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xlnja
Posted on: Jun 12 2020, 12:52 PM


Group: Member
Posts: 122

Yeah, if only I had put everything into Tesla back in 2012 at $35, which I had seriously considered. It's now 30x that price. Hindsight is 20/20.

With U.S. sales, this should be the spring board year for Clinuvel. Let's hope.
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xlnja
Posted on: Jun 8 2020, 12:21 PM


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Posts: 122

FYI non-Aussie investors, the ASX is closed today (Queen's Birthday)
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xlnja
Posted on: May 24 2020, 04:06 PM


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Posts: 122

If half of the $38k is going to the doctor, perhaps that is PW's firewall to competitive entry...the doctors will push the drug that provides the highest incentive.
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xlnja
Posted on: May 24 2020, 04:02 PM


Group: Member
Posts: 122

Interesting reply comment from the FB poster regarding the "other drug" (Scenesse)...

QUOTE
Lindsey Dwyer my friends are already getting the other drug (implant). It's approved and being administered now!!! But it's $38k every 2 months.... we need another option.... hopefully this will be cheaper & drive down the cost of the other!! <3

I wanted so badly to try to get my insurance to cover that implant, but somebody needs to do this trial!!! So I agreed! <3


A couple of observations...

1) Why is the cost $38k? (I noticed this price on GoodRx as well) I thought PW was keeping the cost in line with other countries.
2) Her comment, "hopefully this will be cheaper & drive down the cost of the other"...As investors, that's what we fear if MT-7117 is approved. PW better have a plan.
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xlnja
Posted on: May 24 2020, 08:11 AM


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Posts: 122

...and bite our investment.

We all know PW is ultra-secretive. Since we are not likely to hear anything, we can only hope that PW has satisfactorily addressed the threat from MT with the institutional investors. Surely they have asked him about this.
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xlnja
Posted on: May 10 2020, 11:39 AM


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Posts: 122

A NASDAQ listing would also help with the badly needed liquidity in the U.S. market. The daily volume for CLVLY is so low it's hard to move very many shares quickly.
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xlnja
Posted on: May 2 2020, 08:00 AM


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Posts: 122

I agree. It seems to me that things are moving faster than expected. I had gotten so used to Clinuvel's glacial pace. The flurry of recent announcements is very encouraging.

Political pressure in the U.S. could speed up Vitiligo approval. There's at least one congressman, Hank Johnson, who suffers from Vitiligo and would like to see something soon.
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xlnja
Posted on: Mar 30 2020, 03:28 PM


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Posts: 122

If the AU Government is going to do that, they should ban shorting during the crisis. Not doing so just allows the shorters to run wild.
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xlnja
Posted on: Mar 25 2020, 07:57 AM


Group: Member
Posts: 122

Sounds like the entire market for CLVLY is on this board. I certainly hope that's not the case. We need a lot of new investors to see this really take off.
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xlnja
Posted on: Mar 23 2020, 11:44 AM


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Posts: 122

Thank God!!
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xlnja
Posted on: Mar 22 2020, 10:15 AM


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Posts: 122

It seems to me that if there is ever a time for a takeover it is during or shortly after this crisis. Large pharmaceuticals are the least affected by this stock market downturn since they have a role to play in combating this virus. At the same time, USD to AUD is the strongest it's been in decades.
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xlnja
Posted on: Mar 21 2020, 07:08 AM


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Posts: 122

Unfortunately, it's a race to the bottom on exchange rates. It sucks for us holding CLVLY.
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xlnja
Posted on: Mar 20 2020, 02:32 PM


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Posts: 122

Not racist...Chinese isn't a race

Also, I'm talking about the Chinese Communist Government, not the people.
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xlnja
Posted on: Mar 20 2020, 02:17 PM


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Posts: 122

Yup

QUOTE
And the ones that cry racism when people are simply stating were the virus originated need to STOP with that idealistic BS already.


Totally agree. They are parroting Chinese government propaganda.

China is still not forthcoming about this virus. People are dying and the world economy is collapsing because of their bullshit. I wouldn't doubt the possibility that they planned this. We all know how little they care about their own people. They wouldn't blink an eye at losing a few thousand to accomplish their goal of Chinese domination.
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xlnja
Posted on: Mar 19 2020, 10:42 AM


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Posts: 122

The company's conservative financial approach has turned out to be a godsend. With no debt and a lot of cash on hand, they will be able to weather this CV downturn easily.
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xlnja
Posted on: Mar 13 2020, 02:21 PM


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Posts: 122

I pulled all of my money out of the market during the 2008-09 crash. At the time, I thought the entire market was going to crash, like during the great depression. I was also fairly new to investing and easily spooked. As a result, I waited 18 months to put my money back in, and I missed a lot of the rebound. I decided then that I would never react the same in a similar situation (like we are now in) because if it truly is a collapse, we're all fucked one way or another. So hang tight.
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xlnja
Posted on: Mar 13 2020, 02:58 AM


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Posts: 122

CLVLY is currently at $8.35 USD. That's a nearly 15% drop just today. It will put CUV at $13.21 AUD.

I am getting perilously close to my average cost basis for CLVLY...a situation I would tell friends "could never happen". I think I'm just numb to the stock price at this point. All we can do is hold on.

