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ajshare
Posted on: Jul 25 2019, 10:32 AM


Group: Member
Posts: 326

Willem Blijdorp stepping up..perhaps getting ready to be chairperson.

CHANGE IN COMPOSITION OF AUDIT & RISK COMMITTEE
Melbourne, Australia, 25 July 2019
CLINUVEL PHARMACEUTICALS LTD today announced that non-executive Director, Willem Blijdorp has replaced
Managing Director and Chief Executive Officer, Dr Philippe Wolgen as a member of the Audit & Risk Committee. Mr
Blijdorp will be a voting member of the Committee.
CLINUVEL continues to maintain compliance with rule 12.7 of the ASX Listing Rules and now complies with
Recommendation 4.1 to the ASX Corporate Governance Council’s Corporate Governance Principles and
Recommendations, 3rd Edition.
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ajshare
Posted on: Jul 18 2019, 10:47 AM


Group: Member
Posts: 326

CUV making to Shortman Top100

https://www.shortman.com.au/top

Lots of efforts everywhere to bring it down so cheap shares can be acquired.
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ajshare
Posted on: Jul 17 2019, 08:51 AM


Group: Member
Posts: 326

S&P Biotech ETF ASX:CURE

The ETFS S&P Biotech ETF is run by a company called ETF Securities (ETFS), Australia’s second-oldest ETF provider.

As the name suggests, this ETF invests in US-based biotechnology companies and is designed to track the performance of the S&P Biotechnology Select Industry Index before fees and expenses.

The ETF has around 124 holdings with the largest holding making up just 2.16% of the portfolio. The two largest holdings are Array BioPharma Inc (NASDAQ: ARRY), a $10 billion company, and Global Blood Therapeutics Inc (NASDAQ: GBT).

In terms of market capitalisation, around 57.1% of the ETF is allocated to small caps and 8.2% to large caps.

This ETF has been operating for less than a year, but year-to-date it has returned 21.83%. Over a five-year period, the index that it tracks has returned 18.29% per annum.

====

Not sure if they hold CUV?
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ajshare
Posted on: Jul 17 2019, 08:43 AM


Group: Member
Posts: 326

High profile fundie warns these 10 ASX shares have “bubble” valuations

All stats according to Forager Funds research as at June 25, 2019 reported by fool

Avita Medical Ltd (ASX: AVH) is a regenerative medicine company with just $3 million of revenue and an enterprise value (EV) of $755 million. On those stats it looks a speculative bubble.

iSignthis Ltd (ASX: ISX) is a KYC verification platform that has an EV of $658 million and just $6 million of revenue. I’m also sceptical about this company and its valuation.

Polynovo Limited (ASX: PNV) is a medical device biotech business that made a loss of $5 million on revenue of just $9 million over the last 12 months, but sports an EV of $951 million. It looks like Mr. Johnson might have a point here!

Clinuvel Pharmaceuticals Limited (ASX: CUV) is another biotech that has a SCENESSE drug to treat skin disease that is in the queue for approval from the U.S. FDA. On June 3 it told the market the FDA needed more time to come to a full decision. It posted net income of $16 million on revenue of $27 million over the last 12 months. The market cap is $1.7 billion, but at least this company is a step in the right direction in boasting a substantial profit.

Pro Medicus Ltd (ASX: PME) is a business I have a bias towards as a small shareholder, which reported net income of $19 million on revenue of $45 million over the last 12 months according to Forager. The value is $2.7 billion plus now, whether this turns out to be a bubble will come down to sales and operating performance over the next 3 to 5 years.

Megaport Ltd (ASX: MP1) is the on-demand internet connectivity business that has an EV of $809 million, despite posting a $28 million loss on revenue of $26 million over the last 12 months.

Mesoblast Ltd (ASX: MSB) is probably the biggest capital sinkhole on the local share market in posting a $127 million loss on revenue of $23 million over just the last 12 months. The EV today is $710 million, but, remarkably, has been far higher.

Audinate Group Ltd (ASX: AD8) is a software and digital sound processing business that recently completed a significant capital raising. This suggests its own management and investment banking advisers may be impressed by its valuation. It posted net income of $1 million on just $25 million of revenue over the last 12 months.

Bubs Australia Ltd (ASX: BUB) is the goat-based baby formula business that’s playing heavily on the ‘Chinese demand’ theme. It apparently made a huge $70 million loss on revenue of $33 million over the last 12 months.

Elixinol Global (ASX: EXL) sells hemp oil for use in medicinal cannabis products, which is a hot or potentially bubble-like sector right now. It has an EV of $466 million, yet made a $1 million loss on revenue of just $37 million over the last 12 months. Not my cup of tea.
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ajshare
Posted on: Jul 12 2019, 01:38 PM


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Posts: 326

Curse of newsletter....why are we going down by 10%???
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ajshare
Posted on: Jul 11 2019, 10:04 AM


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Posts: 326

thats what still keep me here...optimism.. Not sure how long the wait will be. Another 6 to 12 months IMO..
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ajshare
Posted on: Jul 11 2019, 09:56 AM


Group: Member
Posts: 326

No news newsletter as always...disappointing.

We have progress from talking about CRL to FDR!!!

In the event the FDA would issue a Complete Response Letter (CRL) denying marketing authorisation, several procedural steps need to be followed by the FDA and the applicant company. Section 562 of the Federal Food,Drug, and Cosmetic Act (21 U.S.C. 360bbb-1) directs the FDA to have dispute resolution procedures in place. An appeal by the applicant is considered by the FDA as a request for Formal Dispute Resolution (FDR). The actual submission of an appeal is known as a Formal Dispute Resolution Request (FDRR). Such matters pertain to scientific / medical disputes.
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ajshare
Posted on: Jun 21 2019, 04:24 PM


Group: Member
Posts: 326

Record Volume 1,866,871
and Record $71,845,794 trading.
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ajshare
Posted on: Jun 21 2019, 04:07 PM


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Posts: 326

greedy short sellers should burn on Monday with a take over offer...
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ajshare
Posted on: Jun 21 2019, 02:39 PM


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Posts: 326

I think it may bring mid 40s if not intervened too much by SSs.
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ajshare
Posted on: Jun 6 2019, 03:56 PM


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Posts: 326

ASX200 announcement tomorrow???
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ajshare
Posted on: Jun 5 2019, 02:57 PM


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Posts: 326

https://www.asx.com.au/asx/statistics/displ...;idsId=02111857

Lapse and forfeit of Unlisted Conditional Performance Rights
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ajshare
Posted on: Jun 3 2019, 09:59 AM


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Posts: 326

I think it doesn't matter as pretty sure it relates to CMC. I was expecting a 6 to 12 month delay with missing April deadline so its good in a way that it reduces chances of a CLR.
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ajshare
Posted on: May 29 2019, 12:30 PM


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Posts: 326

I don't have the right answer my friend. Obviously they want to make a killing.. but I think it is bullish for a share like CUV with a short squeeze coming in soon.
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ajshare
Posted on: May 29 2019, 11:47 AM


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Posts: 326

510,244 shares were shorted yesterday
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ajshare
Posted on: May 28 2019, 04:28 PM


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Posts: 326

Doesn't look like as it is lot higher than overall short positions.

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ajshare
Posted on: May 28 2019, 04:16 PM


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Posts: 326

I haven't seen a day like this before on CUV. Somebody just pumped $30m at 4.00pm
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ajshare
Posted on: May 28 2019, 04:05 PM


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Posts: 326

Crazy Market Depth
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ajshare
Posted on: May 27 2019, 10:45 AM


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Posts: 326

--delete--
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ajshare
Posted on: May 27 2019, 10:32 AM


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Posts: 326

There are only two path from here - Approval or slight delay. Enjoy the all time high's 33.32
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ajshare
Posted on: May 23 2019, 11:52 AM


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Posts: 326

Nearly 46% sell volume coming from the shorts in past few days..

https://www.shortman.com.au/stock?q=cuv
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ajshare
Posted on: May 23 2019, 11:35 AM


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Posts: 326

Another 30K gobbled up..
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ajshare
Posted on: May 17 2019, 01:14 PM


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Posts: 326

Search for Clinuvel brings this up in results like last time...may be something is coming sooner.

Press Announcements | FDA
https://www.fda.gov/news-events/fda-newsroo...s-announcements
6 hours ago - Press Announcements. Note: Press announcements from 2004 to 2015 are available through the FDA.gov ArchiveExternal Link Disclaimer. Some links in press ...
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ajshare
Posted on: May 17 2019, 01:01 PM


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Posts: 326

Anybody with full access to this:

Rudi’s View: Link Admin, Clinuvel Pharma & Altium

https://www.fnarena.com/index.php/2019/05/1...-pharma-altium/

There is a mention of
-June Rebalance For ASX200 Index
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ajshare
Posted on: May 15 2019, 02:27 PM


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Posts: 326

https://www.fool.com.au/2019/05/15/why-near...in-12-months-2/
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ajshare
Posted on: Mar 25 2019, 10:52 AM


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Posts: 326

Another big transaction gone through this morning.

10:45am AEDT 25.30 218,800

5,535,640.00
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ajshare
Posted on: Mar 18 2019, 10:42 AM


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Posts: 326

Thanks. I saw 17 transactions on my NAB brokerage account between the hours of 17:00pm and 07.39am and all of them were for 43,139 shares each with SXXT. May be an error or repeat of the same transaction. Not sure.

Also for sure about 1.2m shares came on the sell side during CSPA 4.00pm




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ajshare
Posted on: Mar 16 2019, 01:26 PM


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Posts: 326

I am not sure if any of you were watching the CSPA action and the total number of shares that came on the market was close to 1.2 million. Due to mismatch in bid and offer the whole lot could not be executed by 4.10pm and was sorted out after the market close.

So after the market close the remaining 733533 also changed hands!!!! Not sure if the volume will show up.

Is anyone able to see and confirm this??
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ajshare
Posted on: Mar 15 2019, 11:32 AM


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Posts: 326

29.80 now All I can say is Wow!!!Recent weeks volume and price action suggest someone wants to takeover...I was thinking ASX200 all this time, but this is on a complete different tangent
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ajshare
Posted on: Mar 6 2019, 11:59 AM


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Posts: 326

Hope he leaves us with a departing gift.
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ajshare
Posted on: Mar 3 2019, 08:58 AM


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Posts: 326

After ignoring CUV for a long time FOOL has started liking it now.

https://www.fool.com.au/2019/03/03/how-you-...ars-on-the-asx/



https://www.fool.com.au/tickers/ASX-CUV/
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ajshare
Posted on: Feb 27 2019, 09:03 AM


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Posts: 326

opening at $25.00....first major milestone. We are quarter of the way through.
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ajshare
Posted on: Feb 25 2019, 08:39 AM


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Posts: 326

No of shares are lot higher and not as tightly held which creates higher volume.
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ajshare
Posted on: Feb 23 2019, 12:00 PM


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Posts: 326

Trending Stock and Strong Buy
http://www.mysmarttrader.com/top-picks.aspx
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ajshare
Posted on: Feb 13 2019, 06:46 PM


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Posts: 326

I think it is looking pretty good unless sky falls. it is at number 175 in all listed ASX companies by market cap as of close today. The volume and price action is suggesting a much higher price before the index is rebalanced so chances are even better by the day....GLTA and hold tight.

