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johnnytech
Posted on: Mar 31 2020, 01:43 AM


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Posts: 513

I came here to post this too. I really hope for some government intervention to restrict shorting.
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johnnytech
Posted on: Mar 28 2020, 10:08 PM


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Posts: 513

You are in an awesome position of having a choice. You've freed up cash tied up in other stocks and that gives you freedom. Before this bounce back to 19 back when we were 12, I wanted to sell CLVLY to buy other depressed stocks, but even a few airlines have bounced back enough to make that unappealing.

One key insight is did CUV bounce up because the market did, or because of the announcement. So hard to tell, but that would inform a lot to new resistance levels.

The other point is figure out what will pressure the shorters to close out. Is just distribution what shorters fear? Or will it be the numbers in next spring report is what the shorters are waiting for. (Watch shortman daily, but I suspect you already are).

Next, fold in covid and what affect that has on distribution numbers.
And, will covid affect insurance reimbursement commitments.
And, one positive thing I hope for CUV is they may actually be seen as a safe haven stock now because of distribution.

If you can sort these out, you can time the bottom of CUV.
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johnnytech
Posted on: Mar 25 2020, 11:44 AM


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Posts: 513

I like your characterization Johnny H. My concern is that the insurance companies will dial back temporarily on their commitment to pay for Scenesse because of covid. Which I'm guessing had something to do with the expedited distribution plan we see now from PW of only three locations. Even if they're not concerned about insurance companies dialing back, I still think covid had something to do with this reduced 3 location plan.
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johnnytech
Posted on: Mar 25 2020, 08:05 AM


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Posts: 513

Again, Btron with 4 posts, yes it doesn't take 6 months to prep for 3 locations. They are all known locations in the EPP community. We were lead to believe the delay was for a greater distribution, and yes that would take time, but not 3 locations.

So I'll turn it around on you Btron with 4 posts, are you saying it takes 6 months to prep three locations while leaving 10 million on the table for the last 6 months? That's 2 months per location for a couple emails and phone calls to get things ready. Who are you really Btron with 4 posts?
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johnnytech
Posted on: Mar 24 2020, 11:06 PM


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Posts: 513

My expectation was the delay in distribution was to prepare the logistics to distribute all over the country. But we get a lackluster announcement for just a mere 3 locations. How much prep work do you think it took for this? It's highly probable this prep work was all done before approval. 3 weeks at best to prepare the logistics needed for this announcement.

They left 10 million on the table in lost revenue and have endangered insurers reimbursement by missing a window before corona virus. I know PW was up to some strategy, and it backfired. PW failed us.
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johnnytech
Posted on: Mar 23 2020, 11:51 PM


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Posts: 513

I genuinely laughed at that... thanks Punk. If I start singing the praises of Tanabe, then you can be worried. (Covid-19 did us a gift of shutting down Tanabe's pill on multiple fronts, and took a 3-4 year ramp for them to 5-6).
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johnnytech
Posted on: Mar 23 2020, 11:00 PM


Group: Member
Posts: 513

So, I'm actually considering selling some CLVLY despite it being crushed. There are other stocks out there that are also crushed and are going to triple up before CUV is likely to triple up.

Airlines and cruises are crushed. United was 90 now 24. Carnival was 50 now 10.

And Zoom the video conferencing system has doubled since December.

Here's the thing, if the shorters weren't hammering on CUV, I wouldn't be thinking of this. But it seems highly likely that the airlines are going to triple up far faster than CUV will.

Thoughts?
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johnnytech
Posted on: Mar 23 2020, 09:03 AM


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Posts: 513

The measures China took to shut down day to day activity and lock people into their homes were pretty draconian with good reason in hindsight. I think reported cases are under reported vastly, but the overall situation is more positive than you are characterizing.

America is going to be hit worst.
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johnnytech
Posted on: Mar 22 2020, 09:36 AM


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Posts: 513

What's the reality of Aussie government temporarily suspending shorting?

And what in practice will it mean? Would the shorters have to close out all shorts? Or just be prevented from more shorting?
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johnnytech
Posted on: Mar 21 2020, 12:20 AM


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Posts: 513

Again, notice the speed of these other countries that have done some various form of reactionary or proactive medicine "breakthroughs" for Covid-19.

I've seen articles for China, Italy, Japan, South Korea, Australia, Germany, Holland, and now Britain. But I've yet to see an article about some USA based effort to work on the cutting edge in this regard. But I do see articles about US-based companies importing those medicines and jacking up prices. I do see articles about Trump trying to buy a German medicine and horde it only for Americans.

It's a complete embarrassment for how the FDA does business, and American culture overall.
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johnnytech
Posted on: Mar 20 2020, 07:35 AM


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Posts: 513

1. Yes.
2. Non US countries are totally accelerating or simple ignoring typical procedures. Afamelonotide is starting at zero just like everybody else including the one announced by our competitor. PW is not taking advantage of this once in a lifetime regulatory situation while all these other entities are driving at 200 mph with no speeding ticket.
3. BTRON with 3 posts, yes PW needs to go.
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johnnytech
Posted on: Mar 20 2020, 04:38 AM


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Posts: 513

The first coronavirus case in the U.S. and South Korea was detected on the same day. By late January, Seoul had medical companies starting to work on a diagnostic test — one was approved a week later. Today, the U.S. isn’t even close to meeting test demand.
Link
This tells me that America is not the place to start for emergency medicine. In fact, probably the last. Sad state of affairs for the US.
Also, re: the article from last week that afamelonotide showed effectiveness with this virus response... I have between zilch and zero hope that PW will follow up on any effort at all to raising awareness of afamelonotide during this covid-19 virus.
PW needs to go.
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johnnytech
Posted on: Mar 13 2020, 11:29 AM


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Posts: 513

The upside to this scare is when the market bounces I expect the shorters to close out big portions. They'd be crazy to not take advantage of this. We could be higher in 3 months than otherwise without the virus.
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johnnytech
Posted on: Mar 7 2020, 06:44 PM


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Posts: 513

I have no choice but to wait, I'm not getting off the train. But they should have prepared better and had sales in the first 4 weeks, not just first 4 quarters. I would vote my shares for a new CEO now because of this alone.
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johnnytech
Posted on: Mar 6 2020, 11:24 PM


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Posts: 513

For us long timers, there is a very valid complaint at the heart of our current issue. And that bellyaching is over whether PW is the right man for the job anymore. We got here because of him. But I have turned the corner and because of the poor execution of this US launch it's time for someone else. MinusSinus said recently if the stock was 45 I would feel differently, but if the stock was 45 that would mean the US launch was done better and we'd have 10M more revenue right now. That's 10M that should have been transferred from insurance companies to Clinuvel. That's 6 months of sun protection EPP patients could have had. The complaint is real, it's not just bellyaching.
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johnnytech
Posted on: Mar 3 2020, 10:10 AM


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Posts: 513

This right here. This is it. This is the reason I'm now backing a CEO change. Absolutely embarrassing. It is such a pathetic turn off events that I gotta wonder if there isn't some strategy in this for PW.
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johnnytech
Posted on: Mar 1 2020, 11:18 PM


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Posts: 513

PW Employee performance review.

The positive points of PW:
1. The brainchild of orphan disease approach in 2004ish was PW's idea.
2. His age and commitment at the time to seeing it through was a perfect alignment of rare events that made him perfect for the job.
3. His style, his approach, and yes his silence over the years for a startup, could be crucial historically to getting us to FDA approval. We'll never know, but I lean that way.
4. The relations he's built in the distribution industry will prove very profitable, but very later.

First rate firing offenses:
1. They should have had the machinations in place to distribute in the US instantly. This is the biggest singular failure of his tenure. It would been the trigger to get the shorters out. They knew how to do this from their EMA experience. Everything short-term hinged on this window, and he screwed it up.
2. Not pursuing NASDAQ listing is a straight up invitation to shorters to keep shorting. No. 2 biggest mistake.
3. Not using marketing and no. 1 and 2 to push the shorters out. I believe shorting is an algorithmic math attack that can be used on any company, and they screwed up by not making themself less of a target.

Secondary offenses:
1. His greed. The incentive package is too high, and with bad back door clauses. This is way too much of distraction.
2. Not acting like a startup. Not investing in people. I think their burn rate is too low right now. There is a PE accelerant to a stock price for startups for a reason.
3. Not hiring enough people to do heavy lifting. Relying on nonprofits to do your work. It's his personality, he doesn't delegate. Why is he still the sole face and voice of marketing. Other people should be showing up at events preaching the gospel of Clinuvel.
4. Nepotism. Handing out Board of Director position to the family of the founding board member.
5. Treatment of shareholders.

At a macro level, PW's value add is negative compared to his competition in the marketplace of drug CEOs. It's time for a new CEO. The marketing of a new CEO itself would be value-add to squeeze the shorters.
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johnnytech
Posted on: Mar 1 2020, 10:08 AM


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Posts: 513

Here's an article about companies hiding RTF letters and rejections from the public.

The CUV self imposed nasdaq deadline last year expired 45 days before they even got the RTF letter. The RTF secret was probably a material omission to us in the context of this article, but in the context of history and the bigger offenders in this article, this doesn't get any lawyer at the SEC motivated enough to wrinkle their nose. And would PW have gone to jail? Definitely not.

https://www.biopharmadive.com/news/RTF-refu...urt-SEC/518446/
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johnnytech
Posted on: Mar 1 2020, 07:33 AM


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Posts: 513

Categorically, PW's slights against you and the shareholders have 0% to do with why they are not NASDAQ listed. You are arguing that PW is able to maintain some advantage with secrets and thus doesn't pursue NASDAQ listing. That is just silly. His one subterfuge doesn't even get a slap on the wrist. Even if there was any truth to it, they change 6 words in filings and they are compliant.

PW's other incompetence examples like letting a non-profit drive patient name collections and apathy for shareholders far far better explain why we aren't in the NASDAQ.
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johnnytech
Posted on: Mar 1 2020, 03:09 AM


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Posts: 513

This has nothing to do with why they haven't pursued a Nasdaq listing. The one singular and brazen lie that we've caught PW in, is barely a blip on the radar of the SEC. There was one vaguely worded sentence in the press release that confirmed the lie about the RTF. Nothing outside of that lie is actionable or has standing with the SEC because FDA private communication is private. Do a search for all RTF letters historically, the announcements always come from the companies. Same with full rejections. The FDA only acknowledges an RTF if the company acknowledges an RTF first publicly. It's in the legal code written this way.

There is not even an SEC mandate to publicize that a drug application was submitted. Clinuvel could have submitted a drug application 2 years ago for vitiligo, and we have no SEC mandate to be in the know as shareholders. Clinuvel has not repeatedly broken FDA rules with the SEC, just once.

And frankly that one lie he did, I'm glad he did it. Cuz I would have sold everything if I had known there was an RTF letter. PW's behavior historically would have been hardly any different had they been NASDAQ listed from long ago. Maybe he changes that one lie, maybe he still makes it and gets a fine or a slap on the wrist. But there's no threat to a NASDAQ delisting, or him going to jail. At best he changes the wording of one sentence in that public press release.

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johnnytech
Posted on: Feb 28 2020, 01:13 AM


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Posts: 513

If the shorters don't start profit taking right now, then what price were they waiting for? They've been handed a gift with the virus scare. I hope they take all the profit and get out.
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johnnytech
Posted on: Feb 27 2020, 05:26 AM


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Posts: 513

>> "The CEO incentive plan recall is most welcome".

Wait, I thought our position was that it was suspicious because it adds 3 years extension to PW's timing window?
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johnnytech
Posted on: Feb 26 2020, 11:25 PM


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Posts: 513

When our sister shorted stock, NEA, went down due to bad earnings report, the shorter's bought back a significant amount. With our tanking stock price here, I half expect the shorters to buy back a full percent of the outstanding shorted capital. And frankly they'd be smart to take profit about now.
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johnnytech
Posted on: Feb 18 2020, 11:16 AM


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Posts: 513

Uho was on this board a very long time ago.
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johnnytech
Posted on: Feb 7 2020, 01:40 PM


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Posts: 513

If this indeed what JH is trying to say, it proves my point. The trading activity describe in Investek's post is not concluded at prices subsequent to price discovery by external factors (I.e. bag management).

The activity in the post is the price discovery, albeit tainted.

Now you might be trying to say that their intention isn't to inject downward pressure, but because of low volume that is the result. And you'd also be wrong. Your altruistic example doesn't hold because you are saying their shorting (downward pressure) is causing their own need to altruistically short more (due to downward movement).
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johnnytech
Posted on: Feb 7 2020, 07:39 AM


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Posts: 513

You've just described the bread and butter of market making. This is a tried and true concept and it doesn't support your supposition that the shorters are following the market. It's a well-known supposition that shorters force the market downward.

The daily activity looks like this... shorters short 20K shares daily, and buy back 10K daily for a net short of 10K. You can see this with the correlation of daily shorts on shortman to daily aggregate increase. (Harder to see this now that short man has disabled the dailies).

