vitiligo day..

More than one would be appreciated, but I pray to God they'll any of these with positive effect on SP
  Forum: By Share Code

mrdax
Posted on: Jun 17 2018, 06:04 PM


Group: Member
Posts: 277

Where did they get the information about insider trades from? Shares sold by insiders the last 3 months??
  Forum: By Share Code

mrdax
Posted on: Jun 17 2018, 05:59 PM


Group: Member
Posts: 277

8 more days till world vitiligo day.

http://25june.org

Will cuv also participate? Will they present anything related? At least they are making quite a lot of advertising or trying to increase awareness w.r.t. vtlgo these days on Instagram and Facebook
  Forum: By Share Code

mrdax
Posted on: Jun 15 2018, 07:59 PM


Group: Member
Posts: 277

IMHO it's quite hard to predict/forecast a full year ahead, and yes we are used to delay after delay by CUV-management.

But do you really think it'd be so difficult to forecast just a few weeks (1 month in fact)? I don't think so.
So I would really be surprised if they gave an update by end of may telling they'll submit the NDA before end of june, effectively forecasting only few weeks, only to announce another delay later. They should have known by end of may already and instead of giving two announcements of delay, they should immediately have given a bigger delay in the first announcement.

Especially if you consider that writing the whole filing has taken years now, so I can only assume that when they announced the delay end of may, that the filing was more or less completed and only some minor changes were yet to be finalized. So where exactly should the new (expected) delay come from?
  Forum: By Share Code

mrdax
Posted on: Jun 14 2018, 04:38 AM


Group: Member
Posts: 277

Yes and feeling like every second day they post something about vitiligo on Facebook
  Forum: By Share Code

mrdax
Posted on: Jun 14 2018, 12:56 AM


Group: Member
Posts: 277

Not so sure about the Stoplosses.

I agree Homm-people are interested in fast money, but still they'd kind of follow his advice. And he gave a clear statement about the SL which should be placed somewhere below 6€. So I doubt that homm-ppl set their SL like seen today somewhere between 7 and 7,5€.

Apart from that.
We've made it to over 300k shares traded in germany.
Purely INSANE
@royco: Edited in parallel without checking for new posts so quickly. Didnt wanna spoil your post biggrin.gif

EDIT: Before Homm was promoting this stock in germany (starting on 1. of Nov2017), 300k shares were traded maybe in 1 or 2 months lmaosmiley.gif

@johnnytech:
Yes somehow I also expect that there's some leak of information.
But in case there is, still wondering why the vol on the ASX was relatively low when compared to germany, even though I'd expect a selloff on big vol in the home-stockexchange.
But nevermind, we'll maybe know within the next few months :D
  Forum: By Share Code

mrdax
Posted on: Jun 13 2018, 11:33 PM


Group: Member
Posts: 277

Incredible volume in germany and still 11% down.
Damn what's going on weirdsmiley.gif

Tradegate 155.037
Quotrix 671
Frankfurt 75.279
Stuttgart 8.528
München 3.000
Nasdaq OTC Other 500
Hamburg 300

SUM = 243315

Have you EVER seen a volume like this in the history of CUV?
  Forum: By Share Code

mrdax
Posted on: Jun 13 2018, 03:29 PM


Group: Member
Posts: 277

Man, a company doesnt only consist of the CEO.
Products? weirdsmiley.gif
  Forum: By Share Code

mrdax
Posted on: Jun 13 2018, 04:15 AM


Group: Member
Posts: 277

Just all of you should report him for continuously posting dubious and shady information and trying to provocate users here until one drops.
  Forum: By Share Code

mrdax
Posted on: Jun 12 2018, 01:39 AM


Group: Member
Posts: 277

Than why bother investing your time here?
Goodbye my friend :-)
  Forum: By Share Code

mrdax
Posted on: Jun 9 2018, 04:11 PM


Group: Member
Posts: 277

Skyler Paris is truly an inspiration. The U.S. Food and Drug Administration thinks this is nothing more than a vanity disease, cover up and you'll be fine. We all know better, the higher our levels of protoporphorin go the higher the risk we have of developing liver disease/failure.

This young man has been hospitalized for over a year now because of EPP.l, had a rare side effect for his liver transplant that left him paralyzed it his courage and determination are prevailing and he is battling back. Despite his health and having to live the last year and then some in a hospital he still managed to graduate on time from high school and keep up with his studies.

https://eu.dnj.com/story/news/2018/06/08/sm...ital/681504002/
  Forum: By Share Code

mrdax
Posted on: Jun 7 2018, 08:55 PM


Group: Member
Posts: 277

Was there still anything unclear? 😆😆
  Forum: By Share Code

mrdax
Posted on: Jun 7 2018, 01:30 AM


Group: Member
Posts: 277

That's something completely different.
This title refers to the expropriation of 30k€ per year per household in Germany
  Forum: By Share Code

mrdax
Posted on: Jun 7 2018, 12:24 AM


Group: Member
Posts: 277

Certainly not $30 because in the past (2017), he wrote about a potential 30 bagger at that time without referring to any older SP from the past. So at that time it was around 4-5€, which would than be 120-150€, but time frame was 10 years.