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ajshare
Posted on: Feb 9 2019, 06:10 PM


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Posts: 326

Not sure if it is outdated or new as unable to open PDF
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ajshare
Posted on: Feb 9 2019, 05:48 PM


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Posts: 326

Tolhurst Noall – update

https://www.clinuvel.com/investors/analyst-...update-21-02-07
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ajshare
Posted on: Jan 20 2019, 08:27 PM


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Posts: 326

Every time iggy spray's the sh*t the shares go up. I always buy big when he is in full force...thanks iggy for your indicators.
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ajshare
Posted on: Nov 21 2018, 12:02 PM


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Posts: 326

CUV is no longer required to issue Quarterly 4C reports as they have been running in profit.
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ajshare
Posted on: Nov 12 2018, 09:57 PM


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Posts: 326

Clever way to make people spit their shares...
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ajshare
Posted on: Nov 6 2018, 03:43 PM


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Posts: 326

Last known major and institutional CUV shareholders. I am sure FIL must be sold out by now and PW has managed to reach the TOP spot. FDA acceptance will bump it further.
Attached File(s)
Attached File  cuv.pdf ( 80.19K ) Number of downloads: 99

 
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ajshare
Posted on: Oct 31 2018, 08:14 PM


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Posts: 326

Magellan Pipeline report now has a FDA Approval date of 25/02/2019

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Attached File(s)
Attached File  mrx_pipeline_october_2018_web_mrx1119_1018.pdf ( 994.34K ) Number of downloads: 216

 
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ajshare
Posted on: Oct 31 2018, 08:11 AM


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Posts: 326

Cash receipts from customers for the quarter were $10,705,000, an 89% increase compared to the same quarter last year ($5,638,000 for the July to September 2017 quarter) and a 3% increase compared to the previous quarter ($10,388,000 for the April to June 2018 quarter). Orders received from European Erythropoietic Protoporphyria (EPP) Expert Centres (EEECs) continue to reflect the seasonal demand for SCENESSE® (afamelanotide 16mg) in the northern hemisphere where orders for SCENESSE® increase in spring, summer and autumn when EPP patients are at a heightened risk of phototoxic and anaphylactoid reactions.

The cash balance as of 30 September 2018 was $44,391,000, an increase of $8,193,000 to the 30 June 2018 cash balance and an increase of $16,452,000 to the 31 December 2017 cash balance.

--------------------
Sitting on a cash pile of $44m and 10m+ in cash receipts. Great result. Wow!
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ajshare
Posted on: Oct 23 2018, 06:42 PM


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Posts: 326

I do not have access to paywall, but in short the reason is as below.

Longer wait for FDA ruling on Opdivo and Yervoy sBLA. ... The OS analysis was also submitted to the FDA, which determined that the submission of this new information constituted a major amendment to the sBLA and told B-MS on Friday that the review period has been extended by three months.
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ajshare
Posted on: Oct 23 2018, 01:45 PM


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Posts: 326

Looks like many are getting delays!!!! Longer wait for FDA ruling on Opdivo and Yervoy sBLA

https://www.thepharmaletter.com/article/lon...and-yervoy-sbla
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ajshare
Posted on: Oct 16 2018, 06:40 PM


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Posts: 326

CLINUVEL steps closer to making SCENESSE available in UK????

https://www.finnewsnetwork.com.au/archives/...work200884.html
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ajshare
Posted on: Oct 16 2018, 06:20 PM


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Posts: 326

I can see the EPP USA Bar moving forward in this updated pipeline chart....


https://www.clinuvel.com/images/CLINUVEL_pi...ed_Oct_2018.png
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ajshare
Posted on: Oct 11 2018, 10:34 AM


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Posts: 326

For a company like CUV, PE can be easily around 80 to 250 so do not get worried. Focus on next 6 to 12 months..
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ajshare
Posted on: Oct 8 2018, 09:00 AM


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Posts: 326

new name....

Daniela Schaefer
VP Global Business Development
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ajshare
Posted on: Oct 8 2018, 09:00 AM


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Posts: 326

SACHS 18TH BIOTECH IN EUROPE FORUM PRESENTATION

Nothing new..
https://www.asx.com.au/asxpdf/20181008/pdf/...1lz45q14r6h.pdf
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ajshare
Posted on: Oct 8 2018, 08:57 AM


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Posts: 326

As far as I know ACN 108 768 896 Pty Ltd is PW's shareholding company.
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ajshare
Posted on: Sep 20 2018, 01:13 PM


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Posts: 326

Posted by UHO in March on Google
--------------
XP is an orphan disease which leads to skin cancers quickly in youth with not a lot of patients/revenues.
But..........

If you map its gene expression pathways relative to Mcr1 and what Sceness expresses at the start of the map trail, and the millions without the gene aberration of XP whom in later life get skin cancer...............the evidence already is not questionable or conflicted to scientific community or to FDA or EMA that just one bifurcation pathway leads to a tan and one simultaneously leads to deoxyribonucleicacid recognition and repair inside nuclei.

The tan pathway is incontrovertibly self evident to prevent delay XP sufferors from cancer..........and the enhanced recognition and dna repair for 3 million plus USA skin cancers of all types and skin aging as a preventative at the earliest possible age throughout entire life.

Scenesse for an 80 year old Caucasian whom just gets diagnosed with any type of skin cancer and or the subtypes of them will be helpful.

But Scenesse will be tremendously more helpful preventativeof skin cancer for the Caucasian 8 year old.

This is a monetization of Scenesse to a available patient market of at least 1 billion patients on a continual lifelong basis way beyond 3 million skin cancer diagnosis USA. It would actually foolish for every Fitzpatrick I or II or III, or anyone whom has a parent with skin cancer to not be using a Scenesse on skin. Youthfulness in skin will not just be a cliche advertising in appearance for legal purpose but for real.

A map of Scenesse biological pathways goes thru XP and is a treasure map.

-----------------------------------
So the priority review voucher for pediatric orphan EPP & XP is in play as well - along with adult XP.

They must be doing the trials quietly to reach Phase II without much information.
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ajshare
Posted on: Sep 20 2018, 10:18 AM


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Posts: 326

I think "Rolling Review" is the king here...Clinuvel got lots of $100bills tucked away doing nothing devilsmiley.gif
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ajshare
Posted on: Sep 20 2018, 10:15 AM


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Posts: 326

Not sure..it showed me this page updated 6 hours ago and we are on number two. Whether they are adding or deleting we will find out.
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ajshare
Posted on: Sep 20 2018, 10:13 AM


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Posts: 326

Thats right. All the NDA mention is now with "Rolling Review"

SCENESSE® awaiting PDUFA date “orphan” porphyria (EPP)

Just noted that new indication in PII on conclusions page.

Photoprotection, DNA repair is coming faster.
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ajshare
Posted on: Sep 20 2018, 10:05 AM


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Posts: 326

NASDAQ Conference Presentation
https://www.asx.com.au/asxpdf/20180920/pdf/...h4yvy318qly.pdf

Webcast
https://edge.media-server.com/m6/p/34dvbwgm
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ajshare
Posted on: Sep 20 2018, 07:45 AM


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Posts: 326

Is NICE doing a U-turn...it seems like further assessment

https://www.rcpath.org/profession/guideline...sultations.html
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ajshare
Posted on: Sep 20 2018, 07:34 AM


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Posts: 326

Don't be too concerned as we will get approval in 2019. Below is a precedent about Alkermes ALKS5461 who had "rolling-review" and it was not an orphan drug.

April 2 2018

Alkermes PLC's hopes to launch a potential blockbuster depression drug later this year have been dashed. The company announced April 2 that it received a refuse-to-file letter from FDA for a new drug application (NDA) for ALKS 5461 for major depressive disorder in patients with an inadequate response to standard antidepressants.

FDA is requesting additional clinical trials before reviewing the application, which suggests a lengthy delay and is particularly problematic for Alkermes given that several other drug developers are circling in on the treatment-resistant depression market.

The refuse-to-file (RTF) letter surprised some investors mainly because management has sounded confident about FDA acceptance and approval later this year, though some investors had remained skeptical because of the data package. During the company's fourth quarter call in February, CEO Richard Pops talked about 2018 as being a year of investment to lay the foundation for growth ahead of the launch of ALKS 5461. (Also see "Late-Stage CNS Drugs Key For Alkermes, But Early-Stage IL-2 Agonist Fascinates" - Scrip, 28 Feb, 2018.)

The company's stock opened 19% lower April 2 on the news at $46.75, and closed down nearly 33% at $45.23. Investors will not be reassured by the fact Pops sounded so surprised about the turn of events during a same-day conference call.

"We have had many interactions with FDA over many years, culminating in a pre-NDA meeting last summer, which led to the commencement of our rolling submission," he said. "While we expected there to be questions during the review process, in none of these interactions did FDA raise concerns which would lead us to expect an RTF."

Alkermes initiated the rolling NDA submission in August 2017, a pathway open because the drug had a fast track designation from FDA, which is intended to help facilitate a faster review of drugs that treat serious conditions or address unmet medical needs. In that way, the letter is unexpected because Alkermes had the opportunity to meet with FDA and agree on the content and timing of the NDA submission.

At the same time, some investors and analysts had remained skeptical that FDA would approve the NDA based on the results of a single Phase III trial. The regulatory approach was considered risky since one trial, FORWARD-5, was positive, but two prior Phase III trials had failed. (Also see "Will Alkermes Data Package Support ALKS 5461 Approval?" - Pink Sheet, 23 Oct, 2016.)

The package included data from four randomized placebo-controlled studies, including Phase II studies, with over 1,500 patients. Another Phase III trial is ongoing.

As Barclays analyst Douglas Tsao put it in a same-day research note, "While we didn't think approval of ALKS 5461 was a certainty, we're surprised that the FDA refused to accept the NDA to review based on a lack of sufficient evidence considering Alkermes' management's confidence in recent months."

More Clinical Studies Needed
The letter cites concerns from FDA about insufficient evidence of overall effectiveness, which doesn't bode well for a quick turnaround of the NDA. A substantial delay could put Alkermes at a competitive disadvantage, given that several rival drugs are advancing through late-stage development in depression, including Johnson & Johnson's esketamine for treatment-resistant depression and SAGE Therapeutics Inc.' brexanolone for postpartum depression. (Also see "How 2018 Will Affect The Depression Market" - Scrip, 7 Feb, 2018.)

Evercore ISI analyst Umer Raffat highlighted the competitive dynamics in an email to investors. "This FDA delay compresses the timelines further amidst several competitor programs making meaningful progress in the depression space," he said. "As a result, we are lowering our peak sales potential (and probability of success) to $800m from $1.2bn."

FDA is requesting additional clinical trials be completed for ALKS 5461 prior to resubmission. The agency has also requested a bioavailability study be conducted to generate additional bridging data between ALKS 5461 and the reference drug buprenorphine.

"This is surprising and troubling to us," Pops said, since the results of the data had been previously shared with FDA in two separate meetings and presented at a major medical meeting.

"FDA did not express their view that the evidence of effectiveness was insufficient to support a full review of the NDA," he said. "We obviously disagree with FDA's conclusions, and we expect them to only render final judgement after a complete review of the NDA."

Alkermes plans to appeal FDA's decision. Pops said the company will immediately request a Type A meeting with FDA to determine the next steps. The company said it may also need to revise its 2018 financial guidance.

The company forecasted in February that revenues would grow to $975m to $1.015bn this year, driven by currently marketed drugsVivitrolandAristada, but Alkermes also expected a substantial increase in SG&A expenses driven by commercial investment in ALKS 5461.

ALKS 5461 is a novel oral medicine that acts as an opioid system modulator. It is positioned as an add-on therapy for patients with MDD who don't respond adequately to current therapies. It is a fixed-dose combination of the partial mu-opioid receptor agonist and kappa-opioid receptor antagonist buprenorphine and a mu-opioid receptor antagonist samidorphan.
--------------------------

Two weeks later NDA was accepted by FDA
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ajshare
Posted on: Sep 14 2018, 04:17 PM


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Posts: 326

thumbdown.gif
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ajshare
Posted on: Sep 14 2018, 11:39 AM


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Posts: 326

Also SGR

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ajshare
Posted on: Sep 14 2018, 11:17 AM


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Posts: 326

suspect they need CASH.
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ajshare
Posted on: Sep 12 2018, 10:28 AM


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Posts: 326

I am sure we will see a new substantial shareholder emerging in next few weeks!!!!!!
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ajshare
Posted on: Sep 10 2018, 02:13 PM


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Posts: 326

Might have to call it a week today!!!!!! biggrin.gif
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ajshare
Posted on: Sep 10 2018, 11:03 AM


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Posts: 326

Are we looking at the same thing???The buying is not coming from offers...probably an insto taking a position.
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ajshare
Posted on: Sep 9 2018, 05:37 PM


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Posts: 326

World Orphan Drug Congress 2018
6 - 8 November
Crowne Plaza Hotel Barcelona, Barcelona

Patient empowerment in access negotiations: The case of “afamelanotide” for the treatment of the ultra-rare light intolerance erythropoietic protoporphyria

Jasmin Barman, Scientific Advisor, SGP
http://www.porphyriafoundation.com/content/Jasmin-Barman
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ajshare
Posted on: Sep 9 2018, 05:20 PM


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http://www.pharmatimes.com/news/nice_u-tur...rysvita_1251387

NICE u-turn approves funding for rare disease therapy Crysvita

The annual cost of treatment, based on Crysvita’s list price, is estimated to range from £77,792 for someone aged one to five, and up to £388,960 for a 16/17 year old (up to 60kg).
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ajshare
Posted on: Sep 8 2018, 05:15 AM


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Posts: 326

Thanks Peter. Love your awesome work and the only analyst coverage that exists out there. Obviously management may have some "madness to the method", but filling that gap was very important and you have done that very well.