So, knowing this I don't see any relevance of your comments about market makers. You seem to have this idea that CUV is naturally declining outside of the shorters influence. And not only is that impossible to prove, it is highly unlikely to be the case because of the low volume and the shorting activity. Maybe I'm missing what you're trying to say, but they're just some fundamentals about shorting that you seem to be arguing against?
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johnnytech
Posted on: Feb 7 2020, 01:05 AM


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Posts: 513

Whether a shorter is immune to closing their position because the stock is in an index, or they have a big cash balance on hand to prevent a margin call... is completely independent of the irrefutable truth that shorting puts downward pressure on a stock. And closing that short or buying puts upward pressure. Amplify these affects when said stock is thinly traded.
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johnnytech
Posted on: Feb 6 2020, 11:55 AM


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Posts: 513

Are there warrants for NEA?
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johnnytech
Posted on: Feb 6 2020, 08:47 AM


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Posts: 513

Shorters did not invest 180M to short CUV since last June because Tanabe maybe maybe might have a tanning pill in 2024 at the earliest, that nobody heard of until October. Piss of LH. I'll gladly invest in Tanabe 5 years later.
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johnnytech
Posted on: Feb 5 2020, 08:24 AM


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Posts: 513

I wrote this yesterday then cancelled before posting, but still want to put this out. Yes the shorters used human sensibilities to choose CUV and NEA to short. The fundamentals were low volume and ASX 200. But, yes I believe everything we've seen since June is 90% algo driven. They didn't invest 150 M up until 4 weeks ago, and then look at the fundamentals last week of no US sales so far, and decide to go another 30 M in the last 30 days. The date math is even wrong. They are bullying themselves through another 30 M. And finally getting traction that their small trades in Nov and Dec weren't getting. They are aiming their deep pockets and armed algos at two stocks and bullying their way to profits despite fundamentals.
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johnnytech
Posted on: Feb 4 2020, 12:50 PM


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Posts: 513

There is one big problem I have with your logic. In essence you are trying to reconcile reasoning of the shorters mindset with your own deeper understanding of CUV machinations. That is the issue.

I believe they are not reading these boards nor making reconciled informed trading strategy choices. I believe their strategy is purely algorithmic driven. A couple of reasons:
1. The short chart of CUV and NEA are identical.
2. They both joined the ASX 200 at the same time.
3. And they started being shorted at the same time on June 10th, 2019.

But the companies have obviously different fundamentals.

Algorithms are powerful and smart. They're most useful asset is low trading volume and lack of news. This is all an algorithm needs to make money. If I'm playing the short game and using 40 million dollars to do it, I'm going to make damn sure my algorithm can beat the odds I can control for the most important thing I need, low volume.

Also think about this, they have a set pool of money and if their algorithms needs to go deep with a short (like this last 30 days), then I need the money in reserve for the algorithm to enjoy that freedom. I can't afford to apply this algorithm to 10 different stocks, I'm going to focus on one or two and turn the algorithm on.

We really don't know what we can't know, but it just seems if they were making informed decisions things would have gone differently since June 10th. They know what they're doing and we are at their mercy.


As I write this the more convinced I am that we really need a NASDAQ listing.
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johnnytech
Posted on: Feb 4 2020, 08:43 AM


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Posts: 513

I don't agree with this. The reason CUV is down is because of the re-energized short attack. In the last 30 days alone, roughly $11.5 million additional USD has been invested by the shorters. And the stock is weathering remarkably well under the circumstances.

On a bad day in my nightmares I think PW is in cohorts with the shorters.
But, on a good day and what's 99.9% accurate is that the shorters are acting in complete ignorance of the recent news of CUV and let their algorithms do their thing. Yes, we need news to slow down the shorters, and we need a NASDAQ listing to turn off the shorters. But they didn't invest $11.5 million in the last 30 days on a gamble of no US based Scennese sales. Hell, if they did do exactly that, great because now we know what their exit strategy will be timed to.

We are now in February. I have my fingers crossed that this magical fourth month after FDA approval is going to do something. I'm hoping this push the last two weeks by the shorters is somehow related to "its darkest right before the light".
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johnnytech
Posted on: Jan 31 2020, 06:32 AM


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Posts: 513

Face it LH. Your avatar is dead here. Your voice was not your own before your first ban, and who cares if it is now. Once again you pump Tanabe which several smart people here have completely debunked as a play in the near or even medium term. I don't look to Tanabe as the threat, I'll invest in them in 5 years. You are the threat. And here you start again in the middle of the most aggressive doubling down short attack thus far, but look CUV is generally holding. You will reply will classic dumper response of attacking me.

Go away and come back as another avatar. I've already clicked the button to have you banned again. Hopefully enough will follow suit.
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johnnytech
Posted on: Jan 30 2020, 11:16 PM


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Posts: 513

Mac, your post made my day. I wake up to a huge downturn, then I see LH has come back with a slimy post timed to perfectly for his nefarious goals. Then I see Dr Wally's best post in a long time tear him apart. And then you agree with Dr Wally. The universal hatred for LH's slimyness has you two agreeing. This isn't such a bad day after all.
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johnnytech
Posted on: Jan 24 2020, 10:48 PM


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Posts: 513

I thought you were referring to when JH said this. I'll try and stay out of your feud then.

JH: "If Clinuvel had been ready to distribute at approval, most US patients would be halfway through their 2nd implant by now. That's quite a missed opportunity, both financially and for the patients who have been patiently waiting in the dark."
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johnnytech
Posted on: Jan 24 2020, 05:44 PM


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Posts: 513

What are you going on about? JH just mused outloud that if PW was on the ball, they could have sold the drug day 1 after approval, which is the normal allowed parameters of MA... market authorization. Outside the unusual post MA FDA hoops that CUV unusually has, in most cases there is no barrier to selling day 1. He was just going through the exercise of showing the monetary loss by selling slow.
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johnnytech
Posted on: Jan 24 2020, 12:18 AM


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Posts: 513

I invite others to go to shortman website and try to figure out this question. Is the overall total capital shortage of all top 100 stocks increased over the last year? I gave up, but would really like to know because it insulates CUV from our little retail concerns and what's happening to CUV could be a small part of a bigger play.
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johnnytech
Posted on: Jan 23 2020, 01:31 PM


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Posts: 513

I calculate since FDA approval, shorters have spent over 33 million USD shorting CUV. That is a massive position increase. Several days in the road now it's a green uptick on shorters shorting more. But yet CUV's got more green upticks than red downticks in the last week. If there's ever a time to be worried for the shorters it's got to be now. I admit I still have this expectation that February is going to be a bounce up so it's a self-serving bias to read data that supports that expectation.

Looking at all the other top 100 shorted stocks and trying to glean insight, I get the impression that there is simply an overall increase in shorting of all the stocks going on. And wonder if there isn't a larger bet going on over the Australian economy shrinking. I discounted the idea because there's no reference of what the total outstanding capital shortage of the top 100 was say a year ago. I also tried to go through a bunch of bottom 100 stocks to see if I could find one where it was obvious the shorters were closing their higher short positions from a few months back. But, it's too painful a manual process and I didn't glean any new insight.
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johnnytech
Posted on: Jan 17 2020, 02:36 PM


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Posts: 513

More shorts. We are now up to 7.56% total. It seems like nearly every day for the past week a new all-time high is established. Compare this to 5.6% on day of FDA approval. And it meandered around up to 6.5% for a bit, but since December 20th it's shot past 7% and has been green upticks non-stop since then.

The upside is the stock price keeps hovering around the same and slightly upticking. The shorters are having to run harder and harder to stand still.
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johnnytech
Posted on: Jan 14 2020, 08:16 AM


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Posts: 513

Uho knows more about melacortins in his pinky than most people here, so his posts are welcome. I'll take the smart and filter out the rest. As for his support for LH2000 as you say, that's another issue, and it's in the past. (Maybe a case of not understanding dumper signals).

Correction, you AND your posts are fine. Dial down the frequency a smidgen and watch your likes increase.
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johnnytech
Posted on: Jan 13 2020, 01:05 AM


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Posts: 513

Top 10 thoughts.

1. Shorters. I think we've lost the natural post FDA approval bump. Shorters have made it so the company has to actually realize good quarterly numbers, and actively chase away the shorters. I check shortman now more than I check this forum. I'm working on my own website that is a variation of what shortman does.
2. There is literally nothing more important than a NASDAQ listing and quarterly sales numbers to me at this point.
3. Dr Wally, you are fine, and your posts are fine-ish. Just dial it back a little. Please. For your own sake, I'll read your posts more if you post less.
4. Uho, come back here after a decade of being away. Seriously.
5. The big package for PW actually gives me some comfort where I sit right now because it tells me he won't start to relax and just take what he's gotten so far.
6. Clearly PW won't use public relations as a means to scare the shorters. And the NASDAQ listing project looks like it's dead. I legit wonder if there's some shenanigans going on. I can imagine scenarios where PW is using the shorters to his own benefit. The slingshot of the stock price is coming, we just need to wait it out.
7. I still have hopes we're going to see a lot of movement in February, but my heart is on pause.
8. I don't think we're being punished as Farma characterized it, but there is definitely some strategizing going on and it involves keeping the market in the dark and possibly the stock price down.
9. I haven't changed my lifestyle. I haven't sold. I retracted my retirement. I delayed house building plans. I didn't buy that Tesla for Christmas that I was planning. Now, instead of waiting for FDA approval, I'm waiting for a stock price of 52/35 before some self indulgence.
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johnnytech
Posted on: Jan 8 2020, 11:14 PM


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Posts: 513

Has anyone been trading the CUV warrants?
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johnnytech
Posted on: Dec 24 2019, 10:03 PM


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Posts: 513

I just want to say Merry Xmas to everyone. This year has seen the realization of a dream started long ago. It has always been about FDA approval, and everything else along the way has just been a distraction. Even though that achievement itself passes by in the night with nary a cent of profit taking, it is the point that defines the entire year.

I raise a glass to you all for 2019, and look forward to what 2020 brings to Clinuvel.

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johnnytech
Posted on: Dec 18 2019, 06:33 PM


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Posts: 513

February...

We now have only 30+ trading days till February. The 4 month post FDA approval reestablishment is coming. I personally am expecting to see 38 or more in February. At current volumes, there isn't enough daily trading action for the shorters to ramp out smooth. So with that in mind and 3M shares to cover, I don't have high hopes for seeing total shorts drop from 7.11% down to 1%... But maybe down to 3%. And even that will put huge upwards pressure. Could this be the beginning of the buy back.

February...
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johnnytech
Posted on: Dec 12 2019, 12:42 PM


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Posts: 513

Shortman is reporting a new all time high of the short positions 7.03%. Due to 4 day reporting lag and weekend, this is as of Dec 6th. (And a quick check shows this aligns with LevelHeaded's ban).

The sister stock for the shorters, NEA, continues to track nearly identically, also hitting an all time high same day.

February...
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johnnytech
Posted on: Dec 5 2019, 02:39 PM


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Posts: 513

It was a clean ban. I've openly called for 3 bans - Controvers, Ignoramus x2, and LevelHeaded. Several others have been banned too over time. Bans are not permanent here. Every time Iggy comes back he starts slow, has a couple good posts, then devolves into his true form of stupid wankery; but he is free to come back every time.

But LevelHeaded, I know you are reading. You violated trust and your avatar is dead here.
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johnnytech
Posted on: Dec 4 2019, 12:58 PM


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Posts: 513

Something I've always wondered... how much influence does this board have on the stock price. It turns out this board has way more influence on the stock price than I would have given it credit.

And it started with LevelHeaded bringing up Tanabe on Nov 22 saying soon Tanabe will release some results. Then he provides the results and then pounds this board with doom and gloom. LH has gone from a must read poster to a paid dumper, if that is even him writing his posts anymore. I was on a Yahoo stock board last year and a frequent poster there revealed that he was approached about pushing an agenda for payment (it was marijuana stocks for the curious).

Still, we have 10 quarters of sales to look forward, but we have to look at a stock price lower that pre approval right now. Maybe now PW will reconsider and push forward a NASDAQ listing. We need liquidity and American sales numbers to force the shorters out.
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johnnytech
Posted on: Dec 4 2019, 06:24 AM


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Posts: 513

Good post. I'm glad to learn this. If I'm a Hollywood star and want a quick tan, I'd take the pill regardless of liver concern because that lifestyle mindset is use to shortcuts.

However.

I had to take a daily pill for fungus infection for 6 months. The doctor urged me to quick drinking and get my liver checked bi-monthly. I did all that but what a pain in the butt it was. If I have EPP and have to go on a daily pill with liver concerns, I'm getting the quarterly injection.
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johnnytech
Posted on: Dec 4 2019, 03:40 AM


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Posts: 513

KRD, I always felt the implant choice was strategic... going back to the theme of avoiding 2004 appearances of a tanning pill.

Now that it's 2019 and FDA accepted the molecule... CUV could tweak delivery and reapply for a pill form of Scenesse.

1. Is this chemically viable?

2. Farma/Johnny H.... does this jive with your understanding of FDA policy?

3. Does this open up a strategy for CUV to shut down the "patient care" loophole for 7117?

  Forum: By Share Code

johnnytech
Posted on: Dec 3 2019, 02:32 PM


Group: Member
Posts: 513

On Nov 22nd, Levelheaded2000 stopped being in control of his account. Either by hijacking or selling out, the voice we know has changed.

I've reported his account. I ask more of you to report his account. This worked with ignoramus and shut him up for several months.

Select his profile and view his posts. Just in visuals alone, (fonts, bold, underline, etc...) it points easily to Nov 22 where he says, "I will not lie, I've done a lot of soul searching since the AGM. I'm now bearish on the stock". I spent an hour nitpicking The style and personality and I'm absolutely convinced of this.

Two days is when he handed control over and then the new voice starts with the ridiculous SWOT analysis post. That day starts a new obnoxious writing style with bold lettering and underlines. It's not even a little deceptive.

Levelheaded, on the small chance this is wrong and you have turned a new leaf, appeal to me privately with a PM and if you convince me I will say it here. I will not respond to you here as I do not think it's you anyway.

  Forum: By Share Code

johnnytech
Posted on: Dec 3 2019, 03:14 AM


Group: Member
Posts: 513

You make good points. But it's not your points that informs me to write now, but your zeal. You are so out of character. You are the level headed investor and use to calm me years ago when I got anxious. For the first time my old friend, it crossed my mind that you are sided with the shorters. I know it's not true, but please be aware of how you come off. The formatting, the bold lettering, the font size, the length, the post frequency. You have stopped being casual, and crossed over to persuasive, agenda pressing, and goal oriented in your zeal. The first sales aren't even in after approval and all I can see is the noise of competition 3 years from now. Maybe CUV won't get to 165 in 3-4 years, but it will get to 90. Maybe it won't be 600 in 10 years but it will be 250. Maybe I'll invest in every company with a tanning molecule. This isn't just a bet on the science but on the man, PW. 7117 doesn't have PW. And if 7117 is within 6 months of approval in 2023, I'll probably start shifting money if I haven't already, but the upside is still there for the next 10 quarters here in late 2019. I miss the old levelheaded.

