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landrews
Posted on: May 21 2020, 06:50 PM


Group: Member
Posts: 362

Is there anything stopping them from doing live online accreditation... or do they really have to be onsite to do it?

Hopefully the professionals at each specialty center can be briefed online on how to inject a Scenesse implant, and how to record patient data in the register.
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landrews
Posted on: May 1 2020, 01:54 AM


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Posts: 362

The question in mind is.....what does Scenesse have, that MT-7117 doesn't have?

Don't get me wrong, I hope that the next MT trial sucks...but.. if they progresses to p3, and are effective, what then?

We have an injection, they have tablets. There's room for both, but not so lucrative with a competitor. PW needs to show that Scenesse can treat something that their drug can't...otherwise short sellers will continue to have a party.

We won't get a PE of 80-100 without a clear competitive advantage. Probably be stuck with a PE of 30-40, until MT monkey is off our back...like it or not.
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landrews
Posted on: Apr 17 2020, 01:43 AM


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Posts: 362

I wish it was $39k per implant btw, but its actually much lower than that
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landrews
Posted on: Apr 17 2020, 01:00 AM


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Posts: 362

Yep, not many can afford to pay the current price, even if it were available off label. But there’s a heap of revenue, $100m plus p/a, just with EPP sales.
I reckon the price will drop a fair bit if Vitiligo is approved, it will still be in the thousands....but off label could expand then.

The DNA repair trial / market is still unannounced and could trump the Vitiligo market...but who knows..they’re keeping cards close to their chest on that.

I think Wolgen has a plan to cash out big time in next couple of years...hopefully he has some aces up his sleeve!
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landrews
Posted on: Apr 16 2020, 11:57 PM


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Posts: 362

It’s pretty simple, millions would use it right now if they could, it’s only been tested on a few thousand. Regulators won’t risk mass useage until safety is proven gradually over time in more and more patients. It will happen eventually, we’re just getting started. I look forward to getting my first skin cancer preventive implant in a few years time!
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landrews
Posted on: Apr 16 2020, 10:26 PM


Group: Member
Posts: 362

Is it possible we’re now living in a new Clinuvel world of under promise and over deliver?
I like what I’m seeing so far in 2020.. price would be closer to $40, if it weren’t for COVID-19.

As I mentioned a few weeks ago, the MT p3 trial won’t start until 2021, if they’re even for real. Lockdown restriction delays, and the follow on effect of attempting to trial a sun protection drug for 6 months over winter will be a waste of money...even if it works. They are 4-5 years behind, and will probably be burdened with further safety trials before they can file for approval. They’ve only treated a couple of hundred patients, CUV has treated 1500 plus with exceptional safety. And our drug can be easily controlled which is a big tick with regulators.

It would not surprise me if MT are shorting CUV though. Anecdotally their drug has some positive effects on EPP patients. I think they’ve been milking it lately though, by posting scant details of an upcoming p3 trial on the APF website, which they know won’t happen. What better way to increase the value of a short position in CUV? ....well played.

However, in reality they have not even released full results from their only p2 trial, and one of their safety trials has been ongoing for over12 months with enrolment/completion delays until October 2020.

No doubt one to watch, but at this pace CUV should have the EPP market fully enrolled, and be nearing approval for Vitiligo, before MT even think about selling to their first EPP patient.

Happy days!
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landrews
Posted on: Mar 27 2020, 10:53 PM


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Posts: 362

Yep, no one has dropped our from nausea or headaches, as they last for less than a day when the implant is injected. Then patients enjoy 2 months of protection.

Watch the shorts start to squirm...they’re not fooling anyone here.
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landrews
Posted on: Mar 18 2020, 09:38 PM


Group: Member
Posts: 362

MT’s p3 trial won’t go ahead this year. If they’re smart they’ll likely wait until Feb/March 2021 to start.

Why risk running a p3 over winter, waiting 4-6 months to compile tainted results, and then wait for the next US summer after that to re-do it properly. That would put them a further 18 months behind.

So if they start it early next year, they’ll be lucky to get approval within 4 years from now... assuming the FDA don’t require further supplementary trials to alleviate safety concerns that will arise.

One thing they also can’t prove is long term safety. That will be a major sticking point with regulators, particularly when Scenesse already treats the same disease they are targeting, most likely has better efficacy, has controlled usage, and has proven long term safety in humans for over a decade. Why would the FDA approve MT’s drug, unless the safety profile can be shown to be impeccable?

Clinuvel will have the EPP market captured with $150m plus US revenue, and be on the verge of Vitiligo approval by the time they start trying to sell pills to EPP patients....assuming it happens at all.
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landrews
Posted on: Mar 14 2020, 08:19 AM


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Posts: 362

Excellent...so by the time they finish recruiting it will be late Sep and they’ll be running a 6 month trial during WINTER, when patients least need the drug.

Good luck generating meaningful p values, even if the drug works!
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landrews
Posted on: Mar 5 2020, 05:46 AM


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Posts: 362

I think Levelheaded hacked the APF account to put up that post, and they just discovered and removed it!

I also find it hard to believe that their p3 trial will include children, when their pharmacokinetics and other p2 trials all excluded children.
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landrews
Posted on: Mar 3 2020, 02:07 PM


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Posts: 362

Clinuvel is planning to run 2 or 3 Vitiligo trials concurrently.

They mentioned this back in the December 2015 Vitiligo update. I guess we'll have to wait until the Type C meeting to find out for sure though.

https://www.asx.com.au/asxpdf/20151203/pdf/...jn2f6ndx9cp.pdf

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landrews
Posted on: Feb 7 2020, 11:26 PM


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Posts: 362

What interesting info have u got to contribute Wally, besides another drunken rant?
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landrews
Posted on: Feb 7 2020, 10:52 PM


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Posts: 362

Good news is shorters are pretty much done pushing SP down. 36k and 13k last two days. As LH predicted they don’t want to sell past $25. Hang on billy, we’re going up from here! Might take a few weeks but happy days ahead!
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landrews
Posted on: Feb 7 2020, 10:01 PM


Group: Member
Posts: 362

If you find it zzz’ng then keep it to your self, and go to sleep! You can have your opinion, but please spare us from repeating every thought you have when someone doesn’t agree with you. Have you ever heard about quality, not quantity?
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landrews
Posted on: Feb 7 2020, 06:35 PM


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Posts: 362

Excellent and well informed post...thanks! I was starting to get dislexia reading all the other posts about index funds and shorting! Was pretty sure they invest to follow the index, rather than taking short positions to try and beat the index.
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landrews
Posted on: Feb 7 2020, 04:04 PM


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Posts: 362

Firstly, not everyone borrows money to buy shares. And anyone who does borrow, does not necessarily have to sell them to pay off their loan. Loans can be paid with cash from anywhere, which won’t necessarily push the SP down. Shorters who don’t already own shares to begin with (which in my opinion most don’t) have to buy them back, which definately will put upward pressure on the SP.

I’m looking forward to when this happens. Shorters have limited upside as the SP can’t go past zero - it’s a short term play for them, particularly with this stock. Longs can benefit indefinitely, just got to wait it out - clinuvel is not going broke, and revenue growth will be very good once US rollout is underway. Even if a competitor enters the market in 3-4 years, clinuvel will be making a shit load more than they are now.
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landrews
Posted on: Feb 5 2020, 07:20 PM


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Posts: 362

You're getting too far ahead of yourself with your MT predictions. They haven't even analysed and released p2 results yet. Their anecdotal comments to date are worth nothing really, other then making shareholders feel happy they haven't wasted money on these trials.

They've run a 16 week trial, where patients have to swallow 6 pills a day for the drug to possibly be effective. The FDA and European regulators have a deep seeded fear of this drug, mainly because the masses want to use it for cosmetic reasons. CUV's implant was approved because the implant delivery is restricted and not open to abuse.

Both regulators will have major issues with a pill that can be swallowed by anyone, just to get a tan. MT will have to jump through a lot of hoops and restrictions, just to get it approved...if it even works.

Last year they said will release results of p2 early this year...the clock is ticking. No results yet, but they still say they will start a p3 this year....good luck. As for an NDA submission in 2021...well, they have a lot of other things going on in their pipeline, and shareholders probably wont even care if the manger of MT 7117 project misses his deadline.

There's 5000 patients in the US, so even if MT enrolled 100, it wont impact CUV cashflow - 4900 other patients out there. Anyway... if it were me, i'd rather be on an implant i take every 2 months, rather than popping 6 pills a day.

As for PW wanting the share price to be lower now, so he can cash out more in 10 years time...... nonsense! He has clear milestones that reward him for increasing market cap within the next 3 years.
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landrews
Posted on: Feb 4 2020, 03:57 PM


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Posts: 362

The best piece of short term news i can think of, on the R & D front, would be if the FDA allowed them to move straight into Phase 3 Vitiligo trial(s) at the next Type C meeting. Approval could be then be in reach within a couple of years.

However, recent correspondence indicates they're expecting to run another US phase 2, before then moving onto a phase 3. So Vitiligo is probably 3 or more years away.
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landrews
Posted on: Feb 4 2020, 01:07 PM


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Posts: 362

I very much doubt a stock gets shorted the tune of $120m plus, and the shorters know nothing about it's fundamentals, and probable future cashflow.

NEA's graph is similar because they were also overbought in the run up to ASX 200 inclusion, and have since had somewhat disappointing revenue downgrades. It will be several years before they have a reasonable PE ratio and as far as i know, don't even make a profit yet.
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landrews
Posted on: Feb 4 2020, 10:45 AM


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Posts: 362

Short sales for yesterday were 74k and the three days prior were 150k, 80k and 160k. The open position is most likely sitting around 9.2% as of today, and looks like its heading to 10% plus.

My thoughts on why this is occurring:

1. The PE ratio has been in the range of 80 – 120 which is probably ok for a high growth company, however we have not shown high growth figures in the last 2 quarterly cashflows. The cash receipts in Europe have been mediocre at best, and there’s no sign of this changing any time soon. From what I’ve read in the last 6 months they still have capacity issues at some centres, whilst other large markets like UK and France etc are probably 12 months away from first sales, if at all.

2. We have US approval, but management have provided no timelines for commencement (probably because they don’t actually know yet themselves) and have tempered expectations that it will be a slow, step by step rollout over an 18 month plus period.

3. I hope I’m wrong but I don’t expect any US sales until at least the Sep 20 quarter, and the rollout will be gradual – probably 20 – 50 patients first quarter and then 50 – 100 the next. Remember… Clinuvel is doing this rollout themselves, something they’ve never done before in the US. They even think that sales growth in year 2 of 10% would indicate exceptional performance.

4. When the final results for 2020 FY are released we will likely only have a net profit of $20 - $25m, which means a very high historical PE ratio continues for another 12 months. The 2021 results probably won’t be dramatically higher either (due to slow, staged US rollout) maybe net earnings of $35 - $40m. Nothing to get excited about right now, given the release of 2021 results is 19 months away.

5. PW has done nothing to sell this company to potential new investors. His newsletter are filled with riddles and fluff, and he chooses not to answer specific questions that any prudent, potential new investor would want answered. I.e. how many patients do you have, what is the selling price, how many patients do you expect in the US, and over what timeframe? What is the potential market for vitiligo, when will you start the next Vitiligo trial, what is the new indication you keep mentioning, when will you actually progress CUV 9900 (does it even work), when will the OTC release happen, how do you even intend to commercialise the drug for DNA repair, if it is effective for this etc. etc. All these questions are either ignored or answered with riddles.

So the shorters have plenty of time to keep a lid on the share price, and with very few new buyers, churn their way out of their position over the next 12-18 months. I’d love for them to be caught out at some point with Clinuvel announcing say a $25 - $30m of quarterly receipts…but I doubt that’s going to happen any time soon.
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landrews
Posted on: Jan 31 2020, 10:20 AM


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Posts: 362

My understanding is that females of child bearing age are strongly advised to cease treatment during pregnancy. Given there are around 350 patients currently being treated, it wouldn't surprise me if 15 or so ceased treatment for this reason. That would explain the 4% fall in retention rate. The good news is that once they have their child, they'll likely resume treatment again.
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landrews
Posted on: Dec 19 2019, 05:36 PM


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Posts: 362

Money talks, and we should be generating $40m additional net earnings in 12 months time. Shorts will have no option but to start buying back when the forward PE plummets.

Chatting to a technical trader the other day and they reckon $55 will be the next high point.

60k of short sales yesterday and probably similar number today, so they are still playing the game and hovering around 7%.

I’ve no doubt it will be a very good 2020 for longs.
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landrews
Posted on: Dec 13 2019, 04:39 PM


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Posts: 362

Thankfully PW didn’t poke someone’s eye out with his sunglasses during that ComSec interview!

More talk about short sellers during last 9 weeks. Sounds like they were offered $80-90m upfront to out source EPP distribution. Obviously a good call to go it alone. Well positioned to get the price they want in US.

Struggles to really ‘sell’ the future potential though. Needs to start talking more about timing of US EPP rollout / Vitiligo trials / DNA repair / and potential to prevent skin cancer - if he’s serious about getting new investors, and lifting the share price. And why else would you do an interview like that.
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landrews
Posted on: Dec 10 2019, 05:47 PM


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Posts: 362

He mentioned it in his interview with Alan Kohler a day or two after FDA approval.
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landrews
Posted on: Dec 10 2019, 05:01 PM


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Posts: 362

Thanks Investek, very interesting to re-read over the pricing strategy details from the 2010 AGM (i'd forgotten most of it).

So they knew well in advance that annual pricing above 15k Euro was possible, but would require "clear evidence of significant improvement in Qol" and that it "may require long and costly negotiations". The ability to show "clear" evidence of Qol was obviously an issue, but regardless they introduced a price level 4 x this. Thankfully Germany finally approved it, although the roll out there since seems to be restricted, and we all know about the ongoing drama's with NICE.

So why set the price so high? I guess it easier to distribute to 350 patients at 60k Euro, than 1400 at 15k. Also, this pricing research was just for the EU. The US has and will pay much more, and Clinuvel's research would have also indicated this (although they haven't released any details). I doubt they would have ever set the price this high to begin with, if they expected "long and costly negotiations" in the US. The price was always set for the US market, and roll out there should be much easier, and therefore far more lucrative.

Wolgen commented recently that there are 4,500 EPP patients in the US, and the slide from 2010 indicates >4,000. I'd be surprised if they can't be treating 800 - 1,000 of them in the next couple of years, at about $100,000 AUD p/a each.

