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Starfire
Posted on: Jun 25 2020, 09:54 PM


Group: Member
Posts: 27

I just checked on the HAS site if the outome on PortugueseMen belows list of phase contradictoire was positive or negative.

Guess what....
All 13 except one (Adcentris) showed a positive decision advis favorable
Only Adcentris showed advis defavorable which means negativ for reimboursement

I just hope that this means we have very good chances for a positive decision.
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Starfire
Posted on: Jun 10 2020, 10:53 PM


Group: Member
Posts: 27

I even see only 350 to max. 400 patients receiving treatment in Europe.
This is looking at last FY results and 4 implants per year leading to about A$95k +- per patient
The more important to get France on board and hopefully some other countries as this will have big significance considering the few patients currently on board.

This is also the reason why US start of treatment should have a huge impact with treatment every two month per label (6 per year) and potentially even a higher sales price per implant.

In the end, we cannot be sure about anything and the numbers were often different than I projected for myself or the numbers projected by highly valued sharecafe board members
Taking the chance to thank you all for your effort bringing valuable contribution to the community.

GLTA
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Starfire
Posted on: May 30 2020, 06:15 PM


Group: Member
Posts: 27

I remember that the US label is advising an implant every 2 month, which equals 6 per year.
In EU, there can be prescribed 4 implants max with the possibility to get more if requested by the prescribing doctors.

That, together with much sunnier climate throughout the year in most US states, should lead to more implants per patient in the US.

Pretty confident, that we will see this in the sales numbers.
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Starfire
Posted on: May 14 2020, 04:11 AM


Group: Member
Posts: 27

I first think of enjoying cyan blue skies without skin cell damage.
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Starfire
Posted on: Mar 25 2020, 05:33 AM


Group: Member
Posts: 27

I hope you are wrong when saying we will see again $14 within the next few days.
But todays move was definitely not just a dead cat bounce, but a move on extremly good news about US rollout.
At least the unusual large EU and US volume is supporting this thought
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Starfire
Posted on: Feb 27 2020, 04:10 AM


Group: Member
Posts: 27

The solution for the winterdip should be the coming US sales.
There are quite a few states which are very sunny throughout the year inclusive winter and there will be propably 6 implants for those patients.
This is a guess, but I think a plausible guess.
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Starfire
Posted on: Jan 27 2020, 08:34 AM


Group: Member
Posts: 27

To all the australiens
Have a great and happy Australian day !
And lets look forward to hopefully some good numbers coming Friday
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Starfire
Posted on: Oct 9 2019, 09:12 AM


Group: Member
Posts: 27

Statement from this mornings anouncement

„The approved frequency for Scenesse is once every two month“

So in the US this means 6 implants per year and patients will be protected all year.
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Starfire
Posted on: Oct 9 2019, 04:42 AM


Group: Member
Posts: 27

Congrats to everybody.

I also was checking in to this board very frequently during the last days and nearly constantly today.
It was really helping to see most of you also on the verge to get crazy.

This is a great board with many members contributing.
Thanks for all the great support during the last many years and keep it up :-)
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Starfire
Posted on: Oct 2 2019, 08:26 PM


Group: Member
Posts: 27

I was always wondering the PDUFA date of Oct 6
The initial date was July 8 and with the 3 month extension, the new PDUFA date is Oct 8
So I do not think there is anything behind the 2 day delay which should be of any concern.

GLTA
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Starfire
Posted on: May 4 2019, 05:00 PM


Group: Member
Posts: 27

The findings from this August inspection most propably prevented Clinuvel getting their NDA submission the „NDA filed“ status.
My understanding is, that Clinuvel adressed all the observations with the submission in November and therefore got the NDA filed in January after 60 days.

So, possibly PW statements about most attention to CMC and GMP issues do refer to frequent information requests other than the inspection report from last year August.

One other note.
The labeling information is supposed to be send out to the applicant 12 days before LCM „late cycle meeting“ for all NME applications under the „Program“.
Scenesse falls under this designation and late cycle meeting should be about mid May.
So lets hope for an information within May.

Of course everything said is kind of speculation and Clinuvel might inform or not publicly.
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Starfire
Posted on: Apr 2 2019, 02:34 AM


Group: Member
Posts: 27

Thanks Royco,

Am just confused why Morningstar (link in Verharvens post below) does not show any shares with Lagoda under „Institutions“
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Starfire
Posted on: Apr 1 2019, 04:12 PM


Group: Member
Posts: 27

Was not Lagoda one of the largest shareholders?
Don‘t see them anymore listed.