February....
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johnnytech
Posted on: Dec 3 2019, 01:24 AM


Group: Member
Posts: 513

I don't agree with the amount of commentary and thought being invested in 7117. And it now seems this could be impacting the stock price. Which impacts resistance levels, so I'm finally speaking up.

1. Is 7117 the same drug and gets around Scenesse's protection? Read the link below. Find the bit that starts "(14) Same drugs means:" and read the detailed scientific jargon and decide for yourself. I read something in there that a smart guy like PW could use to make his case. Same drug? = yes (good for CUV).

2. If 7117 passes the "same drug" test, it has 3 more tests, and it will fail on 1) efficacy and 2) safety, but what about 3) patient care? Well, when you read the guidance, patient care is a smaller footnote compared to the first two, so this will not have the weight of force or momentum behind it. Second, there is no chance FDA will give 7117's tanning pill credible "patient care" kudos over Scenesse's tanning implant. I see no scenario 7117 winning their case here. We are still a long ways from an FDA 'backdoored sanctioned barbie doll' tanning pill for the rich despite our desire to monetize that path. Patient care? = No chance (good for CUV).

3. Oh my God stop talking about this, please. It's actually probably hurting the stock and even if 7117 gets approved, it'll be years anyway. CUV is already working on next pipeline, 7117 has at least 10 quarters of sales reports to catch up. Worst case scenario = years anyway (good for CUV).

https://www.ecfr.gov/cgi-bin/text-idx?SID=f...13&rgn=div8

History shows a post approval pullback happens all the time. And this pullback seems fueled by shorting attack which usually isn't the case. Which is good. It shows the fundamentals are still there. I have 196K of CLVLY. My very life and kids future depends on PW, and I'm literally not batting an eye. Not losing sleep. Not posting. Not reading up on 7117 till 20 minutes ago. Not dissecting. Not freaking out. Nothing has changed!

Lastly, I said earlier and I'll repeat it.
February, February, and February. Remember February. The 4th month after approval is when history shows a consistent turn around. Don't be on the wrong side of history and give your shares away.
  Forum: By Share Code

johnnytech
Posted on: Dec 3 2019, 01:19 AM


Group: Member
Posts: 513

delete
  Forum: By Share Code

johnnytech
Posted on: Nov 26 2019, 10:03 PM


Group: Member
Posts: 513

To the technical analysts on the forum, did the $28.?? level gap finally close?
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johnnytech
Posted on: Nov 23 2019, 12:23 PM


Group: Member
Posts: 513

>> you'll make a great investor.. one day.

Whoa there buckaroo. Your first post was outstanding and you make some good observations here, but you need a few more lollypops under your belt before insulting a well established member with 20,000% more posts and history to this forum than you. Just let off the gas a little ok. Cheers.
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johnnytech
Posted on: Nov 19 2019, 06:04 AM


Group: Member
Posts: 513

I agree with this but I would put NASDAQ listing above these 3. The NASDAQ listing has the highest built in potential to move the stock short term (less than 60 days) than anything else. This directly impacts my quit date more than the other 3.
  Forum: By Share Code

johnnytech
Posted on: Nov 14 2019, 10:27 AM


Group: Member
Posts: 513

Called Ameritrade and voted on at least some of my holdings.

Sharing a screen shot but largely the same as Punk's screenshot. Called the 888 number and stated what I wanted and 10 minutes later it was done. (Voted No to compensation package, yes to everything else). Note, if you are going to try to vote your CLVLY shares, they said the gurantee deadline finished that morning, and now is just a best effort vote.
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johnnytech
Posted on: Nov 14 2019, 05:14 AM


Group: Member
Posts: 513

CUV down 3% yesterday on another shorting attack, but CLVLY up 2% today. This is the first I recall seeing this. This means arbitrage opportunity for BNY to buy CUV shares and convert to CLVLY shares... putting further pressure on the shorters.
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johnnytech
Posted on: Nov 12 2019, 08:32 AM


Group: Member
Posts: 513

I called Broadridge. After 8 different 800 numbers and 3 different transfers, I finally got somebody who deals with proxy votes. He looked up Clinuvel in his system and said they do not deal with proxy votes for Clinuvel. He could not help with guidance on how to find the right intermediary proxy company either.

This is the number if somebody else wants to give it a go.

866-232-3037 general proxy.

I have shares at Wells Fargo, Ameritrade, and Fidelity. I haven't got any push notifications yet. But I'll reach out tomorrow and pull.
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johnnytech
Posted on: Nov 11 2019, 09:37 AM


Group: Member
Posts: 513

There are two distinct excellent posts that summarizes opposing viewpoints. LH's post supporting PW and management style. And Farma's post showing a lack of confidence in the man and his ethics. Both are excellent posts and help surface your own values on the topic. What is lost in translation is there is only one motion to vote on. Yes or No for the compensation package. That's it. I've settled on seemingly opposing viewpoints.

I support continuing current management, even more after learning how devilishly PW lied about the 2nd NDA submission. I want that on my side. But, I don't support the obscene compensation package and vote no. I choose to believe he will stay and another compensation package would be floated in the near future.

As you settle your own opinions, note the difference in how you vote your shares.
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johnnytech
Posted on: Nov 9 2019, 03:44 PM


Group: Member
Posts: 513

So there was an RTF and a second NDA afterall! Holy shit. I feel violated and in awe at the same time. Thank god for his smoke and mirrors because anybody else would have told us the truth, and the stock price would have plunged, and I might have sold.

This RTF realization deflates all my anger over his obscene compensation package. Sure other pharma CEOs could run this company, but PW is a Clint Eastwood gun for hire that will get us to 100 faster than the next guy. It really is about the man, and sorry I forgot that for a moment.
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johnnytech
Posted on: Nov 9 2019, 07:25 AM


Group: Member
Posts: 513

To answer your question, I don't care about dishonesty, that's par for the course and a bit expected. The ultimate question in front of us is the vote on the compensation package, obviously there is shenanigans going on. Need look no further than the family lineage of our most recent board member, daughter to the founding board member. Whether the dishonesty is in the boardroom, management, or in the data, I don't care. I'm not going to vote out PW for sleight of hand.

So your other option, incompetence, is a factor. Write up about incompetence and lay out your smoking guns up front and add supporting evidence. And relax a little bit too.
  Forum: By Share Code

johnnytech
Posted on: Nov 8 2019, 04:32 AM


Group: Member
Posts: 513

That's the post of the week right there. Nicely written.

I wasn't expecting JH to go to those depths and he has since retracted. But, it is also this board's nature and role to play cynic. I welcome all conversation about PW's obscene package, and welcome talks of shareholder voting blocks, despite it being tiny in the big picture, and a sure thing at the AGM.

On the contrary though, whatever JH got from his FOIA request last June should stay off the public radar. No doubt there were some games and happenings going on, but it would only serve to distract and will be totally forgotten soon enough regardless.

I disagree with you LH on one point. You said previously the whole package will not vest, but it will because of the sell out clause. Either by manipulation (fake sale) or an actual sale. Guarantee one of those. And the package becomes more offensive because he's being rewarded on non-performance.

The short attack was 40% of gross trades two days ago. This is not healthy price discovery. The end of shorting is coming.
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johnnytech
Posted on: Oct 31 2019, 05:42 AM


Group: Member
Posts: 513

LevelHeaded, nicely written. You said we could get an experienced CEO at half. I bet we could start the recruiting at 10% according to this article. PW's performance rights put him far above No. 1 on the list of 2018 top 25 paid CEOs. None of the top 25 are pharmaceuticals.

https://www.usatoday.com/story/money/2018/1...-2018/38756663/

No. 25... $30 Million USD.
No. 1... $103 Million USD.
PW's performance rights... $143 Million USD.

(Total amount divided by 4 years. It's conservative as well since it excluded his $2M salary, and the extremely high probability of exercising the Sell Out clause in year 2 of the 4 year deadline to this package).

The question I ask myself, am I ready to move on past PW? The last 10 years wasn't just a bet on the molecule, but on the man himself. So, at what point does it stop becoming about the man, and turn back to the intellectual property of the company? We have reached that point in my opinion.

However, I'm not totally moved to carry a pitchfork and go after PW about the total shares on this package without knowing the CEO candidate market landscape. But, I absolutely want that Sell Out clause revised to mandate a successful transaction, and the elimination of the recession clause. Without those two changes, my vote is no. Besides, if PW drops from no. 1 to lowly no. 24 on a top 25 list, is he going to leave? Yeah right.

The molecule carries Clinuvel forward under any management. Since Willem Blijdorp is such a massive share holder himself, if he loses PW he'd be forced to do some soul searching and revisit strategy... all good activities. Yes, please go after a top 10 experienced Pharma CEO that would easily take $15 Million per year. Or do the right thing Blijdorp and revise the conditions. The deadline to revise the Proxy Form is November 6th, 2019.
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johnnytech
Posted on: Oct 29 2019, 07:34 AM


Group: Member
Posts: 513

I find it implausible that ASX has standing to legally prevent shortman from archiving and displaying historical financial data. Price tracking websites for Amazon have successfully insulated themselves from Amazon's lawyers, and Amazon's data is a private company. ASX is a government regulation service.

Our friend at shortman is being bullied.
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johnnytech
Posted on: Oct 28 2019, 09:39 AM


Group: Member
Posts: 513

Google spreadsheet (or attachment) of CEO's stock holdings with current performance rights, and how much his holdings are worth in AUD, USD, GBP, and EUR. There are two editable colored cells... one for stock price, and one for percentage of the 2019 performance rights.
http://bit.ly/cuvpwmoney

For fun, I've also made a chart for calculating what stock price he needs to buy his hometown soccer team (Ajax). Valuation source cited inside. This does not include a luxury lifestyle or his current salary. This is tongue and cheek fun and hardly precise.
If he gets 100% of his 2019 performance rights, CUV needs to be 178. At 50%, it goes up to 210. At 0%, it goes up to 255.
Attached File(s)
Attached File  pw_holdings_2019.pdf ( 82.28K ) Number of downloads: 98

 
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johnnytech
Posted on: Oct 26 2019, 05:25 AM


Group: Member
Posts: 513

Agreed. Notice the performance rights says nothing about NASDAQ listing. I don't understand their strategy to demote this priority. From where I sit, it should be the literal next thing they go after. Vitiligo is multiple stages with many moving parts. This is a paperwork exercise. It's kinda like them not asking for reimbursement from France. Why?
Edit... just now seeing Farma's comments. I also see a variation where they sell the company for PW to cash out within 3 years. It's written for all to see with the sell out clause (with 3 year deadline). But simultaneously, a higher stock price is value add on all fronts. I don't see a scenario where limping the stock price helps them to sell even if we assume conspiracy theories.
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johnnytech
Posted on: Oct 26 2019, 02:02 AM


Group: Member
Posts: 513

CLVLF is more thinly traded, and as such less chance of your limit order filling (buy or sell). Other than that, all the ticker symbols rise and fall in concert and I wouldn't sweat it too much. If you are holding till 50+, there will be less concern of this. Might even be NASDAQ listed by then (your shares will be auto converted).

If you're going to buy a lot from now (5000+), I'd switch to CLVLY, but I wouldn't sell and re-buy what I already have.

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johnnytech
Posted on: Oct 24 2019, 11:01 PM


Group: Member
Posts: 513

That's a good point, thank you. FYI, 2014 was another good November that is missing from the bottom graph.

I have this expectation that when the shorters close out, it'll be quick. February is my expectation, November is my hope. (February because of FDA approvals averages).

If shorters take a slow exit strategy, then this price movement prediction is off the table. Separately, I don't think they'll wait till a NASDAQ listing either to exit.
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johnnytech
Posted on: Oct 24 2019, 08:38 PM


Group: Member
Posts: 513

Avita is one of the stocks that I used in my original prediction 1-2 weeks before approval, that it would be Feb 2020 before we saw a climb out of the inevitable retreat after approval.

What's different with Clinuvel is the 10 yr avg monthly change chart, and the extreme spike in Novembers for CUV. (Avita has no seasonality to their 10 yr avg). My revised prediction was the short attack may close out in November.

Either way, I think we'll see all time highs in November or Feb and it'll be sustained like Avita.

By the way, I use shortman to find seasonality charts.
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johnnytech
Posted on: Oct 24 2019, 09:13 AM


Group: Member
Posts: 513

Vote Yes to the PC conditions.
Vote Maybe to the reward amount.
Vote big No to the sell out clause unless it's modified to only allow performance rights post an actual sale.

Unfortunately, line item veto isn't a thing, so overall.... yes, because it makes me rich. But I need to take a shower after I vote. The sell out clause invites collusion and totally believe they'll do it. Hell, they put the late Dr. Hank Agersborg's daughter on the board.

The performance conditions are literally the best marketing tool Clinuvel has right now. They should just post "Top 10 highest Paid CEO Ever!" on social media to get word out about the company.
  Forum: By Share Code

johnnytech
Posted on: Oct 22 2019, 05:54 AM


Group: Member
Posts: 513

>> Shorting is a natural part of the markets and it provides liquidity, its not witchcraft or some underhanded way to drive the price down on you, so deal with it.

Don't confuse your shorting with algo systems. Selling exactly 13 shares every 3 cent increments down, day after day on a thinly traded stock, is exactly designed to drive the price down. It is not healthy price discovery. Congrats on your own shorting success.
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johnnytech
Posted on: Oct 21 2019, 10:06 AM


Group: Member
Posts: 513

Get back in friend, what are you waiting for! And using other people's money too, you timed that well.
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johnnytech
Posted on: Oct 21 2019, 09:55 AM


Group: Member
Posts: 513

Levelheaded, I did say 'summarily' but, yes, it does go to a board vote first. I hope you don't miss my point because I stretched it there.
My point is, I don't agree with you that this clause is a performance right. I would vote for a performance right to sell the company, but this clause allows for PW to get all the shares even if the company is never sold. If it was meant to be a performance right, they they should have put it in the performance right matrix, and used appropriate language.