If you don't mind I have shared the link to your updated report.

http://www.equitystory.com/Download/Resear...907_english.pdf
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ajshare
Posted on: Sep 7 2018, 07:11 PM


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Posts: 326

Is anybody going to attend Clinuvel's presentation today in New York??


25TH ANNUAL NEWSMAKERS IN THE BIOTECH INDUSTRY - NEWSMAKERS

View Printable Schedule

NewsMakers presents a hand-picked group of public biotech companies whose corporate and regulatory milestones will drive stock prices. NewsMakers is recognized as the industry's key venue for companies to take their story to Wall Street each Fall. Thus, NewsMakers remains the best opportunity for business development executives and key members of the institutional investment and analyst communities to compare notes and assess the industry landscape.

Last year, more than 500 delegates congregated at NewsMakers, including money managers who controlled more than $600 billion in equity assets, with over $50 billion dedicated to healthcare and $15 billion dedicated to biotech.

LOCATION:
Millennium Broadway Hotel & Conference Center
New York City


DATE:
September 7, 2018
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ajshare
Posted on: Sep 7 2018, 08:43 AM


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https://pink.pharmaintelligence.informa.com...-Public-Hearing

Will NICE Change Its Mind On Scenesse After UK Public Hearing?
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ajshare
Posted on: Sep 7 2018, 08:40 AM


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Last year there were 73 RTFs and only 25 companies announced to the market while SEC was sleeping as well. If the FDA was that competent or sure they can post the RTF on their website.

Clinuvel has orphan, fast track and rolling and I could not find a precedent of a company having all three and getting a RTF.


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ajshare
Posted on: Sep 6 2018, 11:23 PM


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Just trying to look at other companies this year who had fast track etc. and recd. a RTF for their NDA

Came across Alkermes who had a RTF on 30 March

http://phx.corporate-ir.net/phoenix.zhtml?...eNews&nyo=0

FDA accepted the application after 18 days later with some clarification and without any new documents..
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ajshare
Posted on: Sep 6 2018, 08:57 AM


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Posts: 326

I think all we need to do at the moment is keep some patience. I won't believe an RTF until I see the disclosure about and don't shoot the management as yet without knowing the full details.

Also note that while these are not required timelines - they are targets, but the FDA can exceed them if necessary - they are the de facto timelines in almost all cases. Over the past few years, FDA has met the target dates above for about 95% of drugs under review. So we are in the 5%.....

One last thing to keep in mind that we are in D & D division who are at snails pace. I don't believe that we have a major deficiency otherwise it would have been a clear RTF.

A minor deficiency is one that in FDA’s judgment can be easily remedied. As a result, FDA will allow the applicant a prescribed time period (described below in this section) to provide a
response to such deficiencies. In particular, if FDA determines that an ANDA contains ten or more minor deficiencies or one or more major deficiencies, FDA will consider such an
application not sufficiently complete to permit a substantive review under 21 CFR 314.101(b)(1). In such cases, FDA will notify the applicant that FDA considers the ANDA not to have been
“received.” If the applicant decides to submit additional materials to correct the deficiencies the resulting amended ANDA will be considered a new ANDA submission, received as of the
date the amendment to the ANDA is received, and the applicant will be required to pay a new GDUFA fee.

However, if FDA determines that an ANDA contains fewer than ten minor deficiencies (i.e., nine deficiencies or fewer), FDA will notify the applicant of the deficiencies, usually by phone, email, or fax. If the applicant subsequently satisfactorily amends the ANDA to correct the identified deficiencies within 7 calendar days and FDA makes the determination to receive the application as amended, the application will be considered received as of the date on which it was first submitted to FDA. If within 7 calendar days the requested information is not received, FDA will refuse-to-receive the ANDA.

There may be circumstances, however, under which an exception to, or a waiver of, a regulatory requirement may be granted. FDA will consider the merits of such circumstances on a case-by case basis.
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ajshare
Posted on: Sep 4 2018, 06:43 PM


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Posts: 326

Who is acquiring all these shares????? Haven't seen anything on new substantial holders apart from WB
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ajshare
Posted on: Sep 4 2018, 05:39 PM


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Posts: 326

I was trying to workout how it reached at $65+ value. Currently looks like a pie in sky, but $15 looked the same couple of years ago. Below is the link for the model used to workout dcf and fcf.

https://github.com/SimplyWallSt/Company-Ana...d-cash-flow-dcf
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ajshare
Posted on: Sep 4 2018, 05:13 PM


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Posts: 326

05 September comes up as day 74 which will be 6th in Australia....waiting for the FDA gods to bless.

Meanwhile..enjoy this analysis.
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ajshare
Posted on: Sep 2 2018, 08:54 PM


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Posts: 326

The focus is now on happening on Vitiligo too...

https://www.instagram.com/p/BnJWhRID-fo/?ta...pharmaceuticals

A study submitted on WJPR last week..

CONCLUSION
Acquired cutaneous disorder of pigmentation i.e. vitiligo was studied. Their types, symptoms,pathogenesis and recurrent treatment was studied. Also melanin synthesis pathway and effect
of autoantibodies was studied. Afamelanotide is a synthetic analogue of naturally occurring alpha-melanocyte stimulating hormone, which has a potent long lasting properties. It's chemical structure and action of mechanism was studied. Afamelanotide implant brand named as SCENESSE® (afamelanotide 16mg) did give a novel and potentially effective treatment to vitiligo and EPP.

Attached File(s)
Attached File  article_wjpr_1535717939.pdf ( 592.06K ) Number of downloads: 112

 
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ajshare
Posted on: Sep 2 2018, 08:13 PM


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Posts: 326

Still talks about Clinuvel...

http://martinshkreli.com/

8/31/18
Biopharma/Investing
————————-
Much as been made of the WSJ report on investment bank biotech commentators earning several million dollars of annual compensation. One should not be distracted. In the peak of every bull market, some participants will receive excessive rewards for no reason. This transient wealth transfer from an investment bank to an individual does not merit your envy. Once every ten years, if the excessive sum is even $5,000,000, net of taxes, the salary increase is $250,000 annually. Hardly worth getting out of bed for, let alone envying, given this excess applies only to the very few and one only has so many ten-year-cycles in his future. Indeed, do not stray for evanescent earnings–compounding is the only path.

Papers I’ve Read
——————–
Design, Synthesis, and Biological Evaluation of Pyrimido[4,5-d]pyrimidine-2,4(1H,3H)-diones as Potent and Selective Epidermal Growth Factor Receptor (EGFR) Inhibitors against L858R/T790M Resistance Mutation. Hao et al. J Med Chem 2018,61:5609-5622.
These workers produce a very potent and selective EGFR mutant:EGFR wildtype inhibitor but with very weak PK. I doubt this drug will see the light of day when compared to Tagrisso’s profile.

MC4R agonism promotes durable weight loss in patients with leptin receptor deficiency. Clement et al. Nature Medicine 2018.
Well, RYTM is a fascinating company with a fascinating drug, setmelanotide. I’m very familiar with the POMC class which includes Acthar, Synacthen, Clinuvel’s drug, this drug, non-peptide synthetics and other peptide agents. These genetic obesity illnesses are very rare, but the efficacy is profound. The small uncontrolled Phase 3 trials Rhythm are doing will probably “work”(though I’m a bit afraid of some tachyphylaxis or other weird physiological dynamics that occur in appetite control). On the business side, this is a daily drug. Clinuvel’s longer-acting compound probably will do the same thing clinically. The authors do some preclinical work demonstrating this drug engages the MC4R receptor a bit differently than alpha-MSH or a synthetic. I can believe that, I guess, but I wonder if this drug will last the test of time given all of this. Also consider metreleptin didn’t do too well for the same disease state. Fairly modest revenue for that drug, especially in context of RYTM market cap.

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ajshare
Posted on: Sep 2 2018, 08:03 PM


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Posts: 326

Coming from every direction.....


Bio Connections Australia 13-14 November 2018 | Pullman Melbourne on the Park
https://www.informa.com.au/event/conference...ions-australia/

Bio Connections Australia is a brand new event designed to foster the growth of early phase clinical research in Australia. As a unique platform for networking and discussion, the conference will explore drug development, early phase clinical trials, translational research and expediting Australia’s great science into commercialisation.


10:45 AM
Networking Break
11:15 AM
SCENESSE®: an Australian Success Story | A First-in-Class NME Addressing Unmet Clinical Need
Nicoletta Muner, Director, Global Regulatory Affairs, Clinuvel Pharmaceuticals Ltd
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ajshare
Posted on: Aug 31 2018, 05:39 PM


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Posts: 326

Its the home stretch that matters the most.......I agree that today may have helped over the finish line.
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ajshare
Posted on: Aug 31 2018, 04:24 PM


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Posts: 326

Bring it on FDA....

Date Day
31/08/2018 71
1/09/2018 72
2/09/2018 73
3/09/2018 74
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ajshare
Posted on: Aug 31 2018, 04:09 PM


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Posts: 326

Stands at 237 based on the current cap of $705 and I am certain it will be included in ASX300. Worthy for ASX200 on investment grade . Certainly!!!!!

Just $295m short of a 1 billion dollar company.
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ajshare
Posted on: Aug 30 2018, 01:04 AM


Group: Member
Posts: 326

I would assume that releasing the annual report and dividend today after market close has something to do with it. They wanted this to go to market first and release the NDA review results later.

If history is any guide they like to do big news on Friday with a trading halt.

EPS almost doubled and P/E under 50 for a growing company like Clinuvel is huge..most of the Clinuvel style biotechs do not have a positive EPS and a mountain of debt.

Happy days....
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ajshare
Posted on: Aug 24 2018, 01:09 PM


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Posts: 326

we are used to waiting in the long game so it doesn't matter 6 or 10...company is solid and product is super strong...Hope EPP patients get what they deserve and FDA brings same sense of urgency from life style diseases to genetic and metabolic diseases as well.
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ajshare
Posted on: Aug 23 2018, 06:37 PM


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Posts: 326

Expecting a trading halt tomorrow if it is a priority review...if not the chances diminish by the day for priority review. We will for sure hear by day 74 and more likely will be a standard review.

Also keep in mind dermatology division is the slowest of all so they may be just slow...

I am not an expert on it and just a guesswork.
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ajshare
Posted on: Aug 22 2018, 04:38 PM


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Posts: 326

I am also trying to get my head around this and 2800 implants is roughly $56m dollars (around 32 million in Q4 and 24 million in Q1). As they only reported cash flow at the moment we can't see it in any sales done on a 60 - 90 day account. The annual report is due next week and it is reported on accrual basis which may show some more details for at least Q4. My initial assumption was that these numbers were wrong, but that may not be the case as they reported again this week.

