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San Diego
Posted on: Aug 30 2019, 10:39 AM


Group: Member
Posts: 145

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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San Diego
Posted on: Aug 1 2019, 04:16 AM


Group: Member
Posts: 145

I may not be the brightest bulb in the chandelier, but why would Johnny H indicate that he was so bullish as to purchase CLVLY at a premium (spike), if his intension was to cast a shadow on Clinuvel’s FDA approval chances?
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San Diego
Posted on: Jul 11 2019, 10:25 AM


Group: Member
Posts: 145

Are you not familiar with Wolgen speak? This newsletter was like reading Mary Poppins compared to his last newsletter publication of Moby Dick.
“The FDA benefits from the periodic safety update reports and annual reports submitted to the EMA since 2015. It is widely known that the FDA and the EMA share and exchange information.”
“We embrace a cautious optimism”. I had a little trouble sleeping after the last newsletter; I think I’ll sleep just fine tonight.
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San Diego
Posted on: Jun 25 2019, 10:23 AM


Group: Member
Posts: 145

https://www.buzzfeednews.com/article/danver...-women-approved

“About 1% of patients treated with Vylessi in the clinical trials reported darkening of the gums and parts of the skin.”
“20% to 30% of women report low sexual desire”
In my opinion, the details outlined in this article highlight Clinuvel’s continued exclusivity in the photoprotection sector, and that Scenesse has an increased chance of approval for two reasons:

1) It would be unconscionable for the FDA to approve Vylessi, which only shows marginal efficacy, for what is basically a recreational drug that stimulates melanin production in upwards of 475,000 women (1% occurrence in 30% of the US women population), if the FDA truly thought melanin stimulation was harmful.
2) Because 99% of women do not experience melanin stimulation, Vylessi will not be a competitor in the photoprotection sector.

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San Diego
Posted on: Jun 23 2019, 11:23 AM


Group: Member
Posts: 145

I haven’t been following Palatin that closely, because I thought that Bremelanotide wouldn’t get approved with only minimal efficacy for sexual dysfunction, combined with multiple side effects. When it received approval on Friday, I became a little concerned that Clinuvel had a potential competitor in the photoprotection category. Per Wiki, Bremelanotide is an active metabolite of melanotan II that lacks the C-terminal amide group. The C-terminal amide group must be the part of the chain that stimulates tanning, because Palatin would have to list tanning as one of the side effects, if it is one. It appears that Clinuvel will still be in a league its when it comes to photoprotection.
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San Diego
Posted on: Jun 11 2019, 05:45 AM


Group: Member
Posts: 145

After checking into Yahoo’s chat board for CLVLY for the first time in quite awhile, it felt like I had pulled up a seat at the card table in the Oriental Saloon before Wyatt Earp became the dealer. Thankfully, there is a moderator on this site.
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San Diego
Posted on: Apr 24 2019, 02:45 PM


Group: Member
Posts: 145

If Stan's letter didn't talk you off the ledge, none of us will be able to help.
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San Diego
Posted on: Apr 12 2019, 10:02 AM


Group: Member
Posts: 145

So that explains the 100 trades of 5 to 10 shares at a time over the last few months.
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San Diego
Posted on: Nov 9 2018, 08:51 AM


Group: Member
Posts: 145

I was absolutely sure that they hadn’t received an RTF after their Nasdaq Virtual Investor Presentation on September 20th. They listed the status as “NDA filing, rolling review”. The NDA cannot be filed and have received a Refusal to File at the same time. Those two events are mutually exclusive of each other. For those of you that were still convinced that they had received an RTF should probably not be invested in this company, because you are of the belief that Dr. Wolgen is a fraud. After their presentation, I realized that they had only received a WTF.
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San Diego
Posted on: Sep 20 2018, 10:09 AM


Group: Member
Posts: 145

According to today's Nasdaq Virtual Investor Presentation, they do not appear to have received an "RTF". It states that their current status is "NDA filing, rolling review".
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San Diego
Posted on: Sep 18 2018, 03:57 AM


Group: Member
Posts: 145

According to Jennifer on Facebook, she received her insurance reimbursement from the U.S. insurance provider Anthem Blue Cross/ Blue Shield with a PPO out of network plan.
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San Diego
Posted on: Sep 15 2018, 10:35 AM


Group: Member
Posts: 145

Did Gayle ever answer Patty's question? I would like to know the insurance company as well.
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San Diego
Posted on: Sep 7 2018, 12:19 AM


Group: Member
Posts: 145

Your link on Alkermes is encouraging. It’s interesting that their press release stated in no uncertain terms that they had received an “RTF” from the FDA. That sure takes all of the fun out of guessing.
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San Diego
Posted on: Sep 5 2018, 01:28 PM


Group: Member
Posts: 145

Time is of no consequence when you are paid a million dollars per year and are granted a performance package that never expires. If PW blindly runs into the wall enough times, it’s only a matter of time before he will find the door.
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San Diego
Posted on: Jun 23 2018, 12:15 AM


Group: Member
Posts: 145

It sure is great management to put a 2 day trading halt on one exchange and to let all the other exchanges around the world trade on speculation. There currently is a buy order for 700,000 shares @$9.50 for CLVLY.
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San Diego
Posted on: Jun 22 2018, 07:50 AM


Group: Member
Posts: 145

Here's some relevant reading to help the month of June pass by. (Not that making a self imposed deadline is even remotely important to PW.)


https://www.msn.com/en-us/health/wellness/‘...ocid=spartandhp
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San Diego
Posted on: Jun 7 2018, 01:05 AM


Group: Member
Posts: 145

If that's the case, he may have been referring to a shorter horizon, because the title of the video says 30.00 Euro, which I was interpreting as the CUV price converted to Euros.
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San Diego
Posted on: Jun 7 2018, 12:02 AM


Group: Member
Posts: 145

Drawing from my vast German vocabulary that I learned from Hogan's Heroes, I believe that he was referring to a $30 stock price. The exchange that he was referring to is still unclear to me.
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San Diego
Posted on: Jun 6 2018, 11:33 PM


Group: Member
Posts: 145

The term "bagger" is used as a synonym for a multiple of the number. So a 30 bagger would equate to a $360 Australian stock price.
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San Diego
Posted on: Jun 1 2018, 08:25 AM


Group: Member
Posts: 145

Call me an optimist, but they've missed too many self-imposed deadlines to not pad this one. My prediction: June 19th.
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San Diego
Posted on: May 14 2018, 10:00 AM


Group: Member
Posts: 145

The pre-open bid never remains. It's just someone's attempt to prime the pump. More often, the actual opening bid is something closer to the pre-open offer.
In any event, It looks like we will have to wait until the end of August before we find out if an expedited review will be granted.
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San Diego
Posted on: Apr 6 2018, 03:18 PM


Group: Member
Posts: 145

I don't think that PW posted the link as an informative analyst's report. it appears as if he was posting a "For Sale" notice. That would coincide with his generous stock package he will be receiving with the soon to be announced NDA .
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San Diego
Posted on: Jul 3 2017, 03:39 PM


Group: Member
Posts: 145

There was a seven year period, while I was accumulating Clinuvel stock, that I put an inordinate amount of my time and effort into researching all things clinuvel. Once I was comfortable with my acquired position and the fundamentals of the company, I started focusing my efforts on other ventures. From time to time, when I visit ShareScene, I will usually attain a better understanding of Clinuvel’s areas of progress and delays. I am grateful for some of the ShareScene members that contribute valuable information and insight.

I definitely can see how repetitive information from the same member can be annoying, but I fail to see how posting a link that contains valuable information is at all detrimental to a board if it has already been posted. Even though I have seen references to the interview on this board, I hadn’t seen the original link. That is why I thanked Artkatansclean for posting it. Ridicule of duplicate postings may stifle valuable information from new or infrequent members out of concern that the information has already been posted.



  Forum: By Share Code

San Diego
Posted on: Apr 22 2016, 12:05 PM


Group: Member
Posts: 145

Okay, thank you. Then, if there is any material information to be announced, it should be announced tomorrow or on Monday in the US. I'm not saying that it necessarily will be.
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San Diego
Posted on: Apr 22 2016, 11:46 AM


Group: Member
Posts: 145

You do realize that April fools jokes are to be played on April 1st don't you? And if there is an impending announcement, one that I am unable to source, why would you say today or Tuesday? Is Monday a holiday in Australia?
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San Diego
Posted on: Apr 6 2016, 02:54 PM


Group: Member
Posts: 145

I am much more concerned with the reimbursement pricing structure than I am with the finalization of the distribution program. At this point, after waiting the better part of 10 years, it doesn't matter to me if the coming weeks implies 3 or 8 weeks, as long as it is all but fait accompli with the proverbial dotting of the i's and so forth, which I believe it is.