Instead, this clause comes at the end, in the fine print section, and it's long. Longer in words that any of the performance rights. They are digging for reason after reason for any early trigger point for a vote. But don't speak to any end game scenarios of actually having sold the company. It would be like a performance right saying... "if early market indicators suggest a 7.5 Billion valuation sometime soon in the next 6 months, board may vote to just give you the PC1 performance rights now".
  Forum: By Share Code

johnnytech
Posted on: Oct 20 2019, 11:26 PM


Group: Member
Posts: 513

We might be reading something different. What I read comes from the AGM notes where the specific performance rights matrix is, not the annual summary report. After reading again just now, I'm even more cynical on this point.

As it is, there could be a fake and/or failed attempt to buy the company and he still gets 1.5 million shares. And it's immediate. He could sell those shares before the fake/failed attempt is fully evolved. All it takes is the cost of a court filling fee to announce intentions to just talk of acquisition, and he gets the shares inside of a week. Not my idea, it's listed in the small print like this.

If being acquired was the intention (and I agree with your logic below), I would have preferred more on point language in the right section of the document. It's not listed in the performance target matrix. It's listed at the bottom of the whole document under a section called 'summary', where it feels tucked away to me.
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johnnytech
Posted on: Oct 20 2019, 03:30 AM


Group: Member
Posts: 513

There is an escape clause in the small print of the AGM notes about the 1.5 Million performance rights. If there is a take over attempt (which is defined by either court actions, or acquisition of stock on the open market exceeding 50%, or some other variables)... then the board can just execute all of the performance rights and give him the 1.5 million shares summarily.

I like it because this may be the difference that prevents the takeover, but mostly I don't like it because why should he get those performance rights if he didn't... wait for it... perform?
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johnnytech
Posted on: Oct 19 2019, 10:46 AM


Group: Member
Posts: 513

It's not about whether or not the placebo is current best practice. It's about what's the potential downside of being in the placebo group. With EPP, I know I'm not contributing to my early death if I'm in the placebo group. But, with XP I would never take that chance because of the potential. I'm not qualified to answer ethics of studies, but I see the ethical boundaries are more grey.
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johnnytech
Posted on: Oct 18 2019, 10:49 AM


Group: Member
Posts: 513

Billy Boots my friend. I know you are the oldest one here and you have a right to complain about the manipulation. I feel your pain. I cracked a bit in September too. Find strength in knowing that November is the best time of the year for CUV historically over the last 10 years, and good things are coming. Us younger folks here are sending you our energy and support. Stay strong brother.


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johnnytech
Posted on: Oct 16 2019, 11:41 PM


Group: Member
Posts: 513

There is someone we forgot to thank last week.

This forum website, and it's predecessor sharescene, is about Australian stocks. But, 98% of the posts here are Clinuvel related. Or at least for many years CUV was the only subforum that brought visitors here.

Thank you to the mystery webmaster that has kept this site alive for over 15 years. You are a silent benefactor behind the scenes and I hope you make out very well financially. I pray you didn't sit on the sidelines and just watch CUV, but actually invested in CUV as well. I'll assume you did invest, and hopefully a lot my mysterious friend. Thank you.
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johnnytech
Posted on: Oct 15 2019, 12:02 AM


Group: Member
Posts: 513

Article about FDA getting more efficient with new drug applications.

https://www.statnews.com/2019/10/14/fda-sma...latory-science/
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johnnytech
Posted on: Oct 14 2019, 09:14 PM


Group: Member
Posts: 513

I have a post around Sept 2018 that dealt with soccer teams and his share holdings value. Breaking down teams into tier 1-3. His home town favorite is tier 2 (but just finished their best year ever). I also built in taxes and luxury living style. I'm going on memory but I came up with 180+ as a strike price for an upper tier 2 team. Valuations were based on a blog article that talked about this exact thing, how much would it take to buy soccer teams. Please refer to my post history Aug/Sept 2018 for more details. (It radically accelerated at the top. He would need 700+ strike price to buy a top 5 tier 1).
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johnnytech
Posted on: Oct 13 2019, 11:32 PM


Group: Member
Posts: 513

Congratulations my forum friend. That's an impressive trick you pulled off, selling out on approval. I too am mentally attached to this stock. Selling 95% of my shares would be like cutting off my arm. I still haven't sold a share, but will soon. However I did put in quit notice to my boss that I will be leaving sometime in the next couple months. 197K clvly.

I see the "more" fallacy being played out on the forum right now. Everyone of us would have said 3 years ago, "Sure, I'll sell out 95% on approval". But now I hear, "If I hold 95% for just 18 more months....". Maybe not exactly like this, but something similar. And my hypocrisy is in full steam as well as I have no intention to diversify until 50 clvly.

So, it could be a case of "I want more!" or it could be more restrained, possibly well thought out plan, depending on your mental state. Here is how I have come to peace in my mind. The key word here is De-Risked. Right now today, Clinuvel is a safer investment than 97% of my options. Let's face it, when we thought of selling out 3 years ago, we weren't every going to sell to cash and just hold cash for life. So, being all-in with Clinuvel for the first year after approval IS a form of diversification to me. I feel safer for a year than I would in a Vanguard fund. I think this week is literally the best and safest time to ever EVER buy Clinuvel. And I'm trying to convince my friends that didn't invest prior to approval to invest now. Next year, then I'll look at moving 50%, but for now I'll just early retirement and start withdraw expenses monthly from clvly holdings.

It's all about derisked. We have a year of a quarantined bull run.



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johnnytech
Posted on: Oct 13 2019, 08:31 AM


Group: Member
Posts: 513

I don't understand your description of a defense against a hostile takeover... and why this 90% barrier you describe isolates them from a takeover.

Isn't a hostile takeover any attempt to acquire enough shares to oust a board. Anywhere from 30% to a guaranteed 51% is usually what the media and movies depict as the goal in a hostile takeover.
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johnnytech
Posted on: Oct 11 2019, 06:28 PM


Group: Member
Posts: 513

After one day of trading for each exchange after approval, CUV closed 14.0% higher than CLVLY. After second trading day it was 5.6% higher.

Right now, as both markets are closed, CUV having 3 trading days, and CLVLY 2 days, the stocks are less than 1% different (0.25%). In theory, CLVLY shouldn't move at all tomorrow on its 3rd trading day post approval.
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johnnytech
Posted on: Oct 11 2019, 10:14 AM


Group: Member
Posts: 513

All of these shorters, naked shorting, and take over prospects.... NASDAQ listing just became the most important next step for Clinuvel. Do they agree and can they pull it off in 3-6 months will all resources on board?
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johnnytech
Posted on: Oct 10 2019, 06:40 AM


Group: Member
Posts: 513

You are right to be mad. This is the biggest disparity I've ever seen. But it is death by lack of volume. Besides volume, the other mechanism to bring the prices together is BNY Melon's arbitrage privilege. That's the bank behind CLVLY's IPO many years ago. They get to move shares from one exchange to the other for arbitrage to bring the CLVLY in line with CUV. This isn't just a privilege, it's a principal
balancing mechanism of all ADRs. Using today as an example, they would buy up a lot of shares of CLVLY (and thus raise the price) and sell them as CUV tomorrow.

Despite knowing this mechanism, I've never chased down or looked for evidence of it actually being executed in the past. Maybe BNY isn't even watching, but we could use them right now.

We need a NASDAQ listing more than ever.
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johnnytech
Posted on: Oct 10 2019, 03:37 AM


Group: Member
Posts: 513

I'm taking a little profit today on CLVLY (first time ever). But I won't lower my limit price below 29.5 (2% under CUV). I do think it will spike up at the end of the day mostly because BNY Melon's arbitrage privilege usually pressures symmetry in the end.

If it closes at 5% or greater differential it'll be the first time I've ever seen that (right now 15%).
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johnnytech
Posted on: Oct 10 2019, 03:19 AM


Group: Member
Posts: 513

Thank you thank you for catching that. Shortman warns the data has errors, but I didn't think to cross check the 3% closeout on Oct 3rd with trading volume on that day. Great catch!
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johnnytech
Posted on: Oct 9 2019, 01:14 PM


Group: Member
Posts: 513

Whoa, to highlight what verhaven first spotted.... shortman updated from Oct 3rd, and apparently 50% of all outstanding shorts closed out in one day! We've all been talking about shorters's reaction over the next couple of weeks, and come to find out, they 50% closed out last week.

And NEA, which must be manipulated by the same group, also shows same 50% close out of all shorts on Oct 3rd as well.

As of Oct 3rd, only 3.12% of outstanding shares are shorted of CUV. We could be near normal shorting levels right now (under .5%) and not even know until 4 more days from now. It seems like maybe we're almost done with the shorters, but something tells me we haven't seen the last of them. Nevertheless, this is a minor cause for celebration.
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johnnytech
Posted on: Oct 9 2019, 09:10 AM


Group: Member
Posts: 513

This is why the trading halt. Wipe out the existing sell orders to force people to make high opening bids. Very smart on PW's part. Build in resistance early and squeeze the heck out of the shorters. (Sorry for the swearing).
  Forum: By Share Code

johnnytech
Posted on: Oct 9 2019, 04:43 AM


Group: Member
Posts: 513

Holy shit. Just got back from a meeting. I wasn't expecting to be 7 pages of posts too late.
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johnnytech
Posted on: Oct 8 2019, 11:19 PM


Group: Member
Posts: 513

Whoa, I didn't know this. All sell orders on the books get wiped out?! Well, I support Clinuvel's use of trading halts now. Seems like a quality safety mechanism built in for the company to trigger.
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johnnytech
Posted on: Oct 8 2019, 09:55 PM


Group: Member
Posts: 513

I don't like trading halts for announcements personally, but possibly this will spike the stock even higher on opening, open up into the "oh shit" zone of the shorters, and cause then to panic. An aggressive 40% spike would put us right at the all time high in July.
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johnnytech
Posted on: Oct 8 2019, 02:51 PM


Group: Member
Posts: 513

Until the stock reaches 33+, the shorters are in the money, assuming one entity and averaging off the shortman charts. Maybe as low as 31, but not 28. Study this page long enough and it starts to make sense.

https://www.shortman.com.au/stock?q=Cuv

Today was the 5th lowest gross shorting volume in the last 20 trading days. The shorters are losing their nerves.
  Forum: By Share Code

johnnytech
Posted on: Oct 7 2019, 08:18 AM


Group: Member
Posts: 513

Graph from shortman. The redlines are mine. I've looked several dozen shortman graphs of different companies. I'm changing my prediction of a slow exit by the shorters. A couple things of note here:
1) CUV price movements are extremely sensitive to the shorters compared to other companies. When the shorters short, price goes down, and when they buy back, price goes up (redlines). It's uncanny how strong this relationship is compared to other charts. Having only experienced CUV's shorters first hand, I assumed other stocks followed similar twitchy patterns. The fact that they don't track like CUV is good for CUV. They control the market while the market holds their breath.
2. Another company of note is NEA. Their shorting graph just looks the same since July 2019. My gut says the same traders are trying their algos on two companies starting simultaneously back in July. But the share price graph of NEA is not as twitchy as CUV. This is favorable to CUV in trying to predict the future. NEA must have a bigger retail awareness.
3. Reviewing lots of graphs, shorters typically exit slow and controlled. But, they do exit very fast in a couple of examples. A) Shorters for SLR exited a massive 6.2% total shorting position to down below .5% in under 10 days (stock price barely moved too). B) BAL went from 15% total shorts to 2.5% in the last 10 days of September (price did move).

I retract my previous sentiments where I said we could see a long 4 month exit. We'll hopefully see shorters getting scared on a price spike this week and do a quick exit in under 10 days or faster, or we'll see a controlled exit throughout the end of November (more likely). I'm putting a hard finish to their exit by end of November because of this graph I'm linking. This is a 10 year historical seasonal November price surge of Clinuvel, something the shorters will no doubt be aware of even if they aren't aware of Scenesse.
https://www.shortman.com.au/seasonality?q=cuv
Attached thumbnail(s)
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johnnytech
Posted on: Oct 4 2019, 07:06 AM


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What page are you referring to? I'm under the impression from several years ago that the FDA will tell applicants first and allow them to make public announcements. Maybe things have changed...
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johnnytech
Posted on: Oct 2 2019, 11:05 PM


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If clouds formed in the shape of C U V, this group would read demonations into it. No big deal, it's the cost of being lucky to know about Clinuvel before the rest of the world.
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johnnytech
Posted on: Oct 1 2019, 10:11 AM


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35% approval by end of business this week.
45% approval next week.
18% approval following week.
1.5% rejection within the next 2 weeks.
.5% rejection or approval after 2 weeks.

Up to two weeks after PDUFA date still counts as hitting the PDUFA date by FDA internal metrics (it could be up to a month but I'm positive within two weeks is allowed because there are many that go two weeks after, and they take these internal metrics seriously). If they go silent for 3 more months, this isn't a delay (no more allowed... thanks Johnny H for digging that up), it's a tardy response, which is allowed.

Overall, I'm 98% confident of approval and not losing any sleep. If anything I'm annoyed. Just keep in mind we still have a two week window. I know everybody is wound up for an answer this Friday. The sky isn't falling if we don't hear before weekend.

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johnnytech
Posted on: Sep 30 2019, 08:34 AM


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I've become increasingly convinced the shorters won't exit all at once upon approval but will take several months and use the bots and algos to exit under a controlled bot driven strategy. They'll be fighting against the tide, but I believe they still know what they're doing even as they are drowning. Could be 3 weeks to 4 months, but it won't be immediate.
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johnnytech
Posted on: Sep 30 2019, 07:59 AM


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Johnny H, the key Google search word you are looking for is "asset depletion loan". Big banks like BoA, Chase, Wells Fargo are going to be easiest. It helps if you have a "personal banker" assigned to you that can direct you. The goal is you are seeking "manual underwriting". If they can't do asset depletion loans or manual underwriting, then they won't care if you have 100M in stock.... move on to another bank.