Meanwhile cuv is further making aware of vitiligo on FB
https://imgur.com/a/SQyaJJg

I was recognizing that they gained considerable each within the last week's/months, now already 1300 followers. Hope thatll increase further
  Forum: By Share Code

mrdax
Posted on: Jun 3 2018, 01:45 AM


Group: Member
Posts: 277

CUV FB post:

"World Vitiligo Day, later this month, aims to increase awareness of the pigmentary disorder vitiligo.
Throughout June CLINUVEL will share a series of posts to raise awareness of vitiligo and debunk some common misconceptions."

  Forum: By Share Code

mrdax
Posted on: May 31 2018, 06:31 AM


Group: Member
Posts: 277

https://www.finanztrends.info/clinuvel-phar...f-hohem-niveau/

It's just empty phrases about the rise of the SP and resistance and plateaus of it. But it's good to see that even this "famous" guy (would be known of most of the German readers of stock news) writes at least anything, even if it's empty phrases, about our beloved cuv.

I hope that an increasing number of articles like that will be published to gain at least a little bit more attention besides the fundamental development of the stock itself. So hopefully a few new investors ..

Kudos to minus sinus who found it
  Forum: By Share Code

mrdax
Posted on: May 29 2018, 08:26 AM


Group: Member
Posts: 277

Who on this board has direct contact to cuv?

  Forum: By Share Code

mrdax
Posted on: May 24 2018, 06:39 PM


Group: Member
Posts: 277

Lol you're comparing cancer drugs which are used by millions of people every year with a rare desease drug like scenesse?

Cancer treatment is way way way too expensive in comparison of the actual cost of drug/ingredients in it. I have a colleague which is just getting a treatment which is above 100k € for a more or less routine cancer (testicular cancer). I know the purpose it serves to him (living instead of dying) is bigger than with epp patients but if you ask them epp patients which got treated they say they never want to go back to their old lives before getting the treatment
  Forum: By Share Code

mrdax
Posted on: May 21 2018, 05:42 PM


Group: Member
Posts: 277

This is your and iggys short position?
  Forum: By Share Code

mrdax
Posted on: May 9 2018, 02:17 AM


Group: Member
Posts: 277

http://www.ariva.de/clinuvel_pharmaceutica...amp;boerse_id=1

One single transaction with 20657 shares @ 8,50 €

weirdsmiley.gif
  Forum: By Share Code

mrdax
Posted on: May 8 2018, 01:47 AM


Group: Member
Posts: 277

Man, you have a bad quote. I told my father, my girlriend and three friends. 3 of them 5 invested :D One couldn't because didn't own an account to buy stock-shares :D

@Farleap11: Intraday high even 8,34€ which equates to 13,25aud. but yea this will hopefully be all history in a few months.
  Forum: By Share Code

mrdax
Posted on: May 5 2018, 12:08 AM


Group: Member
Posts: 277

I faked myself as EPP patient to get some information from chemnitz whether they treat EPP patients here in germany quite regularly or not - but unfortunately they didnt give me much information about the number of patients being treated there or how big the waiting queue is. They just told me they are fully booked/occupied (whatever "full" means in terms of absolute numbers) and I should try it in düsseldorf or berlin.

I'll plan to check with Münster whether they only do EPP-diagnosis as of now or whether they plan on building an EPP-treatment infrastructure and by when. Let's see whether they plan to treat patients and how many.
  Forum: By Share Code

mrdax
Posted on: Apr 25 2018, 03:47 PM


Group: Member
Posts: 277

The late rise in SP was partially after the 31th of march. The page seems to be giving the held shares at 31th or march - so it could potentially be that this insto increased afterwards. Maybe this is what sharelooker wants to say
  Forum: By Share Code

mrdax
Posted on: Apr 21 2018, 04:12 AM


Group: Member
Posts: 277

I think I'm gonna invest 50 bucks at fiverr to pay for some real followers for clinuvel at insta and Facebook to increase their reach/impact

😃

https://www.fiverr.com/belaanwar/give-you-1...gram-followers#!
  Forum: By Share Code

mrdax
Posted on: Apr 18 2018, 03:07 PM


Group: Member
Posts: 277

At least they registered a Twitter Handle at all
https://twitter.com/clinuvelnews?lang=de