Who the hell is stupid enough to sell at these prices? Morons!

GLTA
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xlnja
Posted on: Mar 5 2020, 02:37 AM


Group: Member
Posts: 122

Clinhope, what's your reasoning that it would take 5-7 years for MT approval? Wouldn't they be able to submit an NDA shortly after a positive Phase III? It seems like that would be 2-3 years from now. At any rate, positive MT news along the way would depress CUV stock price.
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xlnja
Posted on: Mar 4 2020, 08:48 AM


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Posts: 122

Lol, I was about to say the same thing
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xlnja
Posted on: Mar 4 2020, 05:38 AM


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Posts: 122

The email subscription works too...sends a confirmation email, update preferences, etc. Actually works like you'd expect. Nice work!
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xlnja
Posted on: Mar 3 2020, 11:40 AM


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Posts: 122

Yeah, sounds like it would compete in vitiligo also.
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xlnja
Posted on: Mar 3 2020, 10:51 AM


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Posts: 122

Time is of the essence. I doubt that MT will drag their feet if their drug is approved. Based on the comments in that FB post, MT-7117 sounds like a strong competitor. That gives us 2-3 years before they potentially jump in the game.

So, why can't treatment start this summer in the U.S., PW?! If there are hard dates from the FDA, then there's not much you can do, but telling us will ease shareholder concerns. If it's a headcount issue, spend whatever it takes to get this moving. We are losing >$5 million/quarter waiting around.
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xlnja
Posted on: Mar 2 2020, 09:46 AM


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Posts: 122

It's actually up from the CLVLY low, which closed at USD $10.42 on Friday. Currency conversion would make that AUD $16.03. Hopefully the CLVLY low was the bottom.
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xlnja
Posted on: Mar 1 2020, 10:00 AM


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Posts: 122

This assumes competition doesn't come along and throw a wrench into the works. I'd like to know PW's plan to deal with that potential disruptor.
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xlnja
Posted on: Feb 29 2020, 06:47 AM


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Posts: 122

Thanks. Let's hope $100/share comes without having to wait another decade.
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xlnja
Posted on: Feb 29 2020, 04:20 AM


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Posts: 122

Just got around to reading your whole post...it reflects my sentiments exactly. Hopefully, board members and other large shareholders will put the squeeze on PW to finally provide specific answers to the questions you mentioned. Precisely...WHY can U.S. sales not begin immediately? I don't want a vague response saying, "FDA requirements...blah, blah, blah" I want dates...i.e., "the FDA requires this, and this, and this. We are meeting on this date to discuss and the earliest DATE for sales is...."

If the FDA is not the roadblock but it's management, then get the F#@k moving!! Either way, I want to know.
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xlnja
Posted on: Feb 29 2020, 03:32 AM


Group: Member
Posts: 122

Congrats on your seven figure cash out, although it's a bit tone deaf to bring it up at this time considering that many on this board have seen paper losses >$1 million since FDA approval. Hindsight is 20/20.
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xlnja
Posted on: Feb 29 2020, 01:25 AM


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Posts: 122

I think the main driver of the stock plunge at this point is this Coronavirus BS. Bad timing that the misinterpreted half-year report coincided with this virus. Double whammy.

The media is playing up the hysteria on the Coronavirus when it appears to be no worse than the regular flu.
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xlnja
Posted on: Feb 28 2020, 07:55 AM


Group: Member
Posts: 122

If the FDA really was adamant about this post approval tracking plan, then I'll cut PW some slack (hopefully it wasn't his idea).

There should be no delay in order to train doctors though. Have a one-hour WebEx for God's sake. They are doctors after all. They should know what they're doing.
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xlnja
Posted on: Feb 28 2020, 07:20 AM


Group: Member
Posts: 122

I would prefer that there was a takeover at the right price. I've been in the stock for over 10 years. I was hoping to have a partial exit post FDA approval, but the bounce hasn't come, quite the opposite. You would have thought the drug was rejected by the looks of the stock performance.

CLVLY down over 11% today. Highest daily drop in years.
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xlnja
Posted on: Feb 28 2020, 05:48 AM


Group: Member
Posts: 122

The explanation for their behavior that makes the most sense is as I've said before...they want to be acquired. They want to do the least amount possible to get over the FDA finish line while promising future indications and product lines to attract big pharma. Unfortunately, there have been no takers yet, which is surprising, especially given the recent stock plunge and the most favorable USD to AUD exchange rate in more than a decade.

The other explanation is that they think they can just take their time to roll this out over years and not think that aggressive competition will come and end it all.
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xlnja
Posted on: Feb 27 2020, 10:03 AM


Group: Member
Posts: 122

It seems like we must be close to getting kicked out of the ASX 200, which will be another blow to the share price. When will this nightmare end?!
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xlnja
Posted on: Feb 27 2020, 07:16 AM


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Posts: 122

Just curious...has anyone on this board actually been inside the Melbourne office and met any employees? I think Verharven mentioned he lives nearby.

