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macgyver
Posted on: Today, 03:59 PM


Group: Member
Posts: 358

Well, an interesting day all in all. Had to discard some underwear I soiled before midday but otherwise emotionally stable now. Hope we don’t see a repeat tomorrow otherwise it’s down to Target to restock the top drawer.

Looking to break $30 tomorrow, or something...
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macgyver
Posted on: Today, 01:34 PM


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Posts: 358

I’m glad about the focus on the US rollout. Experience gained in Europe with experienced managers facilitating the US rollout should bode well regards expedition and execution. Speaks to confidence in the submission though I’d guess it’s S.O.P as well. Can’t wait for them to hit the ground running the day after approval😜
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macgyver
Posted on: Today, 01:31 PM


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Posts: 358

I thought the comments made by someone just after market open about pushing through $30 by midday and the wild drop in price around that time was more than coincidental IMHO. Beware of falsehoods in this forum. Hang on for dear life...
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macgyver
Posted on: Yesterday, 01:42 PM


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Posts: 358

Ooh maybe, fascinating isn’t it? Is there another lid at $30 I wonder?...
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macgyver
Posted on: Yesterday, 10:23 AM


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Posts: 358

$432? Thats a very friendly takeover wub.gif
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macgyver
Posted on: Yesterday, 10:07 AM


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Posts: 358

An announcement coming tomorrow Hamster? Someone is keeping a lid on the share price today.
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macgyver
Posted on: Mar 18 2019, 09:08 AM


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Posts: 358

Attached Image

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macgyver
Posted on: Mar 17 2019, 04:42 PM


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Posts: 358

edit
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macgyver
Posted on: Mar 17 2019, 04:40 PM


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Posts: 358

I guess a takeover would be a waste of time for the would be raider if they offered $200. That extinguishes all future upside for the next 5 years.
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macgyver
Posted on: Mar 15 2019, 04:02 PM


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Posts: 358

I’m not sure what he’s arguing about either. My point was that, beside the fact it’s a given there is a large buyer doesn’t take away from the fact someone has a lot to sell. Since it was settled after market (which is not the first time such a large volume has settled this way), I take it to be that it was a prearranged deal. It makes sense to suspect it was Fidelity, and it’s not unreasonable to suspect PW may have had a part in this trade either given his recent tranche of newly issued shares. Speculation of course, but given the recent sales by some of our esteemed colleagues after many years of waiting, PW is probably wanting to enjoy the love a little as well...
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macgyver
Posted on: Mar 15 2019, 03:22 PM


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Posts: 358

WTF just happened??

Either the instos dumped to finalise their offload or PW dumped his recent issue..
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macgyver
Posted on: Mar 15 2019, 12:09 PM


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Posts: 358

Someone’s turned the Hoover on and it’s sucking up everything in its path...
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macgyver
Posted on: Mar 15 2019, 10:29 AM


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Posts: 358

Lot of cross trading going on....
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macgyver
Posted on: Mar 12 2019, 02:12 PM


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Posts: 358

Depending on your tax bracket in Australia, it would be 25% if you held the stock more than 12 months (50% discount) and sold all at one time if you were in the top tax bracket (which I would surmise a lot of Aussie folks here would be if they sold in one fell swoop).

Does anyone have tax strategies in Australia to lessen the tax burden? Only capital losses or selling small parcels yearly to minimise gross yearly income can reduce capital gains tax..
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macgyver
Posted on: Mar 12 2019, 02:06 PM


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Posts: 358

Congratulations Johnny, everyone on this board deserves the best for having faith and holding on to this stock. Regarding the Ford, everyone has a price😉😄
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macgyver
Posted on: Mar 7 2019, 01:16 PM


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Posts: 358

Late rally starting X-Ray😉
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macgyver
Posted on: Mar 4 2019, 11:32 PM


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Posts: 358

I see your point @Seeva222. It does appear being in IR can do wonders for your career as our esteemed colleague Frogster pointed out. Lachlan graduated by being the worst IR of all time and ended up becoming general manager for Clinuvel in Europe!
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macgyver
Posted on: Mar 4 2019, 01:50 PM


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Posts: 358

Well Mr Bull, it looks as if you have been indoctrinated by PW already in your first outing as investor relations manager.

Mr Bull: "Well PW, I think we can add a bit of pizzazz here and there and maybe divulge a bit more information about what we are doing at Clinuvel?"

PW puts Mr Bull in a trance: "Look into my eyes and repeat after me: We will only rehash old info to make it look like we are being proactive with our investor relations but not actually giving out anything new. You will do this every time you here the following words - 'Investor Relations'....
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macgyver
Posted on: Mar 2 2019, 09:54 AM


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Posts: 358

Indeed. Also with CUV9900 and VLX molecules there could be other applications from a medicine perspective besides adjunct therapies for vitiligo or OTC products. I enjoyed reading about the bull scenario share price in particular in Peter’s excellent report.