Who knows, if interest rates in Oz drop to .25% and the RBA start QE, it might exchange to $120,000 p/a!

I agree with your comments about there being plenty of (potentially very positive) trial data, that has been strategically withheld - SU, AK, HHD to name a few. I don't hold great hopes for PLE but who knows.

I'd doubt the shorts will maintain a 7% position into June quarter next year..... which means the SP only has one way to go after Xmas!
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landrews
Posted on: Oct 16 2019, 10:16 AM


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Posts: 362

The results of the US Phase 2 trial showed no re-lapse in dark skin patients after 3 month follow up, and only 10% re-lapse in fair skin.

It was a very small sample size though, and its not clear whether re-lapse will still occur after a longer period.
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landrews
Posted on: Oct 16 2019, 09:48 AM


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Posts: 362

I suspect the price per implant may not drop too much for vitiligo, the main reason being that treatment is supposedly curative. So each patient will have 6 - 12 months of treatment and that will be it, as opposed to recurring treatment for life as is the case with EPP. They also have plans for one of the topical lotions to be used as a maintenance therapy for Vitiligo, but that is a long way off.

PW seems solely focused on vitiligo as the next opportunity for Clinuvel, and rightly so. I wouldn't be surprised if we never hear about VP and the other potential orphan indications again.
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landrews
Posted on: Oct 4 2019, 11:38 PM


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Posts: 362

$30 Tuesday, $40 Wednesday, takeover target by Thursday. Happy days!!
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landrews
Posted on: Aug 29 2019, 09:20 AM


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Posts: 362

Not a lot to be thrilled about from the preliminary report....mostly as expected, unless of course your an executive waiting for the next Share Performance Plan. It seems excessive to be offering up to another 10% + to executives who sound as though they'll probably leave in 3 years time.

These guys have shown that they are incapable of managing more than one thing at a time, so I don't think throwing $100's millions worth of shares at them will suddenly make them good at running a large diversified pharma company.

It was quite ironic how the Blijdorp sees no issues with the CFO also acting as secretary, yet both documents submitted to the ASX yesterday had to be re-submitted.

Also, not sure if anyone noticed the update on the VP pilot trial that was supposed to have started 6 months ago. They now say they've "Put steps in place to move into a pilot clinical study to treat patients with VP with Scenesse". So basically they've done nothing since announcing it 12 months ago. Why? It's a small pilot trial, so its not like they're taking on excessive risk that could burn a huge hole in the bank balance. If your not going to follow through with it, don't say you will in the first place.

Anyway, the future is still very bright and the SP should start to climb shortly. Here's hoping for FDA approval!

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landrews
Posted on: Aug 20 2019, 03:44 AM


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Posts: 362

My thoughts are that the recent SP decline has nothing to do with our prospects for FDA approval.

Have a look at Nearmap who are another recent ASX 200 entrant. They’ve experienced nearly identical SP / shorting action in the last 6 months including; a doubling of SP since Feb, all time high in mid June, followed by a 30% decline on increasing short positions since then. Their net short position has also just reported a sharp decrease..

I’m guessing it’s a set play by some big fish to short stocks that’ve had a stella run, and are seemingly overvalued due to artificial buying on ASX200 inclusion.

The global downturn in markets has played into this strategy perfectly, and has led to a much larger % decline then would have been the case.

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

The good news is we have FDA approval around the corner, and it’s just a matter of days / weeks before it starts to be priced in. End of year results next week showing a 60 -70% increase in profit should also help.
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landrews
Posted on: Apr 11 2019, 09:43 PM


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Posts: 362

Plenty “back of envelope” calcs done here before, so here’s mine! A 25% penetration in US EPP market is realistic in a couple of years post approval (1000 patients).

Implant price will most likely be reduced from pricing in Germany - let’s say $12k US per implant (from 15 - 20k euro) x 4 = $48k p/a US = $67k AUD. That’s about $60m profit AUD p/a after expenses. Add that to the $20m profit we’ll make in Europe this year, and you have $80m profit. One of James’ favourite Oz Pharma companies is CSL who have a PE ratio of 35. Multiply that out for CUV and you get a market cap of $2.8b = $56 share price.

Then add on Vitiligo etc etc. Anyways...I have a “feeling” $25 sp will look very cheap in 12 months time!
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landrews
Posted on: Apr 11 2019, 05:24 PM


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Posts: 362

Haha, yep James’ reports certainly live up to the name...Motley FOOL! Apparently no more SP increase for CUV. The reason for that; it’s doubled in the past 12 months, therefore James has a “feeling” the stock price is expensive! If he did more than 15 mins of research, he’d realise how cheap it is now, should we get FDA approval, rather than basing his comments on feelings!
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landrews
Posted on: Jan 30 2019, 05:59 PM


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Posts: 362

I struggle to see how they will ever conduct a placebo controlled double blind trial to determine efficacy in children aged between 6 and 18, as mentioned in Study 6. Clinuvel has already described further trials like this in adults as unethical. How can they design a trial where a 6 year old child, with a placebo implant, deliberately exposes themselves to the sun (risking 3rd degree burns) to see if the drug (they don’t actually have) works?
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landrews
Posted on: Aug 22 2018, 06:05 PM


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Posts: 362

Doses reported as of yesterday = 7900. Doses reported per data package submitted to FDA = 6700, however I think the analysed data would have only included implants delivered up to 30 June 17. So there’s been 1200 implants delivered in the past 13 - 14 months which roughly equates to the income we’re seeing reported.

Hope we get some good news soon...I get the feeling they are preparing us for the longest review in FDA history...not the sort of record I want to see them break!

Here’s an idea - why don’t they raise $50m, do a proper Vitiligo p2 trial, then do a p3 trial and then submit an NDA for that? It would probably be quicker than waiting for the EPP rollout, and far more lucrative.
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landrews
Posted on: Jul 6 2018, 04:55 PM


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Posts: 362

Yep great news indeed! A director wouldn’t invest $13m if he didn’t think FDA approval was a slam dunk. Probably knows they will get priority 6 month review status on 20 August as well.
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landrews
Posted on: Jun 22 2018, 02:33 PM


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Posts: 362

For any other company, the announcement confirming submission of dossier would not warrant a trading halt, particularly when its already been stated 5 weeks ago this would occur by 1 July. The real reason for the trading halt is that PW is going to announce they have finally met their first deadline in 12 years, all be it a deadline that was only RE-set 5 weeks ago!

On a serious note, the only reason I can think of for the TH is that they have, or are expecting shortly, confirmation that the dossier is validated and a decision date handed down...although normally this would take 60 days from filing final module.

Negative news at this point is almost inconceivable.
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landrews
Posted on: Jun 9 2018, 11:40 AM


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Posts: 362

Topical competition?

https://www.bodyandsoul.com.au/beauty/body/...medium=Facebook

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landrews
Posted on: Apr 27 2018, 10:02 PM


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Posts: 362

PW has previously stated that they will announce to the market when the NDA is submitted.

I don’t think there’ll be any secrets about that when it happens (and the the 2 month validation clock will then start to tick). PW suggested a Feb 18 submission at the AGM.....he..hemmm. It’s nearly May....my best guess is that the first 13 months of data in EU is not quite enough for FDA to guarantee approval. I could be off the mark, but I suspect they are now waiting to analyse and submit additional 6 months of data to 31 Dec 17.

Could be another couple of months, but If and when they do submitt it, I’d bet it’s a 6 month decision with almost certain approval.

Maybe then they’ll actually start a proper p2 or 3 vitiligo trial...been a long wait on that!

Not sure what to make of their OTC product release in May...is it a real complementary product that has a unique advantage to the $billions of competitors products out there....or are they just trying to make it look like things progressing whilst the FDA stonewall them.

It doesn’t really fit in with PW’s “focus pays off” mantra over the last decade. Why stuff around with low margin OTC products that have huge competition when Scenesse has so many other potential applications with practically zero competition?

Anyway... can’t complain with the recent SP rise! Might take while to crack $12 but when it does it’s heading to $16!

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landrews
Posted on: Nov 25 2017, 06:49 PM


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Posts: 362

First time in 15 years I’ve alerted the mods to have someone banned..I encourage anyone who is fed up with the penguin to do the same...goodbye!
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landrews
Posted on: Oct 27 2017, 08:24 PM


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Posts: 362

Fair point, but they have also said they have to submit the EU data first which isn’t availiable until Dec, I imagine that is part of the final module so the clock won’t start ticking until Jan / Feb at which point they will get a decision on priority. So yes they are “awaiting” it but subject to further submissions first. PW also makes it clear in his report final approval will likely be in 2018 if they get priority review status. As per usual they could have worded it better.. but no point us clinging onto that sentence with the hope of final review in 2017.
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landrews
Posted on: Oct 27 2017, 04:52 PM


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Posts: 362

What you quoted is the second sentence in the paragraph. If you read the first sentence in the paragraph then you get some more context. Do you really think they mean the review will be completed in 2017!
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landrews
Posted on: Oct 27 2017, 04:13 PM


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Posts: 362

I think they are saying the FDA formal review will be completed in the same year as the Prioity Review decision, both of which are expected sometime in 2018.

The over the counter product strategy is very interesting indeed! Sounds like we’ll be waiting a while for any details on it though.

Hopefully we can crack the $7.30 resistance level when the quarterly is released on Tuesday.
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landrews
Posted on: Aug 22 2016, 04:41 AM


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Posts: 362

Some insight into Iggy's motivations on this link. If he can do better than just quoting "the radio" or "Facebook" he might be promoted to intermediate level one day!

https://forums.anandtech.com/threads/confes...-basher.298760/
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landrews
Posted on: Aug 11 2016, 08:42 PM


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Posts: 362

Ohh dear, now you are getting desperate. Resorting to comments on mental health to get a response is a new low for you. You speak of consistency.....hmmm...one day you argue CUV is fully priced at $5.20 with now hope of a future given their pipeline, and the next you can't stop telling us how the SP is going to $6.50.

At least your consistant with the way you constantly bang on about BHP warrants, why don't you go and annoy posters on that board.
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landrews
Posted on: Aug 9 2016, 06:54 PM


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Posts: 362

No one cares, go and post on the BHP board.
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landrews
Posted on: Jul 21 2016, 05:59 PM


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Posts: 362

The final assessment in Germany will be critical and we should hear about that before end of year. Several countries will reference their pricing to Germany's. NICE won't decide until first half 2017 imo. There will still be Italian & Swiss sales at full pricing but only a select number of health insurers will pay. I'd like to know if the post authorisation data can be used in 6 - 12 months to support a re-assessment in these countries? Their assessment process clearly doesn't consider patient input when it should.

CUV103 should have finished in Singapore in Feb so I expect results next month or two. Results for the US pre clinical Vitiligo study should follow shortly after. With any luck they can obtain FDA approval to commence the full p2 Vitiligo trial early 2017. Combine that with FDA EPP submission and we'll be on the US investor radar. Maybe that's a good time to list.

Don't really follow them but I think MSB has tanked because their one and only partner has pulled out. Now they will struggle to fund all their trials and could be looking at big dilution or slow progress.
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landrews
Posted on: Jul 20 2016, 06:18 PM


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Posts: 362

Double post
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landrews
Posted on: Jul 20 2016, 06:18 PM


Group: Member
Posts: 362

Yes I've read poodaddy's posts and obviously RC has multiple identities here. But he is and has always been extremely bullish and has posted some good info from time to time. Iggy has a one sided agenda to post negative views no doubt, but having read both their posts for a couple of years I can't see them being the same person. Split personality is a possibility but highly unlikely unless you know something I don't. There's a few others you could easily link as being the same person but that's because they post the same unusual one sided opinions.
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landrews
Posted on: Jul 20 2016, 04:56 PM


Group: Member
Posts: 362

Not sure why you think RC is colluding with Iggy. Maybe you'be been off this site for too long & missed a few posts. No bitching from RC or Kiwi lately so happy days. Let's try and keep it that way. I'm sure Iggy will continue to entertain us with his negative posts for some time to come!
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landrews
Posted on: Jul 8 2016, 09:29 PM


Group: Member
Posts: 362

Yep, I appreciate all the info you post, I will respect you more for every moronic post you ignore! We just have to accept that some people have CUV OCD.
Kiwi, I'd appreciate if you scaled back to two bitching posts per day.
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landrews
Posted on: Jun 29 2016, 06:14 PM


Group: Member
Posts: 362

I've shared plenty overs the years, not asking you to trust my judgement, just ask that you don't have to post every time a thought comes into your head. Driving away posters who have good research is a lose/lose for everyone, and several have left past couple of years.

Who would want to join with the nonsense posted now.

I'm no expert, and I'm no comedian, but try to do some research and have an objective opinion, as much as you can when you're invested in a stock.

Hope you don't get pipped with the next piece of breaking news.

BTW what do you think Iggy's angle is?

Edit: you say Iggy is the one who offers an opinion as to why things may be wrong..but why does he constantly do this with no positive news/opinions?
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landrews
Posted on: Jun 29 2016, 05:24 PM


Group: Member
Posts: 362

Unfortunately you are a moron who does not know when to shut up. Stop blabbing your mouth about things you know nothing about and listen for a while. RC is very bullish, and has plenty of arguments here I rather not read about, but at least he posts some good info from time to time. More than can be said for you.

Iggy is here to bait & put a negative spin on any news there is...good luck with that as I'm still buying. Anyone know why an old age pensioner with no financial interest in CUV would do it!

However, a least he does it with a bit of intellect, and doesn't bombard us with 10 posts a day. Why don't you find and post something original, otherwise cut it back to two bs posts per day.

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landrews
Posted on: Jun 28 2016, 04:59 PM


Group: Member
Posts: 362

Yes most of the good info and breaking news is posted here. It's a shame it gets pushed back 3 pages by morons who have their own bs agenda before anyone can read it. Why do people who have nothing interesting to say continue posting 10 times a day just to argue nonsense?
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landrews
Posted on: Jun 26 2016, 06:22 PM


Group: Member
Posts: 362

Good luck to those who want to push the sp down, I'm happy to keep buying at these levels. Expecting break even cash flow next quarter, $10m plus profit this year.

Despite the best efforts from APF I doubt Clinuvel will file an NDA until they have collected & analysed 6 months of data from EU. Hopefully patients in the Netherlands / Germany / Austria are willing to participate. Unfortunately US approval IMO is 2 years away...but there's little doubt it will get US approval. These issues won't hold back the SP too much though.

