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CUV, CLINUVEL PHARMACEUTICALS LIMITED
Dr Wally
post Posted: Aug 30 2019, 01:11 PM
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If acceptance/approval wasn’t in the bag already the recent FDA approval of Vyleesi (Melanocortin same class as Scenesse) has 1000% guaranteed Scenesses FDA approval.

The only concern now is whether the FDA will capitulate (honourably/ logically) to the overwhelmingly positive scientific and real world data in October or in a final act of stubbornness continue resisting the positive decision to the bitter end by hunting down a few more obscure issues to enable another time squandering delay.

Communique VI..... 20.08.2019
“In the latter half of the scientific review the FDA attempts to address **substantive review issues which have not yet been covered** by its committee members. “

As alarming as that statement is I’m feeling 90% confident (Vyleesi) that their preparing to move forward not backwards. Hopefully a new era can begin in October.



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The never ending quest to have Afamelanotide (peptide) accepted for its potent ability to stimulate a natural photo protective therapeutic “tan” was accomplished in 2019.
 
LJS
post Posted: Aug 30 2019, 11:13 AM
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In Reply To: San Diego's post @ Aug 30 2019, 10:39 AM

I get the frustration with the delays and it's not new. As far as PW goes and the performance rights, I was annoyed and flabbergasted that he would receive about 5 million shares in what I though would be relatively short timelines years ago. To date he has about 3 million shares and it's taken much longer than I thought to get here. Perhaps we have some higher expectations than the reality of the space and what they are trying to do. I think few people would still be in the game at this point. Remember the share price strength is a result of the capital management through the process and remains one of the great strengths in terms of underlying value. All going well shares will be hard to procure at a discount and all those wishing to cash in and move on can do so. Not many shares have more than doubled the last 12 months. One thing that I was pleased to hear from Blijdorp last AGM was how his company grew from a few to maybe a couple of thousand and I don't doubt he will be keeping PW honest once the FDA saga is resolved to advance the next phase more quickly -they have the resources now. If you reflect on the NICE response you should be reminded of the attitudes on the other side-it's not all beer and skittles with the regulators. We'll see. Success in Clinuvel rewards all stakeholders and patients awaiting access, GLTA


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San Diego
post Posted: Aug 30 2019, 10:39 AM
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In Reply To: Frogster's post @ Aug 30 2019, 08:45 AM

To your point of "not being able to imagine a big, generous rights package if the FDA says no", and I apologize for mixing metaphors, if there is any silver lining to even suggesting that management should be allowed to push the envelope towards “hog” status, it's that Mr. Blijdorp must be rather confident of an FDA approval.


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Frogster
post Posted: Aug 30 2019, 08:45 AM
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In Reply To: LevelHeaded2000's post @ Aug 30 2019, 03:25 AM

I have no problem with management interests being aligned with shareholders. Indeed, like you, I very much want them to be. However, for me, the detail of how it's brought about and its extent is what matters. We don't yet know the detail of what is being offered to CEO/CFO this time round, so I think it's premature to take a final view on things, but what I'd say from previous experience with their schemes is this:

- any rights schedule should have timelines associated with it. Last time there were no expiry dates. We know how dreadful CUV is at hitting it's own delivery schedule. Sometimes this may be out of their hands, other times not. Whichever is the case, they simply need to accelerate their delivery and stop with their excuses and avoidance of responsibility.

- any performance hurdles need to be real challenges. Last time the 1st Performance Condition was that the rights plan be approved - a somewhat circular achievement! The 4th Condition was the submission of the NDA - not it's approval, but the submission. I don't mind paying up for good outcomes, but I'm less inclined to be so generous for following process.

To me, it should be a matrix of reward. Perform your job, and not especially quickly, you don't get any great bonus. Deliver a stellar outcome, and quickly, get rewarded handsomely.

What's different this time round is Blijdorp is Chair of the Remuneration Committee. He wasn't on the Board in 2014, and had no role in the last big rights package. His view that management should have up to 20% equity is, for me, too high for a company not founded by current management, but I'd be OK at up to 10% or so (with appropriate hurdles to get there). What I do very much like is his view that the Board should NOT be involved in Rights schemes. To me this is how it should be. The current Board has been way too cosy with management, and they shelter themselves from scrutiny by disenfranchising major groups of shareholders. 2 board members have been there for over 10 years - no longer independent by their own measures, and the most recent addition smacks of historical fondness rather than proven board ability. Moving to a more "arms length" approach is to be welcomed, and I'm hopeful that terms associated with the next Rights scheme will be similarly more appropriate.