Any amount north of $10,000 per implant, which most indicators are pointing, should move the stock upward.
  Forum: By Share Code

San Diego
Posted on: Apr 6 2016, 01:52 AM


Group: Member
Posts: 145

I must have missed the memo that said that EPP patients could only receive implants during the Summer months. Why will we have to wait until next March to get excited about sales again?
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San Diego
Posted on: Apr 5 2016, 03:55 PM


Group: Member
Posts: 145

http://www.asx.com.au/asxpdf/20160405/pdf/4369pmbcxnzngc.pdf

"A final reimbursement pricing structure will soon be established."


"Our vitiligo program continues to progress globally. We expect data from the revised protocol study in Singapore to be available for analysis later this year, and patient responses continue to suggest effectiveness."
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San Diego
Posted on: Mar 25 2016, 03:38 AM


Group: Member
Posts: 145

I believe that the atypical trading behavior yesterday was the result of "the calm before the storm", which in my opinion, is a storm that will bring some much needed rain. I would imagine that Fidelity and Lagoda are on the sidelines to avoid the perception of increasing their respective positions shortly before the German reimbursement price that is expected be announced over the next couple of weeks. The lack of any strong demand may be shaking a few shares loose from uninformed investors that do not want to take a chance on the stock taking another dip that has historically been the case after similar run-ups.
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San Diego
Posted on: Jan 19 2016, 02:15 PM


Group: Member
Posts: 145

http://www.asx.com.au/asxpdf/20160118/pdf/434f7rc0zhxt01.pdf

FIL still believes in Clinuvel.

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San Diego
Posted on: Dec 15 2015, 02:06 PM


Group: Member
Posts: 145

Will do, though I'm not sure if the Aussies follow San Diego weather.
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San Diego
Posted on: Sep 22 2015, 07:12 AM


Group: Member
Posts: 145

http://news.yahoo.com/young-gentleman-buys...-191020569.html

Love him or hate him, Mr. Shkreli is one shrewd businessman. CNBC business channel has yet to post a link on its website, but I recommend watching, what was a very informative interview, when they do. He was surprisingly articulate with his responses to two business reporters that clearly wanted to put him on the hot seat. The above link is unrelated to the CNBC interview.
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San Diego
Posted on: Jul 29 2015, 03:09 AM


Group: Member
Posts: 145

I am suggesting that "if" Retrophin was the seller, then there is an excellent chance that PW was instrumental in finding the buyer. In that case, the new buyer may be of like mind with PW. Therefor, his growing compensation may remain unchecked, and will continue the pattern of not being tied to any pricing metric that would benefit the shareholders.
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San Diego
Posted on: Jul 29 2015, 12:08 AM


Group: Member
Posts: 145

Retrophin's exit would be a double edged sword. On one hand, having the enormous lid removed, that was caused by their vast supply of fire-sale shares, may be the signaling of blue skies ahead. Much of the downward pressure will have been lifted, enabling a gradual upward movement in stock price brought about by relatively small purchases from new investors who have learned about the company from the many recent articles. And in the event that there is good news from any of our "irons in the fire", we may actually see an appreciable increase in the stock price.

On the other hand, if it was Retrophin, do you believe that it will have been a coincidence that such a large voting block, that clearly has little love for PW, would disappear shortly before the next shareholders meeting? If there is one thing that we know that PW is good at, is raising money. That is why I find it inexplicable that he didn't find someone to take out Retrophin's position shortly after EMA approval. Retrophin's willingness to sell into every rally, not only kept the price from rising, it has contributed to the continued descent in stock price.

There are reasons that the board of directors is required to be independent. After all, power corrupts, absolute power corrupts absolutely. I already am of the opinion that the structure of PW's compensation package has been beyond absurd, it concerns me that the new shares purchased may fall into lockstep with his marching orders as his yearly compensation increases his percentage ownership in the company.
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San Diego
Posted on: Jul 24 2015, 02:20 PM


Group: Member
Posts: 145

You can't be serious. You really couldn't detect a hint of sarcasm in my post?
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San Diego
Posted on: Jul 24 2015, 02:04 PM


Group: Member
Posts: 145

Hello xyz_xyz,
It's a pleasure to have one of PW's family members on the board with us. Yes, we are fortunate that PW has been Given an "impressive" number of shares. It may be prudent to increase PW's ownership in the company to ensure the prevention of any possible shareholder approved buy-outs or mergers.
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San Diego
Posted on: Jul 4 2015, 04:16 PM


Group: Member
Posts: 145

I never realized that PW was so prophetic. He was able to foresee his 2015 regrets eight years in advance.

That being said, I have to give Dr. Wolgen credit where credit is due. Possible mismanagement of trial data aside, I have always had my trepidations when it came to faulting him for trial design. What other drug trial required participants to exacerbate their condition to the extent that was required in their trial? Typically, the group receiving the drug either sees an improvement or not, with the placebo group being mostly unaffected.

Conducting a trial for EPP patients and expecting them to expose themselves to sunlight would not be unlike conducting a trial for a drug that substantially reduces, but doesn't eliminate, the effects of bee stings in people that are severely allergic, and require them to get stung. Quite frankly, I would not want to participate knowing that I was in the group that received the drug, much less the placebo group.

Previously, after learning the initial "P" values, I thought that PW threw a "Hail Mary" pass with two seconds left in the game and no chance of winning, by creating a makeshift method of data interpretation in an attempt to make the numbers fit. And, if it wasn't for the astute EMA director, Guido Rasi, having the ear of the EPP community, and willing to lobby other member countries to accept the new method of interpreting the primary endpoints, market authorization would have been less likely.

Madman is correct in that "the difference in a primary endpoint being statistically significant or not in a phase 3 trial is of massive potential importance to investors". Their method of interpreting the data was presenting an obstacle not unlike the response that they received to their "tanning" drug from the FDA.

It is now clear to me that Dr, Wolgen and team, were able to overcome this dilemma by creating a new scientific method of interpreting the data and convincing the EMA of its validity.The NEJM is probably the most respected medical journal in the world, and I find it inconceivable that they would publish a peer reviewed article with a veritable "who's who" of experts wanting to have their name attached, without covering every aspect of the trial from start to finish, including the altered method of statistical analysis and possible data mismanagement.

It is my opinion that the NEJM publication just paved the way for FDA approval.
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San Diego
Posted on: Jun 21 2015, 01:00 AM


Group: Member
Posts: 145

I'm Very Sorry! I had just woken up, before my morning coffee, and wanted to give you a quick answer. The only problem is that I read your posting incorrectly! Intuitively, one would think that a "thank you" would be an indication of acceptance, but I can understand why you phrased it that way.
On the positive side, at least you have received another "thank you" for your tally.
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San Diego
Posted on: Jun 18 2015, 11:09 AM


Group: Member
Posts: 145

Contrary to much of the political rhetoric, according to a CNN Money article dated April 13th 2015, nearly 90% of Americans are covered by health insurance. US medical insurance coverage is at its highest level since they have tracked it. From my personal experience, American insurance companies are very good at covering prescribed medications for any disease related ailments. It is my understanding that there are several large insurance companies such as Aetna and United that will even cover Viagra! That being said, I have little doubt that EPP patients will have almost immediate insurance coverage in the US once Scenesse is FDA approved.


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San Diego
Posted on: Jun 16 2015, 01:37 PM


Group: Member
Posts: 145

Other than being paid $1,000,000 per year and receiving enormous stock bonuses that aren't tied to any pricing metric, I can't think of a single reason.
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San Diego
Posted on: May 30 2015, 07:54 PM


Group: Member
Posts: 145

The message would be much louder if PW decided to defer any portion of his income for stock or options.
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San Diego
Posted on: Apr 28 2015, 12:39 AM


Group: Member
Posts: 145

OR, we, as collective owners of the company, should hold management, as our elected representatives, to a standard that reflects the type of leadership that we collectively expect, or replace them with a more representative team.

That doesn't necessarily reflect my view of current management, but I have to shake my head at the "shut up or get out" mentality, despite all of the blood, sweat and tears many of us have put into this company.


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San Diego
Posted on: Mar 28 2015, 01:07 AM


Group: Member
Posts: 145

You may have a point if you are looking at the first few years. One would think that there would be at least 1 out of every 100 people with an appearance altering affliction that would have the desire and the ability to pay EPP prices which would also alter your revenue projections.
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San Diego
Posted on: Mar 27 2015, 11:54 PM


Group: Member
Posts: 145

Whilst I welcome the devil's advocate position, I suspect your 1% patient uptake #'s to be off by about 5 fold, in addition to leaving Asia out of your equation.
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San Diego
Posted on: Mar 27 2015, 03:11 PM


Group: Member
Posts: 145

There is an excellent possibility that if you're someone from the US that has been selling your shares after the conference, I have been the one purchasing them from you. Even though I am not particularly enamored with Dr. Wolgen's tenure, it doesn't mean that I don't find him to be strategic, and he certainly has been given every incentive to be patient.