We should start to see some analyst coverage next FY. $200m market cap won't last long for a biotech who's drug is approved, profitable and with real potential to treat multiple diseases, some which have blockbuster potential.

Oh yeah, there could eventually be a few off label sales too given that the worst side effect is an all over natural tan that protects you from the sun! We just need more safety data, and thanks the the PRAC requirements we'll have plenty in the next two years. It's treats Vitiligo and personally I think the antiinflamotary effects, as evidenced by the treatment of HHD have been excellent.

It's been a long slow and frustrating ride but i'ts hard to see any downside from here. Many have got bored and sold, but right now I don't see a better return for risk over the next two years. Another takeover is always possible too.
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landrews
Posted on: Jun 21 2016, 06:44 PM


Group: Member
Posts: 362

"under exception circumstances" definately caused delays, mainly because they had to wait for approval of the RMP etc before commencing negotiations for distribution / pricing. Negotiations with most health authorities /insurers were always going to take 6 - 12 months from that point though. Germany is the exception & I'd be surprised if even you were to say you don't expect sales to commence there very soon.

Slashing the price now won't change any of that, it might speed up the process an extra month or two...so what? The patients will have their say again and many of the reimbursement processes cater for that, I think they'll do it far better and quicker than the EMA eventually did.

I'm not saying the price won't reduce from $25k, it most likely will, but it will be closer to $15 - $20k than the $7k you and Snaff are advocating for.
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landrews
Posted on: Jun 21 2016, 04:57 PM


Group: Member
Posts: 362

Do you want to make some money from this stock, or are you just in it to see the drug given away for peanuts so that EPP patients in Italy & Switz can continue treatment for the next 6 - 12 months?

Dysfunctional - no. Under resourced and inexperienced for the task they're trying to execute - probably. Poor communication & bs timeframes - definately. Should they change the distribution & pricing strategy because of a few upset posters online - absolutely not.

Most of these delays will occur whether they sell for $25k or $5k. Is it a sensible risk to forgo $1m of revenue for a year, to gain $50m p/a for the next 10 years? Absolutely - we should fire them if they didn't.

The Italians & Swiss should thank their lucky stars they've had access past 5 years. Everyone else has been waiting for official negotiations / reimbursement to be completed, and now they're all waiting together. If anything their complaints build support for a higher price across the EU.

I can tell you're not much of a strategic thinker.

Also, if it's not Clinuvel's fault, why should they share the blame?
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landrews
Posted on: Jun 1 2016, 10:52 PM


Group: Member
Posts: 362

Yes it is obvious you have eliminated the need for research, that must be why your comments are always full of negative bs nonsense which you try and justify by referring to obsecure comments by others. Yep, if they get 15 - 20k Euro per implant I don't care if it takes another month or so, why would I. The worst delays are behind us now.

I don't agree with your nonsense about slashing the price to 3k or 8k so they can speed it up by a month or two in Switzerland. Why the hell do you care anyway Mr "I have no financial interest, and can't see any positives in what this company has or will do"!

Yes there are approximately 4000 - 5000 with EPP in Europe. They will be treating 650 of them very soon. Ultra ultra rare.... so you agree the price is fair then, or perhaps it should be even higher. Listen to the EPP patients..the benefits are there.
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landrews
Posted on: Jun 1 2016, 08:40 PM


Group: Member
Posts: 362

Orphan diseases include those where up to 5 in every 10,000 of the population are affected I.e patient groups of well over 300,000 in Europe. EPP have about 5,000 patients in the EU, so it's safe to say they're at the ultra rare end of the orphan scale. Best not to post opinions so often on things you know nothing about, or at least do some research first.

As far as I'm aware they are waiting on local ethics approval. If they haven't started selling in a month then I'll start to worry about the insurers etc.
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landrews
Posted on: Jun 1 2016, 07:40 PM


Group: Member
Posts: 362

Yes we've all heard your views on how they should price it like a packet of panadol and make no profit. Similar to Snaffew, you either have no understanding of how the pricing for ultra orphan drugs works or you are deliberately trying to post misleading comments. The 18 month delay in sales has nothing to do with the implant price and you know it.
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landrews
Posted on: Jun 1 2016, 07:26 PM


Group: Member
Posts: 362

Why don't you compare the price of Scenesse with the prices of other ultra rare orphan drugs? Seems far more logical than a comparing it to car, particularly if your trying to make a point that the asking price is cheap, expensive or otherwise.

It it because someone already posted that comparison and you know the drug is actually reasonably priced?
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landrews
Posted on: May 27 2016, 05:18 PM


Group: Member
Posts: 362

Sounds like PW's been waiting a while to get that of his chest! Don't think we'll be submitting a Vitiligo application with the EMA anytime soon. I wonder what he thinks about the FDA , they won't even let him submit an NDA for EPP! Need 6 months data from EU PAS first.
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landrews
Posted on: May 20 2016, 06:13 PM


Group: Member
Posts: 362

We're heading that way with Germany but nothing set in stone yet. Their system allows Clinuvel to set pricing first 12 months before negotiations are complete. First country to approve this price level and it's game on!

This orphan drug has so few patients it won't be placing a burden on any EU country's heath system , even if it's $100k per implant.

I feel your frustration X-ray but SP heading north now, happy days! Who knows, we might have the next takeover offer soon!
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landrews
Posted on: May 20 2016, 05:33 PM


Group: Member
Posts: 362

Yep, they've stated a few times they're aiming for consistant pricing across Europe. When the first country agrees it's a good indication of what they can achieve for all. If it's one of the larger countries then it carries even more weight.

At the proposed pricing levels revenue will be $50m plus in 12-18 months. Despite what Iggy says, I think the market will factor that into the SP well before the revenue is actually generated.
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landrews
Posted on: May 20 2016, 04:41 PM


Group: Member
Posts: 362

Nice volume today, might see another substantial shareholder notice from Lagoda soon. The 21k euro price per implant in Germany is great but Clinuvel have essentially set this price whilst the assessment procedure/negotiations continue. When first sales commence we should see another modest rise in SP.

I'm not sure which country will be first to officially approve the ongoing reimbursement price, but when they do, if it's anywhere north on 15k euro, we'll be heading towards $8 -$10 - IMHO.
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landrews
Posted on: May 19 2016, 09:17 PM


Group: Member
Posts: 362

"On the number of implants allowed it is kind of irrelevant also because as of this moment the overwhelming number of EPP suffers in the EU and elsewhere are currently receiving none at all. Zilch".

Haha, more negative nonsense!

I guess the implant price of 21k euro in Germany is also irrelevant, because sales have not yet commenced. How ridiculous it is that the share price went up the last couple of days, don't those fools who bought the shares know....they haven't started selling yet!
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landrews
Posted on: May 19 2016, 07:26 PM


Group: Member
Posts: 362

I get a laugh out of reading his posts now, his attempts to put a negative spin on Clinuvel are getting more desperate and obvious! The only thing that surprised me is that it took him a whole day and a half to weigh in with his last BS post.
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landrews
Posted on: May 17 2016, 08:49 PM


Group: Member
Posts: 362

Module 3A lists the price as 21,971 euro per implant. It seems they only anticipate 70 German patients in year 1, then 100 in year 2 with a 10% increase thereafter. Sorry Iggy, but we wont be slipping below $4.00!

And this from the last module:

Currently 40 patients are urgently waiting for a treatment with SCENESSE® in University Hospital
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landrews
Posted on: May 17 2016, 08:23 PM


Group: Member
Posts: 362

Wow, there's a lot of info to translate and read but Module 1 has my attention. They estimate up to 450 patients in Germany at a cost of 29m to 39m euro p/a. I like the sound of those revenues!
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landrews
Posted on: May 13 2016, 05:15 PM


Group: Member
Posts: 362

Having a more flexible pricing structure won't fast track the roll out. The same process still has be followed in each country and will take 6 to 12 months whether they sell for $1k or $25k.

Interesting that patients are just putting pressure on health insurers etc and not on Clinuvel in regards to pricing. They must think $25k is justified given the benefits. Time will tell, but I think they could settle on $15 - $20k.

Then they can move on to negotiations in Oz so that Iggy can get his much needed treatment!
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landrews
Posted on: May 12 2016, 08:10 PM


Group: Member
Posts: 362

It's about time we stopped pickin on Iggy.

For those who don't know the poor old fellow is now an aged pensioner. He's been on full disability support pension for the past 10 years or so and has a rare form of PLME. It could even be EPP, but it's so rare whatever it is that it's possible no one will ever really know. This is the reason he continues his non stop monitoring and posting on this board, with barely a break to have a meal.

He was invested in CUV until late last year when he announced he had sold all his shares sub $3. He doesn't regret this decision though as he's nearly made enough recently by gambling on ANZ warrants to pay for the losses he made on BHP warrants purchased earlier this year.

His intentions are pure and his posts are rational and objective, after all he no longer has a financial interest in Clinuvel. I doubt he would even buy back in if the price fell back to $3......and nor should you. In fact you're best to sell now while you still can. As Iggy has told us, the drug doesn't work and this company are price gouging frauds.

His recent comments on how "the drug was not developed by Clinuvel" provide further evidence of how fraudulent this company is. I was convinced that they had spent $120m developing the drug past 10 years, but know I know better.

I look forward to more negative posts from the pensioner so we can all be enlightened!
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landrews
Posted on: May 4 2016, 07:49 PM


Group: Member
Posts: 362

I keep wondering how easy this could have been if they didn't screw up the trial data & managed to get unconditional approval. We'd probably be selling in the US by now with potential for off label use. Plus EU rollout would complete. At least it's provided an opportunity to buy cheap shares last couple of years with minimal risk!

SP should keep rising from here with decent jump if implant price is at or above 15k euro. I think we still have a 6month wait for NICE pricing. Not sure how that will reconcile with their plan for a consistant EU wide pricing structure if they want other countries to come on line before then.

The word "novel" comes to mind. Everything this company does seems to be novel. In spite of that, its still low risk with big upside. Looking forward to the next announcement!
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landrews
Posted on: May 3 2016, 03:56 PM


Group: Member
Posts: 362

I'm feeling positive about the CUV SP next 2 months.

You would have made far more money by leveraging an investment into CUV when I told you too.

Don't forget to tell Centrelink when you sell your warrants!
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landrews
Posted on: May 3 2016, 02:53 PM


Group: Member
Posts: 362

I voted against, so no need to memo me on your thoughts re management.

I haven't followed the ANZ story, but I see the SP is still 14% below where it was when Mike Smith announced he was resigning back in October. That's hardly a turnaround worth bragging about.


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landrews
Posted on: Apr 30 2016, 10:14 PM


Group: Member
Posts: 362

$20k may end up being the going rate, who knows. As you know though, commercial sales have not yet commenced, and I don't think anyone here says they have, so why would you expect to see such sales on the last quarterly cash flow statement? Just another baseless negative comment under the guise of being ignorant?
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landrews
Posted on: Apr 30 2016, 09:55 PM


Group: Member
Posts: 362

How strange it is that someone who is just interested in the science/product keeps getting suspended from posting.

If you want to nitpick please substitute the word "Medicare" with "Department of Human Services".

So you have been assessed as having a "physical, intellectual or psychiatric impairment, and are unable to work, or be retrained for work, for 15 hours or more per week at or above the relevant minimum wage because of your impairment". Plus you are a low income earner and have minimal assets.

Sounds unlikely given your exotic trading in warrants. Better stop bragging in case you lose your pension payments!

Given you've seen 6 specialists and have out done them all with you own research, can you give us some links or quotes or any specific scientific info on you rare PLME/EPP affliction. Or is it perhaps a one of a kind disease for which no info exists?

Can you give us some quotes or links on the European sufferers who have been denied support? Referring to comments Snaffew has made offers nothing. In fact referring to Snaffew posts decreases your credibility if anything.

At the end of the day your argument is flawed anyway. The price will exceed $8k per implant, the question is by how much.

Your "snow job" comments regarding the NICE workshop are just baseless down ramping.
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landrews
Posted on: Apr 30 2016, 05:14 PM


Group: Member
Posts: 362

No paranoia or anxiety with me. I understand exactly why you keep posting, but even so I don't disagree with some of your posts.

However, you supposidly have no investment in clinuvel after selling out last year, you continue to and have always posted negative comments, you never provide any research, links or actual facts to help anyone, you continue to brag about better opportunities elsewhere etc etc.

Unfortunately it's your pattern of behaviour that suggests a need for medication, unless perhaps there's another explanation!
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landrews
Posted on: Apr 30 2016, 01:39 AM


Group: Member
Posts: 362

IMO the best time to buy CUV is when Iggy is downramping and can't help but tell us about the money he's lost/won on BHP and ANZ warrants. I wonder if he ever posts on the sites of companies he supposidly invests in?

Now he's dismissing his own implant price predictions because he was influenced by "ramp" posters! Common...you're one of the biggest rampers on this site. Up ramping/down ramping...it's all the same, just less friends when you down ramp, but we all know why you do it.

Perhaps for some credibility with the newbees you should pretend you own some shares. Don't tell them how you sold out your previous position for less than $3 though .....your contrarian views might be seen as foolish!
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landrews
Posted on: Apr 22 2016, 05:42 PM


Group: Member
Posts: 362

Yeah I was aware that XT was a trade between two shareholders who use the same broker. An S3 XT is described by ASX as a special block cross trade.

Possibly Lagoda have taken an off market shortcut and bought out all remaining shares from the seller at 4.20. Either way I think we've broken the resistance at 4.20 and next week it should head north of that.

Happy days! Now we just need that long awaited announcement about first commercial sales.

Hopefully they announce the commencement of sales before they tell us how many shares PW has been issued!
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landrews
Posted on: Apr 22 2016, 04:34 PM


Group: Member
Posts: 362

Not sure what an S3 XT trade is, but there was 142k of shares traded at 4.20 with this code that don't seem to be included in the daily volume total of 96,267 that ComSec are showing.
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landrews
Posted on: Apr 22 2016, 04:18 PM


Group: Member
Posts: 362

Yep, the 70k of shares for sale at $4.20 were gobbled up last hour. There was a bid on at $4.30 for 5000 at the close...I was almost tempted to sell a couple to see it finish at 4.30! Could be heading to 5.00 next week, sellers have dried up and big fish are still buying.
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landrews
Posted on: Apr 19 2016, 03:21 AM


Group: Member
Posts: 362

I didnt see anything in the Corporations Act that mentions 10% as a relevant %.