I'm from the U.S. and actually went to the Melbourne office when I was there last month on vacation. No one was home at the time I visited, which seemed odd.
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xlnja
Posted on: Feb 27 2020, 06:54 AM


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Posts: 122

Yes, I agree the whole thing stinks. The share price clause overrides the market capitalization criteria in the event of a recession. So, yeah, they're trying to make it easier for PW to get his shares whether it be by the share price outperforming the indexes or simply giving him another year to meet the market capitalization criteria. It's all BS.
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xlnja
Posted on: Feb 27 2020, 05:29 AM


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Posts: 122

It should only add up to 1 year extension since it must be granted within 12 months from last AGM.
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xlnja
Posted on: Feb 26 2020, 06:04 AM


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Posts: 122

CLVLY currently at $14.67. Each of the last 6 trading days has closed down for a total loss of 16%. What the F#@k is going on!! STOP THE BLEEDING, PW!!
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xlnja
Posted on: Feb 26 2020, 05:56 AM


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Posts: 122

The alert just now received from my broker..."CLVLY met low target of $15.00"

I never thought I'd see that. Ugh
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xlnja
Posted on: Feb 26 2020, 04:43 AM


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Posts: 122

$20 USD I meant to say. angry.gif
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xlnja
Posted on: Feb 26 2020, 04:05 AM


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Posts: 122

I agree. I bought some more at $20, which I thought was low at the time. If it weren't for my very low total average cost, I'd be really pissed. I'm used to the volatility with this stock. Imagine what the new investors think about this.
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xlnja
Posted on: Feb 26 2020, 02:25 AM


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Posts: 122

I wouldn't even care so much if I knew that everything is on course (U.S. rollout, new indications, etc), but during this period of no information, shorter manipulation, and free-falling stock price, it just adds to the negativity.

This needs some explaining other than "it was a mistake"
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xlnja
Posted on: Feb 25 2020, 01:32 PM


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Posts: 122

Exactly. What the hell is going on? Is this an attempt to lengthen the time PW has to meet the targets? The fine print says...

QUOTE
For a Performance Right to vest and become exercisable to a Share, the Performance Condition must be satisfied within the vesting period. For each Performance Condition, the vesting period is maximum 4 years from date of grant.


Is this PW saying, "Shit, I'm going to need more time. Let's wait until the 12th month before granting"
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xlnja
Posted on: Feb 20 2020, 02:18 AM


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Posts: 122

Hopefully, Clinuvel will see a similar change of fortune with US sales.
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xlnja
Posted on: Feb 19 2020, 03:03 PM


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Posts: 122

And if we had all cashed out of Clinuvel and put it into Avita this time last year, our investment would now be worth 5X (god, I could have retired). Instead, our investment in Clinvuel is worth the same now as it was last year at this time, even after FDA approval. Yes...very big sigh. Don't let us down, PW.
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xlnja
Posted on: Feb 9 2020, 12:28 PM


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Posts: 122

Lol
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xlnja
Posted on: Feb 9 2020, 11:38 AM


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Posts: 122

If they try to do an integration themselves without prior experience, then they are foolish. They need expert help.
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xlnja
Posted on: Feb 9 2020, 09:46 AM


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Posts: 122

If I were PW, I'd prefer a takeover as well. The performance rights would all vest...

QUOTE
In the event of a takeover bid (as defined in the Corporations Act) where the bidder and its associates acquire a relevant
interest in at least 50% of the voting Shares of the Company, the Board may determine that all or a specified number of a
participant's Performance Rights immediately vest.


It would be the most money for him with the least amount of work. Why work your ass off for 3 years for something that might never happen when you can get it all now by just putting on some lipstick and looking pretty for a suitor, lol.

I'm ok with a takeover...just give us a decent price. Also, USD to AUD is the highest it's been in a long time. It would be a steal to do it now.
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xlnja
Posted on: Feb 9 2020, 09:26 AM


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Posts: 122

This is what I meant that doing the minimal amount of work is a sign that PW has wanted a buyout the whole time.
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xlnja
Posted on: Feb 8 2020, 01:56 PM


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Posts: 122

A positive about the FDA requiring strict controls like the EU is that they probably would be less likely to approve Tanabe's drug (harder to control pill distribution).
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xlnja
Posted on: Feb 8 2020, 08:28 AM


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Posts: 122

I think a buyout has been PW's plan the whole time. It would also explain the slow pace (i.e., only doing the minimum work necessary to attract a buyer). The large cash balance and low debt is also attractive to a potential buyer. I would prefer a buyout as well, for the right price.
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xlnja
Posted on: Jan 16 2020, 08:00 PM


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Posts: 122

I was thinking the same thing.
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xlnja
Posted on: Jan 7 2020, 04:11 PM


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Posts: 122

Thanks for the clarification. I didn't know the topical would also work systemically. In that case, sign me up 😁
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xlnja
Posted on: Jan 7 2020, 03:22 PM


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Posts: 122

I'm all for opening it up to the masses, but I think an implant for systemic application would still be preferable. Generally, people screw up the application of topical creams (e.g., unevenly apply the cream or miss areas, which would cause patches of tanning).
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xlnja
Posted on: Dec 29 2019, 04:05 AM


Group: Member
Posts: 122

Now for investors in the U.S., it would be nice for AUD to gain strength to close the currency gap. Back in 2012, AUD to USD was nearly 1:1. Now it's near a 10-year low at .698.
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xlnja
Posted on: Dec 14 2019, 03:51 AM