There is absolutely no reason that Clinuvel should be touting the benefits of a drug that has yet to be approved for the Vitiligo indication. In fact, it could very well be to their detriment. My take is that Dr. Wolgen viewed the convention in San Francisco as obligatory at best. Make no mistake, that was a world stage that had both competitors and regulators making notes.

Measuring the efficacy of a drug for a cosmetic indication can be rather subjective. Wouldn't it make sense to set the bar at a level that can be reached with certainty in the much larger phase 3 trial? When it comes down to voting yes or no, there will be a human element involved when they weigh the benefit vs. risk, and the benefit may end up being mostly perception.

On a final note, why was anyone expecting CUV103 results to be presented at the conference? The CUV103 results will almost certainly be posted on the ASX or on Clinuvel's website, or both, when they are ready, and not at a conference. Clinuvel announced last year that the Phase 2 trial in Singapore was commencing on May 6th, 2014. If you take into account 2 to 4 months to find 60 of the best applicants that fit their specific medical parameters, and also have the desire and ability to complete the trial, and the 7 months of the treatment phase, concluded by 3 months of the follow-up phase, the results will not be ready until June or July.

Please keep in mind, that I am not a medical professional, I just play one on TV. (or in this case, the internet) Actual results may vary, and these are only my opinions.


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San Diego
Posted on: Mar 24 2015, 12:05 AM


Group: Member
Posts: 145

I wouldn't expect to learn anything new from the conference that will have an effect on the stock price, other than the much needed increased awareness of what we already know. Reg FD was introduced in 2000 to prevent a select group, such as the attendees at a conference, from learning actionable information before other investors. Reg FD required that all publically traded information be made available to all investors at the same time. In 2013, the SEC further clarified the ruling by allowing public companies to use social media to disseminate new information with certain caveats.

Full disclosure: I am not an attorney. This is my is my understanding of what is required under the provisions of Regulation FD. I encourage the reader to cross check what I believe to be facts in case I am in error.
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San Diego
Posted on: Mar 23 2015, 02:26 PM


Group: Member
Posts: 145

I would like to apologize to Controvers for my attempt at some pointed light hearted humor. It's just that I can't help but smile a little when I see his avatar and think of the Angry Bird game that my son plays when he posts a complaint. I welcome his point of view every bit as much as yours, Parkview. I do not see Conrovers attacking fellow ShareScene members for stating their points of view. You, of all people, should know what happens to a board when people are afraid or unwilling to state their opinions because of personal attacks. The quality posters go away.

This board would serve no purpose for me if everyone was peering through the same looking glass as I was. If a fellow member sees something differently than I do, or sees something that needs to be corrected, such as when landrews pointed out that Dr. Wolgen receives his 624,975 shares upon FDA submission and not approval, I welcome it. That being said, I don't know how I misread that one. Maybe my brain wouldn't accept that someone could be granted that many shares, or any for that matter, with just a submission.
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San Diego
Posted on: Mar 23 2015, 12:11 PM


Group: Member
Posts: 145

Unless you are getting paid to be the mascot for the video game Angry Birds, it can be healthy to occasionally acknowledge that the glass is half full. Maybe the questions that should be asked are "Why is no one selling?" and "Who has sold 140 shares"?.
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San Diego
Posted on: Mar 23 2015, 10:08 AM


Group: Member
Posts: 145

Reality Check, I was making the case for the most plausible scenario "if" they decide to do a capital raise. I personally think that a capital raise is highly unlikely. A much more strategic path would be to partner with a major pharmaceutical company to utilize their expertise, influence and capital, all of which will be required to see the Vitiligo indication through a phase 3 trial, FDA and EMA dossier submissions and ultimately marketing and distribution, all while staying the course with their current solo EPP distribution plans.

Unlike EPP, where Scenesse is the only viable treatment for a physically debilitating disease with a small vociferous community that is willing to lobby on behalf of the drug, the treatment of Vitiligo is a choice. As others on this board have pointed out, Scenesse will most likely need the expertise and unfortunately, the influence to obtain approval for a cosmetic indication.

I do find Dr. Wolgen to be a strategic person, and with that said, he has learned where his weaknesses lie, especially after barely obtaining EMA approval for EPP with the longest review on record. As Parkview has so aptly pointed out, like it or not, he has more to lose than any of us. If he makes a miscalculation and unsuccessfully attempts to obtain approval for Vitiligo on his own, then the value of his millions of shares will have been greatly diminished through massive dilution and reduced patent terms.

From Dr. Wolgen's actions, he is very risk averse i.e. not purchasing stock or sacrificing salary for an even greater share of the company. It would make all the sense in the world to partner with big-pharma for the reasons I have already articulated, while retaining a tremendous upside in the event of a successful Vitiligo program. This will allow Dr. Wolgen to focus his time and energy on European EPP insurance negotiations and ultimately distribution along with an FDA EPP dossier submission because there are more EPP riches to be had for Dr. Wolgen with 499,890 shares to be granted to him when sales commence in Europe and another 624,975 shares upon FDA EPP approval.
  Forum: By Share Code

San Diego
Posted on: Mar 23 2015, 07:23 AM


Group: Member
Posts: 145

You may be correct about the capital raise, but I definitely hope not. First of all, Clinuvel should have the results of the phase 2 Vitiligo trial published before they run out of money. Secondly, even if they haven't dotted their i's and crossed their t's in order to publish the results, they surely will know the efficacy of Scenesse with respect to Vitiligo.

If they choose to raise money before they need to, and they go back to their go-to group of investors (voting block) before the results of the phase 2 Vitiligo trials are published, all while knowing the results look very promising, I for one, will have a huge problem with the unnecessary stock dilution. I see no reason that, if in deed, the phase 2 results are good, that they shouldn't let the market know what is on the table, hopefully benefiting the stock price, and then raise enough capital for on-going operations and phase 3 vitiligo trials.
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San Diego
Posted on: Mar 19 2015, 02:12 AM


Group: Member
Posts: 145

I do not wish to argue with either Reality Check or you, because there is no reason to believe that my take is any better than either of yours. My take is that Retrophin really wants to liquidate their position, but they do not want to give it away, especially now that the stock has essentially been de-risked at this price after EMA approval. They were basically advertising to any potential large buyers that may want to take their position. That being said, until they liquidate their position, they are creating a ceiling for the price. Yes, it appears that they were selling heavily after EMA approval to the extent that they did not overly affect the stock price, because they did not want to spook the market with heavy volume and a slumping stock price.

I believe that we would have seen a much higher stock price spike after EMA approval had it not been for Retrophin selling into the rally. Until Retrophin has eliminated their position, which I believe will be soon, we will have a substantial pressure on any upward movement even on positive data.
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San Diego
Posted on: Mar 18 2015, 03:24 PM


Group: Member
Posts: 145

The debate that is going on between Snaffew and you reminds me of when I listened to two friends of mine in college argue for at least an hour on whether the song "Winds of change" or "Gorky Park" was the best Scorpions song before I told them it was the same song. Yes, Snaffew, there is no significant demand for the stock, so the relatively small amount of stock in terms of shares that Retrophin is selling is negatively impacting the price. Yes, Reality Check, Retrophin is most likely the largest single seller of the stock in terms of percentage, hence negatively impacting the price, also because there is no demand.
  Forum: By Share Code

San Diego
Posted on: Mar 16 2015, 03:02 PM


Group: Member
Posts: 145

I am going to go out on a limb and predict a major Vitiligo partnership announcement that could happen at anytime within the next 12 months. We may even get a hint of this with Dr. Wolgen's teaser promising a status on the Vitligo program "shortly".
It is now quite apparent that I was way too optimistic regarding the pace of insurance negotiations with each member country, and hence the roll-out of Scenesse which will be much more staggered than I anticipated. After using many different iterations of roll-out scenarios using an estimated $6000-$10000 per implant, I can't come up with one that will cover an estimated $2.5 million per month phase 3 clinical trial for 21 months anytime soon (my estimates, not the company's).


It is my opinion that Clinuvel would currently be putting on, or, at least, announcing plans for an extensive roadshow with the investment community to boost the stock price for the capital raise required to achieve EMA and FDA approvals for Vitiligo. Unless, that is, they were going back to "the well" for a capital raise from their already large voting block, which would be a little too symbiotic to swallow with the massive dilution that would occur at the current stock price.


I would also like to point out that even though I was expecting a much faster roll-out, I am not remotely criticizing because I can appreciate the complexities involved negotiating with all European member countries and it should not be rushed nor taken lightly.