Above 5% and you become a substantial holder and have to lodge notices for every 1% change.

Above 20% and there are restrictions on how much you can purchase without making a takeover offer.

There's nothing on option c, unless it's something to do with an asx specific listing rule, which I doubt.
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landrews
Posted on: Apr 18 2016, 09:26 PM


Group: Member
Posts: 362

Actually, on second glance it looks like they needed to report a correction to previous notice, and decided to list their new purchases since then.
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landrews
Posted on: Apr 18 2016, 08:00 PM


Group: Member
Posts: 362

Does anyone know why Lagoda lodged a substantial shareholder notice last week?

The holding announced on the previous notice dated 15 March was 9.83%. They are only required to lodge a new notice if their holding increases by 1%, or if they make a takeover offer.

Their new holding announced last week was 10.03%. That is a long way short of a 1% increase, so why have they lodged this seemingly unnecessary notice? Surely it's nothing to do with a takeover offer?
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landrews
Posted on: Apr 2 2016, 07:27 PM


Group: Member
Posts: 362

I'm guessing the start of the next Vitiligo trial is 6 - 12 months away and it will be a p2 followed by 1 - 2 p3 trials.

As you say, the efficacy results won't rely on subjective comments from a handful of patients (ala EPP). If it works the regulators will have to give it full unconditional approval.

Off label use will take off no doubt, they know it, hence why we are being grilled every step of the EPP path. There is great evidence already that Scenesse is safe, by the time EPP is rolled out and a Vitiligo p3 is commenced it will be undeniable.

Scenesse is still flying under the radar, in 5 years time it could be the most well known drug on the planet, second only to Botox. The only question in my mind is will it be 3, 5 or 10 years!

With PW and Co's history, and regulators who are shit scared of the massive off label potential, you just never know. Either way, the next 6 months of EPP rollout should be rewarding to shareholders. Even Iggy is acknowledging that! Last year he predicted $3k per implant (as he argued that EPP is not recognised as a disability under Medicare) and now he's increased to $18k per implant, and nothing has changed with Medicare!
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landrews
Posted on: Mar 24 2016, 09:07 PM


Group: Member
Posts: 362

Also, lets not forget, this stock is seriously de-risked. Now that all the time delays are over there is almost no downside. The only reason I've hung on for 10 years is the fact that it has an excellent safety profile, and I don't expect that to change. The most prevalent side effect is that it gives you a tan! There's also an impressive list of potential lucrative diseases it can treat, and unlike many biotechs that have $billion valuations, we actually have approval. CUV won't be flying under the radar for much longer.
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landrews
Posted on: Mar 24 2016, 08:20 PM


Group: Member
Posts: 362

IMO the most price sensitive info by far will be the re-imbursement price in the first 1 to 2 countries where they commence sales. If it's close to $20 - $25k AUD per implant then it's possible the sp will double from the $4.15 close today. Within 12-18 months we will have revenues of $60 - $80m plus. Take out expenses of $20 - $30m and your left with earnings of say $50m. A multiple of 8 times is more than reasonable give market exclusivity of 10 - 12 years once the peadiatric extensions etc are granted. That's a $400m market cap which is more than double where we are now. And that's just EPP in Europe.

If the rumers are true and sales are about to commence in Germany then we should have an announcement on pricing very soon. Surely they can't start selling without telling us the price, even if it's in Germany where they set their own price for the first year. Most companies that set first year price in Germany are usually close to the final agreed price. I think it's clear all the key Europen countries will reimburse at a premium price, it's just a question of how high. The minimal number of patients and the controls in place to restrict useage mean that the costs to various national health systems will be insignificant, even if it is $25k per implant. If the ongoing efficacy and safety data are good then a high price should be maintained.

Then we've got US EPP, vitiligo, HHD and eventually the topical. Not to mention all the other patents for psoriasis etc etc.

I think shareholders will finally see some serious rewards over the next couple of months. If you still have some spare cash and want to make a quick $ then get in while you can! Sellers are drying up.

Happy days!
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landrews
Posted on: Mar 24 2016, 02:50 PM


Group: Member
Posts: 362

This form has been updated with some responses since I last looked at it. http://www.bad.org.uk/shared/get-file.ashx...emtype=document

I found the following comment interesting

"It seems unfair to exclude teenage patients for whom there is no biological or scientific reason to assume that the drug is any less effective of more dangerous than in adults. Teenage patients have a particularly high impact on QAL from this disease".

So they are questioning whether teenage patients under age 18 can also be covered by reimbursement.
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landrews
Posted on: Mar 11 2016, 02:34 PM


Group: Member
Posts: 362

There was approval at the last AGM for a placement of up to 10%.

I'm guessing 2m shares at $3.20.

For previous placements they seem to have set the issue price based on a small premium to the 20 day weighted average price.

It's no coincidence that the SP has spiked up in the last 20 days. Some existing investors possibly got wind of the cap raising and pushed up the price to minimise dilution.

Let's hope the next trading halt is for something sweet like a pricing announcement, FDA filing or even a takeover offer!
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landrews
Posted on: Mar 8 2016, 01:03 PM


Group: Member
Posts: 362

I think they are scheduled to submit a PSUR every 6 months. As they haven't even started selling there is no PSUR data to submit yet.

We should know next week if the updated RMP is on the PRAC agenda for approval in March.
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landrews
Posted on: Feb 22 2016, 03:09 PM


Group: Member
Posts: 362

Anyone know what PW was referring to in the July 2015 newsletter when he said "Clinuvel is now addressing the final arguments towards authorities and insurers for them to include Scenesse in the national list of reimbursable treatments"?

Is it possible there are one or two countries where this process is all but finalised? Perhaps Italy and Switzerland.

Otherwise it seems he was talking bs again, as for most countries the re-imbursement process has only just begun.
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landrews
Posted on: Feb 5 2016, 10:46 PM


Group: Member
Posts: 362

Short term bridge loans, lines of credit, that won't happen.

Either sales will start or there'll be another placement. Tick tock..common PW when will you show us the latest Investor presentation? The roadshow never stops!
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landrews
Posted on: Feb 5 2016, 02:31 PM


Group: Member
Posts: 362

It's possible, but it could be an expensive way to raise a small amount of capital due to disclosure documents required for non sophisticated investors. Plus the sellers at $3 could start unloading at $2.70 before the plan closes, in which case no one would participate.

Perhaps a renouncable rights issue at $2.50? Then you can sell your right if you don't want to invest more. This is outside my area of expertise, Frogster any comments? Cheers.
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landrews
Posted on: Feb 4 2016, 06:45 PM


Group: Member
Posts: 362

This truely is a novel drug, looks like it will continue to break records! Longest time for an EMA approval and probably the longest time between approval and first $1 of sales. What record can we break next!
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landrews
Posted on: Feb 2 2016, 08:30 PM


Group: Member
Posts: 362

Done!
  Forum: By Share Code

landrews
Posted on: Feb 2 2016, 07:39 PM


Group: Member
Posts: 362

Thanks for posting but this has also been posted before.
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landrews
Posted on: Feb 2 2016, 07:38 PM


Group: Member
Posts: 362

Thanks for posting but I think this is old news posted here before.
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landrews
Posted on: Feb 2 2016, 07:28 PM


Group: Member
Posts: 362

Ha ha, so you're not bullish then, and only just realised it after I asked you why you were....yeah right! You should change your name to flip flop!
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landrews
Posted on: Feb 2 2016, 07:19 PM


Group: Member
Posts: 362

Along with the ignore button, I wish they would also introduce topic threads. That would be better for everyone. It would allow posters to challenge the flawed idea's of other posters, or expand on good ideas, without annoying those who have no interest in the topic, and it would prevent good new info or ideas from being pushed back 5 pages in half a day by nonsence.
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landrews
Posted on: Feb 1 2016, 06:28 PM


Group: Member
Posts: 362

If it's a zero sum game, which it is, I still don't see why you suggested it will hold the sp down or as you more recently suggested, push it up. Never mind, I think you've figured it out. You love a chat so can you explain why you are so bullish yet have not bought back in?

What has changed last month or so to turn your sentiment around? I hope you're not considering more BHP warrants before you get back in to Clinuvel!

Surely you didn't sell because of Clinuvel's corporate governance standards, nothing's changed with that last 10 years.

It's amusing you hold the investor Snaffew in such high regard. 6-9 months ago he was telling us what a travesty it is/will be that companies like Clinuvel charge a premium price for an orphan drug like Scenesse!
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landrews
Posted on: Feb 1 2016, 04:19 PM


Group: Member
Posts: 362

No one is freaking out about a capital raising. If they raise 3m shares at $3 then it's only a 6-7% dilution, say 20 cents per share. The dilution from PW's bonuses will be priced in already because we get no cash in return. I was just trying to understand if you had a valid reason why you thought such a possibility was keeping the sp below $3. It clear now you don't, and I accept that you were just posting what ever thought came into your head.

You state the sp will rise when they do a raise but I don't see why that would happen unless it's at a massive premium. Theoretically if they raise funds at or near the current sp then it should have no effect on price.

Nice to hear you are bullish on the stock. Have you bought any yet? You were pretty quick to announce your sellout after the Singapore results were released recently. What has changed between now and then?
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landrews
Posted on: Jan 30 2016, 09:42 PM


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Posts: 362

" You have invested heavily in the success of the company and are now resisting the dilution remedy whereas those that are looking to invest a modest amount in Clinuvel any time soon may be thinking it is wiser to wait for more clarity as to when the marketing and pricing of Scenesse is more certain before investing. Hence my theory of a lagging behind future events share price. Or put another way, dilution already being priced in. I’m waiting for more clarity. "

"Dilution remedy" you should definitely coin that phrase...sounds like it could fix everyone's problems! Waiting for clarity is one thing, and could be a reason for a lagging sp , but suggesting it means there will be dilution is another. More bad reasoning to support you original comments? Anyone waiting to invest a modest amount won't have the luxury of doing so via a cap raise at a low price. Once pricing and sales start you will be paying well above $3.

You say you expect sales next few months so why do you think dilution is going to happen?
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landrews
Posted on: Jan 29 2016, 10:27 PM


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Posts: 362

Correct me if I'm wrong but clinuvel has always made cap raises with new investors. So there's no incentive for existing shareholder to push the price down in the hope of getting a cheap placement. Why push the sp down now if it will dilute your holding even further when someone else invests? If they had any sense, which I think they do, they'll push it up now if they expect a cap raise.

You've been up the garden path for a while, but I'm glad you're on the way back!

You spoke as though a cap raise was a forgone conclusion, but now I see you hadn't thought it through properly. Glad I could help as one inexperienced investor to another!

I'll admit, the question still remains as to who is selling at $3 and why?

Don't worry about the miners, less risk in biotech!
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landrews
Posted on: Jan 29 2016, 08:46 PM


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Posts: 362

"The sp is currently lagging the possible income coming later in 2016 which leads me to believe the big players have already factored in a capital raising sooner, rather than later or not at all. As I have no expertize in such matters it is just my guess at what may eventuate"

Haha, I love how you finish with "or not at all". Totally contradicts the little reasoning you had to start with! Best to not make such statements if you really have no idea.

I still don't see how a capital raise when sales start results in a low sp now.

If they can hold out till then, probably won't need a cap raise. Next p2 Vitiligo trial won't cost too much. The two p3 trials will be more expensive, but EPP sales will be up and running by then, and there should be enough data to entice a partner.

Interesting that all you see is upside yet you still don't own any shares. Better get in soon if you want to recover those BHP losses!

Is that too low brow for you!
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landrews
Posted on: Jan 29 2016, 04:09 PM


Group: Member
Posts: 362

Can you please explain how a capital raise is already priced into the current sp? I don't understand how that is possible. Do you think they won't actually start selling by April/ May/June? There's enough cash for another 12 months, I think they'll make an exception to the usual cap raise trigger level if they know sales are on the horizon. It won't take much to break even, the question is whether they can make enough to fund Vitiligo/ topical / paediatric / US EPP submission etc. All those costs can and have been delayed to date.
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landrews
Posted on: Jan 24 2016, 11:17 PM


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Posts: 362

All done at $4.90....really? Sounds like a nice story about what you wish you'd done. I guess you're forgetting about the shares you supposidly sold under $3 after the Singapore results were released. No one here really believes you have EPP so please stop with that nonsence. Soon you be telling us you recently shorted BHP!
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landrews
Posted on: Jan 20 2016, 10:27 PM


Group: Member
Posts: 362

Haha ...don't rely on Lachlan for your research! Plenty of pics from the first HHD trial and from the US p2 Vitiligo trial! If you're really want to see them you'll find them! Don't expect me to hand it to you on a platter.

I wouldn't expect the Singapore vitiligo photos to be any different to the US p2 (when/if released) although like I said, it's hard to assess how much of the repigmentation relates to sceness vs UVB.
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landrews
Posted on: Jan 20 2016, 09:10 PM


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Posts: 362

In my view the pics for Vitiligo on their own don't really prove too much.

I.e if a single patient shows good repigmentation under the dual therapy that's great, but there's no way to compare it to the repigmentation they would have achieved under UVB alone. If there's no repigmentation at all then we're screwed, but even if there is, it's hard to determine (from a couple of selected photos) how much pigmentation relates to scenesse vs the UVB therapy.

There's some impressive pics from the first HHD trial though, if you can be bothered finding them.

I hope you got stopped out of that crazy BHP option before it went below $15. Best to put what's left of your cash back in CUV, perhaps you'll have a chance of getting your money back!

Why the focus on India......well there 10's of millions of them living there that might benefit from Scenesse.
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landrews
Posted on: Jan 20 2016, 08:15 PM


Group: Member
Posts: 362

Wow, what an informative CEO brief!

PW has managed to write another two pager without telling us anything! At least they've come up with a positive spin on the costly and onerous RMP, and have now confirmed the FDA will require the same, if we ever submit an NDA. Who knows if the data generated from the RMP will be proprietary to Clinuvel anyway?

They are also starting to explain the activity in Singapore (via interview posted yesterday) which they tip toed around in an investor teleconference 18 months ago.

Nothing on possible EU reimbursement prices, timing, FDA filing, HHD results, or vitiligo "animal study" progress. I.e. The stuff we really want an update on.