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Posts: 122

I understand PW's desire to keep everything "in house". That kind of thinking goes with his background in medicine where you have to become an expert yourself instead of relying on external resources. I'm speaking in terms of their practice of having existing employees handle the rollouts, submissions, etc. While this approach keeps costs down and increases employee knowledge and value, it is also very slow. Can you imagine trying to figure out the rules and regulations for all the EU countries and the U.S.? Without experience in those areas, you figure out things as you go and often don't know what you don't know. If we had an unlimited amount of time to do all the rollouts without competition and could wait 50 years for returns, this might be fine, but speed is needed now to capitalize as soon as possible. Get some experts to move this thing along.
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xlnja
Posted on: Dec 6 2019, 08:17 AM


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Posts: 122

Apparently some people weren't fooled by LH. No mention of LH's doomsday prophecies here...

https://au.finance.yahoo.com/news/why-clinu...-041041261.html
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xlnja
Posted on: Dec 5 2019, 09:38 AM


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Posts: 122

Although I welcome alternative viewpoints to keep myself "level headed", it became obvious that something wasn't right when LH kept on pushing the doomsday narrative for over a week. Would someone who claims to be a substantial shareholder do this knowing that his comments, valid or not, could substantially cut into his own profits? I don't think so.
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xlnja
Posted on: Nov 29 2019, 10:25 AM


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Posts: 122

By the way, any word from Mr Homm since the recent MT-7117 report?
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xlnja
Posted on: Nov 28 2019, 02:45 AM


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Posts: 122

Has anyone asked Clinuvel management about MT-7117 and their strategy? (I don't know if they could or would give any information.)
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xlnja
Posted on: Nov 27 2019, 02:58 AM


Group: Member
Posts: 122

QUOTE
What about Scenesse in (micro needle patch) formulation.


Given Clinuvel's extremely slow pace, I don't see a micro needle patch of Scenesse coming any time soon.

Some other concerns...

  • *The MT-7117 results were released one week prior to the Clinuvel AGM. Why did PW not address this existential threat during the presentation or during questions? Surely, management has been aware of MT-7117 for some time...right?! Wouldn't institutional investors have already asked about this? Clinuvel should have at least stated a plan to address the threat.
  • *What will be the price for MT-7117? Clinuvel has only one approved drug priced at $15k USD per implant. Mitsubishi Tanabe has many drugs in its portfolio and can sell MT-7117 at whatever price point is necessary to take all the market share from Clinuvel. Preference for pill, implant, or patch won't matter if Tanabe is selling MT-7117 at $100/pill. It will be a no brainer. Clinuvel will be forced to drop the price of Scenesse to unsustainable levels.


I am not trying to be negative on the stock (I have my life savings in it). I had anticipated a year of smooth sailing after FDA approval that now has been shortened to a month. Perhaps MT-7117 is the cause of the continuing slump in the share price, not day-trading shorters. One thing is for sure...PW needs to lift the gag order and start communicating with investors regularly to stop the bleeding.
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xlnja
Posted on: Nov 26 2019, 05:51 PM


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Posts: 122

Assuming MT-7117 is just as safe and effective, I don't see why anyone would take an implant over a pill.

Before FDA approval, there was a small risk that Scenesse would not be approved, and I was willing to take that risk. The risk to the stock before/after MT-7117 results is much greater. I'll just need to reevaluate my exposure.
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xlnja
Posted on: Nov 26 2019, 05:37 PM


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Posts: 122

Positive results for MT-7117 in early 2020 would be very damaging to CUV, and final approval 2-3 years later would put the nail in the coffin for Scenesse.

This is like a bad dream... We finally get FDA approval in October and then 1 month later the bombshell MT-7117 report lands. Yes, there are still a lot of "ifs", but MT-7117 has just ramped up the investment risk in CUV just when I was finally looking forward to reduced risk. SMH
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xlnja
Posted on: Nov 26 2019, 04:21 AM


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Posts: 122

When is the earliest that MT-7117 could be approved? 2021? 2022?
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xlnja
Posted on: Nov 26 2019, 03:15 AM


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Posts: 122

QUOTE
I can honestly say (for what it’s worth) that confusion and frustration is growing at a time when I truely thought we would be shifting up into a higher gear and celebrating, not idling in neutral and cursing.


My sentiment exactly. It has me rethinking my "all-in" investment. I didn't expect this AFTER FDA approval.
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xlnja
Posted on: Nov 25 2019, 09:43 AM


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Posts: 122

Did anyone ask about competitors during the AGM? They seem to have come out of nowhere and appear to be a real threat.
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xlnja
Posted on: Nov 22 2019, 04:32 AM


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Posts: 122

QUOTE
Striking how threats to Clinuvel have suddenly (seemingly) manifested themselves


It seems that way to me too.

I always intended to give the stock a year after FDA approval before I start selling, but my greatest fear is that some competitor comes along before then and pulls the rug out from under us. Being that I am so heavily invested in this stock, such a scenario would be devastating.

I was hoping that management had a plan to "open the flood gates" after FDA approval. Apparently, that is not the case. Instead, they are moving at their typical glacial pace.