Given HHD and other potential candidate diseases for Scenesse indication, I’m wondering if it will be a good problem to have in the future for PW to decide whether to grant broader access to Scenesse, which would make it harder to control distribution. When 1000s of patient’s descend upon a hospital or other approved treatment centre for administration of Scenesse something has to give because either a terminal backlog of patients builds up waiting treatment, or hospitals and the like refuse to partner with Clinuvel because of the financial, administrative and staffing burden placed upon them.

I won’t say the bogeyman words yet, only: Decisions, decisions....
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macgyver
Posted on: Mar 2 2019, 08:34 AM


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Posts: 358

https://www.debra.org.au/what-is-eb/

A webpage explaining the skin disease epidermolysis bullosa. Appears similar to HHD, just watched a video about a young woman with this terrible affliction. No two ways about it, it’s bad. There’s no cure for it yet, but if the success of Scenesse with HHD is anything to go by, I think this is something where Scenesse may be of benefit. Prevalence is 500k people worldwide, 1000 approx in Australia.
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macgyver
Posted on: Feb 27 2019, 03:27 PM


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Posts: 358

Ah but Fiji is better value than the Maldives. And they’re brilliant with kids. Though I suspect value is not an issue for the some of the players here?💵💰💵💰
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macgyver
Posted on: Feb 27 2019, 02:45 AM


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Posts: 358

It would be astonishing, even miraculous if Clinuvel achieved a share price of more than $100 AUD. This minnow of a company having conquered the world with afamelanotide, becoming one of the biggest companies in Australia to boot. its mind boggling to think of this scenario.

And the funny thing is, I’m almost certain it’s going to happen...
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macgyver
Posted on: Feb 26 2019, 12:14 PM


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Posts: 358

Someone sure wants Clinuvel in the ASX 200, come on $25!
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macgyver
Posted on: Feb 26 2019, 07:12 AM


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Posts: 358

Well then, I guess the priority review will be solely about efficacy. Tick manufacturing off the list of things to do....
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macgyver
Posted on: Feb 18 2019, 05:24 PM


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Posts: 358

James Mickleboro aka The Motley Fool says he’s not a fan of Clinuvel’s shareprice. Probably the only person on Earth who isn’t a fan at the moment🤣🤣🤣
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macgyver
Posted on: Feb 18 2019, 04:17 PM


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Posts: 358

Solid volume for a Monday, hopefully a sign of things to come this week. I’m slightly suspicious (in a good way) that the volume traded is deliberate and in aid of getting into the ASX 200. Feasible? Perhaps, the timing seems more than coincidental.

On the other hand we kinda knew it was going to rise sooner or later leading up to July, admittedly I thought some of the rise was already baked in but since Sphene has Clinuvel at approx $35-42 with FDA onboard for EPP then we might see some unprecedented action in 2019.

And just to be a miser, I thought $23.80 was a poor finish😜🤣
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macgyver
Posted on: Feb 18 2019, 10:31 AM


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Posts: 358

We going to $25?
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macgyver
Posted on: Feb 13 2019, 03:44 PM


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Posts: 358

Last 20 mins of trade today was interesting..
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macgyver
Posted on: Feb 13 2019, 03:39 PM


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Posts: 358

Congrats P.D🤙 Thoroughly deserved although I would’ve recommended the next Tesla Roadster😜
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macgyver
Posted on: Feb 10 2019, 09:18 PM


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Posts: 358

Ok, I thought the reimbursement was on a six month cycle. All good.
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macgyver
Posted on: Feb 10 2019, 07:36 PM


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Posts: 358

Approx 35 patients? Nice.
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macgyver
Posted on: Feb 10 2019, 02:05 PM


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Posts: 358

Nice find Sharelooker wink.gif

I didn't input all of the Italian text into Google Translator, but I take the gist of this document is that Scenesse will be reimbursed at 14100 Euros for a period of six months then will be reassessed at that time in the Lombardy region of Italy?

I vaguely remember that certain regions within Italy were going to allow reimbursement, or rather it was at the discretion of the region in question whether to allow reimbursement. I recall 1-2 regions agreeing to reimburse, while at the same time allowing patients from other regions to come there for treatment and reimbursement so long as there was room in said region's budget for this.

It's taken a while considering how long Scenesse has been available in Italy for one reason or another (compassionate use etc), but its good to see something concrete such as this document. Consider Italy onboard biggrin.gif
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macgyver
Posted on: Feb 7 2019, 09:53 AM


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Posts: 358

One thing that struck me about the newsletter was that Clinuvel is not actively promoting Scenesse in Europe, preferring to leave it to the discretion of the patient’s doctor and the patient. It seems to me that it would actually be morally right to promote the drug in case EPP sufferers are not yet aware of the drug (remote possibility, granted).
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macgyver
Posted on: Feb 7 2019, 09:46 AM


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Posts: 358

Communication from Clinuvel is on a roll, the frequency of non newsletters is increasing... devilsmiley.gif
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macgyver
Posted on: Feb 3 2019, 09:23 AM


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Posts: 358

Given how much Clinuvel has spent on getting Scenesse to market in the E.U and now the U.S, the price is by all means fair. Only thing that bugs me is the opportunity cost of Clinuvel’s pricing strategy, that being lost earnings (no matter how low versus established price regime) and costly court battles. I imagine shortly this statement will be a moot point once FDA approval is received.
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macgyver
Posted on: Feb 2 2019, 04:32 PM


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Posts: 358

If this is accurate, it’s quite a blow to Clinuvel's European operations. I was hopeful that at least France and Spain would come on board. What is disturbing is the lack of communication from Clinuvel about these events if they indeed occurred.