Once again he's confirmed what a great team we have, how hard they're working, and how a big pharma could not achieve what they have/are.. PW wants to go solo as long as he can...I wonder why? No surprise that financing is becoming an issue again. Maybe if they start talking up the company and its prospects the SP might rise! Then they can raise capital with minimal dilution. FFS!

I hope next CEO brief has more to offer.
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landrews
Posted on: Jan 10 2016, 07:38 PM


Group: Member
Posts: 362

EP Iggy, I reckon you'll be regretting buying those BHP call warrants more than selling your CUV holding. Maybe you should start some crowd funding so you can travel to Switzerland to get an implant? With all the friends u have you shouldn't have to wait until your 70 to get some relief! Perhaps then you can provide some useful comments on whether the drug works or not.
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landrews
Posted on: Jan 7 2016, 11:29 PM


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Posts: 362

IMO the main aim has been to conserve funds whilst maintaining the illusion that they're actually making progress with Vitiligo.

The Vitiligo program has been a farce for the past 18 months and it's all because they f'd up the EPP data collection/management. Even 2 years since completing the US p3 EPP trial, and more than 1 year since EU approval, they still won't submit an NDA to the FDA, and it seems they're left with no option but to beg for access to accelerated approval, and that is by no means a fast track or waivor of the usual approval process. Sorry to say it it, but we will not see EPP sales in the US this year.

Delay in EPP sales means delay in Vitiligo development.

They've been talking about the animal studies for 2 AGM's now, as if it's all that's holding them up. Truth is they're low on funds but thought they'd have $10 - $20m in EPP revenue by now to fund a proper Vitiligo trial. The mandate now is to NOT dilute any further via share issues (unless it's to PW), regardless of the time cost. Otherwise they could, should, and would be doing a p2 Vitiligo trial in the US.

The Singapore trial(s) appear to be nothing more than a small experimintation as to how they might best design the next US trial. Besides the added safety record, I don't see how it will assist with approval in the US. It's been a cheap sideshow to cast the illusion that progress is being made.

Long way to go, but plenty to look forward too, let's hope these clowns can get their act together in 2016!
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landrews
Posted on: Dec 19 2015, 11:28 PM


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Posts: 362

I think they both have their tails down at the moment!

I assumed there'd be a few US investors selling out to realise losses before 31 Dec, and I happily bought a few from em last week.
Hopefully I'm not selling in June for the same reason!

Plenty to look forward to in 2016. Even the most critical posters here will struggle to argue against the SP rising next 12 months. We'd have to be rejected by the EU insurers or have an unknown safety issue with the drug, and given it's history that is very unlikely. IMO all the US delays with EPP etc are priced into the current SP.

Don't worry, it won't be long before someone more creditable than MS shows interest in Clinuvel. Thankfully he's not in charge, who knows how much we'd have lost to pay off his creditors!

PW talks BS with his timelines for Vitiligo etc, but I don't think he takes more than what the shareholders approve (although I disagree with his level of remuneration, you can't seriously suggest he's committing fraud like MS). I suspect there'll be plenty of action well before Vitiligo approval. Can he learn to communicate and use the media to Clinuvel's advantage.... Can he find a serious partner.... It's all upside if he does.

IF on the very unlikely chance the market cap falls over next 12 months, then I can't see how PW can continue as our CEO on a multi $m salary. Time for a change...votes against are growing. He's had enough time now...even with EPP "restricted" approval.
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landrews
Posted on: Dec 18 2015, 02:59 PM


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Posts: 362

They've finally caught up with him....

http://www.9news.com.au/world/2015/12/18/0...ercent-arrested

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landrews
Posted on: Dec 4 2015, 05:13 PM


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Posts: 362

I didn't say I was surprised, just that I don't understand why they keep releasing misleading/incomplete statements.

The last announcement says "2 - 3 trials concurrently" when it should have said "a p2, and then 1 - 2 p3 trials concurrently". It makes a big difference time wise, and I think they do it deliberately. They keep trying to make timelines sound better than really are. Even avid investors on this site get confused about what's going to happen.

You shouldn't have to read through 50 pages of AGM slides to interperate their so called "comprehensive" update of the North American Vitiligo program.

I think based on my interpretation of your post we are in agreence!
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landrews
Posted on: Dec 4 2015, 03:23 PM


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Posts: 362

I have agree with Snaffew regarding the timeframe for Vitiligo. Clinuvel are misleading us by suggesting all the US trials will be done concurrently.

IMO the FDA will require a p2 and then, after results are in, they will allow the two concurrent p3 trials. I still don't understand why PW isn't clear and up front with such matters, it would improve his credability. Didn't he say Vitiligo could be as little as 3 years away at the 2014 AGM (thats 2 years now). Some people just say what you want to hear when It helps them get a big bonus!

The FDA still won't accept an NDA for EPP, even though it's approved in Europe and patients have been knocking on their door for 2 plus years. They are playing hard ball.

Patient pressure and media exposure will definitely help but I can't see them allowing any short cuts for Vitiligo. They know once it's approved for Vitiligo that off label use will take off. They will require safety data from thousands of patients before they allow that.

However, just because Vitiligo approval is still 5 - 6 years away, doesn't mean we won't see 5 to 10 bagger gains sometime between now and then. A partnership deal could do it, but I suspect they will wait until the next US p2 results are in now.

Let's hope they can exceed expectations with Eu distribution over the next 6 - 9 months.
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landrews
Posted on: Dec 3 2015, 07:16 PM


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Posts: 362

I have read the announcement in detail now and agree with your assessment.

Something has not gone to plan. If 13 patients won't finish treatment until Feb 16, then they didn't start until April 15, nearly 12 months after recruitment began. I also agree they have deliberately withheld this information until after the AGM.

I never understood why they did the Singapore trial to begin with, when the main game is in the US. It's just another set of rules, regulations, culture etc a small team has to deal with, and it seems they've done a poor job.

It's not like they rushed the initial study design either, they waited 2 years between finishing the US p2 and starting this trial.

Every time this team releases news there are serious unexplained delays. I'm going to ask for an explanation but doubt i'll get one. I'd also like to know if/when the HHD results will be released, or is that another trial they are trying to sweep under the rug.

These guys are unreal!

Can they be trusted to deliver 2 - 3 large concurrent trials in the US whilst managing EPP distribution in Europe? Probably not.
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landrews
Posted on: Dec 3 2015, 12:05 PM


Group: Member
Posts: 362

A possible explaination could be;

They have come to the realisation the the FDA won't place much reliance on the trial done in Singapore. They want results/data from trials conducted on home soil. They will make them do animal studies then P2, then p3, regardless of what eventuates from the Singapore trial.

In addition, May 15 was around the time they became aware of substantial delays in approval of the RMP for EPP, from that point on cash was going to be tight for some time to come.

Why enroll and pay for 60 patients in Singapore if results from 20 will get the same result with the FDA?

The preliminary results are probably based on the first 8 patients to complete the treatment. The other 13 could have been enrolled over 2 - 3 months later, therefore the availability of data to analyse is staggered.

Either way we are in for a long wait with the FDA.
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landrews
Posted on: Nov 25 2015, 11:48 AM


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Posts: 362

I think the FDA have made it clear to them that they must complete and submitt the animal studies before the next Vitiligo trial can commence.

They didn't completely rule out the possibility of going straight to a p3 trial but I think it is highly unlikely. Back when they had done the first Eu p3 for EPP there was some hope that they could go straight to a p3 in the US, but the FDA made them do a p2 first.

I don't understand why the animal studies are taking so long, the chairman said 12 months ago they were already underway and yet it will still be another 6 months from now before they have results.

I suspect they have been dragging things out to conserve cash until EPP sales commence. PW mentioned again that Vitiligo progression is intertwined with EPP. Hopefully they can share more in 2 weeks time when the interim results are released, although I wouldn't be surprised if two weeks turns into a month!
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landrews
Posted on: Nov 24 2015, 03:52 PM


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Posts: 362

Great summary Frogster, that's pretty much nailed it!

One other thing PW commented on was how pleased they were with the peer reviewed article published in the NEJM, and how proud they were that they had not enticed/paid any of the contributors to do this. Then he went on to say that it would have been very handy if they had it two years ago, when they were still trying to get EPP approved. Apparently at the time the EMA raised a concern that there weren't any such articles published, and all they could say in response was they didn't believe in providing enticements to have such articles written.

He also said they will not be sending physicians on trips to Hawaii to entice them to prescribe Scenesse.

Perhaps things might have gone a bit quicker though if they knew how to grease the wheels (legally of course)!
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landrews
Posted on: Nov 24 2015, 02:14 PM


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Posts: 362

Yeah I agree, they actually made comment that the regulators and reimbursement authorities review all the annual reports etc. That's probably also why we aren't hearing much about the Vitiligo sales potential etc this year.
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landrews
Posted on: Nov 24 2015, 01:59 PM


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Posts: 362

The atmosphere was fairly subdued. It was strange watching them present in a dark room with the blinds shut and all the lights off, due to there being a couple of EPP sufferers in the audience. They played a few videos, one being the instructional video on how the implant is administered and another with 14 clips from the dateline episode and other news outlets.

I get the feeling they are under more pressure then ever to deliver a return to share holders, and so they should be. They spent quite a bit of time justifying their strategy over the last 10 years. I think this will take care of itself once they finally start selling.

In a very round about way they conceded to making mistakes but played this off as a good thing that is necessary for innovative companies. (There was a slide with two quotes on this).

I think a Nasdaq listing will happen eventually but they are in no hurry. PW didn't seem to think that a Nasdaq listing would guarantee an increase in value, and pointed to the slide where some companies had actually lost value since listing.
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landrews
Posted on: Nov 24 2015, 12:38 PM


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Posts: 362

The other interesting thing PW said was that with the EMA delays in approving the RMP they lost 1 year of the 10 year exclusivity in the Eu. They have now made submissions to have that year re-instated. Although he didn't comment as to whether he thought they would be successful.
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landrews
Posted on: Nov 24 2015, 12:14 PM


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Posts: 362

PW seems to finally realise that media exposure will help progress the drug, and that the regulators can potentially be influenced by this. The FDA opened their Sep meeting with Clinuvel by making positive comments about the Dateline report on EPP.

PW said they are considering allocating more funds to the general marketing budget. (Sorry just realised Frogster has commented on this already)

They spent too much time talking about the past 10 years and how great they've been raising capital, and how low the dilution has been compared to othe ASX biotechs. It's no surprise there was no graphs on share price or return on equity.....the ones shareholders really care about!
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landrews
Posted on: Nov 24 2015, 11:56 AM


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Posts: 362

The Singapore results will be available in 2 weeks and they seem positive about EU roll out, but not much other good news.

US animal studies won't be available until June 2016 and then they can prepare for what is likely to be a p2 Vitiligo trial in the US. Vitiligo approval is still a long way off.

Peadiatric EPP treatment will be funded out of Eu profits and is 2 - 4 years away.
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landrews
Posted on: Nov 22 2015, 01:07 AM


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Posts: 362

Controvers, it's about time you stop your rants about PW's communication. If you feel that strongly about it, get to the AGM and ask those questions directly. There is no one here that can help you.

I understand your frustration, but you need come up with something more constructive if you want to keep posting here.
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landrews
Posted on: Nov 20 2015, 06:06 PM


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Posts: 362

They were mine...should have held out for a 2.93! The price always seems to drop after I buy a small parcel. Looks like Lagoda have put the chq book away for now. Hopefully they like what they hear at the AGM, and keep buying.

Unfortunately I think 2015 will be the year that never was. No EPP sales, no pricing negotiations completed, no Vitiligo results, no HHD results, no new trials commenced in US, no FDA application & no SP increase! 12 months ago you would have expected a tick in most of those boxes.

Plenty to look forward to, but it's probably quicker to grow an oak tree!

At least PW & co were paid enough to feed the family!
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landrews
Posted on: Nov 4 2015, 08:19 PM


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Posts: 362

Congrats to Lagoda who have snapped up 7% in 3 months sub $3.00......and that's post approval!

Who would have thought 10 years ago that would be possible with the the knowledge that the drug would maintain an excellent safety record (ignore the 10 for 1 reverse split...30 cents back then).

I had a terrible dream 12 months ago that if I won tattslotto I would never get the chance to invest it in CUV before it took off! The odds are almost in my favour now, although I don't have a winning ticket yet!

Yep, I thought I was on to something good back when I first heard about a drug that can protect you for the sun....and give you a tan.... a possible 10 bagger for sure, so long as it's safe. Now I feel like an amatuer for not having waited another 10 years!

It's still a 10 bagger, because it's still safe, but how much longer should we wait? Can a new management team do it better? We'll probably never know. All you can do is keep buying if you're game, and tell management what you think.

The communication has to improve. Good or bad tell us what's going on... unless it's bad and you're about to raise capital! But they shouldn't have to now.

Good times can't be too far away. I'm still disgusted that management reward themselves long before shareholders ever see a cracker!

Time to deliver PW! You suggested $15k per implant last AGM. Better get close to that, or it's another fail.

I don't like the lack of info on pricing based on the excuse that "we're waiting for everyone in the EU to agree on the same price". Common, you can do better than that!
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landrews
Posted on: Oct 30 2015, 09:42 PM


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Posts: 362

Well done PM for manning up and posting those questions! I would like to hear your opinion if you have one, but here's mine.

1. The net cash burn for 14/15 was $4m and they have $9m left. Saying they have 3 years of cash left at that rate is stretching it. And the burn rate has been at an all time low due to lack of progress they are making whilst we wait for EPP rollout. They won't let the cash balance get below $4-$5m anyway so at best there is 12 months left. After seeing the Sep 15 cashflow burn of $1.2m I think they will avoid another cap raise. But is at the expense of more speedy progress for Vitiligo etc.

2. No one really thinks revenues won't increase in the next 12 months.

3. "Why would you have expected more revenues in 14/15 after recent PRAC approval?" Maybe with the extra staff/offices/board members they have announced last 12 months they can now manage to do more then one thing at a time. It's not unreasonable to expect negotiations to be completed in one or two countries 12 months after the EMA release their initial approval decision. Hell, you said they would have rolled out Scenesse across the whole of Eurpoe by now! And PW said himself a couple of months ago they were addressing final arguments with authorities. But the annual report has made it clear they are dragging their feet on that progress.