Let see what happens next week in prelim and if not CUV needs to clarify either the numbers, implant price, rebates etc as it is around 1600 implants in Q4 2017 2018 and approx 1200 implants in Q1 2018 - 19 so far...show us the money..... rolleyes.gif
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ajshare
Posted on: Aug 21 2018, 10:20 AM


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Posts: 326

There is one more reported number

SCENESSE® implants administered globally to date: >6,700 25 Jun 2018

so that makes approx 1200 from 25 Jun 2018 to 21 Aug 2018

44 expert EEEC - average 600 implants a month between them seems reasonable. = 13.63 implants per center per month based on 22 work days

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ajshare
Posted on: Aug 21 2018, 09:50 AM


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Posts: 326

SCENESSE® implants administered globally to date: >5,100 (>4,000 to EPP patients) 14 May 2018 Newsletter

SCENESSE® implants administered globally to date: >7,900 21 Aug 2018 Investor Presentation

Almost 2800 implants in last few months!!!!!!!!!!!!!!!.
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ajshare
Posted on: Aug 21 2018, 09:31 AM


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Posts: 326

https://www.asx.com.au/asxpdf/20180821/pdf/...hsyj916m1lc.pdf

Investor Summary. They are getting started.

complementary non-pharmaceutical products pushed in future and looks like Enfance and two other follow-on molecules are getting fast track. Being an orphan drug Enfance can get them a priorty voucher. An approved molecule should not take that much time.
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ajshare
Posted on: Aug 20 2018, 08:15 AM


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Posts: 326

They did TFWA Asia Pacific Exhibition & Conference - Singapore in May this year.....

I think it will be best to Chivere or Tsumoyle announcement with the priority review announcement as it will get the most initial free coverage..Lot of exciting things happening in next two weeks.

GLTA..
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ajshare
Posted on: Aug 17 2018, 09:55 AM


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Posts: 326

Not sure the relevance of this trial done in 2010 to the NDA review. It was submitted /updated this week

Implant Pharmacokinetic and Pharmacodynamic Study

ClinicalTrials.gov Identifier: NCT03634137
Brief Title: Implant Pharmacokinetic and Pharmacodynamic Study
First Submitted : March 29, 2010
First Submitted that Met QC Criteria : August 14, 2018
First Posted : August 16, 2018 (Estimate)
Last Update Submitted that Met QC Criteria : August 14, 2018
Last Update Posted : August 16, 2018 (Estimate)

https://clinicaltrials.gov/ct2/show/NCT03634137
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ajshare
Posted on: Aug 15 2018, 04:55 PM


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Posts: 326

Orphan Drug and fast Track may change the game...
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ajshare
Posted on: Aug 15 2018, 04:31 PM


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Posts: 326

Pretty much along the lines...
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ajshare
Posted on: Aug 15 2018, 03:30 PM


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Posts: 326

Good to see Johnny put the balls on the line. By looking at the attached chart the odds may be stacked against it given that we are in dermatology section. I hope they get it, but won't be surprised if they don't get a PR.
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ajshare
Posted on: Aug 11 2018, 03:35 PM


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Posts: 326

Good luck with .50cents. This pill is pushed like candy but it's poison
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ajshare
Posted on: Aug 10 2018, 12:19 AM


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Posts: 326

Around 4m shares sold in the last few weeks. We know WB only bought 1.3m so it can't be 90% churning!!!!who's picked up the rest? as I am sure can't be us or retail investors.




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ajshare
Posted on: Aug 7 2018, 11:50 PM


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As long as it pays off in the end..
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ajshare
Posted on: Aug 7 2018, 06:25 PM


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I have started believing in what you are saying. 1 analyst coverage in last 5 years and that too about who's next!!! Not even 1 investor webinar, conference call, presentation, Q&A even after Day 44

http://www.clinuvel.com/investors-21/analy...ho-s-next-in-oz
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ajshare
Posted on: Aug 7 2018, 11:44 AM


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Posts: 326

Do not mix hunting with being hunted as they are two completely different things. The discussion was for Clinuvel hunting for acquisition to put their millions of cash to some good use and also if they found something good and bigger with right fit, funding it with a capital raise with listing on NASDAQ.

All acquisitions are not failure and if they are right fit they can be great. I have trust in PW's ability as he usually runs a very tight ship, which is reflected in product pricing and the balance sheet.

paramour01 do you have any other info.
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ajshare
Posted on: Aug 6 2018, 08:29 PM


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Posts: 326

Recently someone made a comment that CUV is looking for acquisiton..

Clinuvel Pharmaceuticals a Melbourne-based Australian developer of drugs for skin disorders, is stepping up its acquisition hunt as its lead
compound, SCENESSE, starts a US Food and Drug Administration new drug application review.

http://interfinancial.com.au/wp-content/up...d-July-2018.pdf
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ajshare
Posted on: Aug 6 2018, 02:42 PM


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Posts: 326

Something like this will be next..............read CUV instead of INSM biggrin.gif


Insmed Incorporated INSM was a big mover last session, as the company saw its shares rise nearly 120% on the day. The move came on solid volume too with far more shares changing hands than in a normal session. The stock picked up sharply from the near-flat trend of $11.61 to $13.46 in the past one month time frame.

https://finance.yahoo.com/news/insmed-incor...-123112101.html

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ajshare
Posted on: Aug 2 2018, 10:26 AM


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Posts: 326

ASX300 is certain

Australian Financial Review this morning CUV jumping +23
https://www.afr.com/Tables/Share_Tables_Dai...rket-Tables.pdf
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ajshare
Posted on: Jul 31 2018, 05:12 PM


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Posts: 326

A rare genetic condition makes this two year-old allergic to the sun

https://www.cantechletter.com/2018/07/aller...etic-condition/

..........

But there may be some hope on the horizon for Lock. Recently, the FDA said it would review an Australian drug developed to treat EPP that is already availabel in Europe. The treatment, called SCENESSE® or afamelanotide 16mg, was developed over the past 14 years by the Australian pharmaceutical company CLINUVEL.

“Professor Elisabeth Minder, head of Biochemical Laboratory Analytics at Triemli Hospital in Zurich, who was involved in the first clinical trials of the product in EPP and continues to treat EPP patients, says it has potential to change lives.

“My patients tell me, since 2006, that this treatment facilitates a life which was unthinkable for them and their immediate families,” she said. “Therefore, I am delighted that this treatment finally nears the point of becoming available to all American EPP patients.”

A family friend has started a GoFundMe page for Charlie, to help with hospital costs.
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ajshare
Posted on: Jul 31 2018, 04:52 PM


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Review Designation Policy: Priority (P) and Standard (S)

https://www.fda.gov/downloads/aboutfda/cent...s/ucm082000.pdf
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ajshare
Posted on: Jul 31 2018, 12:12 PM


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marked as S3XT

https://www.asx.com.au/documents/products/A...o_MIRs_AGBs.pdf
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ajshare
Posted on: Jul 26 2018, 05:56 PM


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Posts: 326

PRIORITY REVIEW letters sent to the FDA!!

You are an amazing community! We had a great response to the call urgent call to action for patient letters. 511 letters, a petition, and many poignant photos were sent to the desks of decision-makers at the FDA requesting Priority Review for SCENESSE (afamelanotide 16mg).

The new drug application for this treatment was submitted to the FDA on June 22. The FDA has sixty days to decide if the filing will receive Priority Review (6 months) or Standard Review (10 months). Our EPP patients have waiting long enough for treatment. We hope receipt of these letters will help urge the FDA to select the quicker path to treatment. Nearly 6,700 doses have been implanted in over 800 patients.

https://porphyriafoundation.blogspot.com/
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ajshare
Posted on: Jul 20 2018, 12:58 PM


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Novartis to pay as much as $1 billion for skin drug rights

https://www.livemint.com/Companies/1hLEa2oN...rug-rights.html
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ajshare
Posted on: Jul 14 2018, 12:09 PM


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Posts: 326

Appeal: Porphyria (congenital erythropoietic, erythropoietic protoporphyria) - afamelanotide [ID927]

30 July 2018
NICE, 10 Spring Gardens, London, SW1A 2BU
The Institute has received four appeals against the Final Evaluation Determination on this HST evaluation. The Institute has arranged the hearing for the appeals received against the FED for the above HST evaluation. The appeal panel will convene on Monday 30 July 2018 at NICE, 10 Spring Gardens, London, SW1A 2BU to hear oral representations from the appellants.



Registration period: 20 June 2018 to 04 July 2018

https://www.nice.org.uk/event/porphyria-afamelanotide-appeal
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ajshare
Posted on: Jul 13 2018, 12:50 PM


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sorry bad English...FDA priced in was for SPL and that is why it sort of started drifting lower instead of going up. I am looking for a long wall on a yes from FDA.
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ajshare
Posted on: Jul 12 2018, 12:42 PM


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Posts: 326

I would put CUV in SRX (Sirtex) category instead of SPL..FDA review probably priced in, but CUV has many rabbits in the hat.
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ajshare
Posted on: Jul 11 2018, 01:49 PM


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Thanks. Can you please provide more details with numbers etc.
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ajshare
Posted on: Jul 9 2018, 04:42 PM


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UPDATE
UPDATE: CLINUVEL PHARMACEUTICALS - HIGHLY RELEVANT DEVELOPMENT
Published on July 7, 2018 at 16:21 by DZM Team Switzerland

Some sort of update for Clinuvel on Homms website. I am guessing providing update on B&S.

https://www.florianhommlongshort.ch/2018/07/07/clinuvel-3/
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ajshare
Posted on: Jul 9 2018, 10:08 AM


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Posts: 326

Totally agree with you that B&S will be key part in skin care lines. I think the Asian route could be through http://www.bandshk.com/ .

As they are both in distribution and retail it makes it a logical partner https://www.bs-htg.com/ . Also B&S has relationships with all premium skincare brands and with likes of Estée Lauder present at the EPP conference any tie ups are possible.
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ajshare
Posted on: Jul 6 2018, 05:56 PM


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Posts: 326

Did a lookup on Willem Blijdorp and came up with this. Looks like WB is all cashed up with a recent IPO of W&S and may come back for more....

Who is Willem Blijdorp?
The 65-year-old Blijdorp, with a 70 percent stake, is the most important major shareholder in B & S. That is a wholesaler in consumer goods, specialized in tax-free products . B & S supplies, among other things, cruise ships and operates stores at airports.

The company is completely unknown to the general public, but last year with 1,400 employees it had a turnover of 1.4 billion euros. As a major shareholder, Blijdorp is already one of the fifty richest Dutch people. Last year he was 49th on the Quote-500, with an estimated capacity of 610 million euros.

Why is Blijdorp now in the spotlight?
His company B & S will be exhibiting on Friday, March 23 . The owners - in addition to Blijdorp also chairman Bert Meulman and a group of directors - want to redeem part of their shares with the stock exchange listing. The initial public offering must also enable B & S to make more acquisitions. The company will soon be able to pay for these acquisitions in shares that can be traded on the stock exchange.

What will the Blijdorp initial public offering yield?
Thanks to the IPO, Blijdorp can redeem a large part of its shares. The prospectus published on Monday shows that he will sell at least 13.8 million shares. If it succeeds, he even sells 15.6 million. He sells these pieces for 14.50 euros to 17.75 euros. The sale is going to give him 200 million to 277 million hard euros.

What does the stock exchange listing of B & S make to him?
Thanks to the IPO, there is also a clear price tag attached to the shares that Blijdorp does not sell. For the time being, he continues to hold a 51 percent stake in B & S, or 58.5 million shares.

At the now expected value, they are worth 850 million to one billion euros. Even if the IPO is disappointing, Blijdorp will be good for 1050 million euros, and thus become billionaire. With that he will become one of the 25 richest Dutch people.

What is the secret of Blijdorp?
Blijdorp is extremely mediocre, and has hardly been in the limelight for decades. Therefore, not much is known about him. Again he does not want to be interviewed. From some investigation it appears that he certainly was not born with a golden spoon in the mouth.

His parents were fruit growers in the Noordoostpolder, and in the early 1970s he attended the Higher Hotel School in Maastricht. Then he went to work with fellow student Jacques Streng for the Groningen shipping company Kamstra. That was known at the time of the so-called butter cakes .