  Forum: By Share Code

San Diego
Posted on: Mar 3 2015, 02:28 PM


Group: Member
Posts: 145

First of all, I believe you to be an honest person whom which I have always admired because of your steadfast conviction and I have enjoyed reading your posts. That being said, why would I walk away from a stock that I believe has an intrinsic value of $15 per share, excluding EPP FDA approval or Vitiligo, in a fire-sale? It is especially the case for those of us that have stayed with this company through thick and thin for the better part of a decade with the ultimate hope of approval. For the last time, no one is asking anyone to promote the drug, which would not only be counterproductive and fruitless, it could ultimately harm the company.

The fact that the stock is trading at such an absurd valuation, in my opinion, after achieving EMA is unfathomable. I am just asking that the company "inform" not "hype" the investment community of what they have achieved and what they have on their plate. You and I may being willing and able to wait for as long as it takes, but that may not be the case for many investors that have invested with the idea that the stock price would reflect milestones such as EMA approval, so that they could pay down on their mortgages or pay for their kids to go to college. It may be true that Dr. Wolgen has convinced Sean Parker and Fidelity of Clinuvel's potential because it was absolutely necessary to raise capital, but I think that he should use some of those sales skills to inform the investment community and show some respect for the shareholders that have stayed with him for so long.
  Forum: By Share Code

San Diego
Posted on: Mar 3 2015, 01:09 PM


Group: Member
Posts: 145

If you would like, I can post a link to a clinic that specializes in Stockholm Syndrome.
  Forum: By Share Code

San Diego
Posted on: Mar 2 2015, 02:26 PM


Group: Member
Posts: 145

I apologize and will try to follow the storyline, and if I spoke out of school, maybe I should be held back a year. To be honest, I haven't really sharpened my pencil on the earnings per share calculation because I have found that savvy investors give much more credence to revenue and revenue growth than they do to EPS in a small "growth" company showing real growth as I anticipate will occur.

Keep in mind that Vitiligo does not have Orphan status and will require a full phase 3 clinical trial. Because I must have missed where Clinuvel has posted their projected phase 3 expense, I factored in an industry average of $26,000 per participant multiplied by an estimated 3000 participants for a total of $78 million. The average number of participants for a full phase 3 study is 1000-3000. I have always found it prudent to err on the side of caution when making my investment calculations so I used 3000 participants. This doesn't even include any possible follow-up studies. Where exactly did you factor phase 3 expenses into your EPS calculation?

The good news, as far as I can tell, it appears Dr. Wolgen is operating under the assumption that they will be able to generate enough revenue to keep up with expenses to avoid another capital raise which I think is very encouraging.

I would like to correct my previous post, in that I believe that they should be reporting a strong EPS once their phase 3 clinical trial has been completed and their dossier has been submitted for approval, and depending on when they begin phase 3 Vitiligo trials, they should be reporting a healthy EPS beforehand.
  Forum: By Share Code

San Diego
Posted on: Mar 2 2015, 11:17 AM


Group: Member
Posts: 145

I don't believe that it is in Dr. Wolgen's playbook for the company to have any appreciable earnings per share, although we may see glimpses of earnings and glimpses of losses depending on Vitiligo clinical trial expenses in any given quarter. That being said, I am quite confident that Dr. Wolgen will do everything in his power to avoid losses and unnecessarily diluting the stock, especially at these prices.
After further thought, I believe that Dr. Wolgen's endgame is to obtain approval for Vitiligo and then put on the "dog and pony" show to attract the best suitor. Creating the infrastructure to market to the relatively small EPP community pales in comparison to creating the infrastructure to market to the vast Vitiligo community. Scenesse would have a far greater bottom-line value to a large pharmaceutical company with an already established worldwide network.

This model requires that we may have to hold this stock for up to five years or more to see if our investment will come to fruition, and if it does, will mean a huge homerun for all of us. Meanwhile, our risk in going this route, is that every year that goes by after EPP approval, the remaining term of our patent protection decreases and so does the amortized value of a buyout.

Don't get me wrong, I am very intrigued with the idea of holding tight for as long as it takes to achieve a maximum return on my investment. The problem is that I do not like to make my investment decisions in a vaccum, devoid of critical information. History has shown that investors that have invested on blind faith or the charisma of the chief officer hasn't always ended well.
  Forum: By Share Code

San Diego
Posted on: Mar 1 2015, 01:49 PM


Group: Member
Posts: 145

I am in agreement with Ignoramus that Clinuvel will have to be well on their way to having 2500 patients before they will warrant the kind of acquisition price that I put forth as a possibility. The good news, in my humble opinion, is that the patient uptake rate should be brisk once insurance is covering the cost. In addition, I also believe that patient retention will be very high.

It is quite amazing that their retention rate was as high as it was during clinical trials. I can't think of another trial that the placebo actually exacerbates the condition like the Scenesse trials that required EPP patients to uncharacteristically expose themselves to sunlight at their own peril. In spite of this, the EPP community's strong desire for a potential effective treatment gave trial patients the will to withstand the pain despite being quite aware of being given the placebo. They knew that without their sacrifice, there would be no approved treatment.

I only posted the possible acquisition numbers to explain why I am still in the stock even though I have obvious concerns with management's apparent lack of concern for the shareholders or the current stock price. I highly recommend that the reader of any of my posts does their own research before buying or selling this stock. Even though I probably have over 1000 hours of research into this company, I have been wrong in the past, albeit, mostly due to misinformation, there still are some unknowns that I am unable to factor into the equation.
  Forum: By Share Code

San Diego
Posted on: Feb 27 2015, 02:43 PM


Group: Member
Posts: 145

To be fair, I used the projected annual sales of $100 million over the next couple of years for Natpara. The total market is $250 million annually. I would have to use the total EPP market in my calculations if I were to use their total anticipated market. But to appease the skeptics, I will use Netpara's total market of $250 million and a fraction of the EPP market, that I used on a previous analysis, on the next calculation.

Total annualized sales of $200 million for Gattex and $250 million for Natpara for a combined $450 million.

$5 billion purchase price / $450 million in annual sales = 11.11 multiple

Clinuvel calculations:

$6000 per implant X 4/year X 2500 patients = $60 million annualized sales X 11.11 / 44.5 million shares = $14.98 / share

This is what I think Clinuvel would get in a fire sale, using conservative estimates without taking into account the US market or the huge Vitiligo market!


  Forum: By Share Code

San Diego
Posted on: Feb 27 2015, 02:02 PM


Group: Member
Posts: 145

This stock is ridiculously underpriced, and is a strong buying opportunity! I will further articulate my frustrations with management on another post but this is why I am not selling and would gladly entertain a legitimate buyout offer.

Shire recently acquired Orphan drug company NPS Pharmaceuticals for $5 billion. NPS received approval for orphan drug Gattex from the FDA in December 2012 and the EMA the third quarter of 2013. Gattex now generates $210 million in annual sales. NPS just received FDA approval for their other drug Natpara with projected annual sales of $100 million for a combined projected $310 million in annual sales. A $5 billion purchase price puts that at a 16.1 multiple of annual sales.

Now I am going to use relatively conservative projections of what Clinuvel has on its plate without the FDA or Vitiligo or heaven forbid off-label use.

$6000 per implant X 4/year X 2500 patients= $60 million in annualized sales

$60 million X 16.1= $966 million / 44.5 million shares = $21.71 per share!

I personally believe that a large pharmaceutical company would give us a premium above this with Clinuvel's strong initial Vitiligo results.
  Forum: By Share Code

San Diego
Posted on: Feb 23 2015, 02:25 PM


Group: Member
Posts: 145

I am quite sure that they monitor this board. As I have indicated before, I have had a sizeable stake in this company for many years now. I still believe that Clinuvel has enormous potential. Otherwise, I would have sold my position. That being said, it is our job as shareholders to make sure that potential is not squandered or that we are not taken advantage of. I am not trying to disparage the company or my investment. I am requesting that we as shareholders are given a little more credence.
  Forum: By Share Code

San Diego
Posted on: Feb 23 2015, 01:52 PM


Group: Member
Posts: 145

I stand by my assertion that most corporations incentivize their officers to reward their shareholders, whom make it all possible, with a year over year appreciation that exceeds inflation at a bare minimum. There wouldn't be a publically traded corporation in existence, if you were to tell investors that their initial investment wouldn't see any appreciation for at least ten to fifteen years.

As I said before, no one is asking anyone to promote Scenesse "the drug" and upset the regulators. I am asking that they do a better job of making the investment community aware of Clinuvel "the company" and everything that has already been announced via Facebook or on their website. There is no need to embellish or tout anything. Heck, we have a great story with a first in-class drug that has just been approved for a disease that previously had no viable treatment AND has shown very promising initial Vitligo results! Other than my previously posted hypothesis, please tell me another reason why they are hiding?