Once again I think these guys really don't know what they are doing. How many of them have experience negotiating pricing re-imbursements and rolling out commercial distribution for an orphan drug across the whole of Europe? Yet we are paying them like they are experts! Normally you get what you pay for, but our management team still have their L plates on!
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landrews
Posted on: Oct 30 2015, 08:32 PM


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Posts: 362

Yes, 30 days until take off indeed! Only a few days to go now!

I remember no too long ago when he was saying that we would have pricing reimbursement negotiations completed and sales commenced in ALL EU member states by December 2015. We'll be lucky if we have $1 of sales by then.

He told me "you are a douche. great info in the report and you pick up the negative. fuck off already."

I asked him to send a summary of all the great info he see's in the report, but I'm still waiting!

Unfortunately he is blinded by the emotional attachment he has to his investment.
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landrews
Posted on: Oct 30 2015, 07:01 PM


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Posts: 362

I've also received hate mail from ANZ Investor. Unfortunately he is so insecure with his investment that he can't bear to see a negative opinion posted, even if it has merit. What's even sadder is that he lacks the intelligence to explain his rebuttal without swearing. Plus, he never actually has anything of value to say.

At least we don't have to keep hearing about all the conspiracy theories and non sencicle ramping on the public board. It's almost time his privilege to post IM's be shut off too.
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landrews
Posted on: Oct 29 2015, 11:01 PM


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Posts: 362

Yep, the question remains, who is selling and why?

My best guess is that the EMA assessment report has scared off some long term institutional investors. They see more delays with CUV, opportunities elsewhere and have lost faith in management. Now there is a serious buyer they can sell to, and they can get out / reduce exposure whilst still making a small profit. Lagoda know this and are in no hurry to push the sp above $3.00. They may even be close to maxing out their investment as volumns are dropping.

On a positive note, there should be less sp resistance now, should we ever get a good surprise like a lucrative partnership deal.

Bring on the Vitiligo results and let us know where we stand!

Good Vitiligo results will help us more than a NASDAQ listing.
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landrews
Posted on: Oct 29 2015, 09:43 PM


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Posts: 362

"Also, someone mentioned how Clinuvel doesn't have data and only has patients voices on their side for proof of Scenesse's efficacy. I would argue about the data, but irregardless what about physicians who have come out in support of it and published papers on its efficacy?"

Yes that was me. As I've said, the published results were fine, we know the drug works and it's supported by academics, physicians and patients. But from a technical stand point it is basically useless for an official submission to regulators. You don't get approval from the FDA just because doctors and patients say a drug is good! You have to submit VALID trial data at some point. That's why we have unknown delays with the FDA and that's why it's likely another 6 months of data collection, analysis and results will be required.

Why do you think they are still waiting to submit an NDA to the FDA?

What I'm saying is hardly mis-information. Have a read of the EMA assessment report.
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landrews
Posted on: Oct 29 2015, 09:04 PM


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Posts: 362

Ignoramus, after all the Facebook research you've done, what price do you think they will actually negotiate for EPP?

And when were you ever a member of the $200 sp club? You've certainly kept that one under the radar! Haha.
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landrews
Posted on: Oct 29 2015, 08:29 PM


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Posts: 362

"Then the trials were further discredited because even those that were now aware that they had received the active drug were still reluctant to venture into the sunlight because of past social conditioning and the learned behaviour over many years to avoid sunlight. So the end result of the trials was only a small incremental increase in the sunlight tolerance from those that had received the drug."

Yes the pre conditioned behaviour was one of the difficulties I was alluding to with my one line comment on that matter. And I admit that comment was poorly worded. The issue of conditioned behaviour does not discredit the trial results though. It is an explaination as to why the results were not even better than reported. If they had the time and funds to do a 2 or 3 year trial then I'd put my money on the fact that p values and extra time in sunlight would be better.

In my view the results as they stood were good enough for a regular 12-18 EMA approval process. They were not fantastic, but (perhaps besides the last US trial) they were good enough for orphan drug approval. Then we should have been off to the FDA for their approval.

The major problem became apparent when the EMA could not properly verify the data during their audit/review. That is the biggest issue we have, and that was the point I was making. Even if the p3 results were outstanding we would still be in the same predicament because the data cannot be properly verified.

I agree with your comments on PLME. It's a shame they spent big $ on a p3 trial before they realised it had no chance. That money would have been handy for a proper Vitiligo p2 trial.
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landrews
Posted on: Oct 29 2015, 04:03 PM


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Posts: 362

"Finally, why would Clinuvel need another phase 2 for Vitiligo? The one we are awaiting results for is referred to as Phase 2B. They should only need a large Phase 3 after that"

That's a good question for Clinuvel not mis information from me. They are the ones that stated 12 months ago that the next step in the Vitiligo program would be a p2 US registration trial. The first 2 trials were classed as pilot trials due to the small number of patients.

If you think Clinuvel have no control over HHD results then think again. They are supplying the drug, they should be given access to results as soon as they are available.
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landrews
Posted on: Oct 28 2015, 10:40 PM


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Posts: 362

"But I don't see the logic for clinuvel to actively pursue a vitiligo path to market in the us and at the same time go through the cumbersome fda approval process for epp"

EPP should have been a slam dunk. Safety is excellent but you have to show efficacy. With ultra rare/ orphan diseases the hurdles are lowered in terms of patient numbers. Clinuvel have probably trailed 5 - 10% of the total population. That's nearly as rare as the disease itself! It's been difficult due to the nature of the disease and that fact that patients have to risk burning themselves to see if they have the implant or not. But on the face of it, the trial data was good, and showed sufficient efficacy, thanks to the courage of patients concerned.

The fact that the data could not be properly verified by the EMA due to mis-management by Clinuvel and/or it's contractors is disgracful. Someone should be held accountable, but all we've seen is massive share issues and bonuses. I remember when they were talking up how cutting edge they were by using new electronic devices to record patient data. I suspect that was a big mistake and was not properly thought through and managed.

They have created such a problem for themselves that now they have had to spend all resources and 12 months of time dealing with the EMA's post marketing requirements. And they clearly know they have nothing tangible to submitt to the FDA besides patient testimonials. These mistakes have cost a fortune in time, appovals, sales, partnerships and share price.

But all these problems aside, if the drug actually works for Vitiligo then they should push ahead asap. It will need big p2 and p3 trials, but if they prove efficacy (and don't screw up data management) it will be worth 20 times any EPP sales.

As others have said, the Singapore results need to be good, they need a partner, and they need to tell us what the strategy is and when it will be implemented.

Enough is enough. PW needs to deliver the $1billion company he promised 10 years ago or step aside. He can't keep blaming the GFC, regulators or difficulties with the EPP disease HE chose to treat.

I hope we hear about Vitiligo before the AGM but I suspect we won't. Oh yeah, and what about the HHD trial they said would be available towards the end of 2015?

I know you are aware of most of this Royco, but just wanted to share anyway. Cheers
  Forum: By Share Code

landrews
Posted on: Oct 27 2015, 11:09 PM


Group: Member
Posts: 362

I appreciate your optimism Royco but the chairman said they had further animal studies underway in his address 12 months ago. How could it be that they've only just started them? These guys wouldn't drag things along that slowly would they? Well, on a positive note, better late than never.

I doubt Vitiligo is even on the FDA's radar yet. Ask yourself, why won't they submitt an NDA for EPP yet? Wouldn't that be a nice start for the future of Vitiligo in the US? How many EPP trials have they done? Surely they would submitt something...unless they f&cked up the data management.
  Forum: By Share Code

landrews
Posted on: Oct 25 2015, 09:25 PM


Group: Member
Posts: 362

I'm happy to submit questions in writing before the AGM, in a format that they might answer. If you have a question you want answered then please post it. I'm going to this years AGM and will report back.
  Forum: By Share Code

landrews
Posted on: Oct 25 2015, 08:37 PM


Group: Member
Posts: 362

Last year there was 11.8m "for" the remuneration report and 1m "against". About 150k "against" were mine. There's been a lot of shareholders vote since then by selling their shares. If you still own shares and want to see better communication, performance & value for money, then vote! If there's less then 1m against this year then I'll be damned.

And let's not forget all the mis-management of trial data that was covered up before the last AGM when mega bonuses were issued. Thanks to the EMA for making that public, otherwise we would never have known how our management team were really performing. That's why we still haven't submitted an EPP NDA with the FDA, and it's also why Vitiligo is still in limbo after 5 years.
  Forum: By Share Code

landrews
Posted on: Oct 25 2015, 07:58 PM


Group: Member
Posts: 362

Double post...damn I'm frustrated!
  Forum: By Share Code

landrews
Posted on: Oct 25 2015, 07:58 PM


Group: Member
Posts: 362

Well there was 1.4m performance shares issued last 12 month and there's still 1.2m to go, so when you say "not to the extent that was previously issued" I guess you are technically correct. Investor anger will be less fierce when they actually oversee a sustained increase in the SP.

It's a given that sales revenue will start to roll in, allbeit 6 months after anyone expected.. but a what price? PW suggested a possible 15k per implant last AGM. Let's see if he can deliver on that after 18 months. Personally i think he was talking BS again, but I'll be happy if he proves me wrong.

These guys keep talking about the great relationship they have with regulators but I think that is BS too. We need to hire someone who can get the job done before 2020!
  Forum: By Share Code

landrews
Posted on: Oct 25 2015, 05:24 PM


Group: Member
Posts: 362

PW said they were addressing final arguments with insurers back in the July newsletter. Why the hell do we have to wait another 6 months for first sales! Was PW talking total BS again? This team have cost shareholders a fortune with their constant delays and mis-management of trial data. They can't keep blaming the regulators forever. I reckon there's a good chance we'll see another capital raise now. When will we get an update on the Vitiligo strategy, that was promised back in March? PW said possible 3 years until Vitiligo sales last AGM...once again it seems that was total BS. The only thing he's done well is convince shareholders to give him a shiteload of shares. Freaking hopeless!!
  Forum: By Share Code

landrews
Posted on: Oct 25 2015, 05:01 PM


Group: Member
Posts: 362

I must have missed the info on performance rights being extinguished Eagle?? There's plenty more waiting to be issued once the first sale in EU occurs and then more when an NDA is submitted to the FDA. Have a look at the gifts that were approved at the last AGM. Are you still happy with the report?
  Forum: By Share Code

landrews
Posted on: Oct 23 2015, 04:14 PM


Group: Member
Posts: 362

I know how I'll be voting, and I know it won't make an ounce of difference. I'd encourage anyone one who is dissapointed with managements performance and the return on investment they've delivered over the past 10 years to vote "no". If anything, do it as a protest vote for the lack of communication us retail investors have to put up with. It's the only way we might see a change.
  Forum: By Share Code

landrews
Posted on: Oct 23 2015, 03:22 PM


Group: Member
Posts: 362

"Plans are now underway to enable access for the first patients by the coming spring and summer in the northern hemisphere"

Say no more...we have another 6 months to wait. No wonder there is a never ending supply of sellers at $3.00.
  Forum: By Share Code

landrews
Posted on: Oct 5 2015, 05:22 PM


Group: Member
Posts: 362

Sorry, when I say APA I meant APF.

Looking forward to the AGM. Waiting for the date to book a day off!
  Forum: By Share Code

landrews
Posted on: Oct 5 2015, 04:21 PM


Group: Member
Posts: 362

Yep, it feels like some sort of unofficial pow wow that could have happened 2 years ago, and probably only eventually occurred due to the APA's efforts.

If Vitiligo is good then realese the results so we can get a serious partner and make some progress. With EPP, Vitiligo & all the stuff that Uho comes up with!

And some people wonder why the SP is in the gutter!
  Forum: By Share Code

landrews
Posted on: Oct 5 2015, 02:33 PM


Group: Member
Posts: 362

Another announcement by Clinuvel that raises more questions then answers!

What existing QOL data are they referring to, and why don't the FDA have this already? It's been 2 - 3 years since the last p3 trial was completed.

"Expert European & US clinicians were invited to share their experience" - were they at that meeting, or have they only just now been invited to a future meeting, and if so, when will that meeting be held?

How long will it take the FDA to review this data and have their discussions etc - they must have given some sort of timeframe? When do they expect to submit the NDA?

Sounds like the APA have done an exceptional job getting Clinuvel this meeting. It's a pity their hopes a pinned to a bunch of amatures and a hard arse FDA!

What about Singapore results and a Vitiligo p2 in the US?? If they have an ounce of respect left for shareholders then they should be typing that announcement right now. Good or bad, JUST TELL US what TF is going on!

Surely they are not hiding bad news before another capital raise?
  Forum: By Share Code

landrews
Posted on: Oct 1 2015, 10:03 PM


Group: Member
Posts: 362

Unfortunately the FDA don't seem to give a shit about Clinuvel, EPP patients, or our potential to treat Vitiligo. My guess is they would have said, do your European p4, we'll have a look, and then you can apply for an NDA for EPP here. Hope I'm wrong and the EPP patients voices are being heard.

As you'v said, we'll need some serious funds to do a P2/3 Vitiligo trial. Singapore results need to be good, and we need to hear about them before the AGM. Tick tock!

Partnership deal....bring it on!
  Forum: By Share Code

landrews
Posted on: Oct 1 2015, 04:28 PM


Group: Member
Posts: 362

I agree. No one is being fooled by the bots trading at open/close. I reckon Mr Dickey & Co have bought most shares this week. I'd do the same if I could afford it (despite management). If they keep buying at this rate we'll get another notice in the next week or two (450k is a 1% increase). They probably have another 250k by now.

But who's selling? Some say it's the second mystery investor that bought from Retrophin. If Dickey wanted the extra shares why didn't they offer Retrophin a higher price for another 1m off market? And if they did, why wouldn't Retro accept?

Or is someone else selling? If you can afford to wait 6 months then selling seems like a bad move, particularly with a serious buyer snapping up shares in the 2.60 - 3.00 range.
  Forum: By Share Code

landrews
Posted on: Sep 29 2015, 08:15 AM


Group: Member
Posts: 362

I'll never understand why PW continues to give investors false or misleading information.

Nearly 3 months ago he said they were addressing "final" arguments toward authorities and insurers to include scenesse for re-imbursement. To me that implies that fillings have been done, evidence has been presented, discussions have occurred and their final arguments to support the proposed reimbursement price are being put forward.