Ironically, I feel more nervous now about the investment risk than I did before FDA approval because of the "business-as-usual" AGM presentation.
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xlnja
Posted on: Nov 12 2019, 11:47 PM


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Posts: 122

Yes, liquidity and broadening the investor base should be the focus.
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xlnja
Posted on: Nov 12 2019, 10:38 AM


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Posts: 122

All the more reason PW needs to get f!@#ing moving on U.S. sales. We all haven't waited this many years for FDA approval to see our investment evaporate from real competition.
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xlnja
Posted on: Oct 17 2019, 07:58 AM


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Posts: 122

I wonder how much of the stock churn is coming from us on this board. Half of today's CLVLY activity was due to my own orders. We need a NASDAQ listing to get a lot more new blood into this stock before it's going to skyrocket.
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xlnja
Posted on: Oct 10 2019, 11:38 PM


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Posts: 122

...here is the approval letter...

Attached File  210797Orig1s000ltr.pdf ( 1.34MB ) Number of downloads: 156
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xlnja
Posted on: Oct 10 2019, 11:36 PM


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Posts: 122

Scenesse is now showing up on the FDA site

https://www.accessdata.fda.gov/scripts/cder/daf/

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xlnja
Posted on: Oct 9 2019, 04:08 AM


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Posts: 122

Wow, just over 15 years. A long wait that has finally paid off!
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xlnja
Posted on: Oct 9 2019, 03:53 AM


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Posts: 122

How about a free sample for all of us long-term shareholders :-)
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xlnja
Posted on: Oct 9 2019, 03:50 AM


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Posts: 122

My first CLVLY purchase: 17-SEP-2009
FDA Approval: 08-OCT-2019

Just over 10 years waiting for this day. Congratulations everyone!! Now just need to decide when to sell :-)
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xlnja
Posted on: Oct 9 2019, 12:25 AM


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Posts: 122

I think it's likely they already have the information. They have been in constant contact with the FDA, so they at least have a good indication of the outcome. Also, the CEO announcement yesterday seems to suggest they already know it's going to be approved.
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xlnja
Posted on: Jul 22 2019, 09:01 AM


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Posts: 122

Yes, when to divest is the tricky decision. If we end up having the conversation, "why would you sell a 200 usd stock when it’s worth 500 usd", I'll be more than happy to be all out at $200.
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xlnja
Posted on: Jun 22 2019, 10:02 AM


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Posts: 122

The FDA had to approve the drug or no doubt some lunatic group would have screamed sexism for not approving a drug designed to help women's libidos.
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xlnja
Posted on: Jun 20 2019, 03:43 AM


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Posts: 122

Regarding takeover bids...does anyone have an idea on the average timeline from announcement to execution? I assume that the earliest we might see a takeover bid is in October after FDA approval. Retrophin's suggested timeline was roughly 1 1/2 months from announcement to execution ("17 July 2014" to "Late August") Retrophin Announcement

So, that might put an execution at the end of November, but I don't know if Retrophin's timeline is the norm. Given the proximity to the end of the year, the time of execution could have a major impact on capital gains tax.
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xlnja
Posted on: Jun 1 2019, 06:42 AM


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Posts: 122

I agree. Being under the radar, Clinuvel has practically been impervious to market swings.
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xlnja
Posted on: Jun 1 2019, 06:39 AM


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Posts: 122

It almost makes you wish there is a takeover post FDA approval so that you don't have the nagging conundrum..."if only I had sold/held". I say ALMOST. I would still like to see the company grow to its full potential.
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xlnja
Posted on: May 29 2019, 05:16 PM


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Posts: 122

I'm glad you brought up this topic. I've been thinking about this on a daily basis lately, in addition to how to best reduce my holdings in CLVLY and diversify (It's unwise to have 90% of your holdings in one stock, but when that stock has a real chance of producing lottery-like winnings, it's a risk I'll take).

I too have been "coasting" for the last few months in anticipation of the FDA decision. I work as an independent contractor. My last contract ended four months ago, and I have barely looked for the next contract. I have never been unemployed this long in my life, but we live in unusual circumstances as substantial Clinuvel stockholders. During this time, I have gone back and forth thinking whether to retire or not. As others have said, if you do retire, you need to have a plan of what to do with your life to have a purpose. I am leaning towards staying employed at least on a part-time basis because I like what I do and also as a hedge against any possible future financial calamities. Of course, all of this hinges on July 8th (or sooner), but best to have the scenarios planned out before then.
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xlnja
Posted on: May 29 2019, 04:20 PM


Group: Member
Posts: 122

It is possible that the shorters are also long on CUV to hedge their position against a possible FDA rejection. While they would not benefit from the immediate bump in the stock post FDA approval, they also wouldn't lose anything if there is a rejection.
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xlnja
Posted on: May 11 2019, 08:22 AM


Group: Member
Posts: 122

Think I found the answer...

https://www.investopedia.com/ask/answers/08...nyse-nasdaq.asp

QUOTE
While a lot of fanfare may occur when a stock is newly listed on an exchange, especially the NYSE, a new initial public offering (IPO) is not carried out. Instead, the stock simply goes from being traded through the OTC market to being traded on the exchange.