Lagoda leaving would explain partially the large volume in March.
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Starfire
Posted on: Mar 28 2019, 08:43 AM


Group: Member
Posts: 27

Web site is up and running.
Pipeline status seems updated and shows Scenesse approval status same as US status. From what I remember its new.
Also, 1st OTC product seems just before clinical.
Further there is a forecast of announcements in the investor area

Overall, I did not see any major surprises
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Starfire
Posted on: Mar 25 2019, 09:20 AM


Group: Member
Posts: 27

Mid cycle review in February seems to be in line with PR timing.
Quote „3 month after receipt for priority
I also was hoping that it was kind of early

Hope the attachement shows

[Attachment=51358:5348E351...EE5548E5.png]

Attached thumbnail(s)
Attached Image

Attached Image


 
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Starfire
Posted on: Mar 8 2019, 06:23 AM


Group: Member
Posts: 27

March is an exciting month for Clinuvel shareholders with 3 major announcements pending

1. ASX200 decision within the next hours
2. Announcement of new indication for Scenesse was communicated in the last investor briefing to be announced in 1st qtr.
3. NICE decision on reimbursement in Great Britain

GLTA fellow investors

Uups, Farma just updated on NICE issue, lets hope for the best.
Could also be that on April 11 is just the next regular meeting of the Highly specialised technologies evaluation committee
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Starfire
Posted on: Mar 5 2019, 03:16 AM


Group: Member
Posts: 27

@Frogster
When searching with google, than XP is not listed to be a „porphyrias“
So, the second indication could really be XP as was here mentioned before and some on the forum seemed pretty sure about it already, although I do not no how one can be so certain.
We will hopefully find out shortly and I would be happy if indeed it is XP.

Its a really devastating disease and a possibly successful treatment with Scenesse would make this investment even more satisfying !
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Starfire
Posted on: Jan 22 2019, 07:32 AM


Group: Member
Posts: 27

Mine comes out at approx. 8,5Mio.
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Starfire
Posted on: Oct 31 2018, 09:33 PM


Group: Member
Posts: 27

1,3 Mio product manufacturing cost could be due to
preparation of VP trials and trials for the soon
to be announced third indications
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Starfire
Posted on: Oct 12 2018, 10:17 PM


Group: Member
Posts: 27

My prediction and expectation for quarterly cash flow is approx. 17m. AUD
It sounds kind of high, but this is what I calculated analysing half year/prelim full year and quarterly reports.

What is your prediction?
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Starfire
Posted on: Sep 28 2018, 01:04 AM


Group: Member
Posts: 27

$55 would do it for me.
I believe the true value is abit higher, but being taken over would take all the risk out and I would sleep better these days😊
GLTA
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Starfire
Posted on: Sep 25 2018, 05:47 AM


Group: Member
Posts: 27

Clinuvels web site is up and running again.
Looks like the „pipeline“ products bar chart has been updated though the second indication which was shown on the virtual investor conference is not shown.
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Starfire
Posted on: Sep 20 2018, 05:17 PM


Group: Member
Posts: 27

Low volume today compared to the last two weeks despite presenting to the Nasdaq virtual investor conference.
Why would they do the presentation, if they are not targeting to get listed there soon.
This is great news, but trading action today very lame.
Any thoughts?
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Starfire
Posted on: Sep 1 2018, 09:07 PM


Group: Member
Posts: 27

My conclusion for next qtr. cash flow result:

Based on 17/18 revenue and the last known 1/2 year revenue plus 3rd and 4th qtr. cash flows, we should expect around 17Mio. Aus$.
Pretty exciting outlook !
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Starfire
Posted on: Aug 29 2018, 04:54 PM


Group: Member
Posts: 27

Deleted
Redundant information
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Starfire
Posted on: Aug 18 2018, 10:12 PM


Group: Member
Posts: 27

Unfortunately, the „appeal“ against the negative NICE decision was rejected🤮.
But everything else would have been a big surprise!

See link
https://www.google.com/url?q=https%3A%2F%2F...3arAZButsUq7yNA

Appeal rejected

Look at the message in the 5th post.
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Starfire
Posted on: Oct 13 2016, 09:08 PM


Group: Member
Posts: 27

OK, time for my first post

A$6,12

Based on Clinuvel meeting appropriate expectations for 1st qtr., but failing to meet the elevated expectations/hopes of most board members (I am one myself :-)

Thanks

Edit: I do not want to win this cigar, no no, I want Royco to win !
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