With advertising like this one from 1979 Blijdorp filled his tax-free boat trips.
Butter cakes?
Buttercracks are cruises where a ship can enter the international waters in a few hours, so that the passengers can make duty-free purchases. Initially, cream butter was mainly sold, later mainly liquor, cigarettes, perfumes and other luxury items.

After a few years, Blijdorp and Streng bought the Kamstra family. Strict (on round photo left) focused on the tourist activities, Blijdorp (right) collapsed on the purchase and sale of the articles. The sport was to do that as cheaply as possible.



How did Blijdorp buy as cheaply as possible?
Before that, he hunted for spare parts from manufacturers. These are items with which nothing is wrong, but which have, for example, a wrong sticker, or no new packaging.

He was also active in parallel trade, whereby brand items are bought in 'poorer' countries where they are cheaper. In addition, Blijdorp sometimes collided with manufacturers, who were not always happy that their branded items on the market were dirt cheap.

Are there examples of such a collision?
In 1999 the maker of Jack Daniëls seized large quantities of American whiskey in Blijdorp's warehouses, and dragged his company to court. That was hard at the time .

According to the whiskey producer, the attachment was frustrated to a large degree by Mr Blijdorp, despite police assistance, and was even accompanied by the threat of physical violence by Mr Blijdorp against the bailiff. "The goods were subsequently withdrawn from the herd up to two times."

What type of entrepreneur is Blijdorp?
As shown above, of the type with guts. According to his then business partner Streng, Blijdorp was already very entrepreneurial in his twenties. "We were both ambitious, willing to work hard to build up a good career, Willem clearly proved to be the better entrepreneur, I was always more conservative."

His current business partner Meulman described Blijdorp in an interview in the German magazine Entrepreneur as 'a businessman of the old stamp who is more intuitive than on sober calculation'.

Does Blijdorp still manage B & S?
After several acquisitions and the relocation of the head office to Dordrecht, in 2004 Blijdorp stepped out of the daily management of B & S. He gave the helm to his second husband Meulman, and became a supervisor himself. But as the largest shareholder he is undeniably the most important man behind the wholesale trade.

Together with his successor, Blijdorp has made a series of acquisitions in the past ten years, such as the perfume wholesaler JTG (2007), the duty-free retail chain Capi Lux (2012) and shampoohandel Topbrands (2016). The rapid growth earned them the title Entrepreneur of the Year in 2014 .

Is Blijdorp only active in the wholesale trade?
No. He sometimes also buys something outside of B & S. Sometimes he makes a hit with that. For example, around the turn of the century he and a business partner bought the internet company Wish for 600,000 euros, to sell it for 45 million to Maurice de Hond's venture capital Newconomy .
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ajshare
Posted on: Jul 6 2018, 03:24 PM


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I am thinking that Blijdorp will be also involved in distribution of the skincare range of products through his companies so it seems bullish and good news.
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ajshare
Posted on: Jul 4 2018, 02:23 PM


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23 April 2018 SAGE submitted NDA
http://investor.sagerx.com/news-releases/n...lication-us-fda

30 May 2018 SAGE announced acceptance by FDA and priority review
http://investor.sagerx.com/news-releases/n...iling-and-grant

Around 37 days

Can this happen to Clinuvel??? If so, end of this month will look good with 4Q
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ajshare
Posted on: Jul 4 2018, 02:13 PM


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Some interesting posts by clinuvel and discussions on some of the post

https://www.instagram.com/clinuvel_pharmaceuticals/
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ajshare
Posted on: Jul 2 2018, 06:33 PM


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Posts: 326

Do you think they are going to announce to the market something regarding Chivere soon or keep on hiding????
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ajshare
Posted on: Jul 2 2018, 05:55 PM


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To be published in the Official Gazette on 17 July 2018 for the purpose of opposition by any person who believes he will be damaged by the registration of the mark. If no opposition is filed within the time specified by Section 13(a) of the Statute or by rules 2.101 or 2.102 of the Trademark Rules, the Commissioner of Patents and Trademarks may issue a certificate of registration.
Attached File(s)
Attached File  79217953__4_.pdf ( 9.07K ) Number of downloads: 71

 
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ajshare
Posted on: Jun 29 2018, 10:36 AM


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End of financial year today. Last trading day of year.
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ajshare
Posted on: Jun 28 2018, 10:56 AM


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Swahili to Latin to English - I thought people be used to it by now.. rolleyes.gif
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ajshare
Posted on: Jun 27 2018, 01:10 PM


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between 7m to 10m
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ajshare
Posted on: Jun 27 2018, 01:07 PM


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Skin care range coming soon.........

CLINUVEL’s expertise in pharmacology, pharmaceuticals, medicine, dermatology and many other specialties formed the foundation for our current product offerings. Typically, one would find in our products the elementary information on lotion versus emulsion, galenic formulation versus simple topical formulations, water base versus oil base. In our skin care product lines, we provide information on skin types, individual differences and complexions, products to avoid, ingredients, organics, naturals and more. Our scientists are keen to broadcast information on our fields of expertise and encourage users to seek knowledge while using our products.

http://www.clinuvel.com/clinuvel/company-o...oduct-offerings
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ajshare
Posted on: Jun 26 2018, 09:10 AM


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https://www.empr.com/drugs-in-the-pipeline/...article/775779/

EPP patients are affected by exposure to sun- and artificial-light

A New Drug Application (NDA) for the treatment of erythropoietic protoporphyria (EPP) – a rare blood disorder in which patients experience severe biochemical reactions following light exposure – has been submitted to the Food and Drug Administration (FDA).

Due to an enzyme deficiency, EPP patients experience burns, ulcers, and phototoxicity when exposed to sun or artificial light. Scenesse (Clinuvel Pharmaceuticals) is a bimonthly, subcutaneous dose of afamelanotide 16mg. The treatment works by activating melanin in the skin, which can shield chemicals in the blood from light.

Two multicenter, randomized, double-blind, placebo-controlled Phase 3 trials (N=168) compared subcutaneous afamelanotide 16mg vs placebo every 60 days in patients with EPP in the US and Europe. The primary efficacy endpoint was the number of hours of direct exposure to sunlight without pain.

The data showed that the duration of pain-free time was longer in the US afamelanotide group vs placebo group after 6 months (69.4 hours vs 40.8 hours; P =.04) and in the European afamelanotide group vs placebo group after 9 months (6.0 hours vs 0.8 hours; P =.005); the incidence of phototoxic reactions was also lower in the European afamelanotide group (77 vs 146, P =.04). In both trials, the use of afamelanotide improved quality of life.

The FDA previously granted the treatment Fast Track designation in 2016. Scenesse has been authorized in Europe for use in adult patients with EPP since 2014. The Company expects the FDA's review of the NDA to be completed by 2019.
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ajshare
Posted on: Jun 26 2018, 08:58 AM


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Posts: 326

Update report from Sphene Capital

Edit: sorry duplicate post. same link as 0d01
Attached File(s)
Attached File  Clinuvel_UpdateReport20180625_english.pdf ( 433.79K ) Number of downloads: 330

 
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ajshare
Posted on: Jun 25 2018, 10:35 AM


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Posts: 326

New media contacts in announcement with Lachlan Hay

Media enquiries
Europe: Lachlan Hay, CLINUVEL (UK) LTD. +44 1372 860 765 Lachlan.Hay@clinuvel.com
USA: Terri Clevenger, Continuum Health Communications, +1 (203) 227-0209,
tclevenger@continuumhealthcom.com
Australia: Rudi Michelson, Monsoon Communications, +61 3 9620 3333, rudim@monsoon.com.au
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ajshare
Posted on: Jun 25 2018, 10:08 AM


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Posts: 326

Why do a trading halt for a submission only? May be a big deal fro CUV. Nevertheless, It is a good news and finally we can move forward.
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ajshare
Posted on: Jun 24 2018, 03:36 PM


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Posts: 326

Okay. My prediction is that we have priority review. My theory as below:

1. Shortly after the 14th May update the NDA or efficacy supplement was submitted - if it was done before it will be telling a blatant lie to the market. Although there was no need for this update CUV wanted to postpone the 20th May announcement date for new product launch, which was not ready.

2. 1st June performance rights to the management was for condition E, which although met earlier was promised to the management only after NDA is submitted as the timing of it was very odd. This also resulted in signalling to the people in know how that the NDA is submitted. Share price dropped on ASX by selling few thousand shares to create a tree shake and over 300K shares bought in Europe market and ever since. The same thing happened few weeks before EMA authorisation and the share price collapsed from $4.75 on 15/9/2014 to $2.38 on 13/10/2014. The trading halt came on 24/10/2014 and EMA authorisation announced on 27/10/2014.

3. FDA makes a priority review decision within 14 days after the NDA submitted and if a priority review is granted everything is expedited as compared to standard review. (Reference as below from Review Designation Policy: Priority (P) and Standard (S)

RESPONSIBILITIES AND PROCEDURES
 The White Oak Document Room (DR1) is responsible for:
 Attaching the User Fee Validation Form to each application, when applicable.
 The Review Team is responsible for:
 Recommending a review designation to the division director for each NDA,
BLA, and efficacy supplement within 14 days. The recommendation is made
only if the application is to be filed.
 Identifying, within 14 days of receipt of an original NDA; original BLA; or
efficacy supplement, whether the application may qualify for a priority review
designation. If an application is expected to qualify for a priority review
designation, the filing meeting will be scheduled to occur by Day 30, instead
of by Day 45 (the filing meeting date for standard reviews).



MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 6020.3 Rev. 2
determination of the review designation and timeline for the first review cycle
will be determined by the division director at the filing meeting.6
 The Division Director is responsible for:
 Determining final review designation for each NDA, BLA, or efficacy
supplement no later than the filing meeting if the application is to be filed.
The division director will consider the recommendations of the review team
members.
 Communicating the final review designation to the regulatory project
manager (RPM).


4. As Clinuvel is under expedited program due to Fast Track and rolling review and now priority review, RPM is making it happen a bit earlier(still within 60days).

REST we will find out tomorrow or Tuesday.

I am sure that JULY will have many pending announcements coming through including NME - novel molecules CUV9900 and VLRX001, ENFANCE, non-prescriptive products and much more.
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ajshare
Posted on: Jun 24 2018, 01:10 PM


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Posts: 326

Correct numbers and performance conditions attached. PW is around 924K
Attached thumbnail(s)
Attached Image

Attached Image


 
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ajshare
Posted on: Jun 22 2018, 01:57 PM


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Posts: 326

Don't agree with you. It is 2 business days. You can see the trading halt on 11th March 2016. They started trading back on 15th March.

  Forum: By Share Code

ajshare
Posted on: Jun 22 2018, 12:24 PM


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Posts: 326

Pain Trials announced NDA submission on 13th Feb and PDUFA date on 1st March so I am guessing within 60 days does not mean after or 60th day so there is a possibility that they are announcing on Monday or Tuesday morning along the lines.

http://investor.paintrials.com/press-relea...e=10&page=0
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ajshare
Posted on: Jun 22 2018, 11:24 AM


Group: Member
Posts: 326

I sure did. Was lucky to have my buy order filled at $10.30 and within half an hour it just changed the course.
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ajshare
Posted on: Jun 22 2018, 10:26 AM


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Posts: 326

Most likely they have got priority review with NDA submission. It can't be a rejection that early which can be announced to market so I am convinced that is all good news.
  Forum: By Share Code

ajshare
Posted on: Jun 22 2018, 10:08 AM


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Posts: 326

https://www.asx.com.au/asxpdf/20180622/pdf/...z4kf4zvq557.pdf
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ajshare
Posted on: Jun 22 2018, 10:06 AM


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Posts: 326

CUV in trading halt.
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ajshare
Posted on: Jun 22 2018, 12:00 AM


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Posts: 326

I wish Scenesse was available to stop Melanoma.....

