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Starfire
Posted on: Oct 9 2019, 09:12 AM


Group: Member
Posts: 20

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: 20

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: 20

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: 20

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: 20

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: 20

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: 20

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: 20

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: 20

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: 20

@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: 20

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


Group: Member
Posts: 20

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: 20

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: 20

$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: 20

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: 20

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: 20

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: 20

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


Group: Member
Posts: 20

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: 20

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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