But strange to name it this way weirdsmiley.gif
  Forum: By Share Code

mrdax
Posted on: Apr 16 2018, 10:26 PM


Group: Member
Posts: 277

What do you know about country-specific spellings/naming-conventions? Maybe these names fit to the asian region, don't have a clue.
And welcome with new user acc Mr ValueFox graduated.gif

Chivere.com is for sale. I mailed with domainking@163.com, previously he said 3000USD, than went down to 1200USD. I forwarded this to Lachlan, but they don't seem to be interested. Dunno how you can skip the main domain to a product sad.gif Either one should have chosen a brand-name for which the domain is/was available, or just go for it and buy the domain.
  Forum: By Share Code

mrdax
Posted on: Apr 15 2018, 05:43 PM


Group: Member
Posts: 277

Good find again graduated.gif

What does this mean: filed in 2016 already but only now published?
  Forum: By Share Code

mrdax
Posted on: Apr 11 2018, 04:38 PM


Group: Member
Posts: 277

Kudos to Labsolute from German Forum:

http://clinuvel.com/clinuvel/company-overv...tory-and-future
"Currently, the Food and Drug Administration is reviewing the innovative pharmaceutical product for release in the United States."

ohmy.gif
  Forum: By Share Code

mrdax
Posted on: Apr 10 2018, 10:31 PM


Group: Member
Posts: 277

Unfortunately doesn't name the stock.
Don't think many people will know which stock he is talking about
  Forum: By Share Code

mrdax
Posted on: Apr 9 2018, 08:27 PM


Group: Member
Posts: 277

According to this (thanks to walltrader from Wallstteet online):
https://www.youtube.com/watch?v=J_Giymcf_fw&t=1s
The new Homm interview including known Mr Halver should be made public tomorrow.

This new interview should also be made public on focus money.

See this screenshot:


I just wanna recall that the last interview from Homm at mission money attracted a lot of attention, as the interview was watched 300k times:
https://youtu.be/Rv8rSMvOm-U

Hope Homm advertises our beloved clinuvel once more 😂


  Forum: By Share Code

mrdax
Posted on: Apr 8 2018, 02:44 AM


Group: Member
Posts: 277

Plutos long short funds is also accumulating and building its 8% core position with clinuvel. They've not yet publicly posted the official composition of the LS funds but certainly will do soon.

Edit: I'm telling about the LS absolute return funds. Last year I had contact with plutos (Mr. Wolpert) and they told me the funds will have a target market cap of 10mio by end of 2017. So roughly 80k€ invested in clinuvel at that time.. they told me that the core position of 8% is reflecting their expectations about the SP development (I mean it's obvious, just wanted to emphasise it).

Market cap of the multi opportunities funds seems to be around 20mio as posted in German Wallstteet online forum
  Forum: By Share Code

mrdax
Posted on: Apr 5 2018, 07:20 PM


Group: Member
Posts: 277

Full-PDF Link:
http://clinuvel.com/investors/analyst-cove...c8824f0344cd443

Clinuvel uploading this document (it's from yesterday) to promote themselves as take-over candidate? lmaosmiley.gif
EDIT: @ValueFox: Also my thoughts. Dunno what they want to achieve with that. OMG.

A number of potential M&A candidates in Australia, in our view
We looked at Australian healthcare/biotech companies that have: 1) the potential
to operate globally should their technology be proven to work, or 2) if already
proven, be transferred to additional geographies. These include: Clinuvel; Ellex;
Medical Developments; Mesoblast; Nanosonics, Osprey; Pro Medicus and Telix.

These companies include (in alphabetical order):
Clinuvel (CUV):
Clinuvel is a biopharmaceutical company focused on
developing drugs for the treatment of a range of severe skin disorders. CUV's
lead compound is Scenesse (afamelanotide), a drug targeting Erythropoietic
Protoporphyria (EPP). Scenesse is a photoprotective drug; it acts by increasing
the levels of melanin in the skin and shields against UV radiation (UVR) and
sunlight. Scenesse is delivered via a subcutaneous dissolving implant
approximately the size of a grain of rice. Erythropoietic Protoporphyria is a
rare genetic disease characterised by severe phototoxicity of skin. CUV
completed Phase II and III trials in the US and Europe. Trial results showed
Scenesse could reduce the severity of EPP symptoms. The drug has marketing
authorisation under exceptional circumstances from the European Medicines
Agency for the prevention of phototoxicity in adults with the orphan disease
Erythropoietic Protoporphyria (EPP).
  Forum: By Share Code

mrdax
Posted on: Apr 5 2018, 06:00 PM


Group: Member
Posts: 277

There was a post by Frogster where he posted the delay between action taken (e.g. shares awarded to CEO) and public announcement. IIRC there've been delays up to 2 or 3 months. Let's see how soon they'll let us know
  Forum: By Share Code

mrdax
Posted on: Apr 4 2018, 09:16 PM


Group: Member
Posts: 277

I had the same thinking, but one thing which boggles my mind all the time:

Why should they make such a fuss around it?
Is it because they are bloody amateurs and market something which will result in very disappointing news once again?
If it's just a useless lotion which will not have any big impact, than why "market" it like this and not just go again under the radar. I mean, for their core-business, they try to hide under the radar, so for me it wouldn't make sense to promote a known-to-be-sort-of-useless lotion like that in advance.