AN AUSTRALIAN man has described the staggering decision to pay $100,000 for a treatment that could mean life or death

https://www.news.com.au/lifestyle/health/he...93336a29284aec9
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ajshare
Posted on: Jun 21 2018, 04:01 PM


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Posts: 326

PW message to SS
Attached image(s)
Attached Image

 
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ajshare
Posted on: Jun 21 2018, 03:57 PM


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Posts: 326

PW to LH on NDA submission
Attached image(s)
Attached Image

 
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ajshare
Posted on: Jun 21 2018, 03:56 PM


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Posts: 326

PW to shareholders
Attached image(s)
Attached Image

 
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ajshare
Posted on: Jun 21 2018, 12:00 PM


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Posts: 326

I am expecting the unexpected.

Meanwhile -

https://stockhead.com.au/health/ma-watch-wh...biotech-sector/

https://simplywall.st/stocks/au/pharmaceuti...limited-asxcuv/
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ajshare
Posted on: Jun 14 2018, 06:15 PM


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Posts: 326

Squamous cell carcinoma

http://www.innovateus.net/health/how-squam...rcinoma-treated

Topical creams:
QUOTE
Afamelanotide topical application
is used to stimulate the production of melanin by the melanocytes, thus making it useful to prevent skin squamous cell carcinoma. Melanin helps by protecting skin against the harmful effects of UV rays.

Does anyone heard about Afamelanotide topical application or this article is BS?
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ajshare
Posted on: Jun 6 2018, 06:49 PM


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Posts: 326

I don't understand German either but I use google translate to give me English subtitles. I have attached the screen shot which shows how you can do it. starts at 5.44

https://youtu.be/rftch-jOHC8?t=345

Attached thumbnail(s)
Attached Image



 
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ajshare
Posted on: Jun 6 2018, 11:13 AM


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Posts: 326

Florian Homm video. suggest 30 bagger. around 5.40

https://www.youtube.com/watch?v=rftch-jOHC8
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ajshare
Posted on: Jun 5 2018, 09:48 AM


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Posts: 326

At No. 298 CUV made into AFR Top300

The AFR National Markets table is a weekly summary of trading in all main board ASX stocks, using the AFR’s own direct data feed from the Australian Stock Exchange. The Top 300 is a quick reference for investors concentrating in these stocks.

https://www.afr.com/Tables/Share_Tables_Dai...rket-Tables.pdf
  Forum: By Share Code

ajshare
Posted on: Jun 1 2018, 05:14 PM


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Posts: 326

I am sure we will find out more on Monday if they care to announce. F doesn't make sense in 2017 report anyway as it was over 10m euro in 16/17
  Forum: By Share Code

ajshare
Posted on: Jun 1 2018, 04:46 PM


Group: Member
Posts: 326

Thanks. Looks like could be E or F as the change of directors interest notice has not been issued and that rules out A,B, C, D.
  Forum: By Share Code

ajshare
Posted on: Jun 1 2018, 04:37 PM


Group: Member
Posts: 326

Normally there is a change of directors interest notice following 3B...hopefully tomorrow morning will bring a clear picture. I think it is linked to NDA as nothing else has happened to give performance shares and all the EMA related ones are already issued.
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ajshare
Posted on: Jun 1 2018, 02:53 PM


Group: Member
Posts: 326

Can't work out what this performance issue relates to.

2014 AGM document attached,. May be some of you will work out..as the numbers don't match or everyone else got theirs except PW

https://www.asx.com.au/asxpdf/20141027/pdf/...6t06kgrcyrr.pdf
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ajshare
Posted on: Jun 1 2018, 02:14 PM


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Posts: 326

What is this related to? Can you please enlighten.
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ajshare
Posted on: Jun 1 2018, 02:05 PM


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Posts: 326

From Investek
Attached thumbnail(s)
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ajshare
Posted on: Jun 1 2018, 01:55 PM


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Posts: 326

Looks like ti has been issued to PW..so must be NDA related.
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ajshare
Posted on: Jun 1 2018, 01:44 PM


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Posts: 326

New issue announcement,
application for quotation of additional securities
and agreement

Is it related to NDA!!!!!

Is NDA submitted??

https://www.asx.com.au/asxpdf/20180601/pdf/...h0l9ntbgqr9.pdf
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ajshare
Posted on: May 28 2018, 08:59 PM


Group: Member
Posts: 326

People need six implants and not four as the health insurance company are supporting only four becoming a problem for some

Article and link below:

QUOTE
But there is a catch: when treated in Switzerland, the health insurance companies support four treatment cycles, with doctors recommending a refresher every second month. After an initially successful treatment Jolina Braun suffered a strong relapse. The refresher of her drug came too late. Now it's the beginning of summer and she can not go to the playground with her children again.



https://www.focus.de/gesundheit/ratgeber/ha...id_8953918.html
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ajshare
Posted on: May 23 2018, 01:13 PM


Group: Member
Posts: 326

Post-Brexit UK needs to commit to life sciences strategy
https://www.aapsnewsmagazine.org/articles/2.../psu-2018-may2b
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ajshare
Posted on: May 22 2018, 03:33 PM


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Posts: 326

"FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example analgesics or antacids. For each class, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients. New products that conform to a final monograph may be marketed without further FDA review. Those that do not conform must be reviewed by the New Drug Application process. A drug company may also petition to change a final monograph to include additional ingredients or to modify labeling. "

Can the above apply to Scenesse or it is only OTC related?
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ajshare
Posted on: May 15 2018, 08:28 PM


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Posts: 326

I use nabtrade 14.95 per trade. Try

https://www.canstar.com.au/online-trading/
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ajshare
Posted on: May 13 2018, 12:03 PM


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Posts: 326

65K CUV
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ajshare
Posted on: May 4 2018, 06:31 PM


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Posts: 326

Belgian Final List as on 30/4/2018 . Not sure about any distribution in Belgium

Belgian Final List
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ajshare
Posted on: Mar 28 2018, 08:49 AM


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Posts: 326

Newsletter out

https://www.asx.com.au/asxpdf/20180328/pdf/...sdtbf2430nz.pdf
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ajshare
Posted on: Mar 19 2018, 12:47 PM


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Posts: 326

You are right about page 40 timeline where the Expert EPP Meeting does lineup with Priority Review Decision. However, I think that we will hear about Priority Review decision in 4-6 weeks from now. I am pretty sure that if they get it PW would sell it.
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ajshare
Posted on: Mar 19 2018, 09:15 AM


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Posts: 326

QUOTE
======Feb Newsletter=======
At present our statisticians are pooling the European data on real-time use and clinical trial data before submission of the final clinical module. In evaluating the use of the SCENESSE® in EPP, the focus is on safety, frequency of use, altered lifelong behaviour following drug treatment, and quality of life.

Once the final module is submitted, our teams will report on the safety aspects to date as observed during last year’s post-authorisation distribution in Europe.
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ajshare
Posted on: Mar 16 2018, 02:23 PM


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Posts: 326

Don't believe anything to do with Homm's newsletter. The pattern is more Lagoda style vaccum cleaner and not retail. Perhaps Lagoda or another fund buying.
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ajshare
Posted on: Mar 16 2018, 11:53 AM


Group: Member
Posts: 326

There is no specified rule, but price change need to be around +-10% and volume change around 10 times or so. If it's a low volume stock with an odd buy pushing it up, that wouldn't attract attention.
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ajshare
Posted on: Mar 16 2018, 11:02 AM


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Posts: 326

Not enough for a speeding ticket yet...
  Forum: By Share Code

ajshare
Posted on: Mar 14 2018, 09:48 AM


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Posts: 326

Price and volume action in play...hint! hint!!
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ajshare
Posted on: Mar 13 2018, 08:21 AM


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https://stockhead.com.au/health/biotechs-ou...lth-coming-age/
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ajshare
Posted on: Mar 7 2018, 06:09 PM


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Posts: 326

1. Safety and Efficacy data from Europe already complied (remaining item on FDA submission

2. May 20 date of launch of new products. I am sure that is planned to maximise the limelight on Clinuvel, Chivere when PDUFA dates are announced. (20th May minus 74 days points to this week.in March). Won't be surprised if NASDAQ listing comes somewhere around these dates.

3. Increasing volume action in last 3 sessions with today being the highest in 2018 (somebody knows about it)

4. End of Feb submission plan from PW v2.0 in the last newsletter who now keeps his words as demonstrated in February.
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ajshare
Posted on: Mar 7 2018, 03:06 PM


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Posts: 326

I believe the NDA is finally submitted. Just waiting on PW to announce or drop hints.
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ajshare
Posted on: Feb 28 2018, 08:56 AM


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Impact of selling cheaper. receipt from customer down by 200K+ even after 28% increase
====================

Commercial sales of SCENESSE®
(afamelanotide
16mg) in Europe totalled $5,332,828, compared to
$4,180,724 for the half year ended 31 December 2016,
an increase of 28%. The number of countries in Europe
who have agreed to reimburse SCENESSE®
at the
global uniform price for erythropoietic protoporphyria
(EPP) has remained the same for the two reporting
periods, however the 28% increase in commercial sales
has been supported by a higher number of accredited
expert treatment centres placing sales orders in the
current reporting period (13 centres compared to four
centres for the six months ending 31 December 2016).
New patient enrolment in the post authorisation safety
studies increased 117% between the two periods,
however offsetting the increase in order demand was a
16% downward change to the reference price uniformly
set across Europe, consequent to the agreement
reached upon arbitration with the German National
Association of Statutory Health Insurance Funds on 31
March 2017.
The supply of SCENESSE®
implants under the special
access reimbursement schemes generated $1,736,720
in sales reimbursement for the six months to 31
December 2017. This is compared to a sales
reimbursement result of $2,669,292 for the six months to
31 December 2016, a 35% decrease. The change in
reference price for SCENESSE®
impacted the
reimbursements received under the special access
reimbursement schemes in Switzerland. Prior to
November 2016, the supply of SCENESSE®
in Italy was
recorded as a sales reimbursement under the Law
648/96 special access reimbursement scheme,
contributing to the 21% decline in SCENESSE®
sales
reimbursement units. During the six months to 31
December 2017, SCENESSE® was exceptionally
supplied and reimbursed in Spain under a special
access arrangement.
  Forum: By Share Code

ajshare
Posted on: Feb 23 2018, 12:43 PM


Group: Member
Posts: 326

EMA safety data reports on the Scensse due on 2nd March 2018. I believe same data will be used for FDA submission. Timeline is interesting. Details below:


http://www.ema.europa.eu/docs/en_GB/docume...WC500133159.xls


PSURs are reports providing an evaluation of the benefit-risk balance of a medicine. Marketing authorisation holders (MAHs) must submit PSURs at defined time points following a medicine’s authorisation. PSURs summarise data on the benefits and risks of a medicine and include the results of all studies carried out with this medicine, both in its authorised uses and in unauthorised uses.

The Agency uses the information in PSURs to determine if there are new risks identified for a medicine or whether the balance of benefits and risks of a medicine has changed. It can then decide if further investigations need to be carried out or can take action to protect the public from the risks identified, such as updating the information provided for healthcare professionals and patients.

http://www.ema.europa.eu/ema/index.jsp?cur...ting_000361.jsp
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ajshare
Posted on: Feb 16 2018, 04:43 PM


Group: Member
Posts: 326

All you need to know is Clinuvel's history and how it started and what products it developed - it had 15 years to tweak these products and I believe they would create a market size as big as EPP.

Why launch in May? NDA being submitted this month. 60+14 days brings the PDUFA dates and FDA approval in May. FDA is out of the way and not being risked.