Separately, as I found a blog on asset depletion loans last week, I also found these.
In late 2020 or 2021 I plan to finally diversify (probably 50%+ at least of clvly) and plan to follow a self managed 8% a year retirement plan like this.

https://bit.ly/2nHy49E

https://bit.ly/2m86uC9
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johnnytech
Posted on: Sep 26 2019, 11:23 PM


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I'm trying to totally ignore the short traders.

1. They aren't playing with their own money.
2. All our exit strategies and waiting for years are psychologically tied to this PDUFA date. Their exit strategy is tied to script code line no. 164. You can't beat it, but you can play it.
3. If approval is positive, try and hold 4 more months. Please don't sell big chunks in October out of unmet expectations. From my loose research, 4 months later is a much better share price to sell then days after approval.
4. It could even be this 4 month historical period is accounted for in script code line no. 164, which means the shorters will buy back everything over the next 4 months, not the next four trading days before October 6th. I don't know that, but it seems to be playing out that way.

JT
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johnnytech
Posted on: Sep 26 2019, 09:47 PM


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Sharelooker is that you in the video?
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johnnytech
Posted on: Sep 24 2019, 02:39 PM


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I agree a little. The true long term number I'm looking for is the share price 4 months after approval. That price will be more of an indicator of 12-18 months market trajectory than the immediate post approval bump.

In other words, I feel I can predict if CUV will break 120 share price in late 2021 more based on the Feb 2020 price than the 2019 Oct 10th price. That Feb 2020 price will be when I make major life choices.

Don't let a post approval poor performance dissuade you. Wait till Feb 2020 to really feel shitty about yourself.
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johnnytech
Posted on: Sep 10 2019, 10:14 PM


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The graphs from Verharven tell me that the technical traders are playing a completely different game. There is at least a 50% statistical chance to hear a response from the FDA between Sept 6 and Oct 6, yet these god like traders with steel balls still hold their high short positions.

If they buy back today, it would surely send the stock even beyond the previous highs of 39. They are gods among men for their courage. But, in 30 years time when they look back on their careers, they will say they made no greater mistake than to hold short on Clinuvel back in September of 2019.
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johnnytech
Posted on: Aug 30 2019, 07:14 AM


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

Anyway, my main problem isn't the "more" fallacy, as I said it's the lack of checks and balances. As more friends on the board get power, the votes are diluted. There is no scenario where this power consolidation is more profitable for retail investors over the next 20 years.
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johnnytech
Posted on: Aug 30 2019, 02:34 AM


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Dr. Wally may have overwritten and wasn't as smooth as Farmazutical, but both posts are not in opposition. Both are right. Both their targets suck here. Wally's 2nd paragraph is completely spot on, and Farma's main point about paying PW even more at this point is totally on target. It's a cash grab and.... and a power grab.

It's evil smart for them to take even more power at this opportune time. They manage intellectual property under the permission and privilege of a board, propped up by the check and balances of a voter base. Well, the voter base is disenfranchised (CLVLY), and the board is self serving. It'll be that much harder to wrestle runaway egos away from power at the right moment later. They are stacking the deck as managers and it is utter bullshit.
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johnnytech
Posted on: Aug 27 2019, 08:28 AM


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I agree with this. The fall from high in the last 4 weeks makes the next 4 weeks a grind. I just don't see us getting back to 39 before announcement and the momentum for a pop the day after will be on a price sub-par to my expectations 4 weeks ago.
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johnnytech
Posted on: Aug 24 2019, 10:14 AM


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I would think if BNY Mellon was doing arbitrage and transferring shares, it wouldn't show up on retail lists. That shorting is a bit of a curiosity though at this stage. Watch that closely, if there are any news leaks, more likely to be amongst Americans with FDA insider ties, and they are going to go to CLVLY or CLVLF. Hopefully it's just regular retail shorting.
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johnnytech
Posted on: Aug 22 2019, 07:26 AM


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Your first point bears repeating just in case it's not clear to everyone. The FDA might respond on October 9th or early, and as late as October 11th (Friday), and still meet their internal metrics. But they could also miss the date and it might be as late as December 10th or January 10... just like the two outlier cases from 2017.

As far as extensions for changing the PDUFA date again, what Johnny H found was gold and I didn't know that previously, there are no more extensions to be had. They have to approve or reject and the clock is ticking. It almost makes me wonder if PW purposely left them low-hanging fruit to find, (to give the FDA fodder for an extension), because how can you screw up a simple response about a manufacturing question 5 months ago when you were given the question 9 months ago. It's almost as if he planned it. If he was that calculating, kudos to him.
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johnnytech
Posted on: Aug 21 2019, 06:01 AM


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FDA is measured internally on hitting that PDUFA date. In that list of date differentials I posted earlier, it's rounded to every two weeks in the spreadsheet with a complicated time/date formula, but almost all those results are within 3 days of the rounded result anyway.

Doesn't it seem odd that they always hit the date or earlier in such a complicated team effort of evaluating a drug? Why is their miss ratio so low? Well, I read somewhere a long time ago that FDA is under high scrutiny internally based on performance metrics on hitting those dates.

The inference of this from my own conjecture is that the PDUFA extension mechanism is just a function to keep their metrics looking good. Otherwise why even bother with an extension. With the pressure to keep "fast tracked" drugs within parameters (can't keep extending priority drugs, looks bad), and crossing this with internal FDA performance metrics, I think there is a higher chance of rejection than extension. They don't want to extend our go over. Approval chances on our before PDUFA deadline.... 96%. Rejection... 3%. Extension or missed date... 1%.
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johnnytech
Posted on: Aug 20 2019, 02:33 PM


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Delete
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johnnytech
Posted on: Aug 19 2019, 09:13 AM


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I'll be honest, I don't know. I've largely stopped my FDA research because Johnny H and Farmazutical took over the heavy lifting. My guess is though we won't hear from FDA publicaly since we are in the quiet period. However, I also don't understand how Johnny H got materials during this time through an FOIA request, because congress has given FDA exception clauses to FOIA requests during quiet periods. So, I'm not confident saying we won't hear, but I'm guessing not. Of course, Clinuvel may tell us but that's a nice roll too.
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johnnytech
Posted on: Aug 19 2019, 07:10 AM


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Farleap, last year I shared a Google sheet of all 2017 fast tracked drugs. 17 drugs in total. The goal was to see the differential of actual approval vs PDUFA date. Below is the column of the 17 differentials. These numbers are rounded to within 1/2 month increments. -1 means approval came one month before PDUFA date. As you can see, we have a fair chance of coming early or on time. Out of 17, only 2 were late.

-2, -2, 0, 0, -1, 0, -0.5, 0, 3, 0, 0, 2, 0, -3, -0.5, 0, -1
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johnnytech
Posted on: Aug 7 2019, 11:40 PM


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Why is Palatin surging?
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johnnytech
Posted on: Aug 1 2019, 11:55 AM


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Even though I just attacked Johnny H, I'm going to defend him now to you.

>> I don’t understand why anybody would believe anything this narcissistic day trader of Clinuvel says.

Because he has taken on the mantel of FDA research that we all benefit from. I will continue to read his posts. Only Ignoramous deserves ignorance. I don't disagree his posting is a bit prolific. But then again, so are yours, in the past mine, etc...

Did he use his profound understanding to influence this board in preparation for a $80,000 USD purchase a week prior? Hopefully not, probably not. Does this board influence the market. Absolutely.
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johnnytech
Posted on: Aug 1 2019, 08:19 AM


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I remember you pushing negativity about something you received from the FDA over the phone because you called somebody. And then to buy the volume I know you buy at so shortly after it dips. And then to produce the good news when you made it sound quite dire. It seems suspicious. The timing is too convenient.

I may have it wrong. 99% you are not a shill. In fact, because you research FDA stuff, I stopped researching FDA stuff. But you are human and you might have taken the opportunity considering the volume you just bought. Nobody buys that much without planning it. I may have it wrong, but I'm not feeling apologetic towards you for the way you came after me about RTF. I mean you came after me like a witch hunt saying how effing stupid could you be to not read the black and white, producing and cross-referencing every FDA angle you could find. And in the end I was right.
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johnnytech
Posted on: Aug 1 2019, 03:54 AM


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What the HELL Johnny H?!

This is the document you got from the FDA through your connections to the FDA or something. 20 days ago you strongly implied to the whole board the data you got was damaging about the manufacturing response. You said to PM you for details and you'd send it. I did PM you, but you didn't send it. On the contrary, this data is good.

Then last week you told the board you were the cause of a big one day spike for CLVLY because you bought a lot.

IT LOOKS LIKE YOU WERE TRYING TO CAUSE A DIP IN THE STOCK PRICE FOR YOUR OWN GAINS! WTF!
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johnnytech
Posted on: Jul 22 2019, 01:44 PM


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The difference between 150 and 300 for retail folk is nice to be sure. But, there is a profound difference in PW being able to buy his home country's primary soccer team, Ajax. And since he controls the nasdaq listing, AND he is playing the long game, I'm not surprised to not see a nasdaq listing.

I think I calculated several months ago PW would need 175ish to buy Ajax. Since they are having their best year ever, probably up a bit from there, and that much more desirable to PW.
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johnnytech
Posted on: Jul 22 2019, 07:55 AM


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I don't think the listing differences you found is why we didn't see a new listing before the June 30th deadline. But, I really like your mindset and applaud your effort and gave you an update.

I think it's a matter of what events in a certain order maximise a future stock price. When the incentive was made several years ago, they probably expected to be where we will likely now be late 2020. The wrong order of key events could easily change relative action and resistance levels that could make a 30%+ difference in the stock price in 3 years. I do think we will see a new listing about 3 quarters after US sales are under way.
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johnnytech
Posted on: Jul 17 2019, 09:58 AM


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Do you know of a US exchange equivalent? I like the balance of small cap to large cap. Looks like a good place to park CUV profits.
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johnnytech
Posted on: Jul 17 2019, 03:19 AM


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If you have access to trading on the Brussels exchange, Acacia Pharma ACPH could be a very smart buy about right now. I put this on my calendar to research in July, but unfortunately there is no American ADR I found out. Their lead drug was FDA rejected not too long ago for the second time over manufacturing issues, and the stock went down. It's starting to show signs of recovery. After the first rejection, they resubmitted the 2nd time quickly, but didn't change manufacturer. They are changing partners now, so 3rd time is probably a good risk to reward investment.

https://endpts.com/fda-rejects-acacias-lead...acturing-issue/

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johnnytech
Posted on: Jul 12 2019, 09:11 PM


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The shorters didn't read the newsletter that well. We got the best news I could possibly hope to hear, and probably the biggest reveal in the last 8 months (except for original PDUFA date announcement). Tucked away at the back of the newsletter was hard confirmation that Clinuvel did not receive an RTF letter from FDA last year. Nothing is sweater to my ears on the eve of approval.
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johnnytech
Posted on: Jul 11 2019, 03:21 PM


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This board has gotten quite cancerous lately. Notice I have not posted in quite awhile. Unfortunately, we are in a painful waiting period, and there hasn't been a lot to comment on, until now.

The most debated topic here for the last 9 months has been if an RTF was issued or not last year. For those of you catching up, an RTF letter is a rejection to the original application. Since our application timing fell outside of normal time ranges, and a resubmission was mathematically possible, this was hotly debated, and for good reason. An RTF would have been a very bad sign. For the record, I had flip flopped on this a couple times myself, but settled into a "probable" opinion around 60-40 RTF, but leaving option open because I firmly believe the FDA plays fast and loose with their own rules.

And PW has finally set the record straight in today's press release, that there was no RTF. Yeah!! This.Is.Huge. This single piece of news gives me breathing room as I've been getting nervous recently.

And kudos to GoldenCondor for paying attention. Yes, I have fully loaded my entire savings into CLVLY, including proceeds from a home equity loan that has more than doubled since I did that loan. I also bought some land recently, and timed it for July to pay in cash. But now with the 3 month extension I've taken another loan instead of selling any stock to pay for it. (I calculated a $300k opportunity loss based on my Xmas price prediction). I will have no money worries after an approval, but I live tight and modest now, and will be penniless (literally) if it went to zero.


I do not recommend this investment strategy, and tell my sons often to not copy me in their future. I hope they invest their money in a way more safer and predictable fashion... like being a crack cocaine dealer, or an international gun runner, maybe even a blood diamond smuggler. All safer and less stressful ways to make a small fortune than invest in Clinuvel.
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johnnytech
Posted on: Jul 1 2019, 09:12 AM


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For word count, volume of text, and the research you put in, I thanked you. But I'm not entirely sure what you're trying to speculate. But here's to you anyway smile.gif.
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johnnytech
Posted on: Jun 28 2019, 04:47 AM


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Punk, did you run the numbers on that play?

Like you, I've made lots with CUV, but I'm thinking "hold till 4 months post approval, then take some profits and diversify" is still the best play in front of me. But, I'll admit that is part 'back of the napkin' math, and part religion to see it to the end.

How did you reconcile what you just did?
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johnnytech
Posted on: Jun 22 2019, 01:23 PM


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Are you all in with PTN like you are with CUV? I didn't think so. I wouldn't trust their management to get anywhere near Scenesse.
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johnnytech
Posted on: Jun 22 2019, 12:21 PM


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This approval is great news. The ASX 200 announcement drove up the price, and this approval boost Clinuvel's success predictors even higher. When you are all in, this is the news that calms the nerves. Don't care about second place... focus is about crossing the finish line.
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johnnytech
Posted on: Jun 6 2019, 04:48 PM


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My emotions were very high when the delay came out. My 3 kids college funds are fully funded, and I strongly considered selling in those 3 accounts, but I didn't. In fact, I bought more today.

This is how I've reconciled the delay.