However, the stock symbol may change. A stock that moves from the OTC to Nasdaq often keeps its symbol. Contrarily, a stock that moves to the NYSE often must change its symbol, due to NYSE regulations that limit stock symbols to three letters. The OTC and Nasdaq both allow up to five letters.
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xlnja
Posted on: May 11 2019, 07:51 AM


Group: Member
Posts: 122

With a NASDAQ listing, will the CLVLY ADRs all be converted to the new NASDAQ security? Or will they both continue to be traded?
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xlnja
Posted on: Apr 27 2019, 02:46 PM


Group: Member
Posts: 122

For us long timers, the one consolation should the shit hit the fan and FDA approval not be granted is that our low average sp means we can handle a fairly large sp decrease before we're in the red. Fingers crossed.
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xlnja
Posted on: Apr 9 2019, 03:27 AM


Group: Member
Posts: 122

Regarding today's FDA target date for communicating labelling and post-marketing requirements...do we expect any such communication to be made public by the FDA or Clinuvel?
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xlnja
Posted on: Apr 1 2019, 06:43 AM


Group: Member
Posts: 122

I agree. 30x is a pie-in-the-sky figure, but even if it only goes to 5x, I'd be more than happy.
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xlnja
Posted on: Mar 27 2019, 08:13 AM


Group: Member
Posts: 122

Collaborating with Congressman Hank Johnson?! blink.gif I really have to hold my tongue about that guy. There's got to be a better sponsor than him, but whatever works I suppose.
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xlnja
Posted on: Mar 14 2019, 02:24 PM


Group: Member
Posts: 122

QUOTE
I feel those shorting really don't understand the full history of this company when they just see a parabolic SP rise that is 'due for a correction' when the shares are so tightly held by many LTers who are here at a minimum until the FDA decision


Exactly...the bulk of shares are held by institutions and LTers who are not selling anything until at least the FDA decision. New buyers who want to acquire any sizable amount of shares are going to drive up the price quickly. There is huge upward pressure on the stock. Us LTers are finally reaping the rewards of the massive amount of risk we took on over these years.
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xlnja
Posted on: Mar 12 2019, 02:43 PM


Group: Member
Posts: 122

The worst case would be a takeover resulting in the recognition of all the capital gains in one year. I am hoping to spread the gains over 2-3 years. Since many of us are sitting on "lottery size" gains, moving to a no-tax state like NV, TX, or FL could literally save hundreds of thousands in taxes. I guess you could ask yourself...if someone offered you $300k to move to a no-tax state for a year...would you do it?
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xlnja
Posted on: Mar 7 2019, 07:26 AM


Group: Member
Posts: 122

The AUD/USD exchange rate is reflected in the ADR price. I've been monitoring CUV converted to USD against CLVLY for many years, and the price moves in lock step with the exchange rate factored in.
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xlnja
Posted on: Mar 7 2019, 05:27 AM


Group: Member
Posts: 122

The exchange rate drop has been annoying. The bulk of my shares were purchased with an average AUD rate of .90...so the current AUD rate of .70 represents an over 20% drop in the ADR price due to exchange rate variance. grrr.gif
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xlnja
Posted on: Mar 6 2019, 01:12 PM


Group: Member
Posts: 122

This is what I would like to know as well..."what would happen to current US holders of the ADRs if NASDAQ listing happened". I assume ADRs would be converted to NASDAQ shares. Is that correct?
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xlnja
Posted on: Mar 6 2019, 07:08 AM


Group: Member
Posts: 122

It's like a runaway freight train. Assuming inclusion in the ASX200 and no issues with the FDA Apr 8 labelling communication, I don't see any reason for a significant pullback up to the Jul 8 PDUFA Date. I wouldn't mind a small pullback though to buy some more :-)
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xlnja
Posted on: Feb 20 2019, 12:26 PM


Group: Member
Posts: 122

If it were like the old days (i.e., no news, no hard timelines/dates), I would expect another 15-20% drop, however now that we have a fixed FDA approval date, I'm not so sure. It sucks because I was in the process of transferring funds to purchase my last chunk of shares at the time of the Jan 10th jump. I believe johnnytech had the same issue. I've still got my order out there waiting for a drop, but who knows? On the positive side, the continued stock price increase is great news for everyone's current holdings.
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xlnja
Posted on: Feb 15 2019, 09:27 AM


Group: Member
Posts: 122

I've noticed the same thing. I have a spreadsheet with CLVLY and CUV converted to USD. The spread between the prices on close/open has increased a little over the last few months.
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xlnja
Posted on: Feb 1 2019, 11:24 AM


Group: Member
Posts: 122

I agree. It's better to hear all opinions than only those we want to hear. Echo chambers are not helpful.
  Forum: By Share Code

xlnja
Posted on: Sep 28 2018, 10:12 AM


Group: Member
Posts: 122

Once the SP hits $40 AUD, I plan to sell enough shares to cover the total cost basis of all my shares plus a small return. I started investing nearly 10 years ago, so fortunately my cost basis is low and wouldn't require selling very many shares. If the shit should hit the fan afterwards, at least I will have recovered my initial investment.

After that initial sale, I will likely start liquidating the remaining shares evenly over 2-3 years (still deciding on that range).
  Forum: By Share Code

xlnja
Posted on: Sep 1 2018, 07:09 AM


Group: Member
Posts: 122

Isn't it great that many of us find ourselves in this situation of huge gains that require serious consideration of our tax situation?! :-)

Here is a good explanation I found on Nerdwallet (link)...