Why launch in Asia? As the regulatory regimes are easier, if the products are good they will find the way through in the global markets soon either way.
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ajshare
Posted on: Nov 29 2017, 02:49 PM


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Posts: 326

Looking at the presentation I saw two separate distribution channels - one is OTC topical and other one is going through the FDA/EMA route
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ajshare
Posted on: Nov 29 2017, 10:01 AM


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Posts: 326

My take on this is that they submitted or will submit 1st part to FDA which Clinuvel thought was enough. Now morons at FDA wants more and hence the talk of 2nd EMA report. I think FDA is playing hardball here and hence the timelines are pushed out.
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ajshare
Posted on: Nov 28 2017, 09:26 AM


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Posts: 326

http://www.asx.com.au//asxpdf/20171128/pdf...n6c5k23mn2y.pdf
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ajshare
Posted on: Nov 28 2017, 08:59 AM


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Posts: 326

Chair Address to AGM
http://www.asx.com.au//asxpdf/20171128/pdf...n41njvympfw.pdf
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ajshare
Posted on: Nov 27 2017, 11:01 AM


Group: Member
Posts: 326

The trademark Chievre is still not registered in the US and there was a refusal by the officer. A small glitch at the moment as not sure if this will make Pw and CUV holdback on Chivere annoucement tomorrow or not.
Attached File(s)
Attached File  79217953__3_.pdf ( 31.45K ) Number of downloads: 63

 
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ajshare
Posted on: Nov 25 2017, 07:39 PM


Group: Member
Posts: 326

controvers - the reason you get negative reaction to your posts, because your own posts are repeating same things over and over and everyones time is wasted reading the same things over and over. May be out of few hundred post you have made 1 or 2 have genuine information.

You don't want to accept critics, while in every post you are criticizing and insulting ASX and Australia, CUV, PW and the management and ranting about NASDAQ. You are also counting chickens every 15 minutes. Count in your own mind and don't tell the count to everyone every 15 minutes in a 5000 word essay.

This board is not about sharing mindless thoughts - it is about sharing useful and worthwhile information so that we all can learn something and add value to our investment. Thats all I seek for on sharescene and I am thankful to sharescene and all the people who post useful information here as it is the reason why I am invested heavily in this company.

Go and spend time reading your own posts and see what you make of it yourselves.

Enough of it and take your whinging elsewhere.

QUOTE
Mr Jones and ashare it's not the first time you both give a negative reaction to my posts. To accept critics isn't always that easy, certainly not at a very critical moment we're in right now!

Do you both know where a board is for? Yes, you do. Sharing eachother thoughts, nothing more nothing less, to broader your vision.
  Forum: By Share Code

ajshare
Posted on: Nov 23 2017, 03:13 PM


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Posts: 326

You are a serious and professional time waster...
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ajshare
Posted on: Nov 21 2017, 10:06 PM


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Posts: 326

Current ASX Rank for CUV 387..

200 is a long way to go pingu.
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ajshare
Posted on: Nov 21 2017, 09:59 PM


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Posts: 326

Cutting the orphan drug tax credit would take away my day in the sun

https://www.statnews.com/2017/11/21/orphan-...t-rare-disease/
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ajshare
Posted on: Nov 11 2017, 09:13 AM


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Posts: 326

There may be some in the list below where Clinuvel is referenced and may not be patent by Clinuvel
  Forum: By Share Code

ajshare
Posted on: Nov 11 2017, 08:30 AM


Group: Member
Posts: 326

Patents by Clinuvel

1 9801924 Therapy for vitiligo   
2 US20170304406 NEW INDICATION FOR ALPHA-MSH ANALOGUES   
3 EP2865422B1 Alpha-MSH derivatives for the treatment of photodermatoses  
4 EP3212220A1 INFLAMMATORY DISEASE  
5 EP3212219A1 NEW INDICATION FOR ALPHA-MSH ANALOGUES  
6 US20170143796 ENGINEERED NUCLEIC ACIDS AND METHODS OF USE THEREOF   
7 9572775 Non surfactant hydro-alcoholic foamable compositions, breakable foams and their uses   
8 US20160296589 COMPOSITIONS AND METHODS FOR TREATING VITILIGO   
9 9447164 Engineered nucleic acids and methods of use thereof   
10 US20160235819 METHODS OF INDUCING MELANOGENESIS IN A SUBJECT   
11 9345911 Methods of inducing melanogenesis in a subject   
12 WO/2016/066702A1 INFLAMMATORY DISEASE   
13 WO/2016/066700A1 NEW INDICATION FOR ALPHA-MSH ANALOGUES   
14 US20160058873 Cyclodextrin-Based Polymers for Therapeutic Delivery   
15 US20160024171 ENGINEERED NUCLEIC ACIDS AND METHODS OF USE THEREOF   
16 EP1789076B1 METHODS OF INDUCING MELANOGENESIS IN A SUBJECT.  
17 EP2957292A1 THERAPY FOR VITILIGO   
18 9181319 Engineered nucleic acids and methods of use thereof   
19 EP2939686A1 COMPOSITIONS AND METHODS FOR INDUCING MELANOGENESIS IN A SUBJECT   
20 EP2278992B1 THERAPY FOR VITILIGO  
21 EP2368562B1 Compositions and methods for inducing melanogenesis in a subject  
22 WO/2015/067503A1 ALPHA-MSH ANALOGUES FOR USE IN THE TREATMENT OF PSORIASIS   
23 WO/2015/063102A1 ALPHA-MSH ANALOGUES FOR USE IN BULLOUS DISEASE   
24 WO/2015/063099A1 ALPHA-MSH ANALOGUES FOR USE IN THE TREATMENT OF HAILEY-HAILEY DISEASE   
25 EP2865422A1 Alpha-MSH derivatives for the treatment of photodermatoses   
26 JP2015052012A THERAPEUTIC PEPTIDE-POLYMER CONJUGATES, PARTICLES, COMPOSITIONS, AND RELATED METHODS   
27 JP5655147B2 A complex of therapeutic peptide * polymer, particles, a constituent, and a method of relation  
28 EP2056855B1 ALPHA-MSH DERIVATIVES FOR THE TREATMENT OF PHOTODERMATOSES  
29 8822663 Engineered nucleic acids and methods of use thereof   
30 US20140243399 ENGINEERED NUCLEIC ACIDS AND METHODS OF USE THEREOF   
31 US20140213504 Cyclodextrin-Based Polymers for Therapeutic Delivery   
32 US20140135254 THERAPEUTIC PEPTIDE-POLYMER CONJUGATES, PARTICLES, COMPOSITIONS, AND RELATED METHODS   
33 JP5449673B2 A constituent and a method for guiding the melanin formation in a candidate  
34 EP1689349B9 A METHOD OF INDUCING MELANOGENESIS IN HUMANS WITH MC1R VARIANT ALLELES  
35 US20130344153 METHOD FOR REDUCING INCIDENCE OR RATE OF DEVELOPMENT OF SKIN CANCERS AND RELATED CONDITIONS   
36 EP2673295A1 HEXAPEPTIDE WITH IMPROVED ACTIVITY IN THE REPAIR OF CELLULAR DNA OF DERMAL CELLS  
37 US20130331331 HEXAPEPTIDE WITH IMPROVED ACTIVITY IN THE REPAIR OF CELLULAR DNA OF DERMAL CELLS   
38 8569234 Compositions and methods for including melanogenesis in a subject   
39 JP2013536198A The complex of therapeutic peptide * polymer, particles, a constituent, and the method of relation   
40 EP1689349B1 A METHOD OF INDUCING MELANOGENESIS IN HUMANS WITH MC1R VARIANT ALLELES  
41 US20130210724 Cyclodextrin-Based Polymers for Therapeutic Delivery   
42 US20130203670 Therapy For Vitiligo   
43 JP5230941B2 How to guide melanin formation in the humans who have a MC1R mutant allele  
44 EP2056855A4 METHOD OF TREATMENT OF PHOTODERMATOSES  
45 JP5208504B2 A method for guiding melanin formation by a candidate  
46 8334265 Method of treatment of photodermatoses   
47 US20120302505 CYCLODEXTRIN-BASED POLYMERS FOR THERAPEUTIC DELIVERY   
48 WO/2012/145632A1 CYCLODEXTRIN-BASED POLYMERS FOR THERAPEUTIC DELIVERY   
49 WO/2012/131090A1 METHOD FOR TREATMENT OF XERODERMA PIGMENTOSUM   
50 WO/2012/107592A1 HEXAPEPTIDE WITH IMPROVED ACTIVITY IN THE REPAIR OF CELLULAR DNA OF DERMAL CELLS   
51 EP2487185A1 Hexapeptide with improved activity in the repair of cellular DNA of dermal cells   
52 US20120065252 ENGINEERED NUCLEIC ACIDS AND METHODS OF USE THEREOF   
53 US20120052097 THERAPEUTIC PEPTIDE-POLYMER CONJUGATES, PARTICLES, COMPOSITIONS, AND RELATED METHODS   
54 WO/2012/024530A2 THERAPEUTIC PEPTIDE-POLYMER CONJUGATES, PARTICLES, COMPOSITIONS, AND RELATED METHODS   
55 WO/2012/019168A2 ENGINEERED NUCLEIC ACIDS AND METHODS OF USE THEREOF   
56 WO/2011/134026A1 COSMETIC METHODS AND COMPOSITIONS   
57 US20110263508 Compositions and methods for including melanogenesis in a subject   
58 EP2368562A1 Compositions and methods for inducing melanogenesis in a subject   
59 EP2056854A4 METHOD FOR REDUCING INCIDENCE OR RATE OF DEVELOPMENT OF SKIN CANCERS AND RELATED CONDITIONS  
60 EP1789076A4 METHODS OF INDUCING MELANOGENESIS IN A SUBJECT.  
61 US20110130705 THERAPY FOR VITILIGO   
62 EP2278992A2 THERAPY FOR VITILIGO  
63 US20110020252 METHOD OF LONG LASTING HUMAN SKIN TANNING   
64 EP2259794A1 METHOD FOR TREATMENT OF PHOTOSENSITIVITY AND PHOTOTOXICITY  
65 7745408 Method of inducing melanogenesis in humans with MC1R variant alleles   
66 US20100120668 METHOD OF TREATMENT OF PHOTODERMATOSES   
67 US20100113337 METHOD FOR REDUCING INCIDENCE OR RATE OF DEVELOPMENT OF SKIN CANCERS AND RELATED CONDITIONS   
68 WO/2009/118191A3 THERAPY FOR VITILIGO   
69 WO/2009/118191A2 THERAPY FOR VITILIGO   
70 WO/2009/103816A1 METHOD FOR TREATMENT OF PHOTOSENSITIVITY AND PHOTOTOXICITY   
71 EP1812034A4 COMPOSITIONS AND METHODS FOR INDUCING MELANOGENESIS IN A SUBJECT  
72 EP2056855A1 METHOD OF TREATMENT OF PHOTODERMATOSES  
73 EP2056854A1 METHOD FOR REDUCING INCIDENCE OR RATE OF DEVELOPMENT OF SKIN CANCERS AND RELATED CONDITIONS  
74 US20080305152 Methods of Inducing Melanogenesis in a Subject   
75 EP1689349A4 A METHOD OF INDUCING MELANOGENESIS IN HUMANS WITH MC1R VARIANT ALLELES  
76 JP2008515815A The composite and method for guiding the melanin formation in a candidate   
77 JP2008508324A The method for guiding melanin formation by a candidate   
78 WO/2008/033395A3 MELANOCORTIN AND TRANSFERRIN FUSION PROTEINS   
79 WO/2008/033395A2 MELANOCORTIN AND TRANSFERRIN FUSION PROTEINS   
80 WO/2008/025094A1 METHOD OF TREATMENT OF PHOTODERMATOSES   
81 WO/2008/025074A1 METHOD FOR REDUCING INCIDENCE OR RATE OF DEVELOPMENT OF SKIN CANCERS AND RELATED CONDITIONS   
82 US20080004213 Method of Inducing Melanogenesis in Humans With Mc1R Variant Alleles   
83 US20070265952 SYSTEMS AND METHODS FOR INVESTING   
84 US20070255633 SYSTEMS AND METHODS FOR INVESTING   
85 EP1812034A1 COMPOSITIONS AND METHODS FOR INDUCING MELANOGENESIS IN A SUBJECT   
86 JP2007514656A How to guide melanin formation in the humans who have a MC1R mutant allele   
87 EP1789076A1 METHODS OF INDUCING MELANOGENESIS IN A SUBJECT.   
88 EP1689349A1 A METHOD OF INDUCING MELANOGENESIS IN HUMANS WITH MC1R VARIANT ALLELES   
89 WO/2006/037188A1 COMPOSITIONS AND METHODS FOR INDUCING MELANOGENESIS IN A SUBJECT   
90 WO/2006/012667A1 METHODS OF INDUCING MELANOGENESIS IN A SUBJECT.   
91 WO/2005/048967A1 A METHOD OF INDUCING MELANOGENESIS IN HUMANS WITH MC1R VARIANT ALLELES   

Can do further research here

https://www.google.com.au/search?tbo=p&...eFcKJ8wWbl4XIDg
  Forum: By Share Code

ajshare
Posted on: Nov 9 2017, 03:13 PM


Group: Member
Posts: 326

243 shares on both sides can't be coincidental!!!
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

ajshare
Posted on: Nov 7 2017, 08:34 AM


Group: Member
Posts: 326

Another patent granted last week.