I understand the one price fits all strategy, this may need revising soon however. Can’t fight multiple fires in Europe and diminish the war chest.
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macgyver
Posted on: Feb 1 2019, 09:41 AM


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Posts: 358

Yahoo huh?

Come on FDA!!
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macgyver
Posted on: Feb 1 2019, 12:35 AM


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Of George Orwell’s novels, I prefer Animal Farm to 1984, if only because animals make the bleak message behind the novel ever so slightly palatable.
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macgyver
Posted on: Jan 31 2019, 11:31 AM


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Posts: 358

I hope this isn't a precursor to what could be a slowing down of sales in Europe. We really need 6 implants to bump things along in the established countries in lieu of new countries coming on board. With Norway and the UK rejecting Scenesse, it potentially sets up a gloomy scenario receipts-wise where Clinuvel's time and expense is continually wasted fighting legal battles with those countries holding out.

5 years this year since EMA approval, and I think I speak for everyone when I say that the current number of customers/countries in Europe is woefully inadequate.
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macgyver
Posted on: Jan 28 2019, 04:19 PM


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Posts: 358

Ignoramus’ views are diverse if not downright wacky (and probably the extreme opposite of what most of us here believe) but he wouldn’t be included in an invite only forum. The beginning of confirmation bias?
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macgyver
Posted on: Jan 28 2019, 08:28 AM


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Posts: 358

I agree, shouldn’t need to go anywhere else. Sharescene has been my go-to source for many years and I appreciate all the hard detective work that’s gone into finding info pertinent to our investment. I also agree that you invite confirmation bias if you only have a select group of people who only want to read what they want, which in itself could be manipulated with nefarious purpose. Besides, starting your own group by invite only smells slightly elitist (no offence intended X-Ray), which would punish those silent Sharecafe members who come here purely to seek info. Ignoramus raising hackles is done for sport as much as anything else. Give it to him in spades😜
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macgyver
Posted on: Jan 25 2019, 10:54 AM


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Posts: 358

In that context that’s understandable, and I don’t have an issue with Q&A over the topic. It’s just on occasion someone tends to get their back up over off label generally which I think is foolish.
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macgyver
Posted on: Jan 25 2019, 09:52 AM


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Posts: 358

I totally agree, and I get annoyed when someone here tells someone else to zip up about off label use. It’s a legitimate topic and one that will always be discussed in terms of potential future earnings. I’m not looking for a tan l, I just want to make a killing on my investment same as everybody else here. The same people who despise off label talk would change their tune pretty quickly if all of a sudden off label use of Scenesse exploded and billions of revenue started coming in. Amazing what a three digit share price can do to a shareholder’s attitude about their investment.

Just because PW tells punters it is counterproductive to discuss off label use, I’m not a lemming. Discussing issues such as a crappy website and logo, minimal information (which we read a lot about from everyone here probably to the chargrin of PW) etc could be viewed as counterproductive too but these people aren’t going to zip it because PW told them to are they??

If anyone here thinks a couple of posts concerning off label use is somehow going to destroy the FDA application they’re living in cuckoo land. No chance, no way. This board is not so important that Scott Gottlieb views it everyday looking for tanning shenanigans, so I’m not sure what the fuss is about every time off label is raised.

Granted, off label isn’t happening in the near or intermediate future and I’m ok with that. Posters getting told to zip it because someone doesn’t like off label talk is not ok. I could be cynical and suggest some here are secretly waiting for off label use but don’t like it discussed here in a public forum. I don’t think anyone here represents a major insto investor (maybe so) so respectfully I don’t think anyone’s opinion here matters in the big scheme of all things Clinuvel.

P.S: I would like to see off label for HHD. If you’re not convinced, have a look on google images for HHD sufferers. HHD, for lack of a better word, truly sucks. Perhaps a workaround is for HHD patients to be diagnosed by an EPP centre and administered Scenesse under strict supervision. This could serve everyone well: Clinuvel, patients with serious skin afflictions, and investors while at the same time distribution still being strictly monitored. Innovation is the key.
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macgyver
Posted on: Jan 21 2019, 02:24 PM


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Posts: 358

I think the only thing that will be destroyed will be the pill’s efficacy travelling through the stomach as opposed to the systemic slow release Scenesse implant. Interesting how it hasn’t been done before.... I wouldn’t have thought adding baking soda to melanotan would be an efficient way of releasing afamelanotide to the system....
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macgyver
Posted on: Jan 21 2019, 12:25 PM


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Posts: 358

I wonder if all the alternative treatments that Iggy has put forth (i.e. Cimetidine, MT2, Dr Parnassum’s Snake Oil, powdered tiger balls) has contributed to the percentage rise. You have to allow for a margin of error (1%), other factors such as personal circumstances, availability, laziness (1%) and then taking into account the ever increasing number of patients lending itself to a higher percentage of those not continuing treatment (1%). Using my shoddy mathematic reasoning, everything looks quite good😜
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macgyver
Posted on: Jan 18 2019, 07:37 PM


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Posts: 358

Thank you for your reply. That is great news patients can be administered 6 implants and that they can be reimbursed. I’m surprised it wasn’t mentioned in the recent newsletter, perhaps it is just a formality that was going to happen sooner or later and immaterial compared with the FDA PDUFA announcement.