Is the delay further proof of PW's devious messaging? Yes.
Would I change his messaging? No. Because that messaging kept the stock propped up through a probable RTF and built up resistance. Farma is right. My trust in him right now to get us to approval is no longer about integrity or his principles or SEC compliance. The ends justifies the means for me now.

Will NASDAQ listing be affected by this? No.
Will there be a NASDAQ listing in July? 60/40 yes.

Do I believe the delay is singularly about manufacturing concerns? Yes. And I bought more because of that belief.

Today bought another $16K clvly that I wasn't going to. Put off some other short term plans. And yes my land purchase in July is screwed up and I'm taking out a zero down loan to pay for it instead of selling stock.
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johnnytech
Posted on: Jun 4 2019, 07:02 AM


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Thank you for this! I have been racking my brain trying to find a way to rationalize the delay. I really like this. It is notable that most of these are not the DDD department. But in proportion of DDD drugs (dermatology division) to internal medicine drugs, DDD is notable a much smaller ratio of new drug applications. And this resourced differently internally. But, I'll take this as a win. Good work compiling all that.
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johnnytech
Posted on: May 28 2019, 01:23 AM


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Once an RTF is released, the only legal way to get back to an acceptance is through another NDA. There is specific wording to this, which was bypassed. That's the fast and loose part.

Doesn't mean there aren't other loopholes they invoked, and I acknowledge your fine and better research here than mine, but I'm convinced the FDA will bend the rules on a case by case basis. This is the same FDA that rewrote drug manufacturing inspection policy last year without warning to their customers.

Let's not argue about the FDA. You and me should be choosing which Caribbean cruise do we invite the forum to join next year to celebrate!
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johnnytech
Posted on: May 27 2019, 07:01 PM


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Posts: 513

You are right, an RTF instead of CRL last August. But I don't agree receiving one was a sure thing. I remain cautious 70/30 vs you at 100/0. Yes, I read the same law as you, I get it. But the FDA has proven they don't follow it over and over. Several examples came through this forum. Most specifically the exact same issue as us... another drug didn't receive RTF letter for 3-4 months (outside law), they complained and then received an acceptance without a second filling (outside law), and then received approval early (outside policy). I made the comment at the time another example of FDA playing 'fast and loose' with their policies. You and I exchanged on it as well.

We agree that having received one rejection (RTF not CRL), sets us up for better success on the eve of the finish line. Good luck to us all.
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johnnytech
Posted on: May 27 2019, 10:02 AM


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I'm 70/30 that we are already on our second submission, and thus we already got a CRL last Aug 22, about labeling and manufacturing concerns. The evidence of our first CRL is only circumstancial, but I believe we already got one. To be clear, THERE IS NO FDA or Aussie SEC requirement to divulge a CRL to the public.

The first thing I'll do after approval is celebrate. The second thing I'll do is read the approval letter from the FDA because every approval letter lists the submission date. This will be the final proof if the upcoming PDUFA is based on the first submission last June 22, 2018, or the phantom submission around the Xmas time frame. Honestly, the dates line up so phantom submission seems quite probable.

All this to say... our chances of a first time rejection are zero because we likely already have had a rejection. We are better off for it. The stock price is way higher because of it, and we get higher price resistance baked in before approval. Even though we had to wait, PW has once again proven his worth with this messaging strategy.

Separately, his hometown soccer team is having their best year ever. I bet he'll own them within 5 years or less.

I think there is a chance (18% historically) we will see a June 10 announcement.
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johnnytech
Posted on: May 20 2019, 02:54 AM


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Okay, discussion time. Topicals to me is complex and I'm a bit skeptical of topicals to CUV's future bottom line. Please change my mind.

If targeting as a sunscreen alternative, then it has to match existing expectations.

-If I rub it on my body but don't go out into the sun, do I tan??
-When I rub it on my body, is it highly localized? like if I miss a spot on my shoulder does my shoulder then sunburn once I get to the sun? You would think so and not even need to ask the question, but if so, then I'd just rather take a pill.
-If a CUV topical is chemical induced like the pill is, do you put on CUV topical the day before you go to the beach? Or 45 minutes before you go to the beach?
-I also put on a light and expensive SPF 15 on my face everyday. How does CUV topical improve on this routine?

The cash cow strategy of a topical to me would be cancer prevention for the masses. But so is regular sunscreen now. How is a CUV special topical formula going to be an improvement? When I first heard of a topical from CUV, it sounded like a slam dunk. But in execution, it just gets complex without knowing more of their strategy, or the topical formulation.

The one advantage I see now and suspect is real, if the topical is chemically induced, it's probably safer for our oceans and coral reefs. As long as it's cheap, then I see this being enough of a reason to pick up a bottle of CUV lotion over anything else.

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johnnytech
Posted on: May 16 2019, 10:20 AM


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Posts: 513

CUV is first and best in class. Look at Tesla. It trades at more than double what traditional fundamentals suggest. Plus, I don't agree that CUV is trading above P/E for the circumstance of a first in class pharmaceutical. In other words, we are not even close to Tesla style over pricing. 65 right now would be overpriced pre approval. 130 in 24-36 months won't be.
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johnnytech
Posted on: May 11 2019, 01:37 AM


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Posts: 513

BNYM plays an important arbritage role. When the exchange rate between AUS / USD, AND, the market demand are out of sync, there is an arbritage opportunity. Doing arbritage helps stabilize the ADR and bring it into alignment with the parent stock. It guarantees they move in lock step.

Only BNYM is allowed to arbritage CLVLY because they were the original underwriter. Only they can remove shares from CLVLY and convert them to CUV, and vice versa. For that responsibility, they have the privilege of profiting on that discrepancy. This is an inherit function of investment banks that underwrite ADRs.

Now, moving on to the announcement, this is not the bank taking ownership stake in the company. This is an administrative task. Possibly related to an upcoming NASDAQ listing.
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johnnytech
Posted on: Apr 28 2019, 02:11 AM


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Posts: 513

"Every dollar you take out of CLVLY is 4 dollars you won't have in 2-4 years!"

This is literally been my mantra since 2014. I have avoided buying a better house. I have avoided buying better cars. I have taken out multiple loans to invest. (I haven't skimmed on vacations though). I have paid off credit cards with 12 month 0% balance card transfers to another card 3 years in a row now. I keep working because there's still a risk, and I don't want to draw.

But, I'm running out of patience and time. All in the spirit of the mantra. I already am committed to drawing 50K USD by middle August.

Yet every day I remind myself each dollar I take out is 3-4 I won't have later. But my resolve is breaking. It's getting real hard as I near 50 to keep the waiting and waiting, and I struggle. CUV needs to hit 45 by end of Nov. for me to feel I successfully won the game because come hell or high water, I have to start drawing for plans I have and it'll suck if it's below 45 for any dollar I draw.
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johnnytech
Posted on: Apr 20 2019, 07:57 AM


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Very interesting post Mr. Rat. It's given me pause.

All signs coming out of Clinuvel point to every intention to build the company organically to a significant large pharmaceutical company, with no intentions to sell out. All signs except..... your post here. Very interesting. Not sure what to make of it, but nice catch nonetheless.

I'd like to ask you how do you know their scientists are unpublished? And, is this standard? Maybe they've hired some young hot chemical engineers and silenced them with NDA? Looking for more opinions here....
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johnnytech
Posted on: Apr 19 2019, 12:44 AM


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Posts: 513

Not to be that guy, but just for clarification, there wasn't an official new drug application to the FDA from Clinuvel (aka Epitan) back in early 2000s. The FDA did not 'reject' the first formulation in the typical sense because it wasn't even brought up for official submission. The story I've been telling for years is the FDA just told Epitan in private discovery conversations that they would not approve a purely suntan barbie doll drug. And thus they pivoted to hiring PW and changing company name, direction, and mindset.

And thank goodness that happened for my own self interests because at my young age back then I would have blown all my profits and have nothing to show for it now. Instead I've been steadily working and accumulating over the years and have four times as much right now 2 months before approval then I had hoped to walk away with in 2007.
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johnnytech
Posted on: Apr 12 2019, 05:25 AM


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He is assigned to your account and has visibility. But normally never bothers to call you because you are likely noted as a self directed account. However, his trigger alerts probably alerted him to your gains and I'd bet after you spoke to him, he put Clinuvel in his watch list at least, or better, invested himself.
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johnnytech
Posted on: Apr 1 2019, 05:45 AM


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Wait, he actually says upwards to 30X inside 3 years. That's just plain irresponsible fluff and I would have preferred not to have known this because I thought he was a trusted vlogger.
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johnnytech
Posted on: Mar 27 2019, 05:48 AM


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A nasdaq listing would have a profound affect. Right now CLVLY is a penny stock and that is a large black mark against clvly. You can't trade penny stocks without submitting paperwork to your broker. Mainstream mutual funds are restricted from penny stocks. Of course there are funds with penny stocks in them, but then the fund itself is catering to a different type of investor and the casual investor misses out on penny stocks. Being on the nasdaq legitimizes Clinuvel.
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johnnytech
Posted on: Mar 26 2019, 09:33 PM


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THANK YOU!

This is the second biggest news (price trigger) we can look forward to, and it has a deadline of June 30.

A nasdaq listing (and/or an acquisition). If this happens in such proximity to positive FDA announcement, 55+ is a non-dramatic realistic expectation very soon.
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johnnytech
Posted on: Mar 26 2019, 12:42 PM


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Does anybody know about an incentive package for the CFO to get a nasdaq listing. I remember somebody posting about it, and I kind of took it for granted. I also remember the poster saying that there was a deadline to this incentive.
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johnnytech
Posted on: Mar 22 2019, 06:17 AM


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Hi juxtaposer, long time. Nice to know you are still with us.

I'm starting to think about diversifying end of summer a bit. I like this area of skin medicine so I'm intrigue by Avita. Does Avita have an ADR for Americans with USD?
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johnnytech
Posted on: Mar 21 2019, 06:29 PM


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I don't understand why Fidelity wants to liquidate at this moment. It was incredible foresight for them to be an early big investor, but closing out their position completely with what they know at this exact moment seems fiduciary irresponsible to their customers.
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johnnytech
Posted on: Mar 21 2019, 03:45 AM


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Investek, LevelHeaded, Waz, and Verhaven.....

Thank you to these 4 posters. These posters turned me onto https://www.shortman.com.au/stock?q=cuv. the website that lists daily shorts of CUV. I didn't break a sweat at the down turn last night because my gut is better informed due to this website. Thanks guys.


In the last couple of months, I now believe completely that the people who have the balls to short this stock really know what they are doing and how to manipulate the market (more likely), or have advance knowledge (less likely).

This website exposes to us a small marker in their behavior. I suspect we will see of lot of the shorts close out when the website updates next week with end of this week's activity. Last week there was an uptick in short positions, it was only a matter of time that this happened. The people who short at that level are too experienced to lose money, so to me, any major new short positions is a marker of future market movement that us retail investors have little control over.
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johnnytech
Posted on: Mar 19 2019, 05:08 AM


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Royco, it does seem to put the horse in front of the cart to approve labeling in advance of approval, but the overall process is designed to include the minor details like this so the drug is marketable on July 8. As with all application approvals, the approval is effective immediately. Clinuvel can literally sell the drug same day as approval and thus all the details need advance sorting out.

Another example of this is last fall the FDA even added manufacturing inspections to the approval process (which we aren't affected by I think because of the timing of the policy announcement), which were previously a case by case detail or a later event like a health inspector might surprise inspect a restaurant.

As for any info conveyed to us in April, I have zero expectation that we will see an announcement. I hope we do because it keeps the stock going north, but that is secret private work product and no obligation to disclose.
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johnnytech
Posted on: Mar 18 2019, 12:49 AM


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To the casual readers that may not see the connection, I'd like to call attention to sharelooker's post below. It you didn't know, BS group is a fast growing global distribution company for consumer goods into many different channels. BS Group was started by Willem Blijdorp, was their CEO for 27 years, and is the majority stake holder now in BS, which is a privately held firm.

Willem joined the Clinuvel Board of Directors last fall when the longest senior director retired. His joining the board, and his own personal investment in shares in Clinuvel is huge. This is the strategy of a company not willing to sell in a friendly takeover until 200.

I didn't know this news sharelooker posted about BS's acquisition of USA based fragrance.net last year. On the surface it looks like a play to setup distributing future Clinuvel products into America. Another nod to PW for his strategy and partnerships. I see strong parallels in Willem's career and what PW wants.... more confirmation to not worry about a friendly take over. Hostile take overs are a different story and x-ray is right to not ignore it.

By the way, 45 people have clicked on my spreadsheet for PW buying a soccer club. There are more casual readers here than I thought.
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johnnytech
Posted on: Mar 17 2019, 09:19 AM


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PW was born in France and raised in the Netherlands. I badly mistook Danish for Dutch. I sincerely apologise for my American geography upbringing. At least I know Australia is over there by Ireland. 😀
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johnnytech
Posted on: Mar 17 2019, 04:06 AM


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I'm comfortable there will not be a willing take over before 150. After doing that exercise in my last post, PW needs 150+ to buy a mid+ soccer club like his native Danish home team Ajax. And he also probably wants another +25 share price on top of that for his own cash flow.

Companies that are built from the ground up with the long-term business strategy to eventually sell out the company, simply do not act and behave as Clinuvel has for the last several years.


1. Absolute terrible marketing until just recently.
2. Building a worldwide organic distribution network instead of outsourcing.


A forced takeover is the only real option, and those are kind of a thing of the past. I'm pretty certain nobody has to move to Puerto Rico before 170.
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johnnytech
Posted on: Mar 16 2019, 01:29 AM


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Posts: 513

How high does the stock price need to go for Wolgen to buy a soccer club? Now that PW has his latest stock options, this seems like a fun exercise.