Now they are telling patients that filings and discussions are only just now occurring, and presentations from patient groups will still be required (but god knows when). That could easily take another 6 months. Clearly they are having trouble justifying the price they want. They've had nine months to deliver on this and once again have performed like amatures.

When will they stop making excuses about it being a complex process. If it's too complex for them maybe they should employ a CEO who has done this before and knows what they're doing!

No wonder we rarely get updates, they must be too embarrassed to tell us what's really going on, because they don't know themselves.

Feels like Groundhog Day!
  Forum: By Share Code

landrews
Posted on: Sep 18 2015, 05:58 PM


Group: Member
Posts: 362

LJS, thanks for you posts, but can u hit return on iPhone to make some paragraphs. Much easier to read then. My posts are all on a phone too so riddled with spelling mistakes etc. cheers!
  Forum: By Share Code

landrews
Posted on: Sep 18 2015, 05:31 PM


Group: Member
Posts: 362

We are no doubt due for some news in the next week or two.

A positive PRAC decision probably won't do much for the SP. Who expects further delays at the point anyway?

The reimbursement prices will be key, and the number of countries they have negotiated with. PW said in the last newsletter that they were addressing FINAL arguments towards authorities & insurers (plural). If that's true then they should actually start selling in the next month or two.

The market will expect 7,000 euro per implant, if it's more then we will see a SP rise. Patient numbers are also unknown and that won't be confirmed until we actually treat them. 6 months before we see that in the financials.

Hope I'm wrong but I don't expect much on the FDA front. I sense they want data from the European roll out before anything progresses there. I suspect this is why Vitiligo progression is "intertwined" with EPP. Show us data in more than a few hundred patients and we'll let you do a serious Vitiligo trial.
  Forum: By Share Code

landrews
Posted on: Sep 16 2015, 10:44 PM


Group: Member
Posts: 362

I've never been bothered to post cross forum comments in the past but I'm a bit board waiting for PW & co to deliver something...anything, so here goes!

An absolute gem from GG "Being patient does not mean waiting ten years, and then reacting, it means to forever be patient. Be patient always"

It's almost as if PW is talking to us himself. And this is from someone who talked up a $200 SP for more than 10 years and then just before the approval announcement in Oct last year, predicted a negative decision....a decision that would have resulted in a 50c SP.

The blind faith that is given to PW by these people after 10 years is almost laughable. PW wouldn't even answer a simple question Uho asked during the investor teleconference last year.....have you thanked him for that yet?

Uho, how long will you support this management team before you accept that maybe there are better options? Do you really think we should give PW an unlimited timeframe with unlimited pay?

We all know the drug works and has $billion opportunities. Do you want to see this potential realised by Clinuvel or not?
  Forum: By Share Code

landrews
Posted on: Sep 11 2015, 10:14 PM


Group: Member
Posts: 362

Sorry to harp on this Royco. You mentioned that only since 2015 has PW's interests been aligned with shareholders.

Back before PW got really greedy, he was issued with share options. If the SP rose above a set price, then he would be rewarded. He could exercise his options and make lots of money....if the SP went up above the strike price. If that isn't aliging his interests with shareholders, then I don't know what is.

Unfortunately for PW after 5-6 years he couldn't oversee a rise in the SP, so his options were worth nothing and expired. That's the way it should be. Deliver nothing, get nothing!!

Now the board give him shares and cash for free! How much should we give him before his interests are truely aligned?
  Forum: By Share Code

landrews
Posted on: Sep 11 2015, 05:16 PM


Group: Member
Posts: 362

The meeting highlights won't be made public until Monday evening 8-10pm AEST (however they may not include specific details on Clinuvel). I could be wrong, but I expect an announcement from Clinuvel before open of trade Tuesday morning...if it's positive. Hopefully they couple it with a positive update on reimbursement negotiations/pricing.
  Forum: By Share Code

landrews
Posted on: Sep 10 2015, 06:22 PM


Group: Member
Posts: 362

So at $1.7m p/a you think we've received good value for money? How much would it take before you would say he's been over paid? What if this goes on for another 10 years before we get rewarded with Vitiligo approval. There's not guarantee the minute sales from EPP will do wonders for the SP. But you can guarantee he'll be getting more pay rises and bonuses.

Some think that PW is the only person that could have raised capital and led us to orphan approval allbeit after 10 years. I disagree, and I'd go so far as to say, he's been learning on the job, every step of the way. That's why it's cost shareholders so much in time, and dilution. He's been paid as a pro, but has executed like an amatuer.

Shareholder deserve to see some rewards before he gets any more fat pay cheques or bonuses.

Also, why don't they hire a PA, tell him to delegate some work, and take some annual leave every so often.
  Forum: By Share Code

landrews
Posted on: Sep 10 2015, 02:53 PM


Group: Member
Posts: 362

PW has advocated for both...and it seems he's received everything he's asked for.

Believe it or not, this is what he's been paid since he became CEO.

Salary $5,700,808

Bonuses $3,254,177

AL cashed $ 298,827

Super $ 117,590

Expenses $ 604,886

Shares/Options $7,271,267

Total $17,247,555

And.. as others have pointed out, during this time, the SP has nearly halved, and our ownership has been diluted by a similar %. He has not met any of his own deadlines and his communication has been appalling.

It's almost criminal that he's been paid $3.2m in cash bonuses!


  Forum: By Share Code

landrews
Posted on: Aug 31 2015, 07:57 PM


Group: Member
Posts: 362

"The company commenced a non-clinical chronic toxicology study towards the end of the financial year as part of its USA vitiligo development program."

Anyone know why this is necessary and how long it might take, and why they've only just started it? I thought the additional lab testing etc preliminary to the next vitiligo trial was supposed to be well underway as at the date of the last AGM??

Sounds like we still have some waiting to do for Vitiligo.
  Forum: By Share Code

landrews
Posted on: Aug 28 2015, 08:49 PM


Group: Member
Posts: 362

In case you didn't notice I'm I a jovial mood tonight, don't take my posts too seriously! Yes of course the SP can go down. Most trades today were at $2.60 but it was nice to finish on a high albeit with small volume.

I think we should all give ignoramus a thanks for acting as a circuit breaker on this board! I don't know what we'd do without him. It's possible if he wasn't here we could mistakenly talk each other into buying more shares!

It's nice to know that he has our best interests a heart though.

  Forum: By Share Code

landrews
Posted on: Aug 28 2015, 07:58 PM


Group: Member
Posts: 362

I wouldn't pay too much attention to the comments of the chairman. He clearly should have said "will soon" be a reality. If one thing is for sure, the staff at Clinuvel have a terrible record predicting what the regulators will do. They must be confident of positive decision in Sep though, god help us if they're not!

I cant wait for the first re-imbursememt announcement, hopefully in October. Then it's game on!
  Forum: By Share Code

landrews
Posted on: Aug 28 2015, 06:40 PM


Group: Member
Posts: 362

No chance at all, this ship has sailed...you will regret not increasing you bid today, for the rest of your life!! Unless of course ignoramus breaks up with his red head girl friend!
  Forum: By Share Code

landrews
Posted on: Aug 28 2015, 05:22 PM


Group: Member
Posts: 362

The SP closed up 14% today.

If the stock price merely reflects the facts, then can you explain what facts changed today to produce this gain?

Was it something to do with you chatting up red heads!
  Forum: By Share Code

landrews
Posted on: Aug 21 2015, 08:11 PM


Group: Member
Posts: 362

PW....if you don't deliver a treatment for the Vitiligo on the Penguin's belly soon, then we might all go crazy! Hurry up!!
  Forum: By Share Code

landrews
Posted on: Aug 8 2015, 07:14 PM


Group: Member
Posts: 362

Retro ain't integral to Clinuvels past, they pushed the SP to $5 pre approval when Martin was in charge, then smashed it down when Martin was sacked, and have been trying to get out ever since, with no regard to the Clinuvel's prospects. We'd probably be at $5 now if it weren't for them dumping shares post approval. In 2-3 months time they will be irrelevant.

I'm happy to read a few words about retro, but anyone who continues to suggest we've missed the boat by not accepting their takeover offer is talking BS.
  Forum: By Share Code

landrews
Posted on: Aug 7 2015, 09:13 PM


Group: Member
Posts: 362

I think the attitude is; better the devil you know that the devil you don't. Scenesse simply hasn't been administered to enough patients yet to confirm what the side effects may or may not be. Off label use will be massive....eventually, the regulators know this...they are not naïve.

The EMA have locked down this risk with conditional approval, I'll be (pleasantly) surprised if the FDA don't do the same.

If this company is delaying FDA submission due to lack of resources, then they should hire more staff, or we should fire the board. This snail like pace can't be tolerated any longer.

Oh, and to all the posters who keep banging on about Retrophin's SP. If you have so much faith in that company then why not sell your CUV and invest in them? Then you can post on their board, if they have one. Sure, you could have made a 4-5 bagger if you invested at the right time, but would you really take that and snuff out any potential you have with Clinuvel? I suspect not as most of you are still here!
  Forum: By Share Code

landrews
Posted on: Aug 7 2015, 05:56 PM


Group: Member
Posts: 362

I don't quite see the contradiction. The regulators know as well as everyone else that orphan drugs won't be developed unless there is money to be made. There are reduced requirements in terms of trial patient numbers, proof of efficacy / safety etc, and you can charge a premium once you get approval. But you still have to submit some valid trial data to get approval.

After 10 years Clinuvel still doesn't have enough valid data to submit an NDA to the FDA. Otherwise they would have done so.

If the FDA are pushing back on EPP then there is zero chance of early access for Vitiligo - IMO.

Scenesse will have to be trialled on thousands of Vitiligo patients in phase 2 and then phase 3 trials before it has a chance of approval for that, and the efficacy will need to be good. Funding free compassionate use for EPP won't change that.

Vitiligo is not a life threatening disease.
  Forum: By Share Code

landrews
Posted on: Aug 7 2015, 05:13 AM


Group: Member
Posts: 362

Hi Royco

You are suggesting that Clinuvel's next trial in the US will be a Vitiligo p3, however the company has previously stated that they will need to do another p2.

IMO vitiligo approval is therefore still 6 years away. That's plenty of time to make some money off US EPP.

I don't see why they would want to cover the cost of compassionate use for every patient in the US. That would be very expensive.
  Forum: By Share Code

landrews
Posted on: Aug 1 2015, 01:38 PM


Group: Member
Posts: 362

There was nothing noteworthy about the cashflow that wasn't covered already, although some posters still seem to confuse "sales" with "cash receipts". Retrophin selling out is the news item of the week. I'm surprised you still don't get that.

The NEJM would have had no influence on such a pharma savy board as you call them. There was nothing new in that article that wasn't already known.

IMO Retrophin sold as many shares as they could without completely tanking the SP and taking a big loss. They would have stopped selling when they realised they needed to find an off market buyer due to low volumns. If they continued to push down the on-market price, their bargaining position would have been weaker when negotiating the off-market sale.

For someone who likes to chatter on this board so much I find it strange that you aren't willing to share you reasons for remaining invested.
  Forum: By Share Code

landrews
Posted on: Aug 1 2015, 10:52 AM


Group: Member
Posts: 362

1. Not worth discussing
2. The fact is, you are one sided. Whether the SP goes up or down is irrelevant.
3. My argument is not nonsense, your just saying that because you know I'm right and don't want to admit it! It's economics 101 supply vs demand.
4. Not worth discussing
5. There was never going to be a second takeover offer. That was obvious when retrophin started selling shares. Try not to confuse your dreams with reality.

Is there any reason left now as to why you are invested?
  Forum: By Share Code

landrews
Posted on: Jul 31 2015, 07:59 PM


Group: Member
Posts: 362

You say "I see no value in taking a one sided view in any company" yet that is exactly what you are doing!

I made a perfectly reasoned argument as to why most investors see Retophin's exit as a positive yet you say that I just don't get it!

Quite an ironic statement for someone who admits they are ignorant on the subject!

Your reasoning for expecting a Retrophin takeover is lame given the history that is publicly available. The skill set of the boards is irrelevant in this conversation.

Finishing with the comment "good luck with you investment" is something you say when you've lost the argument and want to end it!

Sometimes I do see some value in your comments, but not this time. I hope I don't fall out of your top 10 after this post!
  Forum: By Share Code

landrews
Posted on: Jul 31 2015, 05:36 PM


Group: Member
Posts: 362

Why all the joy? It's pretty simple. When one of the largest shareholders starts selling shares in a thinly traded stock, and publicly announces they intend to liquidate the remainder of their position as soon as they are able, the SP goes down, and stays down until they are out.

Now that they are out there's a much better chance for the SP to run up if/when we get some good news. Most investors would see this as a positive.

You didn't seriously think they were going to launch another takeover bid did you?
  Forum: By Share Code

landrews
Posted on: Jul 30 2015, 05:43 PM


Group: Member
Posts: 362

Yeah I noticed that too, I think you're correct. Otherwise we would have seen another notice on the ASX today.

We might see them listed in the top 20 shareholders summary in the annual report.

If the shares are legally held by a trustee/nominee then we may never know who really owns them unless they crack 5%.
  Forum: By Share Code

landrews
Posted on: Jul 30 2015, 11:19 AM


Group: Member
Posts: 362

They have 2 business days to report, so we should find out by tomorrow at the latest.

Personally I think Retrophin have sold and I'm glad they're out. The SP would have been higher than it is now had they not been dumping shares post approval.

Very interested to see who the buyer is at $2.40. Presumably if they are willing to buy 2.6m shares off-market, they would be happy to buy some more on-market if the price dips to $2.40.

It's not a bad risk/reward trade off to buy in now, despite management incompetence.
  Forum: By Share Code

landrews
Posted on: Jul 27 2015, 02:50 AM


Group: Member
Posts: 362

.
  Forum: By Share Code

landrews
Posted on: Jul 16 2015, 05:28 PM


Group: Member
Posts: 362

You can't be serious!!

If you can't charge a premium for spending $100's millions on an orphan disease, then those sufferers will never have a treatment.

Wouldn't that be a greater travesty?
  Forum: By Share Code

landrews
Posted on: Jul 16 2015, 02:50 AM


Group: Member
Posts: 362

Yes the "intertwined" comment was very strange.

Perhaps the FDA also want results from the new animal studies before Clinuvel submits anything further.

Thus submission of the EPP dossier, and approval to commence the next US Vitiligo trial, could both be dependant on these results, amongst other things.