"Long-term capital gains (LTCGs) are a separate rate you pay on investment property you have held for at least 1 year + 1 day. While they are taxed separately, the rate is dependent on your ordinary income tax bracket. If your tax bracket including the gain is 10% or 15%, then your LTCG rate is zero. If your gains push you into the 25%, 28%, 33%, or 35% tax bracket, you will pay 15% on the gains. Beyond that, you will pay the top LTCG rate of 20%.

Short-term capital gains are taxed as ordinary income, period."


I normally do my own taxes, but I will be employing a Tax Consultant before I sell these shares.

Good luck!
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xlnja
Posted on: May 23 2018, 02:41 AM


Group: Member
Posts: 122

Looks like bad news from NICE. This is the only article I have found on the subject, but it was posted today...

http://www.pmlive.com/pharma_news/daily_br...nd_more_1236401

"NICE rejects Clinuvel’s rare photosensitivity disease treatment

England’s cost effectiveness watchdog has given a ‘final evaluation determination’ (FED) for Clinuvel’s rare disease treatment Scenesse.

The drug is a treatment for patients with erythropoietic protoporphyria (EPP), a condition in which exposure to light causes painful and debilitating reactions in the body.

Scenesse (afamelanotide) has not been launched in the UK, but the company has stated that the cost of an implant will be £12,020 (excluding VAT).

The marketing authorisation recommends an implant is administered every two months before expected, and during increased, sunlight exposure from spring to early autumn, and recommends a maximum of four implants per year.

NICE’s Highly Specialised Technologies (HST) committee concluded that overall the drug “doesn’t appear to provide value for money” as a highly specialised service, and cannot be recommended for routine NHS funding.

The appraisal is one of 10 NICE highly specialised drug appraisals in development NICE, with a further three proposed."


The NICE website "Final evaluation determination document" also confirms the ruling...

https://www.nice.org.uk/guidance/gid-hst100...nation-document
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xlnja
Posted on: Mar 1 2018, 05:44 AM


Group: Member
Posts: 122

The new logo is a busy mess, but if they're going to put it up on the website, at least upload a high-res version. Having a low-res version up there screams amateur web design. It looks really bad on mobile devices.
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xlnja
Posted on: Jul 16 2017, 03:54 AM


Group: Member
Posts: 122

Tell me about it. I've held CLVLY for eight years now, and I tripled my position after the EMA approval. If I had put that money in Tesla or Amazon, I'd be a millionaire by now. Instead, I'm continuing the endless wait for this stock to make a break out.
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xlnja
Posted on: Jul 8 2017, 11:11 AM


Group: Member
Posts: 122

They haven't updated the web page in a long time. It says at the bottom..."Date of last update: September 2008". Still, you'd think they'd be excited enough about Scenesse to update the page.
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xlnja
Posted on: Jan 10 2017, 12:17 PM


Group: Member
Posts: 122

Accounting terminology...it means payment on invoices is due 30 days from receipt.
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xlnja
Posted on: Mar 18 2016, 06:54 AM


Group: Member
Posts: 122

"Back in black, I hit the sack, I've been too long I'm glad to be back..."

Finally!! CLVLY closes at $2.78, and my average holdings are back in black. Now, let's keep this train rolling!! :-)
  Forum: By Share Code

xlnja
Posted on: Mar 10 2016, 01:32 AM


Group: Member
Posts: 122

This stock has never followed the market, which sometimes has been a good thing. I could always count on my CLVLY holdings remaining relatively stable when the market crashed. There is just far too little awareness of this stock for it to follow technical analysis.
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xlnja
Posted on: Dec 16 2015, 12:59 AM


Group: Member
Posts: 122

I wonder if there is any precedent of a pharma having its stock price steadily decline by half after its drug is approved...

CLVLY Chart

This has to be a rare occurrence. It's just our luck we get to go along for this nightmarish ride. In the meantime, I still believe in the company. What else can I do with 10s of thousands of shares that are nearly impossible to unload without a loss? Maybe one day, we will all look back on this time and laugh...I hope.
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xlnja
Posted on: Nov 28 2015, 03:35 PM


Group: Member
Posts: 122

Wow, how did you catch that? It's only visible for like a 10th of second.
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xlnja
Posted on: Nov 25 2015, 05:21 AM


Group: Member
Posts: 122

Next AGM is too far away. Waiting another year for results is ridiculous. I've been waiting for an ROI on this stock since 2009, and many here for longer than that.

I'm hoping that after revenue starts flowing from EU that a big pharma comes in and makes a reasonable buy-out offer of at least $6 AUD.
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xlnja
Posted on: Nov 14 2015, 12:11 PM


Group: Member
Posts: 122

Can we please get a decent return on this stock, or at least get in the black before this global turmoil brings down the economy and CUV along with it!? We've waited too long to have the stock sabotaged by global turmoil. Time is of the essence here!
  Forum: By Share Code

xlnja
Posted on: Aug 21 2015, 01:28 PM


Group: Member
Posts: 122

It better get back up to at least $3 USD. That's break-even for me after my post-approval purchases ratcheted up my cost basis. Imagine that, six years in this stock with an approved drug, and I'm not at break-even, actually 35% in the red!