I put the math in this spreadsheet and used two options of soccer club evaluations.
https://goo.gl/61QPp7


Quick facts:
-His total stock = 3,296,364.
-His favorite clubs are United Manchester and his native Dutch team Ajax.
-And a quote from this interview, "It's one of my life's ambitions to buy a club."
-https://www.theage.com.au/business/enigmatic-drug-keeps-ceo-on-his-toes-20070908-ge5s00.html


Here is the short of it.
-He can already buy a low level club starting at share price 6.
-To buy a top 6 club (United Manchester), the stock price needs to be 575+ using the cheaper valuation.
-There are two valuations. I suggest reading the link to option 2. That one seems well thought out.
-Right below the top tier clubs are the midtable teams, and puts the stock at 120-230.
-See spreadsheet for more tiers and the price ranges.


Thanks to the posters who post real information. This is just a little fun exercise to end the weekend.
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johnnytech
Posted on: Mar 15 2019, 01:48 AM


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IS THE STOCK 45 YET?!!


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johnnytech
Posted on: Mar 12 2019, 09:16 PM


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Iowa
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johnnytech
Posted on: Mar 12 2019, 11:26 AM


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Well, I've gone and done it. I've spent my first Clinuvel money to buy some land. I did have to sell $20K USD worth of stock last week, but this was a now or never and I couldn't put it off. I'll need another cash infusion of $150K to get construction going, but the lawyers wrote the paperwork in a way that I can put that off till end of July. This is my first taking of profit since 2003, and I'm exhilarated.


So, I bought 14 acres of land, and I got very lucky. Right time and place sort of deal. The owner (78 yrs old) had to unload quickly because he was 5 years behind on his property taxes and we closed 48 hours before he was going to lose his property. There were several people lined up to buy it, but I was just the lucky one. It's a great woodsy acreage in my town with a pond. The guy has an old shed and a 40 year old log cabin he built in his 30s. Both which will come down in preparation for a new modern home, and I plan a nice Japanese style rock garden surrounding the pond.


Here are some pics. Inside the shed he has a 1940 Ford that hasn't moved in 25 years. It's condition is freaking amazing. I'm currently trying to buy it from him, but he's not wanting to sell it. Says it's promised to his grandson, which I can appreciate it. But, it's so beautiful. Enjoy the pics.
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johnnytech
Posted on: Mar 7 2019, 12:36 PM


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You said this...

>> If you have purchased ADR's and your functional currency is USD then you are not subject to the second risk.

I'm just trying to help you understand the second risk of exchange rate fluctuation is still there. There is no scenario you can invest in Clinuvel as a foreigner and not be at risk of fluctuating exchange rates. If you are trying to say something else then I apologize.
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johnnytech
Posted on: Mar 7 2019, 12:14 PM


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Posts: 513

QPR, the two risks you specify are not mitigated by holding Clinuvel in the CLVLY variant compared to the CUV variant. If the CUV stock price remains steady with absolute zero change over 15 days. But the exchange rate goes up and down over those 15 days, the CLVLY price will change as well to reflect that up and down motion of the exchange rate. And this happens separate of retail investors.

How does this work? The reason is because the originating investment house behind the ADR initial public offering has the privilege to arbitrage the stock. They can remove share numbers of CLVLY from American market and shift to Australian market until the stock price comes inline where it makes no financial sense to do so. This of course happens both directions. This is allowed by design, and only to the originating investment house that did the initial public offering, to keep the ADR price in precise motion with the Australian price, inclusive of the exchange rate.
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johnnytech
Posted on: Feb 27 2019, 04:56 PM


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I disagree. History has shown that while some stock bump is priced into expected FDA approvals, there is always a very measurable and statistically significant jump. I originally expected 80% because that was some average I remember from long ago, but 50% bump is what I'm hoping for now. Mind you, that is a next day peak, which retracts 30% pretty quick and we won't see that peak for awhile again. But a couple months later, even that peak is in the rear view mirror.
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johnnytech
Posted on: Feb 27 2019, 08:16 AM


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I'll be more astonished if it's not over 100 AUD in 5 years. Like wtf surprised. I conservatively expect 180 in 7 years.

But before that happens, my personal demons are: 1) buy out and 2) my lack of patience.
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johnnytech
Posted on: Feb 20 2019, 12:50 PM


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Posts: 513

Bite the bullet and get in before the ASX 200 bump. Or risk it to possibly miss the ASX200. If it does make it, wait about 2 weeks more for the small but inevitable retraction.
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johnnytech
Posted on: Feb 19 2019, 01:15 AM


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Posts: 513

How do you execute a CFD trade? Ameritrade for example? And because the underlying stock is CUV, is the trade restricted to Australian based market maker? Much like I had to use an Australian trading house (not Ameritrade) when I originally bought CUV.
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johnnytech
Posted on: Feb 18 2019, 02:15 PM


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Is that a CUV thing or is it eligible with CLVLY too?
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johnnytech
Posted on: Feb 18 2019, 11:52 AM


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Anybody here trading on margin? Last year I looked at trying to buy CUV with options for leverage, but not possible with this stock. So instead I took out a second mortgage of 90K USD last year and put it all in at last summer rates. Also just did a one year zero interest credit card transfer for $15K. That went into clvly last week at 16.00. This is my 3rd one but I paid the others off after the year was up. I think I'm tapped out and done buying. Sad face.....
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johnnytech
Posted on: Feb 15 2019, 02:44 AM


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I watch the relational movement of CUV and CLVLY daily, and I'm seeing an unusual pattern recently. I have a real time ticker on my phone home screen. It's constantly in my view daily so this is based more on gut than hard data. For years and the last 12 months, every uptick/downtick of CUV is followed the next day by CLVLY uptick or downtick. They are in lockstep daily. But recently, in the last 30 days, these uptick/downticks are not in lockstep. Over the whole period, yes CLVLY mirrors the longer chart movement of CUV, but the daily uptick/downtick seems at least 50% if not more out of sync. Instead of the correction being 24 hours, it's 48 hours instead and thus the uptick/downtick are opposite day to day.

Not sure why, but an observation.
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johnnytech
Posted on: Feb 13 2019, 11:07 PM


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Yeah you are exactly right, but gotta be happy for punk and his new car. It's well deserved now or next year.
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johnnytech
Posted on: Feb 12 2019, 10:13 AM


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This is a intriguing release, if not just straight up odd. For one, it's posted via ASX, trying to send the message it's official status, or at least some sort of obligatory release. Maybe I'm not aware of some Australian SEC policy, but this is marketing fluff in America and not released via SEC channels.

Reading it fast, I see little to no direct investor information. This is the sort of stuff we were literally starving for 5 years ago and we'd relish in reading between the lines. But we don't need to read between the lines of investor releases anymore, so a fluff piece like this.... Well it's just kinda not what I was expecting.

Update as I know some of you asked, I finally got back in today after holding a small % of my holdings in cash as I moved money across borders. I calculated I lost about $14K USD in the transaction due to market action. I really thought it was going to go back down to high 13s (clvly) in middle February, before we get the ASX200 announcement. My pricing reads for 2 years have been really good, but the last 2 months I'm just shaking my head in wonder. I agree with Poly's long post. The market is reacting better than what feels right to me so I decided to bite the bullet and get back in. Can't explain the market nor the fluff communique, but it's all pointing to higher post approval numbers than I was expecting.
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johnnytech
Posted on: Jan 27 2019, 05:02 PM


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I'm not joining another forum to run from Iggy. Click the report button on his posts and he'll be silenced again. We did it last summer and it got us like 5 months of blissful silence, then 2-3 months of slow ramping up, and now he's back to full strength ninja wanker.
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johnnytech
Posted on: Jan 25 2019, 10:36 AM


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I don't interpret any of the comments below as showing concern over off label discussions. Just some Q&A over the topic. I for one pray it happens and entirely agree with clinhope's statement that total controlled distribution without end would be unprecedented. I think most everyone is just resigned to the unlikely chance of it happening soon. My exit strategy doesn't include expectation for off label bump and that's sad.

Except iggy's comment below, but I refuse to acknowledge him totally now so his posts literally don't count.
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johnnytech
Posted on: Jan 25 2019, 05:15 AM


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If you are sincerely creating a financial model that you plan to make decisions on, then you must eliminate the cosmetic affect from that model. Not only is there practically no publicly known info younger than 13 years. Clinuvel has a scorched earth attitude against the use of the drug in cosmetic matters. Good or bad, right or wrong, we wouldn't be here today with anything less than this hardcore policy.

Maybe in a couple years that will change, and if I'm still holding in 4 years, that would absolutely be a major factor in my continuing to hold for another 5 years beyond.

But for your financial model now in 2019 it has no bearing in a realistic short term model. I know you don't want to hear this, but hard truth.
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johnnytech
Posted on: Jan 18 2019, 04:40 PM


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This is perfectly normal activity. On July 8 Clinuvel will receive a positive "market authorization letter". What we call approval. The package gets down to the nitty gritty of what the label looks like and the words Clinuvel is to use to go to market.

Too bad the FDA can't disapprove the company logo.
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johnnytech
Posted on: Jan 14 2019, 11:38 AM


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Welcome back everyone. Sorry for the hiccup. We return to our regular program of songs such as, "Money Money Money" by ABBA. "If I Had A Million Dollars" by Bare Naked Ladies. And watch your stock "Fly Like An Eagle" by the Steve Miller Band.
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johnnytech
Posted on: Jan 12 2019, 04:14 AM


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It's less than 3% of my holdings, so I'm not sweating it. But, look at the retraction after the ASX300 announcement. There is always a retraction. Even after the approval there will be a retraction. Share price of CUV 32 won't come till 3-9 months after approval at a minimum. Just look to the shorters... they have balls of steal and know what they are doing. The last round of shorters predicted it too.
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johnnytech
Posted on: Jan 12 2019, 02:22 AM


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13.1-13.4 for clvly is my next entry point (and last). I think we will see a slow 30-60 day retraction down to high 12s again, where it will meet too much resistance to go lower. And then back up to 14 as we approach July (today high 15s).
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johnnytech
Posted on: Jan 11 2019, 09:40 PM


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No, I didn't get back all in. Strike price shot up too much on the announcement which totally blindsided me. I don't want to miss the approval bump, but I'm not in a hurry. The price will be back down in a month or two. Those day traders that are shorting right now know what they are doing (but I'm too squeamish to attempt it). All bumps like this are followed by a retraction, even the approval bump in July will have a retraction.
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johnnytech
Posted on: Jan 11 2019, 09:21 AM


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Question? What ratio of drugs that get a PDUFA date are approved/denied?

Seeva, that is extremely hard to track because drugs that are denied are not given a drug portal page nor FDA acknowledged. I like to use a couple 3rd party websites to track drugs approved per year as a history exercise. But, when you look at various indexes of drugs on 3rd party websites, they get the data from official FDA approved drugs lists and FDA portal pages of each drug. The only way to track them are individual company announcements. Having said this, the FDA might publicize these kind of rates since the details are obfuscated.
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johnnytech
Posted on: Jan 10 2019, 12:08 PM


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Advisory committees invoked when there is some unknowns or controversies involved. The last drug with an Advisory Committee I did a deep dive on was a children's drug (thus very emotional) for a wicked disease. (It got a lot of press throughout the process... Advisory Committee work product is not secretive).
The safety record of Scenesse doesn't lead one to believe the Advisory Committee was going to be invoked, so I'm very glad those warnings from Clinuvel didn't pan out.


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johnnytech
Posted on: Jan 10 2019, 12:36 AM


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You are right on all points. I lost about $4000 USD in the process. The reasons are boring, but mostly housekeeping. There is hardly any capital gains anyway since those CUV shares were purchased early 2000s when the stock was near it's pre-split high.
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johnnytech
Posted on: Jan 9 2019, 11:04 PM


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I suspect the small stock price run up is due to the high profile conferences Clinuvel participated in this week. We've seen it before. I'm also responsible a bit for clvly. Volume is low right now and I've moved shares across borders equivalent $350K USD. Getting out of CUV was easy, like 3 hours, and price barely blipped. Getting into clvly has taken a couple weeks and still have a little left.

We have had ZERO definitive information from Clinuvel going back quite a while. It's fun to speculate, that's what we do here, but in the end we don't know what we don't know and FDA is not a perfect entity we can read precisely by circumstantial evidence. No matter the policies, they miss PDUFA target dates by 25%. Usually a couple weeks to a month, but up to 3+ months a couple times. My spreadsheet analysis with 20ish drug PDUFA dates unfortunately shows we must accept this. I still am 50/50 on RTF or not.

It looks like there is a real mindset shift going on at the FDA right now and I couldn't be happier at this point, even though in theory Clinuvel is not supposed to profit from these changes in terms of approval methodology, well.... it's the government and shit happens... like Dr. Marcus's single signature overturned a unanimous denial for a drug
in 2016.

I suspect the price will retract a bit here soon. I predicted 2 years ago $13 (clvly) the day before approval and $21 the day after and those numbers are playing out. I also timed my money movement for January because I think the next significant step will be made public mid February.
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johnnytech
Posted on: Dec 28 2018, 02:51 AM


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Priority review would have put the pdufa date October 30ish. So we probably have here a missed PDUFA date, which happens 25% of the time as this is a soft target, not hard target.

You're right about the portal page. While double checking I came across this page that says if after 1 year if no resubmission is made, the FDA considers the NDA abandoned. So, during that 1 year, the work product is protected. I should think after 1 year they might release work product, or at least would comply with FOIA requests.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.110
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johnnytech
Posted on: Dec 27 2018, 04:44 PM


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For those following along, a CRL is the official FDA letter for a final denied result from the FDA. (Complete Response Letter).

Thanks for the link. That July press release announces they passed initial review early July. Following this they likely were denied priority review a couple weeks later, and were given the regular 8 month Dec 30ish pdufa date that is tied to their initial NDA submission date end of April. The timing of today's end of December announcement puts it down to just days before the PDUFA deadline. This all seems to button up despite the loose language. Good work. We should see an official FDA drug portal page 30 days from now and the CRL and all work product around this NDA will be posted for us to witness and confirm.