I also thought it was strange how they stated there were a number of reasons why they pursued EPP approval in Europe first, and then they continue on without giving any reasons.
  Forum: By Share Code

landrews
Posted on: Jul 15 2015, 07:38 PM


Group: Member
Posts: 362

Geezz.... the delays continue!

Here's my (pessimistic) summary

European Release of Scenesse

After 9 months we've nearly established a disease registry. It was very hard and required multiple reviews by the EMA, because it's different to what has ever existed. What we really mean is, we've never done it before, had no idea what was involved and how long it would actually take.

Don't expect off-label use because they'll be watching us like hawks.

The good news is these barriers gives us a competitive advantage. We know that's irrelevant due to market exclusivity....but let's look on the bright side.

US Program For EPP

The FDA have seen the EMA's public assessment report and have said not to bother submitting an NDA until we have final analysis from the Singapore trial, HHD trial, and 6 months of safety data from EU distribution... see you again in a year or two.

Vitiligo progression is intertwined with US EPP, so expect similar delays with that too.

Vitiligo

We're holding off telling you anything until we have final results from Singapore. The truth is, we don't know what we're doing after the not so good feedback from the FDA, and need to buy some more time to figure it out.

Intrinsic Value

Trust us, the stock should be worth even more then it was last time we spoke to you...our team is awesome, and deserve all their rewards.

We will negotiate a price for Scenesse in Europe, but don't expect to it to be as high as I suggested at the last AGM, I've since found out that there is pressure to curb health care costs.....and the EMA assessment report sucked!
  Forum: By Share Code

landrews
Posted on: Jul 2 2015, 05:32 PM


Group: Member
Posts: 362

Can you share with us how it is that you've been accessing afamelanotide for the past 5 years?
  Forum: By Share Code

landrews
Posted on: Jul 1 2015, 08:59 PM


Group: Member
Posts: 362

Agree with most of your comments. However I don't think that off label is "unlikely or impossible" with the implant. Just need unrestricted approval for EPP in the US, or Vitiligo approval somewhere. Topical sales will be 20 fold, but that is a different drug and it won't be marketed for 10 years plus (if it actually works).
  Forum: By Share Code

landrews
Posted on: Jul 1 2015, 06:46 PM


Group: Member
Posts: 362

Mullo, you're sounding like the most ignorance tool we've had here for a while. If you don't hold, have intention to buy, and have no idea about the stock and its prospects then stop posting your opinions! Watch, research & learn for a while.... maybe then you can post something intelligent.
  Forum: By Share Code

landrews
Posted on: Jul 1 2015, 06:16 AM


Group: Member
Posts: 362

Royco you seem to be suggesting that Vallaurix and its topical treatments are the only hope we have for blockbuster sales and an increase in the sp.

I sure hope not because it will be at least 10 years before Vallaurix starts selling anything.

What about Vitiligo treatment with Scenesse and the eventual flow on in off label sales? That seems like the best prospect for now (pending results in Singapore), or are you expecting the results to be poor?
  Forum: By Share Code

landrews
Posted on: Jun 30 2015, 06:06 PM


Group: Member
Posts: 362

Yep, we need solid Vitiligo results, and a creditable program to approval within 5 years (nearly 4 years now as promised at the last AGM), otherwise we're no closer to serious returns than what investors expected 10 years ago.

Every day that that passes without comment on the Vitiligo strategy raises more doubt in my mind. EPP ain't gonna make anyone filthy rich, and they clearly don't have resources to trial for other lucrative indications.

A serious partnership deal would change CUV's prospects, be seems unlikely for a while.

I hope we're not here in another 10 years saying the same thing.

Sad to say again, buy maybe some sales today were to realise capital losses to offset gains in the rest of investors' portfolios!

Next year will be the year for CUV.....surely!
  Forum: By Share Code

landrews
Posted on: Jun 26 2015, 12:02 AM


Group: Member
Posts: 362

And maybe if they hadn't of f@cked up data collection in the PIII trials, European EPP sufferers would've had access to the drug 18 months ago. And US patients would be very close to having access as well. God help the paediatric patients, most will be 18 by the time VLRX gets anything approved.

Kind of a desperate bluff saying that, if you use the black market product then we won't give you our drug (if we ever actually start selling it). Yeah right..they'll be selling to as many EPP patients as they can. It only takes two months for the effects to wear off, how will they police that.
  Forum: By Share Code

landrews
Posted on: Jun 23 2015, 06:27 PM


Group: Member
Posts: 362

Spot on Seeva.

The wait continues.

The Vitiligo update is way overdue. If I was to be exceptionally optimistic I would suggest that the interim Vitiligo results are known, they are good, and management are in negotiations with potential partners to fund the US trials, and this will be announced soon.

Unfortunately the SP doesn't support this theory. Either there have been no leaks, or Vitiligo is on the back burner to focus their limited resources on EPP in Europe.
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landrews
Posted on: Jun 18 2015, 07:58 PM


Group: Member
Posts: 362

From RC today

"Again, I'm just learning as I go......."

Yes, we all are to some extent, Clinuvel is a unique investment. However you seem to have a steeper learning than most.

Many investors have been in this stock for a long time (some much longer than me), and have learnt how to read this management team, they also have a solid understanding of the timelines involved with progression from here. Silence from Clinuvel is not good, it means delays, regardless of the best efforts from D Lyons. PW said Clinuvel would be a $1b company by 2010....tick tock tick tock...you probably don't get that.

I don't mind optimistic predictions, as I've had (and still have) plenty of my own. But when you continually bang on about unrealistic projections, and dismiss anyone who disagrees, you are bound to get negative feedback.

If your aim from posting so often is to push up the SP, then you are failing dismally.

You should take on board some of the "negative" feedback you get. It will help you post more realistic projections. Maybe then your "positive" comments will have more credability.

This forum seemed to be a lot more civil whilst you were on a break.

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landrews
Posted on: Jun 18 2015, 02:50 AM


Group: Member
Posts: 362

She's not wasting her time at all, she's raising awareness and improving Clinuvels/EPP patients chances of success when the time comes for the FDA to eventually make a decision.

I still don't see any possibility of US sales prior to the submission, assessment and approval of an NDA though. Maybe she should lobby Clinuvel to get rolling on that.
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landrews
Posted on: Jun 17 2015, 08:40 PM


Group: Member
Posts: 362

Some gem's from Mr Dalton today.

"There is not a country in the EU that will not reimburse, and there is not a FDA member that will not approve. Once Scenesse is distributed and a track record is built, the regularatory restrictions will be loosened and hello to off-label use (quiet and don't tell the regulators). Whether it be for sun related protection, a simple good tan, or just an extended erection, scenesse will have a lot of demand. I'm in until $100, and then I will reevaluate my options"

Hahaha...some of the worst stock pumping you'll ever see! If you had any more sense than RC you would at least know that Scenesse does not cause erections, there's a different company with a different drug pursuing that. I won't bother telling you why your off label predictions are BS as it's been covered in detail here recently.

I also laughed when I read this prediction:

"It's been a long road but all will be known in just a few short months."

Utter nonsense. You are all out of credibility.
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landrews
Posted on: Jun 16 2015, 07:29 PM


Group: Member
Posts: 362

I like your idea about giving Wolgen 12 months and then judging performance. You need to set some KPI's though.

I see you have't ruled out a June FDA filing yet, should that be the first KPI? After all, it's been 3 1/2 yeas since the EMA filing, and the U.S. P3 was completed 18 months ago? Or should we give some more leeway given the "issues" with data collection in the EU trials?

Start of EU distribution in Sep sounds like a good one. I'd be happy to give him until Oct or Nov at this point, but it's likely to be Jan 16 onwards.

Starting the next U.S. Vitiligo trial is a big one, would you say that should start before Dec 2015? So far we've waited 2 1/2 years since results from the last U.S. Trial.

What about Singapore results? You say the trial started in Sep 14, but It was actually commenced in May 14. When should we have final results for that? Oct/Nov 15?

Should they try and seal a lucritive partnership deal so some of the other possible indications can be progressed and realised in the next 10 years?

Oh yeah, what SP should be attained after nearly 10 years as as CEO? Would you say $10 plus? It was $3 - $4 when he took over.

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landrews
Posted on: Jun 5 2015, 10:27 AM


Group: Member
Posts: 362

You gotta feel for the EPP patients....another summer without Scenesse. It sounds like they have covered off on the training to everyone that attended the conference. That's good, I thought they might have to visit individual centres for this.

Hopefully they will have completed pricing negotiations with at least one or two countries by September and can start selling in Oct/Nov.

Now, how about an update on Vitiligo and the US submission? Also, as you say, they should have interim results for the Singapore trial and the HHD trial, how about sharing that with us?
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landrews
Posted on: Jun 5 2015, 02:33 AM


Group: Member
Posts: 362

Wolgen talking about the importance of being open with payors and providers suggested to me that Clinuvel has information that is not helpful to their negotiations, and that a "lessor" CEO would want to hide.

Maybe I'm just reading into this too much! To be honest I never read the whole article from the link Royco posted as the Financial Times link was broken when I checked it, and still is.

Regardless, we should hear some pricing news in the next few months, if it's north of 10,000 euro the SP won't stay at $3.00 for long!

Also CUV052 is only expected to test 12 EPP patients, I guess it's possible this trial could get underway with some Italian or Swiss patients, prior to completion of pricing negotiations elsewhere.

The larger post marketing safety trial will have to wait though.
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landrews
Posted on: Jun 4 2015, 08:05 PM


Group: Member
Posts: 362

Good points Madman. I also expected a higher implant price of 10,000 euro plus after PW's AGM comments. But now after his comments on being honest and upfront with authorities, the botched trial data and their weak negotiating position, I'm expecting about 6,000.... hope I'm wrong, the patient input will no doubt be a positive.

Also hope CUV 052 is underway but doubt it. If it is, I don't understand why they wouldn't tell us, have you heard about this?
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landrews
Posted on: Jun 4 2015, 07:44 PM


Group: Member
Posts: 362

Yes I agree, you can move the price 10% by trading only a few shares, but who isn't aware of this? It's a thinly traded stock and has been for most of its history. If you somehow think a trade of 7 shares tricked someone into selling 230,000 shares at a lower price the next day, then think again.
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landrews
Posted on: Jun 4 2015, 07:01 PM


Group: Member
Posts: 362

There was a 100k buy order at $2.50 hanging around for about a week. It's now gone so I assume they were keen enough to pay $3 the other day.

I'll never understand why some people continue blame manipulation for a poor SP.

IMO the stock is currently priced on the following factors:

- Data from two pivotal EPP trials was ok, but cant be verified properly, so technically useless for FDA submission, expected wait for US filing now 12-18 months.
- European rollout taking time as expected, likely number of EPP patients in 12 months following start of distribution about 650.
- Expected price per implant similar to current prices in Italy & Switzerland.
- No takeover or partnership deal on the horizon.
- Next Vitiligo trial unlikely to start until 2016.
- VLRX investment worth nothing, as minimum 10 years from commercialisation.
- Not enough to capital to start trials in further potential blockbuster indications.
- Management team that are inexperienced and don't ever deliver on their own timelines (no matter how near or far).
- Management team that do not know how to communicate to stakeholders.
- but, an AWESOME DRUG with excellent safety profile and a multitude of potential blockbuster indications.

If news is released to show a substantial change in any of these factors, then maybe we'll see a serious movement in the SP. I'm tipping the last one won't change, so surely the SP can only go up from here!
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landrews
Posted on: Jun 1 2015, 03:40 AM


Group: Member
Posts: 362

I said applying a multiple to sales is inherently flawed because you can end up placing a value on a business that may never even make a profit (I think you'll agree this is the least preferred method), although I do accept that it is used.

If you've followed this site long enough you'll see there's been plenty of people apply P/E ratios to sales.

You seem knowledgable on the subject of valuations. What is roughly an appropriate multiple for Clinuvel using your favoured method then? Also if you were using the dcf method what equity risk rate would you use for a pre profit biotec?

Do you think the stock is under priced and if so by how much?
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landrews
Posted on: May 31 2015, 11:08 PM


Group: Member
Posts: 362

Well how much do you think the EPP treatment will sell for after exculusivity ends? Maybe a few hundred dollars...it will be worthless. Hopefully we'll have vitiligo up and running by then, but we're not trying to value that. BTW, using dcf, an annunity over 10 years discounted at 15% is valued at about 5.6 times the annual cashflow amount (net that is, after expenses).
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landrews
Posted on: May 31 2015, 10:31 PM


Group: Member
Posts: 362

I reckon a discount rate of 15% would be fair for a pre profitable biotec. What dcf value would that translate to for EPP based on your expected earnings for term of exclusivity?
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landrews
Posted on: May 31 2015, 09:45 PM


Group: Member
Posts: 362

Multiplying sales to value a company is inherently flawed as a company which is unprofitable making continual losses, is still given a value. I'm not saying CUV won't make a profit, clearly it will, but people here seem to throw around P/E ratios without considering expenses at all. And when they start to crunch vitiligo numbers they don't consider that we will likely only receive a 20 - 30 % royalty (if we're lucky). People estimate what they think sales might be in 2 - 3 years, multiply that by a PE ratio and wonder why the SP isn't there yet.
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landrews
Posted on: May 31 2015, 09:12 PM


Group: Member
Posts: 362

We had reports like this a couple of years ago, and they were so bad that you knew CUV wasn't being taken seriously... nothing has changed!

If you're crunching numbers like that, maybe you should factor in the extra 2m shares that will be issued to management before you see any profits.

BTW when multiplying to get a valuation you should use earnings per share, not revenue, earnings is AFTER expenses. No one seems to think Clinuvel will have any expenses once they start selling.
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landrews
Posted on: May 31 2015, 08:27 PM


Group: Member
Posts: 362

Nice find NTC, but history shows that the analysts covering CUV know less about the stock than the average poster on Sharescene. Their analysis and projections are based on nothing more than what they garner from the website / ASX announcements (and they've probably only read the last 18 months worth) I doubt they have even spoken to management, and I'd trust in RC's posts more than their reports. In short, they are garbage! Probably some work experience kid doing his first report. Don't spend too much time trying to decipher it!
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landrews
Posted on: May 31 2015, 08:02 PM


Group: Member
Posts: 362

Sorry, I'm nearly done bitching, but I think I also heard we'd get an update on the Vitiligo program shortly (about 3 months ago). Maybe they're still too busy jumping for joy after the share bonuses at the last AGM!
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