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CUV, CLINUVEL PHARMACEUTICALS LIMITED
royco
post Posted: Feb 8 2019, 05:57 AM
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In Reply To: Zodiac1's post @ Feb 8 2019, 05:12 AM

Tipping point
After 15 years
Enjoy the ride
If there is no take over to spoil the fun we are set for a decade of substantial growth.



--------------------
Ἀρτεμίσιον

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Zodiac1
post Posted: Feb 8 2019, 05:12 AM
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In Reply To: sharelooker's post @ Feb 8 2019, 12:32 AM

I agree! Good info, well written. Things are moving forward. Never been prouder to be a long holder. Might sound like I'm pumping but really I am just getting excited, again, it's been a long time coming.


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NewToCli
post Posted: Feb 8 2019, 01:00 AM
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In Reply To: sharelooker's post @ Feb 8 2019, 12:32 AM

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

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

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

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


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investek
post Posted: Feb 8 2019, 12:46 AM
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In Reply To: Farleap11's post @ Feb 7 2019, 09:28 PM

11.3 What happens after the appeal decision is published?
There is no possibility of further appeal against the decision of the Appeal Panel. However, this decision and NICE's decision to issue the final guidance may be challenged by applying to the High Court for permission to apply for a judicial review. Any such application must be made promptly and within 3 months of publishing the final guidance.

https://www.nice.org.uk/process/pmg18/resou...-72286661671621

And some text from a past High Court challenge
“For the avoidance of doubt, it was correct for you to allow the Institute’s appeal before initiating any judicial challenge,...”
https://www.nice.org.uk/guidance/TA111/docu...ing-high-court2


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sharelooker
post Posted: Feb 8 2019, 12:32 AM
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A great newsletter! I also like the mention of a new financial reporting system. Obviously they are expecting massive cash inflows in future or they need a new system as a requirement for NASDAQ listing.




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sharelooker
post Posted: Feb 8 2019, 12:32 AM
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A great newsletter! I also like the mention of a new financial reporting system. Obviously they are expecting massive cash inflows in future or they need a new system as a requirement for NASDAQ listing.



 


seeva222
post Posted: Feb 8 2019, 12:24 AM
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As exemplified previously, we have seen the need for us to change our infrastructure to be able to compete in years to come, this requires investments in technology and, at opportune times, in further expansion of the Group through acquisitions.

 
MinusSinus
post Posted: Feb 8 2019, 12:00 AM
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In Reply To: NewToCli's post @ Feb 7 2019, 10:53 PM

QUOTE
Clinuvel hired a new IR Manager, Malcom Bull, he joined Cuv in January in Melbourne.


Great name for that role.




--------------------
Comments on Clinuvel on my value investing blog (English):
https://www.minussinus.de/2017/11/14/for-english-readers-of-minussinus/

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NewToCli
post Posted: Feb 7 2019, 10:53 PM
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Good news !!!! Clinuvel hired a new IR Manager, Malcom Bull, he joined Cuv in January in Melbourne. He is a well experienced banker and IR Manager..
Look out for him in LinkedIn

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


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Farleap11
post Posted: Feb 7 2019, 09:28 PM
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In Reply To: investek's post @ Feb 7 2019, 07:36 PM

I am not sure why but Mr Babul's paper dated 6 February 2019 makes reference to the 2017 NICE decision not to recommend reimbursement for Scenesse as an EPP treatment, and goes on to say that this ruling was upheld in 2018 on appeal.


My understanding of the situation from a Clinuvel Company Announcement on the 10 October 2018 is that CUV's Appeal against the NICE recommendation was upheld and that the matter was to be referred back to the Highly Specialised Technology (HST) Committee for further review.


Whilst revisiting the 10 October announcement, I noted that it went on to point out that - " No further appeal avenue is available under the NICE Appeal Process, however consultees [CUV and 3 other EPP representative bodies], have up to three months to apply to the High Court for judicial review." In addition in a follow up 'Pink Sheet' report dated 12 October 2018, Dr Wolgen is quoted on page 3 as saying that, " Clinuvel's position is to wait but not too long, to see if NICE takes the initiative [to make reasonable adjustments after revisiting their original recommendations],. If not, then our path is still open for applying to the High Court for a judicial Review. In fairness, we could wait a couple of weeks, but certainly not months." He said the company "could apply for a judicial review tomorrow but we should give them a chance to come back to us. we have three months to appeal - I don't think we should wait that long, but I am open to their phone call,"

The next reference I could find to what happened after these October 2018 announcements is contained in the last paragraph of the Philippe Wolgen Communique dated 15 January, which reads in part, " ...Clinuvel is still in process of requesting NICE to respect the EMA's outcome (marketing authorisation: October 2014) and make Scenesse available to British EPP patients. we will keep you informed later this quarter as we expect news from NICE/NHS England around this time. " It seems clear from this that the process is ongoing; however it does beg the question as to whether the three month count down for a High Court for a judicial Review begins from the date of the initial NICE decision or from when the review decision of the NICE/HST Committee is announced? Logically one would think that it should be 3 months from the date of the final decision i.e. after further review. However Wolgen has sowed a seed of doubt in my mind when he says that the company, "could apply for judicial review tomorrow. etc. ..

Can anyone enlighten me please !


And yes Clinhope, I was surprised but pleased with todays closing price on the ASX. I think it is being influenced to the increasing speculation surrounding entry into the ASX 200 (or not).


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