(One point of difference, my understanding is that PDUFA deadlines are soft, whereas the 60 day post NDA submission filing deadline is hard (i.e. law bound)).
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johnnytech
Posted on: Dec 27 2018, 03:18 PM


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A couple of items to note here.
The FDA is producing work product between Dec 25th and Jan 2nd, and during a government shutdown. Kudos to FDA.
This example by WAZ is a similar mystery to our situation. No known RTF and no PDUFA date, and the FDA drug portal page not setup yet for VivaGel. Yet an 8 month review window ending in a setback letter. It seems CUV is not the only drug experiencing an odd passage through the FDA process.

Johnny H, did you verify a source somewhere about the CRL for VivaGel? I looked but can't find one...
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johnnytech
Posted on: Dec 18 2018, 09:36 AM


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I would slightly prefer without the advisory committee because they weren't in the Nov 2016 FDA/EPP meet & greet. Whereas the chief scientist of the derma division was and lead the conversation and heard the patient base's pleas. The advisory committee may not be up to speed with the RWE approach CUV won on previously, and using traditional analysis methods may not be in our favor. Two years from now may be a different scenario but my instinct is to prefer without.

Having said that, I'm not worried either way.
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johnnytech
Posted on: Dec 12 2018, 03:36 PM


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Posts: 513

>> Really, Dr Wally, maybe you need a refresher....

Seriously, Iggie! WTF. You were gone for like 2 months and it was peaceful. Then you started creeping back real slowly with some "likes", and I knew you were lurking and not gone for good. And then you started posting, but real pleasant at first, but I was watching. And then I even "liked" a couple of your posts to send the message that, hey everyone is welcome and deserves another chance, and to give you good vibes. But then you started being a sketchy twat again.

And now here you are full frontal assaulting anyone that crosses your piss stream again. It only took you 3 weeks. You've gone and proven that people don't really change. 2 years ago I was straight with you and you shut up about PW at that time. But you've pushed me beyond my accommodating nature. Just piss off and be gone forever.
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johnnytech
Posted on: Dec 9 2018, 09:27 AM


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I agree with all you are saying about how it should be. I'm confused by what you think I'm saying.
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johnnytech
Posted on: Dec 8 2018, 11:34 PM


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I'm giving props to Frogster's nice summary of the rtf theory. CUV never said technically they didn't get an rtf, and only painted the situation with very clever broad strokes. We already know PW has a wordsmithing devil's tonge. What's holding this unlikely theory afloat is it puts the FDA back on the side of operating fairly within their own rules, and that's a powerful moral rightening of the FDA universe.

It's also notable, and bears repeating, this will be a minor historical footnote in the end and we'll be thankful for this perfectly legal deception because the share price would have tanked for a bit otherwise.

I happen to be leaning towards a different theory that the FDA is just acting twatty to CUV under the guise that 'all these changes - omg' at the FDA obliviate the accountability to follow the rules. If you've ever tried to get a driver license at the American government offices known as the DMV (the evil 2nd cousin of the FDA), then you know the accountability Teflon mindset.
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johnnytech
Posted on: Dec 5 2018, 12:49 PM


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I would be equally reassured if they did their inspection after a PDUFA date is decided, or even 12-36 months after approval. That's a wide birth and as a citizen consuming FDA's safety protection, I'm fine with that window. But what is remiss is to make it a part of the initial 60 day review period for every NDA when they likely will reject some % of them for lesser cause. What's most remiss is not announcing 24 months in advance a significant policy change so massive that it makes the existing mandatory policy date guidelines impossible. It seems their own policy is just a nuisance to themselves. Nuisances abound everywhere.
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johnnytech
Posted on: Dec 5 2018, 08:48 AM


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This delay is totally out of Clinuvel's hands or powers of influence. But, it is completely in character of another delay in the Clinuvel story line. It's like a bizarre Cinderella story where the second hand approaches midnight but the minute hand never advances.

The EMA/Nice orgs look like a well oiled Nascar engines compared to the utter chaos of the FDA right now. At least those orgs played with rules. I'm still in shock at the wanker FDA leadership for these unannounced mass factory inspections.
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johnnytech
Posted on: Nov 30 2018, 06:20 AM


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I believe the recent revelations about the FDA now doing on site manufacturing checks as part of early review process is a blindside that removes all predictability. My last post predicted PDUFA by Xmas, but then some good discovery by the board brought to light this new FDA activity. All projections based on historical data and published policy are out the window, even more than they already were.

What is very upsetting is the FDA is a strongly policy driven process, and significant changes to tried and true policies should be announced well in advance. What we have here is blindside policy change with no warning from the FDA.

There is no recourse, but especially avoid any day trading right now because you could get caught with your pants down before buying back in.
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johnnytech
Posted on: Nov 24 2018, 01:48 AM


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I'm surprised that manufacturing processes (inspections) are non-insignicant steps to the approval process. Enlightening article from Farma down below. I would have thought this would have crossed my reading up till now. I remember the Sept press release spoke of FDA questions about processes, but as far as an actual on-site inspection.... I feel a bit blindsided.

Clinhope, I didn't know the vitiligo solution had a topical maintenance component to it. Good catch. I'm guessing this doesn't mean it's OTC though like the other skin care topical products Clinuvel has spoken about.
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johnnytech
Posted on: Nov 23 2018, 08:12 AM


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Where is the source material that said FDA is going to do an inspection?
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johnnytech
Posted on: Nov 22 2018, 03:39 AM


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Posts: 513

Thanks for everyone's field reports. Frogster, I remember you as having consistently reported an AGM review. Cheers.

Communications: C+
I was really hoping for more verbal descriptions of the FDA events following the NDA submission. They probably feel they put enough out in their press releases, but just imagine if questions were allowed how much they would have been pounded with questions devoted to this. This is 98% of the reason I was considering traveling to Australia for the AGM.
I also wanted a confirmation that PW won't exercise his options based on June 23rd NDA submission.

Probably the most telling thing I've learned is from Peter's post. His very valid complaint of being ignored despite being a devoted analyst covering Clinuvel. To me this speaks volumes. It doesn't mean bad news is on the horizon, it's just means we are returning to pre 2016 culture of just bits and scraps of news, and the need to read very closely between the lines and look for word play and subtle deception in everything they release. Despite my 98% convincing they didn't, I still want to hear the concise words, "we did not receive an RTF". There is much word play from them and expect it only to get worse as they get more silent. I also can't dismiss the notion that Clinuvel won't start withholding substantial FDA communications from us (as is their right).

The announcement about Japan application being in the approval pipeline already is a total blindside. It also counters what was published recently in the chairman of the board's letter. This is D- communications and reeks of amateurism.

Fundamentals: A
There are a lot of gloom faces around here. Keep your chins up. The lack of positive news doesn't have to lead to negativity. The 'old is new again' quiet Clinuvel is a return to yesteryear's sytle. But we all endeavored those years because the fundamentals were strong, and they're stronger than ever.

I don't see the stock steadily going down. We saw red for a week in a row, then green for several days, now a string of red. I believe we're seeing the old up and down share price manipulation game rebooted, and why shouldn't it. That's what professional bot traders do. In my mind, this is the price of the entry fee to get on board the CUV train. I don't care.

Ignoramus thinks the bottom is coming and it's 12-13. This got me thinking. I think it's 14.78 for CUV and 10.75 for CLVLY. This was the day before the news broke in Sept of ASX 300 when the Instos started invested. They won't (can't) sell, too much resistance around there.

Predictions:
I want a PDUFA date before Christmas FDA shutdown. The FDA traditionally does a lot of work in December. I've noted in the past December use to be one of the heavy months for NDA submissions (but that trend has leveled out in recent years). I'll be very surprised if we don't get a PDUFA or an RTF by xmas.

I'm raising my target pre approval number from CUV $12-14 to $19-$21 for the share price the day before approval.

If we get a pdufa announcement before Xmas, I expect a target date between Feb 23 and April 23. This is due to the internal metrics are measured on original submission date, not pdufa announcement date.

If we get a pdufa announcement after the holiday shutdown, then to me this is further evidence that the FDA has thrown out the rulebook and then I predict the target date to be 4-6 months after the actual announcement.

The first one means we're on target within guidelines. The second one means the FDA is not playing by their rules and maybe accepting Clinuvel's approach as a test case. (This is a reference to their "global regulatory" approach announced in their last press release). If we find ourselves here, I think there will be too much pressure to let this lead to an ultimate denial. Success is paramount to any future of global regulatory cooperation. A failure would put that back a decade. So, I'm OK with either, but am expecting a PDUFA announcement in December.
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johnnytech
Posted on: Nov 18 2018, 04:17 AM


Group: Member
Posts: 513

Dr Wally, very elegant and articulate post. This would make an excellent marketing campaign for Scenesse. Seriously.
Can you spin this into a new logo as well. You get my vote for honorary CMO.
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johnnytech
Posted on: Nov 17 2018, 05:40 AM


Group: Member
Posts: 513

There is no mistaking it. His reference to xmas present was a reference to approval, not PDUFA date announcement. But, approval before xmas is out of bounds of best case scenario according to standard FDA guidelines. And because PW is normally so care taking and guarded, it makes it such an odd ball comment to make.
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johnnytech
Posted on: Nov 13 2018, 03:37 AM


Group: Member
Posts: 513

I don't disagree with the spirit of your words, but for purely selfish reasons I hope the FDA does accept it. It all but guarantees approval.
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johnnytech
Posted on: Nov 9 2018, 02:38 PM


Group: Member
Posts: 513

I'm going to break my silence with my review of PW's Nov 5th newsletter. I wrote this 3 times and deleted it because my words failed me. But now I have found the right words. For me it all comes down to these two sentences...

"The US regulator is not used to reflecting on an integral surveillance program, and typically a qualified person for pharmacovigilance does not have the same remit in the US as it has in the European Union. CLINUVEL’s proposal to the FDA is to harmonise the European commitments with a US program encapsulating all aspects of EPP patients’ follow-up into one global program."


There are two things here that stick out. 1. Recognition that FDA is in uncharted territory themselves. 2. And the word "global". The significance of global is huge. In a 2014 interview, the director of the FDA affirmed their mission is funded by Congress to protect Americans. Implying that the EMA and other countries can bugger off. But, the new director last year publicly reversed this opinion and stated a desire for EMA cooperation. And now we have the first NDA with Clinuvel talking about a "GLOBAL" approach. I'm not even sure what it means, but do not underestimate how important this is to at least someone important at the FDA. This is like the first man on the moon. Maybe you don't want to be that first guy, but I'm fine with it. In fact, hell yeah. Because somebody at the FDA wants this "Global" test to succeed, and they aren't going to pick a bad drug to start with. Please, walk my drug to the finish line with a bow wrapped on it. Thank you.


The downside is, whatever FDA guidelines on timing there is, throw it all out. There is no rulebook anymore. No more guidance to fall back on. No more "yes/no RTF blah blah". We don't know anything until they tell us. As for PDUFA timing, at the very earliest is February 23 (and yes I believe that is still a remote hopeful possibility). And I hope no later than June 23, 2019 because that's 12 months. But, this is based on the old rulebook so could be longer.


A reminder for everyone, there are no karma points here for who best guessed if we got an RTF or not. And lastly, yesterday was my 20th year marriage anniversary. What a lovely share price close for our celebration dinner last night.
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johnnytech
Posted on: Nov 5 2018, 11:51 AM


Group: Member
Posts: 513

The aussieballs.com report from a couple days ago was very enlightening. That report correctly predicted 10 out of 11 buy or sell signals over there last 6 months. I'm not sure how to use a resource like that though. The thought of doing more than buy and hold scares me that I would end up with less in the end.
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johnnytech
Posted on: Nov 1 2018, 03:22 AM


Group: Member
Posts: 513

About that report and Feb 23 date, technically....

They review period has timeline guidelines timed to the NDA submission.

The PDUFA date is announced after review period.

The PDUFA date timelines and internal reporting is retro timed back to the original NDA submission, not the PDUFA announcement date. I think this is misunderstood here.

In theory FDA could review for 8 months (breaking those guidelines), give a 2 month PDUFA date, follow through on time and announce 2 months later. The result is a standard 10 month application process and it would be recorded in the authorization letter to the company as a 10 month total process.
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johnnytech
Posted on: Oct 31 2018, 12:14 AM


Group: Member
Posts: 513

My main drive for going to AGM is to ask 2 questions, and to celebrate the recent 40% uptick. Honestly though, the retraction has taken the wind out of my sails and I'm just not feeling it. Not enough to try to be a proxy or force the issue at this late stage. 3 years in a row I tell myself next year, and I actually am going to follow up on it for next year since I've already opened up some lawyer conversations.
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johnnytech
Posted on: Oct 30 2018, 09:56 AM


Group: Member
Posts: 513

I cannot go to the AGM. I've exhausted my legal options on this short notice. (I tried to find a lawyer in Australia to support my case to get in with CLVLY. I approached 2 large legal firms and neither want to take up the fight).
I really want to ask if Clinuvel received an RTF letter or not. If there is no open question format, then I'd blurt it out and not let him get away with an evasive answer. Once the question is asked politely or otherwise, it's hard to evade. It's a yes or no question that deserves a yes or no answer.
Is anybody here going and willing to put themselves out like this?
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johnnytech
Posted on: Oct 30 2018, 03:21 AM


Group: Member
Posts: 513

>> That said it really is an RTF and don't know why people keep thinking otherwise.

That doesn't matter on the surface as much as it use to. The evidence is contradictory. And even if I knew it was an RTF, the impact is not known until we know if they are sticking to the rulebook or not. Don't forget, we saw an RTF recently that was accepted 2 weeks later... breaking the rulebook. We need the full picture, and we can't commiserate or celebrate what we don't know.
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johnnytech
Posted on: Oct 30 2018, 01:08 AM


Group: Member
Posts: 513

This sucks. There is no way around it. I can spend time rationalizing their silence in many different ways, but it's just that, rationalizing. It's times like this that make me second guess my all in bet. Will it go back up to 20+ in short order, or is bad news coming and we're looking at another 12 month delay.
It's hard to go shopping for undeveloped real estate when I just don't know.
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