Hopefully Düsseldorf will have the means in 2019 to cater for those waiting for relief.
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macgyver
Posted on: Jan 18 2019, 09:13 AM


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Posts: 358

Apologies for my ignorance but can somebody clarify the following:

- Patients in Germany or Europe can now get 6 implants annually?

- Regulator will only pay for four implants annually in Germany?

- The centre in Düsseldorf was out of implants but is now administering them?
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macgyver
Posted on: Jan 16 2019, 01:34 PM


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Posts: 358

Sharecafe upload screwed as well...
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macgyver
Posted on: Jan 16 2019, 10:40 AM


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Posts: 358

That wasn’t quite the example I was looking for but I see your point😜
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macgyver
Posted on: Jan 16 2019, 07:59 AM


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Posts: 358

You’re absolutely right, PW has worked hard and shareholders have endured a lengthy period to get to this point. Does anyone know of instances where drug companies have controlled distribution of their drugs to prevent off label use? I would imagine this would be anathema to many drug companies in the US.

I’d like to see indications aggressively pursued as well. Clinuvel has a significant warchest building up and it’s time to open up several fronts in pursuit of these indications.
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macgyver
Posted on: Jan 15 2019, 09:07 PM


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Posts: 358

This might be a special case regards Clinuvel. I actually think PW has put it to the FDA to restrict off-labelling to better the chances of or expedite approval for Scenesse. Follow that with a receommendation to institute a PASS-type protocol in the U.S and it could tie up Scenesse in a regulatory bind concerning off-label.

Edit: Perhaps for the initial 2 years Scenesse is available to EPP patients, access to the drug will be restricted to EPP centres only thereby denying GPs etc from accessing the drug through wholesale market.

Dont get me wrong: I hope to hell that Scenesse will be used off label. People suffering from HHD will be prepared to pay a premium (or their health insurance), its just too long to wait for suitable treatment for this terrible affliction. I think more likely in the US than in Europe will people be prepared to pay through the nose for this drug. PW is sticking to his guns concerning drug control though.

Can you imagine what will happen to the share price if off-label use is permitted?
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macgyver
Posted on: Jan 15 2019, 12:44 PM


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Posts: 358

biggrin.gif
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macgyver
Posted on: Jan 12 2019, 04:25 PM


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I’m in the same boat as hibchibbler. This is one of two good stock tips I’ve ever given. Told everyone in my sphere and people thought I was onto a turkey. Some work colleagues used to rib me about the stock saying it was a lemon. Those people I now tag in posts on Facebook with screenshots of Clinuvel’s stock price chart all the while commenting “It’s not too late to jump in!!” ($21 and rising 🤣🤣🤣)
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macgyver
Posted on: Jan 11 2019, 08:38 AM


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Posts: 358

$2.5 billion is realistic I think. I was hoping for a $5 billion market cap but that would require some seriously innovative management or financial gymnastics..

Perhaps the most intriguing in terms of potential earnings for me is vitiligo in the US and XP in Japan, and what the cost of Scenesse would be for those indications.
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macgyver
Posted on: Jan 10 2019, 07:07 PM


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Posts: 358

I was hoping we might get some movement on lodging submissions in Australia and Japan. Since we have priority review, surely at least preliminary discussions with the respective authorities could begin?
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macgyver
Posted on: Jan 10 2019, 09:44 AM


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Posts: 358

Wow!!!!

I did something else in my pants🤣🤣
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macgyver
Posted on: Jan 9 2019, 12:02 PM


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Posts: 358

Run up to $24, or beyond?😀
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macgyver
Posted on: Jan 4 2019, 12:36 PM


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Posts: 358

Haha, a thorough retort. What say you heathen Ignoramus?
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macgyver
Posted on: Jan 3 2019, 10:59 PM


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Posts: 358

You have to move over to Sharecafe and login there. It’s fully functional.
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macgyver
Posted on: Jan 3 2019, 10:20 AM


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Posts: 358

They can’t take Clinuvel’s fee? Doesn’t seem that bad. Shutdown won’t last much longer.
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macgyver
Posted on: Jan 3 2019, 09:54 AM


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Posts: 358

I’ve been thinking about potential share price elevation with FDA approval. Given that the current share price, while it is a vast improvement on last year, is generally thought to be undervalued. I like to think the market is the Great Arbiter and that the current price is a fair price based on slow rollout in Europe, stretching timelines for FDA approval etc. However, FDA approval unlocks the US market and is the key to seeming riches. That value in itself appears underestimated by folk. What is it worth? Does it add to the premium for US EPP sales?

