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CUV - CLINUVEL PHARMACEUTICALS LIMITED


colaiscute

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The funny thing is Clinuvel's mgmt is probably older than most of us. You'd think they would want to get the show on the road sooner so they might enjoy the fruits of their work? Maybe these regulators really do slow time down to a crawl? However, I did read that bit in the report about making sure the "Group" or senior staff were well paid in order to ensure the greatest level of effort and consistency, or whatever ... does it really take 15-20 years to cash in on an investment? Well, I'm still in my capsule on the way to Mars. Going back to hyper sleep.
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Damn i hate when IÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢m right about this company :thumbdown:

 

So...for those more adept at analytics, the projected cash flow on page 19 looks good to me, kicking off mid 2018 nicely. Obviously others arent impressed at all...

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I,m nearly 71 yrs old, and I would like to see this take off, bearing in mind it still has not got to the pre consolidation value. But I have to say that I am currently well in front as my average price only $2.50.

Watching the ASX live each day at least shows me that the price is being sat on, and the way the ASX works we can not do a damn thing about it except hope that the reason for this is good.

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looking forward to the update or monthly newsletter from f homm.

will be interesting to hear what he thinks about growth 2020.

 

No word about nasdaq.

Structure intact it seems, no change.

still self congratulations on past.

no new director.

no word sbout chivere brand.

 

Vallaurix going cosmetic and enfance, might buy existing licenses.

japan and australia submissions next year.

clinuvel to grow slowly in the eu on epp expansion only, eu market clearly locked up for the foreseeable future.

nda slowest fast track ever will go on for next year too! usa market locked until 2019.

2016 ceo.mentioned first half.of 2017 then half 2017 L Hay mentioned end of the year and mentioned agressive timelines by management.

no extra sales until 2019. vitiligo developments suffering same delays.

new website early next year.

 

any q&a.done?

impressions?

 

 

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Pleasantly surprised there has not been a universal call for mass sackings etc. I think there are some interesting bits in the presentation- see milestones. Launch Clinuvel skincare solutions first half 2018.Maybe just getting the brand out there? The two questions asked at the meeting were related to further delay with the FDA into 2019. Perhaps PW being conservative and not assuming a fast review. Otherwise pretty much to their current time line (not withstanding previous missed timelines). The other with miscommunication from Lachlan in his interview- PW quite defensive given they believe their social media foray has been a resounding success to date (thanks to the patient groups IMO)- I think his answer related to interpretation of what they might be proposing or hoping vs reality -hence the disclaimers regarding authorites and other third parties. In other words the company can still say they hope for a timeline but they don't necessarily own it-depending. Sounds like a CUV message probably.

 

I think the mention of a takeover is also interesting.

 

They display financial results against the high prediction of 2015. I also think this is a positive as revenues should increase significantly over the next two years just for EPP. So company figures should look promising to analysts.

 

No mention of full nasdaq listing or getting into the top ASX 300 etc but positive in the interest and ADR's in the USA. Let's face it if the USA investors get interested what Aussies have to offer will pale into insignificance.

 

Their strategy is pretty much in concrete. I'm sure they will appoint another Director, I hope a good one. I don't expect surprises and I don't expect a ten bagger. Any who do might want to scan the penny mining or currency stocks -good luck with that!!

 

 

 

 

Unfortunately it's difficult to absorb the presentation and ask specifics in the AGM. I don't think it's deliberate, just the timelines they are subject to. I hope the interest from new investors in Europe and USA prop the price up for a while.

 

Enjoy the summer holiday with updates maybe FEb/ March.

 

 

 

 

 

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Sorry to be slow with a little write up after the AGM this year. It was so dull at the meeting I fell into a slumber and could not be roused from it.

 

Hmmm. What to say?

 

In summary - if anyone was expecting any kind of enlightenment ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã¢â‚¬Å“ it was a bit of a fizzer. There seemed to be a lack of energy in the room, and possibly a few less attendees this year than last.