Any ideas?
  Forum: By Share Code

mrdax
Posted on: Mar 29 2018, 08:54 PM


Group: Member
Posts: 277

They just posted a new article -> "Cost of drug discovery - value for money?"
http://clinuvel.com/social-media/subq/cost...value-for-money

What I just discovered: As already discussed, they are bloody amateurs. Not even having setup a free Let's Encrypt https-ceriticate. The page is shown as "not secure" in Google Chrome sadsmiley02.gif It'd be free and done in 5-10minutes for every average webmaster. OMG!
  Forum: By Share Code

mrdax
Posted on: Mar 28 2018, 05:33 PM


Group: Member
Posts: 277

I really hope they will proof-read the NDA filing a few times to avoid mistakes like the ones mentioned in the newsletter: 2108.
  Forum: By Share Code

mrdax
Posted on: Mar 27 2018, 04:56 PM


Group: Member
Posts: 277

Yes vol in germany is quite impressive these days.
I guess these are the investors who follow Homm's advice to setup a stoploss, who first sold shares and than were afraid of missing the rocket, hence buying back devilsmiley.gif
  Forum: By Share Code

mrdax
Posted on: Mar 24 2018, 04:56 AM


Group: Member
Posts: 277

IPO
It's probably overpriced
  Forum: By Share Code

mrdax
Posted on: Mar 22 2018, 09:58 PM


Group: Member
Posts: 277

Italien friend told me this means that this hospital (policlinico) is requesting Clinuvel to make an offer for 75 implants, but for a price which is lower than the price given in the PDF (14.1k €). This seems to be their max price.

Anybody having a different opinion?
  Forum: By Share Code

mrdax
Posted on: Mar 22 2018, 07:11 PM


Group: Member
Posts: 277

Homm set a SL at 6,15€.
We currently are at 6,45€ in germany.

So if SP drops by ~4,6% from now, the SL will take affect for 1/5th of the position.

If you think, how many people were motivated to invest by the first letter from Homm (this was by 1st November) and what happened to the SP -> it went from 4.8€ to 6€.

Now think about the inverse event to happen whenever the SL will take affect. Happily only for 1/5th of the positions and I doubt that every of his followers set the SL accordingly. But nevertheless, I hope w edon't drop by 4.5% by now weirdsmiley.gif
  Forum: By Share Code

mrdax
Posted on: Mar 22 2018, 04:04 PM


Group: Member
Posts: 277

He releases a new video EVERY week, but most of the time it's about general topics.
In this case, it's only about financial engineering, so he talks about the simulation of growth by buying back shares, which effectively decreases the number of shares by which the earnings are divided by.

But he released a short update on Clinuvel a few days ago in his letter saying that for 1/5th of his total position, he sets a stoploss at 9.80AUD. IMHO pretty bad because this can be easily reached and if really many of the investors are selling at that point, no good rolleyes.gif
  Forum: By Share Code

mrdax
Posted on: Mar 19 2018, 09:14 PM


Group: Member
Posts: 277

Yes I've seen all of these old articles from 2006 and 2007, but as Clinuvel is now mentioned in your article from 2018, I'm wondering whether they've digged deep to list CUV there, or whether there is something new going on. It's been 10 years since the information about the Phase 2 trials has been posted.So anything new expected here?
  Forum: By Share Code

mrdax
Posted on: Mar 19 2018, 09:02 PM


Group: Member
Posts: 277

I wasn't aware of that market-segment, and neither Homm did mention that in any of his past research.
But whenever you google "Actinic Keratosis clinuvel", there are a lot of pages from clinuvel.com pointing in this direction, e.g. there's this cached page here:

http://webcache.googleusercontent.com/sear...nt=firefox-b-ab

When you click on these pages from the current page, you'll find a login-form. So either this page doesnt exist i.e. was removed and thus redirects to the register-form, or it is currently just blocked because again they want to hide something. Your opinions on that? (e.g. on link would be: clinuvel.com/science-of-skin/skin-conditions/skin-cancer/actinic-keratosis)

So is all that information known already and old stuff, which just gets warmed up by the article that royco posted, or is there really something going on w.r.t to CUV1647 for treatment of Actinic Keratosis?
  Forum: By Share Code

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