I’m hoping for a significant boost with this value factored in elevating the sp to above fair price, unless the Great Arbiter has something to say about it...
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macgyver
Posted on: Dec 30 2018, 07:51 PM


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Posts: 358

I’m curious about the sequence that the FDA assesses a prospective application. Let’s hope manufacturing was the last issue they had with Clinuvel’s application. At least we know safety is, for lack of a better word, safe.
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macgyver
Posted on: Dec 21 2018, 03:09 PM


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Posts: 358

Nice action just before Xmas...
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macgyver
Posted on: Dec 19 2018, 03:56 PM


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Posts: 358

I see, roger that👍
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macgyver
Posted on: Dec 19 2018, 03:34 PM


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Posts: 358

I see what you mean. The language has changed considerably. The forward looking statements seem to suggest that Clinuvel is now looking beyond FDA approval to events concerning supply, availability, manufacturing. All the aspects of supply and manufacturing as it were. It has the language of a company engaged in business in its chosen markets..
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macgyver
Posted on: Dec 19 2018, 02:17 PM


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Posts: 358

Do you mean the inclusion of Australia and Japan in the forward looking statement?
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macgyver
Posted on: Dec 19 2018, 10:55 AM


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Posts: 358

Interesting observation about cultural shunning of darker skin in the CUV 103 Singapore vitiligo trial. It must be said that if you know anything about Asian cultures, it is a preference to have whiter skin that would be commonly known. This in my opinion isn't a revelation, the participants in the trial were obviously surprised by the extent of the darkening of the constitutional skin areas compared with baseline, to the point where some opted out.

This presents a clear path concerning African American vitiligo sufferers. Given their darker skin complexion, it would seem this group would be the ideal candidates for Scenesse treatment based on the PR, both ethnically and culturally. It doesn't exclude other groups of people, some of which who may be willing to go through a period of abnormally contrasting skin colours if it is known or seen that once treatment finishes the contrasting skin areas would become more uniform in complexion over time. Clinuvel hasn't incorporated this end result into their initial trials, which I think they should've done so as to have complete sets of data concerning beginning of treatment to a desired end result expected by patients. This would make it easier to convince patients to undergo a period of discontent if they know they will get close to achieving a desired end result. I don't pretend to know the psychology or thinking of vitiligo sufferers, certainly in Asian patients the treatment can cause reservations, I would think less so in African Americans given their vitiligo is more accentuated through obvious skin complexion differences.

The timing of the PR is odd, perhaps a tidbit of news to see out 2018 in lieu of news about the FDA filing. I do believe, or sincerely hope, that Clinuvel will launch a full assault on other markets once FDA approval is in hand, they would have no reason to dilly dally anymore and time is of the essence. I would think it essential to raid the war chest and apply for multiple indications.

Scenesse is not a niche drug, it is a panacea drug.
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macgyver
Posted on: Dec 18 2018, 08:19 PM


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Posts: 358

Fascinating. Serendipity, fate, chance. You name it, it’s happened. TGA next on the block as soon as FDA is a lock. Good to see.
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macgyver
Posted on: Dec 18 2018, 03:32 PM


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Posts: 358

I don’t think anyone anticipated the preliminary review to take this long. I was hoping for first sales in the US by end of 2019, now mid 2020 at the earliest. That’s almost 4 years since EMA approval. Which is precisely why I think PW is making a mistake by not putting in applications to the TGA in Australia and Japan simultaneously with the FDA’s. Money burning a hole in Clinuvel’s bank would’ve been good money spent on these applications by hiring more staff to prepare. Glacial or tectonic?...🤷🏽‍♂️
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macgyver
Posted on: Dec 12 2018, 01:56 PM


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Posts: 358

I think an insto is still offloading, the volume has been down considerably when compared with the recent high rise action. Downward pressure abounds, hopefully only for a short while and then straight back up😜
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macgyver
Posted on: Dec 9 2018, 07:10 PM


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Posts: 358

That certainly seems very plausible.
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macgyver
Posted on: Dec 8 2018, 05:20 PM


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Lol. Sounds like you’re writing Santa Claus a wishlist for Xmas. I think PW has written him one too, hence the comment on the Your Money program about hoping for an early Xmas present. There it is, we’re all praying to the gods and fairies now. Come down the chimney FDA!!!!
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macgyver
Posted on: Dec 8 2018, 05:16 PM


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Ne’er a truer word spoken that best represents the agony that this company mets out to its investors: excruciating.
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macgyver
Posted on: Dec 5 2018, 06:06 PM


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This is a long shot but lately the FDA are full of surprises. Does anyone think that the manufacturing inspections signify an impending priority review?
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macgyver
Posted on: Nov 24 2018, 02:14 PM


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Delete
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macgyver
Posted on: Nov 23 2018, 09:28 AM


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Attached Image



Insto still offloading?
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macgyver
Posted on: Nov 22 2018, 11:00 AM


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Thank you for your comments. Can you tell us Lachlan: Did there seem to be a noticeable contingent of Asian/Chinese investors in the audience?