 

Stan got the formalities underway at a little after 10am, and started by telling us all to switch off phones and computers. This is interesting because they donÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢t provide hard copy handouts, so as the AGM progresses there is no ability to look at slides and really try to understand the interesting ones. The time with which you can digest each slide depends entirely upon the pace Wolgen scrolls through things on the big screen. Personally I felt he roared through the ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“MilestonesÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ slides with barely a moment to digest them and their implications.

 

The instruction also means itÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s impossible to pick up questions that you may have emailed through after the meeting started. If you did, sorry.

 

Willem Blijdorp turned up half way through StanÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s intro, but he got there in the end I guess.

 

Wolgen came on at about 10.30, promising to get through his stuff in 25 minutes. It took more like an hour.

 

There was the usual historical discussion about what they done in the last 10 years, and how hard the job had been. This year it was presented ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã¢â‚¬Å“ at least in part ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã¢â‚¬Å“ in a different format with a whole bunch of hexagons spread around a page. Maybe its interesting to see that they expect the General Public stakeholder group to climb in the hierarchy from near bottom historically to near top in the 2017-2020 period. Expect some press and advertising?

 

The financial discussion was pretty much a repeat of previous years with updated data. As far as the development of a significant US presence goesÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¦..nada. TheyÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢re watching. TheyÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢re waiting. In the July newsletter, regarding basing in the US they said ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“In the coming weeks, we shall make our decisions public regarding the repositioning of the GroupÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ÂÂ. So now we know. 5 months is not enough weeks to make that decision.

 

FDA filing as you know is further delayed. This seems to be largely down to the EMA data needing to be included. The full statistical analysis they expected in Dec 2017 (19/9/17 release) will now only be due in February 2018. So, when they say , on 9/11/16,ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ÂÂCLINUVEL will submit the modular dossier on SCENESSEÃÆâ€â„¢ÃƒÆ’ƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚® on a rolling basis during the first half of 2017ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ to Wolgen that apparently doesnÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢t actually mean that they have stated a time line to the market that they will submit the dossier in the first half of 2017, and when Hay says (6/6/17, ScripRegAff)ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“(submission will be) Certainly by the end of this yearÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ he apparently doesnÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢t actually mean that it will, with certainty, happen before the end of the year either and itÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s not selective disclosure to make that certain statement to a closed audience.

 

So, really this underlines what we should already know. Trust nothing they say about timelines. They seem to feel no responsibility or formal association with them even when they make some pretty clear statements. Probably the same goes for the expectation stated last year that they would add 7 new countries to the EPP roll out this year. The moment it leaves WolganÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s mouth itÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s free to circulate, unencumbered by any sense of ownership or responsibility for those statements.

 

EU rollout and Media: they showed a clip of a Swiss TV debate where the insurers were given a hard time for only selectively reimbursing. The for case was argued by Rocco F. It was good to see just how strong the patient desire is to get the actual product.

 

Apparently a Judge in the AMNOG arbitration stated he was awarding Clinuvel 87% of their applied for price due to their transparency and integrity. .

 

DidnÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢t notice any mention of how many new EU markets are expected online in the coming year.

 

Growth 2020: dose regimen to be upped from 4 to 6. Marketing Application to be made in US, Japan, Australia. When? See above for timelines guidance.

 

They will look to makes acquisitions ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“eventuallyÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ÂÂ.

 

So, overall, more hurry up and wait. Still some very powerful long term opportunities, not least because patients are crying out for the drug, but ClinuvelÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s stepwise management approach will keep us waiting longer yet.

 

No really sure what else to say.

 

 

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Nice summary Frogster. I was there too and really nothing additional to add - it was a snooze fest and there was little insight given to things people here haven't already gleaned from looking at the slides. The lack of energy in the room from the team was disappointing. We all know how they are with timelines and when Frogster called them out on it as he indicated, was shut down. It seems the definition of 'will' has been redefined as 'may' by PW so if you aren't doing it already, treat any guidance they give on timeless as strictly for entertainment purposes. So more waiting as they inch along, but the direction is at least forward. At least the recent SP run up has kept things interesting.
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