If anything, the regulators would have increased respect for a company, that provides medication to the public, as it becomes more financially sound. And in the event that Clinuvel needs to raise money, they would be in a better position to do so, without unnecessarily diluting our interest.
  Forum: By Share Code

San Diego
Posted on: Feb 22 2015, 12:42 PM


Group: Member
Posts: 145

You are correct in that there isn't a need to market Scenesse to a finite group of EPP patients. As it is, there is little doubt about the anticipated uptake from the target market. That being said, Clinuvel has been virtually incognito in the many investor and investment banker conferences. It would take very little exposure, with such a thinly traded stock, to double or triple the price. This leads me to believe that Dr. Wolgen wants to keep the stock down for a number of reasons at the expense of the shareholders.

He stated that it would be unlikely they will need to dilute the stock with another offering. Hence, there is no need, at least under his apparent plan, to promote the stock. This is why most corporations usually reward their officers with stock options tied to a stock price with set time periods to exercise, instead of granting a percentage of the company with stock. Dr. Wolgen hasn't be given an incentive to want the stock price to trade higher. In addition, if the stock price is higher at the time of his next assuredly generous incentive package, it will seem like he is granting himself a larger package even though it is the same amount of shares. One million shares at $3.00 per share doesn't seem as much as one million shares at $15 per share.

It looks like Dr. Wolgen is playing the endgame plotting along, putting his proverbial ducks in a row, and acquiring as much of a percentage of the company that shareholders will allow him to take, before capitalizing on the Vitiligo market. That would be the ultimate endgame in which the necessary mass product marketing would translate into market exposure and finally stock price. At that point, Dr. Wolgen would be a very wealthy man and could realize his dream of owning a soccer team. Unfortunately, it would be on the suffering backs of the long term stock holders such as myself. Unless, you have resigned yourself to holding this stock for a minimum of five years, I believe that a legitimate buyout offer is our best bet.

I hesitate to be negative at the expense of my investment, but I am hoping to effect change or at least put Dr. Wolgen on notice to start treating stock holders as partners instead of a means to an end. We have an approved drug; there is absolutely no legitimate reason not to promote the company at this juncture.
  Forum: By Share Code

San Diego
Posted on: Dec 23 2014, 12:27 PM


Group: Member
Posts: 145

I am not sure why there has been so much speculation as to whether the European Commission would ratify a CHMP recommendation, because they essentially act in the same capacity as the FDA. They do not function as an advisory committee. There is only one case that I am aware of, where the CHMP gave a recommendation for approval of an antibiotic and the EC sent it back because new information surfaced between the time of recommendation and ratification. The CHMP ultimately gave a recommendation against approval.

Hence, this is why there has been no appreciable bump to the share price. There will be many milestones that will bump the price, but this is more akin to receiving a trophy after they already won the game.
  Forum: By Share Code

San Diego
Posted on: Nov 9 2014, 02:10 AM


Group: Member
Posts: 145

For those of you that feel that you may not live long enough to financially benefit from Clinuvel's full exploitation of the complete potential of Scenesse, this may be interesting reading, and no, it's not written by Orson Welles.

Positive early results in human trials for an anti-aging metabolic co-enzyme NAD compound that has been proven to reverse the senescence (not to be confused with Scenesse, although probably a root derivative) process in mice have just been announced.

http://www.iflscience.com/health-and-medic...veal-no-adverse




  Forum: By Share Code

San Diego
Posted on: Nov 5 2014, 08:32 AM


Group: Member
Posts: 145

Okay Madman, you have the internet chatter buzzing with your reference to Lolley 113 as LJAMESH. It may help others sleep at night if you were to elaborate.
  Forum: By Share Code

San Diego
Posted on: Nov 4 2014, 09:27 AM


Group: Member
Posts: 145

I was thanking KRD for the link and not his last comment. Other than EPP, Hailey-Hailey and Vitiligo, I really believe we need to fly below the radar until we have FDA approval at a minimum. We all know the tremendous, unprecedented opportunities that Lie ahead for those that are patient. Once Scenesse is used by thousands of dermatologists worldwide for Vitiligo and EPP, then Katy bar the door for the endless potential uses. This is why I am not faulting Dr. Wolgen for still continuing to keep a relatively low profile until after FDA approval.

Much like the vociferous EPP community and their doctors, patients with other ailments will demand our product without Clinuvel having to upset regulators by pushing or "peddling" it in their eyes.

If you thought that a small EPP trial was difficult to show efficacy. Try proving a negative. It would be very difficult to show that Scenesse prevents skin cancer in controlled trials.
  Forum: By Share Code

San Diego
Posted on: Nov 4 2014, 05:26 AM


Group: Member
Posts: 145

After having one indignant poster in which several members called him out, it seems, according to this Google poster at least, we have completely broken down into an out of control attack board:

The Sharescene CUV board is now deteriorating into another Yahoo CLVLY board with posters attacking each other.

The real problem is that the blokes that run Sharescene are apparently no longer interested in policing the b.s. behavior. The one bad thing about Sharescene is you can't put people on ignore. So you get these tools like Lolly123 who show up and just start destroying the place. I am sick and tired of idiots accusing ignoramus of being Martin. Any half-wit would see that ignoramususes Aussie language / spelling rather than American English. And that is just one clue. That now leaves this place for quality reading. Until the #$@# venture over here with the attack posts...


It seems to me that Google Group posters went way out of their way to attack Maura Jane for wanting to set up a more intimate, intellectual and cohesive group without dealing with attack posts that she abruptly received after making the suggestion, accusing her of having a "high school" mentality. If she is who she claims to be, a resident dermatologist, I am quite sure that her contributions and opinions would be very welcomed over at ShareScene where condescending comments seldom go unchecked.


If I am one of the "idiots" that you are referring to accusing Ignoramus of being Martin, I'm concluding that you can't quite comprehend the nuances of playful sarcastic inferences. I have read Martin's twitter feed where he was both rude and clueless as to the identity or existence of Farma Zuetical in which Ignoramus is both respectful and very aware of whom Farma Zuetical is.The reason that the jury is still out for me with regard to Ignoramus is that I believe that his recent posts are antithetical to some of his earlier posts, maybe due to his short or long position in the stock at that point in time. Even so, he has usually makes a valid case in point no matter which side of the argument that he is on. Maybe I missed the small print in the ShareScene rules of conduct that prohibits playful banter or humor.


As for your absurd reason that Ignoramus could never be Martin because he uses Aussie spelling and terms considerably underestimates Martin, whom has been called the "boy genius", to be able to muster a little Aussie colloquial dialogue.
In conclusion, after reading both Google and yahoo, there is much more civility among members at ShareScene.
  Forum: By Share Code

San Diego
Posted on: Nov 3 2014, 11:35 AM


Group: Member
Posts: 145

Hello Lolley, One can never be sure as to the motivations of anonymous internet posters. I have been very open, as I believe many others on this board have. I am not looking to have anyone agree with me, I am hoping to educate where I can and have my opinions challenged when they need to be challenged. As I have stated before, the jury is still out for me with regard to the motivations of Ignoramus, but Madman has never given me pause as to his motivations. Even so, I have found both of them to be very knowledgeable and insightful and respectful to others on this board. I continue to value what both of them bring to the board and I could care less who they are. If you have a disagreement with Madman, I think it would be appropriate if you made your case respectfully and let other members reason both sides of the argument.
After all, isn't the object of this board to get a better understanding of the company that we are investing in? I believe that a well reasoned argument on both sides is the only true way to make an informed decision. Otherwise, there would just be a prosecutor OR a defender in court and the outcome would be predetermined for better or worse.
For the record: I am very long on this company; I just want it to be all that it can be!
  Forum: By Share Code

San Diego
Posted on: Nov 3 2014, 07:53 AM


Group: Member
Posts: 145

The European Commission will automatically ratify a CHMP recommendation because they essentially act in the same capacity as the FDA. They do not function as an advisory committee. There is only one case that I am aware of where the CHMP gave a recommendation for approval of an antibiotic and the EC sent it back because new information surfaced between the time of recommendation and ratification. The CHMP ultimately gave a recommendation against approval.
  Forum: By Share Code

San Diego
Posted on: Oct 31 2014, 07:29 AM


Group: Member
Posts: 145

My interest in the melanocortin peptide hormone was originally peaked after hearing about the research taking place at the University of Arizona in the 90's. Over the years, I have been fascinated by the mechanism by which the peptide works along with its possible uses. More recently, over the last several years, partially with the help of Uhoh and others, my eyes have been opened to the almost endless possibilities of this veritable wonder-drug.