The five year roadmap ends in 2024. "Clinuvel 2024"
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macgyver
Posted on: Nov 21 2018, 04:40 PM


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Posts: 358

Frogster's dissection of today's AGM does convey a sense of weariness at the same information being regurgitated over and over again. These AGMs are a lost cause. In the last 4 years there has only been one AGM I can remember that has presented what I would consider new or interesting information.

The problem is very clear: When you have a single product winding its way through regulatory purgatory, of which it takes 2-3 years per country depending on where the company sits regards having adequate trial data etc, the time in between is occupied by filler. To rehash old information/history in another way is a wasted opportunity for the AGM. Whats the point of telling people repeatedly about the imminent arrival of the data from the CUV103 trial when it would be more pertinent to let us know whether the supplier for the OTC products has sorted his shit out and is now on the cusp of supplying to market those goods which were announced for release in July of this year?

I understand the PRs released by Clinuvel throughout the year are a tactic to keep investors hanging on by a thread to hope that something imminent is about to occur, when in actual fact it is just filler to see us through the year. An example of this 'baiting' would be the slide that shows Australia and Japan in the approval stage. Dossiers haven't even been lodged to the corresponding authority in these countries let alone being anywhere near approval. This slide is inaccurate and it sucks.

Of all AGMs, this is the year in which all relevant news (barring any commercially sensitive information and considering the Clinuvel 2020 strategy) should have been laid bare to those shareholders who had the gumption to turn up to the meeting, albeit with a hint of reservation about what they might expect. What is happening regards Japan and Australia? What has happened to the OTC products? Have these products been sidelined as a strategic decision awaiting the outcome of the FDA review? What is happening with the NICE issue? How are preparations for the VP trial progressing?

There is a lot I would like to know, some important and some perhaps trivial to others, and I would have done myself a favour to turn up to the AGM. However, it is my sense of resignation to Clinuvel's secretive strategy that I would not be any the wiser had I stood up and asked those questions directly to PW. I can only hope that if and once FDA approval is in hand, that Clinuvel's communication culture will change dramatically (which I doubt), though it is reasonable to expect that it should change given the two biggest markets would then be in the pocket.
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macgyver
Posted on: Nov 21 2018, 10:53 AM


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Someone here pointed out reporting obligations being reduced due to certain parameters being met (Frogster or ajshare?), which according to the AGM presentation is to occur in 2019. What effect does this have in general on share price performance, or other factors concerning the company? I would think that such a reduction in reporting would have minimal effect, but I am curious to know if historically there is more speculation from the market given it has less information at hand to work with.
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macgyver
Posted on: Nov 21 2018, 10:47 AM


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The Clinuvel 2020 strategy has been upgraded to Clinuvel 2021🙄🤣
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macgyver
Posted on: Nov 20 2018, 07:34 PM


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Congrats on the all-in my friend. By the way, that is the only motto Clinuvel should stick to: There is no such thing as a safe tan

This motto will be used to entice millions to buy Scenesse for melanogenesis, a browning of the skin as it were (at least that’s what someone told me it was)🤷🏽‍♂️
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macgyver
Posted on: Nov 20 2018, 02:19 PM


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But the good Doctor Wolgen said in the Your Money interview last week that the FDA is more concerned with safety than efficacy. I find that hard to believe though since the FDA has approved some dubious substances in which you almost have to experience death before you get better. Safety, as Dr Wally eloquently reminds us, is indisputable with Scenesse. Which means it’s a two-trick pony instead of one...
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macgyver
Posted on: Nov 20 2018, 12:26 PM


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Dr Wally, afaik Scenesse does not induce tanning, period. It does however induce melanogenesis. In fact I don’t even know what tanning is. Never heard of it. Is it similar to a tannery?
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macgyver
Posted on: Nov 20 2018, 05:23 AM


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That’s quite a list of issues to be raised, and rightfully so. Expect PW to get tetchy after about the third question....

Ironically, this year will be my first opportunity to attend the AGM, but I won’t be going. Melbourne traffic isn’t worth the non-info I hear...
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macgyver
Posted on: Nov 17 2018, 09:12 PM


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Posts: 358

Single malt Walnut?🥃
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macgyver
Posted on: Nov 17 2018, 12:14 PM


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Given the FDA’s penchant for extending timelines, and how the cogs of bureaucracy turn slowly, FDA approval even with priority review will not occur till second half 2019 at the earliest imho. And I feel that’s being optimistic.

Six months for priority review then 4-8 weeks give or take for finalisation of review and miscellaneous paperwork might see approval granted between August and September 2019. Standard review might see approval in November/December 2019. If Clinuvel have learnt lessons from the European rollout, then I’d expect U.S. rollout to be somewhat expedited but I would think it a job well done to actually have first sales before the end of 2019. Remember, the above hinges on a PDUFA being issued before the end of this year, all in all for U.S sales to be up and running, I think it’s reasonable and realistic to expect that to occur a full year from now at the earliest...
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macgyver
Posted on: Nov 16 2018, 10:47 AM


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Definitely in the next 4 weeks🙏
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macgyver
Posted on: Nov 14 2018, 01:21 PM


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My man. Thanks for this.

Regarding the FDA will give approval, the Your Money headline was inaccurate.