So, I'm willing to wait to see the details before taking a view, but no doubt I'll remain very skeptical that the delay in negotiating new terms is down to the executives being busy as opposed to driving the AGM vote into the nice warm window we'll all experience if the FDA says yes. I can't imagine a big, generous rights package getting up if the FDA says no!



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Dr Wolgen is a magician.
His end game for Scenesse will impress, or even amaze.
En route, along with glimmers of truth, there will be distractions, illusions, sleight of hand and misdirection.
Enjoy the ride.

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Boat2float
post Posted: Aug 30 2019, 08:19 AM
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In Reply To: Dr Wally's post @ Aug 29 2019, 11:01 PM

I think its a stupid reason for FDA to deny a drug because of its tanning effects which may get people out of the ritual of tanning beds and harmful UV rays. Even if its used for off-label, WHO CARES. Off-label happens all the time by respectable MDs and even botox is being marketed as a cosmetic drug with FDAs endorsement. If there is any real reason for delay, its probably that the US sold the patent to Clinuvel not realizing they had a blockbuster and Australia is benefiting and marketing to the US. 2019 is alot different than it was in 2004. Maybe they are waiting for the patent to expire?

 
HoustonTX
post Posted: Aug 30 2019, 07:54 AM
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In Reply To: johnnytech's post @ Aug 30 2019, 07:14 AM

I’m not sure what Australian law says in the matter, but I think it’s almost universal that shareholding’s have nothing to do with the power of each director on the Board of Directors. Each one has one vote, and owning shares is not a prerequisite to being a director.

Some decisions of the board may need to be ratified by the shareholders, in which case holdings do matter, but not most decisions.

The board appoints and can remove the CEO, subcommittees of the board determine compensation and the board generally steers the strategy of the company and has to approve any material contracts and expenditures. Shareholders may have to approve things like a sale of the company, but that may depend on the structure of the deal.

Shareholders may also be able to nominate or remove directors upon a vote, but we would have to see the articles of incorporation or organization or a similar instrument to know those particulars.

 

sentifi.com

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johnnytech
post Posted: Aug 30 2019, 07:14 AM
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In Reply To: LevelHeaded2000's post @ Aug 30 2019, 03:25 AM

Nice eloquent points, but that is the "more" fallacy. Blijdorp bought his way in with external money. That's entirely different from PW. PW is a hired gun, who delivered on his original contract and got paid for it handsomely. There are other hired guns out there available for hire for the next phase. For a company that he didn't start, he is way WAY above the norm for 1) pure ownership %, and 2) walk away wealth.

Anyway, my main problem isn't the "more" fallacy, as I said it's the lack of checks and balances. As more friends on the board get power, the votes are diluted. There is no scenario where this power consolidation is more profitable for retail investors over the next 20 years.


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odi01
post Posted: Aug 30 2019, 03:58 AM
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In Reply To: seeva222's post @ Aug 30 2019, 03:21 AM

https://onlinelibrary.wiley.com/doi/full/10.1111/pcmr.12802


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LevelHeaded2000
post Posted: Aug 30 2019, 03:25 AM
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I take a much less cynnical view than everyone on the board. I want the executives interest aligned with the shareholders. The performance metrics are for specific actions that will help the company. If they are succeeded we all benefit. One thing to consider is that Clinuvel is paying shares in place of money. If they did not offer the shares, then they would be forced to offer more money-in-hand whether to PW or to another CEO. It's not like the performance rights share come freely.

So, given that, the fact that PW and executives are taking shares in place of money compensation indicates they feel confident about the company's future.

Blijdorp owns 1.7 million shares and he is head of renumeration. He isn't selling. He doesn't get any performance rights, so he is not benefiting from this plan directly. He was not given his shares, but bought them on the market. So, he has real skin in the game. I am pretty sure that he is fully analyzing the options and doing what he thinks will make his investment 10x from here.

I can only hope the executives meet all the various performance goals. If they do, then Clinuvel will be executing well and that is worth a few %.


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seeva222
post Posted: Aug 30 2019, 03:21 AM
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In Reply To: sharelooker's post @ Aug 30 2019, 01:51 AM

significance for the uneducated?

 
 


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