Now, to address Dr. Wolgen. Yes, he is a smart, methodical individual that is very talented and careful when walking the public relations vs. regulators tightrope. That being said, he is no genius. The long delays with respect to his own set benchmarks fall squarely on Dr. Wolgen's shoulders. It was ultimately his decision to allow the trials to involve such a subjective measurement by asking patients to measure how long they were willing to expose themselves to the sun, despite years of subconscious survival instinct sun avoidance tenancies. The patients should have been required to expose themselves to the sun for set times and then measure the melanocortin benefits vs. the placebo group. This miracle drug wasn't approved because of Dr. Wogen, it got approved in-spite of him. His decision to move in a different direction from cosmetic to medicinal was because he had no other option after meeting with the FDA. I have been on and have studied the psychology of corporate boards. I have always been very careful not to be influenced by "irrational exuberance" (thank you Alan Greenspan) when evaluating an idea, concept, project, or person. The EMA's decision to launch an unprecedented pilot program involving patient input was created because the EMA had subtantial lobbying by a vociferous EPP community that had years of life changing benefits from trials and compassionate usage. The EMA wanted to approve this miracle peptide but it took an extra year or two because they had to figure out how to get around a poorly implemented Phase 3.

We have a smart CEO and I believe that we will ultimately make a tremendous amount of money, but that doesn't mean we should write him a blank check or believe that he is the only man for the job. In my humble opinion, the large stock offering to Dr. Wolgen was warranted but the huge salary caused unnecessary dilution to which the effects will be greatly magnified when this stock reaches $50 per share. Finally, to address your question, there is strength in numbers. That is why publicly traded corporations are required to have voting at shareholder meetings. I will never give blind trust to anyone that is motivated by profit, in which they should be, but I will give my support.
  Forum: By Share Code

San Diego
Posted on: Oct 31 2014, 02:40 AM


Group: Member
Posts: 145

Make no mistake, I was given the entire bike shop. Now, my options are to sell it or to maximize its profits. I was hoping that if only half of the posters on this board were being honest, that we would make an influential voting block. I now realize that was just an idealistic fantasy. As I mentioned before, I used to own north of 200,000 shares and sold off small portions over the years as Dr. Wolgen substantially missed his own milestone predictions. From my experience, that is a very ominous sign. Even though I have been on this board for many years, I have never felt the need to participate in this support group until I was feeling uneasy going into the final decision still in possession of most of my Clinuvel investment without the support of like-minded investors. In retrospect, I realize that I was extremely foolish, because, ultimately, there was little upside for what would have been a cataclysmic downside if approval was denied.

Now, for all intensive purposes, we have been de-risked, and the fact that I am soundly in the "long" camp, I would like to see that this company maximizes its profits. That being said, it's clear that these board only have two types of posters:

1) Investors that need constant reassurance that this is a once in a lifetime investment and they have made the right decision.
2) Investors that have a self-serving agenda that is contrary to the first group.

I no longer feel that I need the "support" to hold onto my investment. I have no plans on selling and may even consider increasing my position. I understand the need for these boards, but its clear that there isn't a lot of opportunity for constructive dialogue. I will still post from time to time because there are a few very knowledgeable individuals on this board from whom I value their feedback.
  Forum: By Share Code

San Diego
Posted on: Oct 30 2014, 09:22 AM


Group: Member
Posts: 145

I personally wouldn't have minded that Dr. Wolgen was to be granted 2.5 million shares upon EMA approval as long as that huge upside went along with a salary offset that was slightly below average. There would have been substantially less share dilution over the last several years if Dr. Wolgen wasn't commanding a hefty $1,000,000 a year salary. It appears that he has never heard, or at least doesn't believe in, the saying "can't have your cake and eat it too". His compensation package for a relatively small company with negligible revenue has been way above average. I still think that he is doing a great job, but I also believe that he is looking out for #1, first and foremost.

Note to Poodaddy: I know that you are Clinuvel's greatest cheerleader and I have actually enjoyed reading your posts, so please don't add me to your conspiracy theories. I am a fairly substantial shareholder that is unwilling to give blind trust to an individual that has been greatly rewarded at the expense of the shareholders. I am recommending a no vote to any more bonuses to Dr. Wolgen. What is his option...walk away? No way. He has already been given plenty of incentive to stay and see this through to a successful completion.
  Forum: By Share Code

San Diego
Posted on: Oct 25 2014, 01:34 PM


Group: Member
Posts: 145

Murphy always lives. Someone may come up with a cure for Vitiligo instead of a treatment along with many other countless "devil's advocate" scenarios. There are no sure bets, only good ones and my many thousands of hours of research indicates to me that a post-EMA approval-Clinuvel is a Very good bet.
  Forum: By Share Code

San Diego
Posted on: Oct 25 2014, 01:13 PM


Group: Member
Posts: 145

From my calculations, taking into account a probable Vitiligo joint venture with big pharma, I am projecting a $50 stock price within a three year horizon. That being said, I hope you are right and I am wrong.
  Forum: By Share Code

San Diego
Posted on: Oct 25 2014, 11:55 AM


Group: Member
Posts: 145

Well played my friend.
  Forum: By Share Code

San Diego
Posted on: Oct 25 2014, 10:49 AM


Group: Member
Posts: 145

Has anyone heard from Martin... I mean Ignoramus?
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 09:31 PM


Group: Member
Posts: 145

Madman, have you decided which tropical island that you are going to purchase yet?
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 09:28 PM


Group: Member
Posts: 145

I think that everyone here deserves A's on this research project. Well done my friends!
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 10:49 AM


Group: Member
Posts: 145

If you read the Market Release, the trading halt was requested by "the company" (Clinuvel) pending a release of an announcement by "the company" (Clinuvel). Then, it goes on to say that any decision on the Scenesse MAA WILL be included in the highlights to the meeting which may be published by the EMA approximately midday today (UK time).

In summation, it does not matter when trading resumes as long as we are not left hanging with regard to the EMA decision. I personally believe that Clinuvel asking for more time for their press release extending past the EMA release is a positive sign.
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 09:40 AM


Group: Member
Posts: 145

I would be very surprised if there is a trading halt in the US because the information will be released by the EMA before the US market opens. It will be very interesting to watch the trading activity.
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 09:28 AM


Group: Member
Posts: 145

Here's my take: There are only two outcomes (not including the nuances of the decision) which are a positive or a negative opinion.

1) Negative opinion: Clinuvel beats the EMA to the punch trying to spin the result and stay upbeat about the on-going opportunities of
their entire business model putting out a press release of their own before the EMA.

2) Positive opinion: Take their time writting a press release to shore up the approval-contigent deals with Joint Ventures and outline a business plan that will get this ship sailing.

I'm of the opinion that they are working on option #2.
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 08:31 AM


Group: Member
Posts: 145

I going to see if my doctor can prescribe me a 12 hour sleeping pill.
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 08:25 AM


Group: Member
Posts: 145

There was no way that they were going to let a full day of trading occur on the ASX with known critical information that has yet to be released.
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 08:22 AM


Group: Member
Posts: 145

I knew it!!!!
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 08:22 AM


Group: Member
Posts: 145

I knew it!!!!
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 08:19 AM


Group: Member
Posts: 145

From my 1000's of hours of research over the last 8 years, I truly believe that our approval chances are north of 90%. That being said.... Murphy lives.
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 08:06 AM


Group: Member
Posts: 145

I'm going to say $2.79 with no announcement, $5.80 with a positive decision and $.87 with a negative decision.
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 08:03 AM


Group: Member
Posts: 145

I meant if there is no announcement.
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 07:59 AM


Group: Member
Posts: 145

It's a little difficult to play poker, but how about we make a little game of it? Lets all put in a guess what the price of the first share sold will be on the ASX prior to any announcement.
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 07:41 AM


Group: Member
Posts: 145

Per Rabbitrun's reference:

Farma Zutical 2:28 PM (8 minutes ago) Not that I want to be a party pooper - our friends over at ShareScene obviously have a party going - but I think we'll need a lot of coffe if we are to stay up until the EMA announces its decision. Remember that it is Clinuvel UK Limited who filed the MAA. So the decision is probably going to be addressed to the UK branch. The earliest possible time would probably be 9AM UK time / 4 AM EST / 7 PM Australia. 2 coffee, please. GLTA.