I liked his dig at Shkreli spending 7 years in prison.
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macgyver
Posted on: Nov 13 2018, 01:45 PM


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I watched it as well, at the bottom of the screen there was a headline saying " Wolgen: Clinuvel product will get FDA approval". Cant recall him saying that exactly so I hope the Your Money team didn't jump to conclusions or take what he said out of context. Trying to upload a photo I took of the headline but Sharescene won't let me upload. Besides, PW is too clever to make an unguarded statement like that I reckon...
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macgyver
Posted on: Nov 13 2018, 11:36 AM


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Posts: 358

This comment from the same Instagram post. Curious.
QUOTE
crystin_linares17#I'mCured!!! Oh my God😱 I'm So Excited I Can't Believe Herbs Could Cure Herpes I had for 5 years! This worked like magic to me. I'm forever grateful.
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macgyver
Posted on: Nov 11 2018, 03:32 PM


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Don’t understand how their filing was accepted for review in 60 days when compared to Clinuvel’s scenario. I can only imagine their two Phase 3 trials must have been very successful, and that the submission was watertight. Something to aspire to...
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macgyver
Posted on: Nov 10 2018, 08:33 AM


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Maybe the clock was started again. Do they need to give themselves a full 60 days to analyse new information? If so then I would expect a response or confirmation of acceptance of submission for review to be forthcoming no later than the end of January. Any later than that would be plain annoying and a travesty...
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macgyver
Posted on: Nov 9 2018, 03:02 PM


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Posts: 358

Happy wedding anniversary JohnnyTech. Hope you can buy your lovely wife that Rolls Royce Wraith she’s been pining after this time next year wub.gif
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macgyver
Posted on: Nov 9 2018, 09:49 AM


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Hope the PDUFA date isn’t a bone of contention devilsmiley.gif
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macgyver
Posted on: Nov 9 2018, 05:48 AM


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Fair. I wasn’t sure what was going on to be honest, I was just hoping there wasn’t an RTF issued. Now, I’m more confident of approval than ever.
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macgyver
Posted on: Nov 8 2018, 09:43 PM


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Posts: 358

I think Johnny H wants to chat privately with you, which is cool by me. No big deal.

Johnny H and Johnnytech were adamant about the RTF. I think even Farma was pretty sure about it too. If you’re a stickler for the rules then by rights an RTF should’ve been granted. But really we were all in the dark about this, however PW clarified everything in the newsletter and showed us the FDA has discretion and levels of protocol dependant on the individual submission. That PR was the antidote to the speculation surrounding the possibility of an RTF.
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macgyver
Posted on: Nov 8 2018, 11:04 AM


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A new possible indication I read about on BBC: trichothiodystrophy.
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macgyver
Posted on: Nov 8 2018, 10:48 AM


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I imagine the distinction between standard and priority review is based on a very critical unmet need e.g serious life threatening diseases. The odds don’t look promising based on the record of the Dermatological Dept of the FDA. With that I’m assuming standard review will be granted even if Scenesse does meet statutory requirements.

The anticapation of an announcement regarding acceptance of submission for review is getting palpable, as evidenced in the rising share price. Surely we must hear something before the end of the year, no?
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macgyver
Posted on: Nov 8 2018, 10:07 AM


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0.0001% for margin of error? devilsmiley.gif
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macgyver
Posted on: Nov 8 2018, 01:02 AM


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Bottlenecks. Invaluable patient data. Structure in place for further indication trialling. PASS has been a blessing in disguise...
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macgyver
Posted on: Nov 7 2018, 08:56 PM


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Posts: 358

X-Ray is faithful to the takeover...
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macgyver
Posted on: Nov 7 2018, 01:45 AM


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You’ve might have taken this out of context. The FDA has asked specifically about manufacturing and product, this says information about efficacy and safety, long term safety plan and paediatric information leading to evaluation and approval of manufacturing and product processes. I think there’s a difference in that the FDAs requests for info is not related to efficacy and safety concerning the drug, merely the manufacturing/product process itself. With that there is still discretion available to the FDA I believe.
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macgyver
Posted on: Nov 6 2018, 04:45 AM


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Not sure why there seems to be this rigid adherence to regulation and law from some posters regarding an RTF. It’s completely feasible that there is flexibility in the way the FDA deals with individual submissions. Perhaps the rules are guidelines only, with the FDA being a large bureaucratic organisation it would be extremely wasteful of resources to issue an RTF simply because a reviewer requires more information about a less than critical component of the submission dossier.

I have more trouble believing PW’s story about the OTC delay rather than the FDA delay.
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macgyver
Posted on: Nov 5 2018, 03:04 PM


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You're right, I place too much emphasis on timelines regards Clinuvel. I should know better, my bad. I'll go and sit in the corner...

P.S: I feel the vitiligo results from Singapore will be a blockbuster, considering its taken months to analyse the results from all 6 patients. A trove of data that cannot be analysed overnight, 6 patients is quite the workload... devilsmiley.gif
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macgyver
Posted on: Nov 5 2018, 02:49 PM


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Posts: 358

QUOTE
Due to unforeseen circumstances incurred by our suppliers, a knock-on effect was seen to CLIUVEL’s timelines for the new OTC product line and impacting the launch. We are confident that these issues will be resolved to ensure the registered product line can be launched in the New Year.