I am also worried about the global stock markets. We are teetering on a possible crash. Time is of the essence. Although CLVLY has typically been immune to market trends, it would be just our luck if we hear good news in September at the same time that the global markets crash and take the sp with it.
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xlnja
Posted on: Aug 6 2015, 01:23 PM


Group: Member
Posts: 122

I just saw a TV commercial for Belsomra in the U.S. It's a sleeping aid. The list of possible side effects was so ridiculous that I had to post them here...

BELSOMRA may cause serious side effects that you may not know are happening to you. These side effects include:

*sleepiness during the day
*not thinking clearly
*acting strangely, confused, or upset
*“sleep-walking” or doing other activities when you are asleep like eating, talking, having sex, or driving a car.


So, a drug that can cause you to drive a car while asleep and not even know it the next day gets FDA approval, and yet Scenesse with hardly any side effects has to go through the wringer because, ohhhhhh, it causes tanning. Total bullshit!!
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xlnja
Posted on: Jul 28 2015, 02:52 PM


Group: Member
Posts: 122

Exactly, it is because of the "Non-communicative attitude of our CEO" PW moves at a snails pace. The momentum behind the post-approval bump has completely eroded, and we are now trading at pre-approval levels. We need a CEO who moves quickly and communicates. What the hell was the company doing all this time before approval? Apparently, nothing. They could have researched and prepared themselves to hit the ground running after approval. Instead, it appears they just started figuring it all out afterwards.

PW's slow and steady approach is killing this stock. There should be frequent updates to hype the progress being made, not silence for 6 months. PW has done us all a disservice. I am currently 10s of thousands in the red on this stock. I know from years of experience that this stock can turn around quickly, but I fear it could go so low that a takeover or privatizing initiative will get approved that will still leave me in the red...and after 6 years in this stock!!
  Forum: By Share Code

xlnja
Posted on: Jul 28 2015, 06:03 AM


Group: Member
Posts: 122

"For those that don't like the current state of affairs, your only recourse is to sell your shareholding."

The problem is that with such a thinly traded stock it is almost impossible to liquidate your holdings without incurring additional losses. I have been increasing my holdings in CLVLY for about 6 years. I now have a very large portion of my savings locked into this stock with no way out until the thing starts trading like a normal company. My cost average was about $1.90 before approval, but now it is much higher given the large purchases I made post-approval, because, after all, everyone expects a company with an approved drug to get a sizeable bump, right!!!? Wrong!!! What a disaster.

I just looked at CLVLY right now, and it is trading at $1.85!! What the hell PW!? Get your sh#t together...communicate, partner with a larger firm, or something. You are in over your head trying to market to the entire EU. You don't have the resources or the know how to do that in a timely manner.
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xlnja
Posted on: Jul 23 2015, 03:03 AM


Group: Member
Posts: 122

Trading now lower than pre-approval. What the f@#k!!
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xlnja
Posted on: May 3 2015, 01:44 PM


Group: Member
Posts: 122

It's irritating that the EMA and FDA are even concerned about off-label use. We have a proven drug with a long safety record. They shouldn't deny broad use of a drug because of cosmetic use. As someone with Type 1 skin, I would love to have this drug, and so what if it's for cosmetic reasons. It's BS that these regulators prevent me and others from enjoying these benefits just because they don't like the idea of a tanning drug. Anyway, just venting.
  Forum: By Share Code

xlnja
Posted on: Nov 3 2014, 05:27 AM


Group: Member
Posts: 122

Is there any history of a drug receiving marketing approval and not being ratified? Or is the ratification a foregone conclusion?
  Forum: By Share Code

xlnja
Posted on: Oct 30 2014, 01:51 PM


Group: Member
Posts: 122

I am also feeling extremely frustrated post approval. I started acquiring shares 5 years ago. I doubled my stake in the stock just after approval with shares in the $3-4 range. Now, Clinuvel makes up the largest percentage of my portfolio. I thought for sure the stock would maintain a minimum level of $5, which would give me some comfort that at least I wouldn't lose what I invested. Instead of feeling relaxed post approval, I find myself more stressed with this extremely disappointing post-approval "bump". It sucks!
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xlnja
Posted on: Oct 29 2014, 05:54 PM


Group: Member
Posts: 122

Yes, 2015. Good! I've held this stock for many years, like most here. No need to delay this payoff any longer.
  Forum: By Share Code

xlnja
Posted on: Oct 29 2014, 05:52 PM


Group: Member
Posts: 122

He originally had 2016, but edited it recently to 2015
  Forum: By Share Code

xlnja
Posted on: Oct 29 2014, 05:46 PM


Group: Member
Posts: 122

Actually, it appears Uhohinc edited his post to now show 2015 (perhaps based on this blog). I hope it is not 2016.
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xlnja
Posted on: Oct 29 2014, 05:45 PM


Group: Member
Posts: 122

As far as having Scenesse in the major European countries, it sounded to me that he said 2016, which sounds far off. 2016 is also what Uhohinc posted on Google....

https://groups.google.com/forum/#!topic...vel/ku7tkdM-g5w
  Forum: By Share Code

xlnja
Posted on: Oct 29 2014, 05:02 PM


Group: Member
Posts: 122

Is there any history of drugs obtaining approval from the EMA and subsequently not being ratified?

By the way, I am new to this blog. I've held shares for over 5 years and recently started monitoring this blog just prior to the approval. Great advice here and nice to be in company of other long-term investors.
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