My comment: I think it is irresponsible to have the market trading for an entire day on the ASX. If Clinuvel does not release this critical information until tomorrow, I believe that a trading halt should be in order.
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 07:06 AM


Group: Member
Posts: 145

It feels like our Clinuvel team is on a talent competition and the judges know the answer, but they won't let us know if we have been eliminated until after the damn commercial. Give us an initial release now and then follow-up with a more comprehensive release later.
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 06:45 AM


Group: Member
Posts: 145

If I were a betting man (this Clinuvel investment aside), I would bet that this will be the first place to read the announcement which should be sometime in the next 2 1/2 hours.

http://www.asx.com.au/asx/research/company...amp;asxCode=CUV
  Forum: By Share Code

San Diego
Posted on: Oct 24 2014, 04:01 AM


Group: Member
Posts: 145

The EMA's up to the minute postings on their "What's new?" section appear to be revisions to previous approvals. It seems that it would be irresponsible to have a major announcement disseminated in that fashion without a coordinated response from the submitting company. Typically, a major announcement would be preceded by a trading halt or after the market is closed. I am anticipating an announcement sometime between the U.S. market closing today and the ASX opening.
  Forum: By Share Code

San Diego
Posted on: Oct 23 2014, 10:50 AM


Group: Member
Posts: 145

It feels like Christmas Eve when I was 7 years old hoping for a new bike but worrying that the Grinch was going to ruin Christmas. I don't think that there will be any more pre-decision trading in the U.S. markets.
  Forum: By Share Code

San Diego
Posted on: Oct 23 2014, 04:11 AM


Group: Member
Posts: 145

It seems that it would be much easier to announce an approval or decline once the market closes in the U.S. at 4:00 EST which is in 1 hour and 50 minutes from this post instead of a trading halt.
  Forum: By Share Code

San Diego
Posted on: Oct 22 2014, 08:54 AM


Group: Member
Posts: 145

It appears that we may be able to take our tin foil hats off this Thursday the 23rd which is the last day of the CHMP meeting of October 20-23. This is the press release on September 25th regarding the approval of Vylaer Spiromax by the EMA on the last day of the CHMP meeting of September 22-25.

http://www.ema.europa.eu/docs/en_GB/docume...WC500173696.pdf
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San Diego
Posted on: Oct 19 2014, 06:33 AM


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I am in the finance industry and have closely watched the US Treasury market for many years. I have learned that it is nearly impossible to create a model that will predict the direction of interest rates without applying the Economics 101 term "ceteris paribus", a Latin phrase for all things remaining the same, which is virtually meaningless because in real world applications almost never occurs. The only constant that I have learned over the last several decades studying the movement of interest rates is that investors panic sell their positions and will strategically and cautiously buy which correlates to sharp increases in interest rates and slow steady declines. So yes, I believe that there were several small investors that did not want to be caught "shutting out the lights", that sold their positions and it will take several positive news releases and or postings from sources that they deem to be reliable before they will begin to recapitalize their positions.
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San Diego
Posted on: Oct 18 2014, 03:50 PM


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I am no longer in the camp that you may be Martin Shkreli unless you are one heck of a chess player which is possible. Martin Shkreli responded to Farmazutical's question on twitter as if he had no clue who he was. You, however, I am quite sure knows who Farmazutical is. As to your comment that these boards are of no influence to a thinly traded stock, defies any sense of logic or common sense. That compounded with a comment like " Afemelanotide is likely to not get approval and Clinuvel is the Shell Company" coming from the most followed, knowledgeable and prolific poster of all things Clinuvel greatly magnifies the effect.

My earlier post commenting about Uhoh not having a "filter" was definitely not a complaint. I greatly appreciate the unfiltered immediate information that he provides. That being said, I have been following his postings for many years since the Yahoo board and am very familiar with his posting style. After an initial posting, he often steps back and re-examines his initial analysis. Someone else that reads a posting so dire from the consensus expert may have a very different take than me and panic sell their position which would greatly affect our thinly traded stock.
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San Diego
Posted on: Oct 11 2014, 01:38 PM


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Here is an excellent response to your question by Farma Zutical

Clinuvel has announced the AGM to be held on the 28th of November. That's later than usual. Clearly, that has to do with the CHMP opinion a month prior to that date. But can we conclude if Clinuvel expects a positive or a negative vote ? No. But I think there is a strong possibility that they are preparing for a yes vote.

If a sponsor wants to appeal a negative vote that has to be done within 15 days from day 210. That would leave the company with plenty of time before the AGM which could then have been scheduled for November 15th.

If Clinuvel gets a thumbs up from the Duma they have a lot of work to do.

At day 215 at the latest (5 days after approval) Clinuvel has to submit a revised summary of product characteristics, labeling and package leaflet in 20 languages.

At day 232 at the latest Clinuvel has to submit the final product summary, leaflet and labeling in 20 languages taking into account the feedback the company will get at day 229.

By day 246 Clinuvel has to provide the EMA with a full color mock-up of the inner and outer package and labeling. This is by day 36 after CHMP opinion hence November 25th. I think it is clear that Clinuvel needs more time to prepare a launch than to prepare an appeal. Not saying that Scenesse can't be rejected. But if the postponed AGM tells us anything I think it tells us that they need time.


Clarification: Clinuvel would have to communicate it's intend to appeal before day 15. The actual appeal would have to be launched before day 60. Logically, if they were preparing for refusal the AGM could very well had been scheduled a couple of weeks before November 28th in order to give them time to write the appeal application. Show trimmed content
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San Diego
Posted on: Oct 11 2014, 08:46 AM


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I completely agree with you.
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San Diego
Posted on: Oct 11 2014, 06:34 AM


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That would be classic and one of the greatest charades that I have ever heard of, yet extremely unlikely. I wouldn't be surprised if Uhohinc is highly functioning autistic. His in-depth analyses are nothing short of genius which would humble the average M.D. I do not believe that his recent very negative comments were in any way sinister; I just don't think that he has an internal filter.

The real question that begs to be asked is if Ignoramus is Martin. Neither one of these comparisons are meant to be disparaging in any way because I have admiration for both.
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San Diego
Posted on: Oct 10 2014, 10:09 AM


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I wasn't trying to temp Uhohinc into making my point by turning a 180 on his Clinuvel position. He truly is a genius, but with many geniuses, there is often irrational behavior. It appears that the market may be softening as a direct result of his recent posts, much like the last recent drop after his previous decidedly negative posts. His arguments for approval have far exceeded his recent arguments against. There has been nothing new. The Singapore joint venture has been in the works for quite sometime as has been the EMA's patient input program.
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San Diego
Posted on: Oct 8 2014, 06:13 AM


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I purchased my final tranche of CLVLY today. I am now officially "all in" and have buckled up and have prepared myself for the ride. I can not see a viable reason that Clinuvel won't receive a 50% plus one vote at a bare minimum, and for reasons already articulated in recent posts, a unanimous approval. My early concern that Retrophin may want to change course has now abated.
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San Diego
Posted on: Oct 8 2014, 02:32 AM


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An alter ego (Latin, "the other I") is a second self, which is believed to be distinct from a person's normal or original personality.

I am inclined to agree with you! Whilst both are very intelligent, observant and well educated, that is where the similarity ends. One appears to be very honest, straight forward, emotional and sometimes irrational; the other appears to be cold, calculated and steady.
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San Diego
Posted on: Oct 3 2014, 06:14 AM


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I purchased 30,000 shares of CLVLY today at $2.75. Obviously, someone was selling but no one was unloading. If it was Retrophin that was selling, it doesn't appear that they are wanting to free up capital at the expense of their holdings. It looks that we will be riding a steady ship all the way till the 24th!
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San Diego
Posted on: Oct 2 2014, 11:50 AM


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I agree with you that there is no feasible way to sell their sizable stake in the company without taking a loss. That being said, I do think that they are in at a price that they can, at the very least, reduce their risk. If they can hold tight and we obtain approval, I believe that they will go the distance with Clinuvel unless they become cash strapped which may happen. I wouldn't want to be the one to be presenting to Retrophin shareholders and having to inform them that they have made close to a $5 million investment into a company that did not get their one drug approved. I hope that they do not sell because I have a sizable investment myself, but if they do, I will be a buyer.
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San Diego
Posted on: Oct 1 2014, 01:36 PM


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I realize that. That is why I think that they will be selling because Marty has made a very large highly speculative investment into a a small pharmaceutical company that has yet to have an approved drug. The board could sell off quite a few shares and still make a huge profit IF there is an EMA approval. I wasn't making the case that they had inside information. I was making the case that a new rational board of directors may want to reduce their risk.
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San Diego
Posted on: Oct 1 2014, 10:18 AM


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Does Retrophin own CUV or CLVLY? Also, does Marty have the financial capability to purchase a block from Retrophin? If they own CLVLY, the selling that may occur over the next couple of weeks may not show up on the ASX.
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San Diego
Posted on: Oct 1 2014, 09:28 AM


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Unfortunately, I wouldn't be surprised if there was some Retrophin profit taking before the announcement unless they know something definitive that the rest of us are not privy to. How are the buy and sell orders stacking up today?
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San Diego
Posted on: Sep 29 2014, 01:41 PM


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Thank you for your in-depth post. The strength in the market is definitely bitter sweet. On one hand I was looking at a possible buying opportunity and the other it shores up the value of the shares I have.
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San Diego
Posted on: Sep 29 2014, 12:46 PM