The present invention relates to a therapy for vitiligo. In particular the present invention provides a pharmaceutical composition comprising an alpha melanocyte stimulating hormone (alpha-MSH) analog either alone, in combination with narrow band UVB and/or in combination with one or more corticosteroids, immunosuppressants, anti-inflammatory agents and/or photochemotherapeutic agents for the treatment or prevention of vitiligo.
Attached File(s)
Attached File  US9801924B2.pdf ( 286.14K ) Number of downloads: 710

 
  Forum: By Share Code

ajshare
Posted on: Nov 7 2017, 08:25 AM


Group: Member
Posts: 326

Speeding ticket arrived from ASX. CUV knows nothing.

http://m.asx.com.au/m/index_terms.xhtml?ne...0qpkg2lzw5t.pdf
  Forum: By Share Code

ajshare
Posted on: Nov 7 2017, 08:21 AM


Group: Member
Posts: 326

Does anyone has any idea about this new Indication and patent by PW on neurodegenerative disorders published on 26/10/2017

Doc attached
Attached File(s)
Attached File  US20170304406A1.pdf ( 64.29K ) Number of downloads: 554

 
  Forum: By Share Code

ajshare
Posted on: Nov 5 2017, 11:33 PM


Group: Member
Posts: 326

Looks like Clinuvel trademark application for CHIVÉRE has hit a snag with USPTO with a PROVISIONAL PARTIAL REFUSAL letter issued.
Attached File(s)
Attached File  79217953.pdf ( 20.68K ) Number of downloads: 81

 
  Forum: By Share Code

ajshare
Posted on: Nov 5 2017, 11:27 PM


Group: Member
Posts: 326

I think you are bit captivated by Homm.. Given his experience with Clinuvel and his knowledge of stock market, his timing is probably the biggest influence and nothing wrong about using that as a leverage. As Royco rightly pointed that NDA and PDUFA are key here and lot of people with connections move early on this sort of information.

A priority review is on the cards as well and the price tag of that voucher alone is $3-$6 AUD per share should Clinuvel choose to sell the voucher. Sarpeta sold it for $125mln and United Therapeutics for $350mln USD.

NASDAQ listing, distribution partners, Chivére line of OTC products announcements are coming soon enough, .






  Forum: By Share Code

ajshare
Posted on: Nov 5 2017, 09:49 AM


Group: Member
Posts: 326

Cutaneous Porphyrias Overview by Robert Dawe- published 30/10/2017

Scottish Cutaneous Porphyria Service, Scottish Photodiagnostic Unit, Department of Dermatology, Ninewells Hospital and Medical School,
Dundee, DD1 9SY, UK

Good overview with numbers

Attached File(s)
Attached File  a2ccaaa2_0cc1_4f3f_a59a_1cd7e5f6d1a8_10101___robert_dawe.pdf ( 578.25K ) Number of downloads: 50
Attached File  10.12688_f1000research.10101.1_f1.pdf ( 239.72K ) Number of downloads: 27

 
  Forum: By Share Code

ajshare
Posted on: Nov 3 2017, 10:05 AM


Group: Member
Posts: 326

Not enough rise for this to happen.
  Forum: By Share Code

ajshare
Posted on: Oct 27 2017, 02:36 PM


Group: Member
Posts: 326

PW might have found a way. He normally would not talk about it in newsletter and reading it again he is hinting that FDA submission is done from CUV side and is in 74 day review. Also that there is a full line of cosmetic topicals coming and not only 1. He will only open his mouth on things like that when very sure. Hope my thinking is on the correct lines.

This was in report today
QUOTE
SCENESSE® was awarded orphan drug designation in 2008, Fast TrackDesignation in 2016 and is awaiting a decision on Priority Review bythe FDA. It is expected at the time of printing, that the formal FDA review of SCENESSE® will be completed in the same year.
  Forum: By Share Code

ajshare
Posted on: Oct 27 2017, 12:36 PM


Group: Member
Posts: 326

This could be a real winner if it is coming on the shelf in 2018/2019

Status of CHIVÉRE in USA. File attached with details. Key details as below. PW is telling the truth that he is waiting for the trademark registration. International registration done in July, but USA still in process.

Date Description Proceeding Number
Oct. 25, 2017 ASSIGNED TO EXAMINER 93047
Oct. 17, 2017 APPLICATION FILING RECEIPT MAILED
Oct. 12, 2017 NEW APPLICATION OFFICE SUPPLIED DATA ENTERED IN TRAM
Oct. 05, 2017 SN ASSIGNED FOR SECT 66A APPL FROM IB


Attached File(s)
Attached File  79217953__1_.pdf ( 54.6K ) Number of downloads: 365

 
  Forum: By Share Code

ajshare
Posted on: Oct 27 2017, 11:09 AM


Group: Member
Posts: 326

QUOTE
We expect VALLAURIX to make its first topical product line public in 2018/19, whereby we now await registration of the first products.


http://50.97.5.219/ctm/chivre-016323867.htm

I am assuming that Chivére relates to this and does not have to go through the BS...of EMA and FDA as it is from the family of approved drug and coming directly to public in 2018/2019. Can anyone with more knowledge comment on it.

  Forum: By Share Code

ajshare
Posted on: Oct 27 2017, 07:25 AM


Group: Member
Posts: 326

It was nothing else and purely sarcasam...simply wall st is full of shxx, pretending to be something what it is not. It is very sad that bots and AI has taken over Internet and has filled with garbage like this all over. Some of it may look good, but it is missing the key bits which only humans can understand and analyse.

  Forum: By Share Code

ajshare
Posted on: Oct 26 2017, 05:14 PM


Group: Member
Posts: 326

I think Lagoda should subscribe to simply wall st as they are paying too much devilsmiley.gif

The calculations below outline how an intrinsic value for Clinuvel Pharmaceuticals is arrived at by discounting future cash flows to their present value. We use analyst's estimates of cash flows going forward 5 years.

See our documentation to learn about this calculation.

5 year cash flow forecast
2017 2018 2019 2020 2021
Levered FCF (AUD, Millions) A$8.28 A$9.86 A$11.63 A$13.61 A$15.78

Source Extrapolated @ (20%, capped from 49.91%) Extrapolated @ (19%, capped from 49.91%) Extrapolated @ (18%, capped from 49.91%) Extrapolated @ (17%, capped from 49.91%) Extrapolated @ (16%, capped from 49.91%)

Present Value
Discounted (@ 8.55%) A$7.63 A$8.36 A$9.09 A$9.80 A$10.47
Present value of next 5 years cash flows:
A$45

Terminal Value
Terminal Value = FCF2021 × (1 + g) ÷ (Discount Rate – g)

Terminal Value = A$16 × (1 + 2.76%) ÷ (8.55% – 2.76%)

Terminal value based on the Perpetuity Method where growth (g) = 2.76%:
A$280

Present value of terminal value:
A$186

Equity Value
Equity Value (Total value) = Present value of next 5 years cash flows + terminal value
A$231 = A$45 + A$186

Value = Total value / Shares Outstanding (A$231 / 48)

Discount to Share Price
Value per share:
A$4.84

Current discount (share price of A$6.95): -43.54%



Estimate of Discount Rate
The discount rate, or required rate of return, is estimated by calculating the Cost of Equity.

Discount rate = Cost of Equity = Risk Free Rate + (Levered Beta * Equity Risk Premium)

Discount rate = 8.55% = 2.76% + (0.8 * 7.24%)



Estimate of Bottom Up Beta
The Levered Beta is the Unlevered Beta adjusted for financial leverage. It is limited to 0.8 to 2.0 (practical range for a stable firm). Note the market value of equity is used not the book value (A$331,759,827).

Levered Beta = Unlevered beta (1 + (1- tax rate) (Debt/Equity))

0.414 = 0.414 (1 + (1- 30%) (0%))

Levered Beta used in calculation = 0.8



Assumptions
The risk free rate of 2.76% is from the 10 year government bond rate in AUD.
The bottom-up beta is estimated by analysing other companies in the same industry.
The Equity Risk Premium is calculated by subtracting the risk free rate from the market return premium (7.24%) (source: Buffet).
The dividend discount model is automatically used for companies in the following industries: Banks, Insurance, Real Estate Investment Trusts (REITs), Diversified Financial Services and Capital Markets.
Attached thumbnail(s)
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  Forum: By Share Code

ajshare
Posted on: Oct 17 2017, 12:26 PM


Group: Member
Posts: 326

My take on newletter

- First year real-life data (July 2016 - June 2017)
- Data analyses are under way and require our teams to critically evaluate clinical reports by hospitals and patients (2-3 months)
- inching towards the complete new drug application (NDA) submission (final module submission in progress)
= PDUFA Date coming soon (biggrin.gif )
  Forum: By Share Code

ajshare
Posted on: Oct 12 2017, 10:24 PM


Group: Member
Posts: 326

More details on shareholding
Attached File(s)
Attached File  cuv_sh.pdf ( 231.29K ) Number of downloads: 120

 
  Forum: By Share Code

ajshare
Posted on: Oct 12 2017, 09:33 PM


Group: Member
Posts: 326

Some new names

SHAREHOLDER CAPITAL (%)
J P Morgan Nominees Australia Limited 20.16
National Nominees Limited 16.95
HSBC Custody Nominees (Australia) Limited 13.22
Acn 108 768 896 Pty Ltd 7.8
Ender 1 Llc 5.43
Citicorp Nominees Pty Limited 3.49
Dr Mark Edwin Badcock 1.76
HSBC Custody Nominees (Australia) Limited - A/C 2 1.64
National Nominees Limited <Db A/C> 1.46
Biotech Lab Singapore Pte Ltd 1.27
M Badcock And P Chu Superannuation Fund Pty Ltd 1.05
BNP Paribas Noms Pty Ltd <DRP> 1.02
HSBC Custody Nominees (Australia) Limited-Gsco Eca 0.85
HSBC Custody Nominees (Australia) Limited <Euroclear Bank SA NV A/C> 0.76
Headstart Global Hold Ings Ltd 0.71
ABN Amro Clearing Sydney Nominees Pty Ltd <Custodian A/C> 0.57
Merrill Lynch (Australia) Nominees Pty Limited 0.43
Mr Davi D John Lewis 0.42
Mr David Will Iam Trevorrow 0.41
Dr Corinne Ginifer 0.39
Total Held by Top 20 Shareholders 79.79
  Forum: By Share Code

ajshare
Posted on: Oct 10 2017, 09:01 AM


Group: Member
Posts: 326

Company’s Annual Report will be lodged with the ASX no later than 27 October 2017.
  Forum: By Share Code

ajshare
Posted on: Oct 10 2017, 09:00 AM


Group: Member
Posts: 326

AGM Date

CLINUVEL PHARMACEUTICALS LTD [ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION: CLVLY; XETRA-DAX: UR9]
today announced it will hold its 2017 Annual General Meeting of shareholders on Tuesday 28 November 2017 at
10.00am AEDT at Arnold Bloch Leibler, Level 21, 333 Collins Street, Melbourne, Victoria, Australia 3000.
  Forum: By Share Code

ajshare
Posted on: Oct 3 2017, 01:07 PM


Group: Member
Posts: 326

LAGODA has up the ante in last few days..Anything under $7 is sucked in quickly. They surely have talent in hunting and tree shaking and have been averaging well at around $6.75. October has been the lucky month for Clinuvel and won't be surprised if it repeats last year October performance.
  Forum: By Share Code

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