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Quite to the dismay of the contrarians, we are seeing a tremendous amount of support in the $2.50 range. I was actually looking for a buying opportunity. Can someone show the market depth today?
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San Diego
Posted on: Sep 28 2014, 01:35 AM


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I guess if I had really thought about it, I would have sold all of my shares in the middle of a rally that had no foundation and then repurchased the shares upon approval. Even if I would have had to repurchase at twice the price, it's a small price to pay for a company that I believe has a 50 fold potential while eliminating the risk of not getting an approval.
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San Diego
Posted on: Sep 24 2014, 02:08 AM


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I haven't seen any evidence of any stock pumping on this board in an attempt to sell their shares. That being said, I have seen plenty of evidence of tree shaking in an attempt to acquire more shares. With regard to missing the boat, there is a long way to go in shareholder value as long as there are no unforeseen icebergs along the way.
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San Diego
Posted on: Sep 24 2014, 01:52 AM


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Posts: 145

At least we can take a little comfort in Ignoramus trying to acquire more shares. I would be a little concerned if he were pumping it at this point.
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San Diego
Posted on: Sep 18 2014, 01:55 PM


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You're right! I knew that if I'd thought about it. I was just referring to the ASX current pricing graph.
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San Diego
Posted on: Sep 18 2014, 01:39 PM


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Posts: 145

It looks like there are others that are in the same camp as you minow with an anticipated September approval. We just hit a 52 week high at $4.50. I do not believe there would be such a strong run up in price if investors thought they had another six weeks. I hope this doesn't double post because I'm on my iPhone.
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San Diego
Posted on: Sep 18 2014, 12:54 PM


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Posts: 145

Wow! Great find. This is a very positive independent multi-million dollar U.S. Vitiligo study.
  Forum: By Share Code

San Diego
Posted on: Sep 18 2014, 12:54 PM


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Posts: 145

Wow! Great find. This is a very positive independent multi-million dollar U.S. Vitiligo study.
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San Diego
Posted on: Sep 16 2014, 10:16 AM


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Is the $4.00 on the buy side and the $4.50 sell side accurate as listed on the ASX?
  Forum: By Share Code

San Diego
Posted on: Sep 16 2014, 09:39 AM


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Posts: 145

This is a more direct link to the speeding ticket Company information - ASX
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San Diego
Posted on: Sep 16 2014, 09:35 AM


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Then I guess it's onward and upward.
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San Diego
Posted on: Sep 16 2014, 09:31 AM


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http://search.asx.com.au/s/search.html?que...amp;profile=web Here's a reference for others on the speeding ticket. How is this affecting the market depth?
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San Diego
Posted on: Sep 12 2014, 09:36 AM


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Posts: 145

Prices will continue to rise with that kind of lopsided buy/sell ratio. We will know when the price has stabilized once the buy/sell demand becomes more balanced. Thank you Verharven because most of us do not have trading accounts that will show market depth.
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San Diego
Posted on: Sep 11 2014, 12:52 PM


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Thank you, that worked. That is very strange because I have had asx.com in my favorites for awhile now without the .au.
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San Diego
Posted on: Sep 11 2014, 12:36 PM


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Posts: 145

Does anyone know why asx.com has been down for the last couple of days?
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San Diego
Posted on: Sep 10 2014, 02:33 PM


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That's the way to hang tough Madman. I'm sorry to say that I've gone the other way. I first started acquiring Clinuvel in 2008. I was up to about 200,000 shares at a $2.10 average. I am now down to 160,000 shares because I have been selling a little each time they have missed an anticipated milestone. I'm hoping that won't happen again.
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San Diego
Posted on: Sep 9 2014, 08:18 AM


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Posts: 145

How many shares were on the buy and sell sides respectively? I would like to know if there is the pent up demand to acquire Clinuvel in the U.S. with respect the limited desire to sell as on the ASX. Barring any negative news, that kind of consistent demand will be pushing the stock higher on a daily basis even before an approval.
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San Diego
Posted on: Sep 9 2014, 03:39 AM


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Posts: 145

Does anyone have access to the market depth of CLVLF and CLVLY?
  Forum: By Share Code

San Diego
Posted on: Sep 8 2014, 10:38 AM


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Posts: 145

How many shares remaining on the buy and sell sides?
  Forum: By Share Code

San Diego
Posted on: Sep 5 2014, 04:39 PM


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Posts: 145

From Verharven's lips to god's ears......We hit $3.00 per share this week as predicted!
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San Diego
Posted on: Aug 29 2014, 01:24 PM


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It looks like we are at a break-thru point of $2.75. Verharven, when it is convenient, what is the demand and market depth?
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San Diego
Posted on: Aug 28 2014, 11:15 AM


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Posts: 145

I wouldn't doubt that the Retrophin offer was to set a price that would entice shareholders to sell their shares because the hope and dream of EMA and FDA approval for EPP and ultimately Vitiligo would no longer be realized without the significant dilution from Retrophin. However, there is no logical reason that I can see that Clinuvel would be in collusion with Retrophin. They are probably looked upon like a thorn more than anything else. Now if this little play, would have been before the last money raise, I would have my eyebrows raised.
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San Diego
Posted on: Aug 27 2014, 03:18 PM


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Thank you. I wonder if the demand is from new investors or our new east coast buddy.
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San Diego
Posted on: Aug 27 2014, 02:48 PM


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I see that we are inching up to the $2.75 offer price. How many shares are on the buy side and can you see how many shares are being offered at $2.75 and the next closest offer price after $2.75?
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San Diego
Posted on: Aug 24 2014, 03:15 AM


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Posts: 145

That's the ticket!
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San Diego
Posted on: Aug 24 2014, 02:07 AM


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I believe that Benjammin was referring to the September agenda for the CHMP meeting and not the published results of what was discussed. With only a cursory review of EMA's site, I had difficultly finding the September agenda. I cut and pasted this from another discussion board. If anyone has the EMA link that provides this information, I would be interested in looking at it as well. Thank you!





5.2. Orphan designated products for discussion prior to adoption of CHMP opinion

5.2.1 (1R,2R)-octanoic acid[2-(2',3'-dihydro-benzo[1,4] dioxin-6'-yl)-2-hydroxy-1-pyrrolidin-1- ylmethyl-ethyl]-amide-L-tartaric acid salt for treatment of Gaucher disease; Genzyme Europe BV (EU/3/07/514)

5.2.2 Ramucirumab for treatment of gastric cancer; Eli Lilly Nederland B.V. (EU/3/12/1004)

5.2.3 Ruxolitinib for treatment of polycythaemia vera; Novartis Europharm Limited (EU/3/14/1244)

5.2.4 Olaparib for treatment of ovarian cancer; AstraZeneca AB (EU/3/07/501)

5.2.5 [Nle4, D-Phe7]-alfa-melanocyte stimulating hormone for treatment of erythropoietic
protoporphyria; Clinuvel (UK) Limited (EU/3/08/541)

5.2.6 Signifor (Pasireotide) for treatment of acromegaly; Novartis Europharm Limited (Type II variation) (EU/3/09/670)


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San Diego
Posted on: Jul 26 2014, 04:17 AM


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http://www.ema.europa.eu/ema/index.jsp?cur...b01ac058004d5c1

It appears to me that as of today, the committee has announced that 5 new medicines were recommended for approval and one application was withdrawn. I still believe that there was a chance, albeit infinitesimal, that we could have seen a recommendation for approval today.
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San Diego
Posted on: Jul 25 2014, 03:24 PM


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I was hoping that a consensus vote would take place.
  Forum: By Share Code

San Diego
Posted on: Jul 25 2014, 03:24 PM


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Posts: 145

I was hoping that a consensus vote would take place.
  Forum: By Share Code

San Diego
Posted on: Jul 25 2014, 03:19 PM


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Posts: 145

http://www.ema.europa.eu/ema/index.jsp?cur...b01ac058004d5c3
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San Diego
Posted on: Jul 25 2014, 10:20 AM


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Posts: 145

Are we all waiting for a decision in the next 12 hours?
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San Diego
Posted on: Jul 16 2014, 10:28 AM


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Posts: 145

Now that I have read the newsletter on the ASX site, my question regarding previous approvals with the COMP agenda stating the drug status is an "on-going procedure" seems rather moot. It now appears that we are looking at September or October for a decision. I still am curious if there have ever been any approvals when the drug is listed as "on-going procedure" on the COMP agenda just in case it is still listed as such come September.
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San Diego
Posted on: Jul 16 2014, 04:43 AM


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Posts: 145

Has there ever been a vote for approval for any drug when it is listed on the COMP agenda as "on-going procedures"? I would like to think that there is a possibility for an approval this month.
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