Don't see how this could've happened. PW announces new OTC product launch for sometime in July 2018. You wouldn't do this if you weren't confident you didn't have ample supply. The launch is now delayed by 6 months minimum. 6 months?? There is some other reason that PW is not telling us about, or he decided at the last minute to can it until the FDA accepts the submission for review.

To note, its quite possible we will see the famed vitiligo trial results from Singapore within the next 3 years....
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macgyver
Posted on: Nov 5 2018, 02:31 PM


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Posts: 358

If an RTF was to occur, it would've happened by now. An RTF should indicate that the submission was less than adequate in more than one important aspect. This newsletter, if it is to be believed, implies that the submission is more or less satisfactory in most areas.

Product and manufacturing are non-issues for me. If the FDA was asking for more data from EPP patients then that might indicate a problem with efficacy or safety, the biggest factors concerning the success of a submission or market approval. Since that hasn't occurred (yet), then essentially, the submission is about to be accepted for review.
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macgyver
Posted on: Nov 5 2018, 10:56 AM


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Posts: 358

Silly stock....🙄
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macgyver
Posted on: Nov 5 2018, 09:30 AM


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Posts: 358

Attached Image

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macgyver
Posted on: Nov 1 2018, 08:07 AM


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Posts: 358

3Q18 beat 2Q18 dollarwise, sustained and improved compared with 2Q & 3Q 17. Very positive sign.

1Q19 over $5-6 million would be very impressive and indicative of increasing patient numbers, even through the winter months. The clinics could be starting to turn the tide regarding bottlenecks...
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macgyver
Posted on: Oct 31 2018, 03:45 PM


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I’ve been trying to rationalise today’s trading. Doing so will lead to insanity, in which it appears you’re halfway there. Welcome to the club!!🤪🤪🤪
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macgyver
Posted on: Oct 30 2018, 10:27 AM


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Posts: 358

Attached Image



A lot of NXXT in there...🙄
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macgyver
Posted on: Oct 30 2018, 10:13 AM


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Posts: 358

Agreed, buying orders nearly matching sell orders.
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macgyver
Posted on: Oct 30 2018, 09:17 AM


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Posts: 358

There’s no rationale for the current trading the way it is. The share price would be in free fall regardless. I figure the instos drove the price up to a price where they could start to offload all the way down to x amount. Watching the trades this morning, it’s clearly obvious someone (shorters?) is intent on driving it down. Why sell x amount of shares 50 cents below the last trading price? Knowing this I’m comfortable with the knowledge that this stock is still capable of being manipulated anyway the players see fit. It doesn’t change the outlook based on the fundamentals one iota...
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macgyver
Posted on: Oct 29 2018, 03:46 PM


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Posts: 358

I only really discerned 3 things from that PR:

- They're building a building.

- The building will house new analytical methods/tools.

- The sp dropped an enormous amount today.

Also, correct me if I'm wrong, did they say when they set up Vallaurix and did some studies that they discovered CUV9900? I thought they already had that before Vaullaurix was established. I dont know, its all getting murky again....
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macgyver
Posted on: Oct 29 2018, 03:18 PM


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Posts: 358

Lagoda and FIL did alright I think...
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macgyver
Posted on: Oct 29 2018, 02:21 PM


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Posts: 358

Is today the biggest one day loss ever?? FML...
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macgyver
Posted on: Oct 29 2018, 10:23 AM


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That announcement wasn't material to anything. It was pure rubbish. As stated, there is other more important news we could be updated on. Wouldn't hurt PW to actually tell us what he thinks the current time frame is for the FDA to review the information recently requested. Or some tidbit. I didn't find the mention of new analytical tools inspiring.

I need some soothing SP rise ointment....
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macgyver
Posted on: Oct 29 2018, 09:46 AM


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Posts: 358

Wow, what a catastrophe...🤷🏽‍♂️
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macgyver
Posted on: Oct 26 2018, 09:53 AM


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Off market trade? Its usually recorded somewhere on a trading platform. Special rule allowing trades to go through off the books so to speak?
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macgyver
Posted on: Oct 26 2018, 09:46 AM


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Posts: 358

LevelHeaded, whilst I appreciate your efforts to assuage the anguish I feel at not having bought at the bottom, it cannot diminish the reality that most gamblers experience when they regret the timing of their bets.

That aside, I am confident Clinuvel's sp will be right back up over $25 in short order. However, in every instance regardless, I like to win.
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macgyver
Posted on: Oct 26 2018, 07:15 AM


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Posts: 358

Damn, I should’ve bought shares today...
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macgyver
Posted on: Oct 24 2018, 02:14 PM


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Posts: 358

25% slide? Yes, I'm thankful its not 50%.

I should waited till today instead of yesterday to spend my super on Clinuvel shares. What a bugger...
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macgyver
Posted on: Oct 20 2018, 07:06 AM


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Posts: 358

I’m ashamed to say this, but XP would be more lucrative than HHD, although I have longed hoped that HHD would soon become an official indication given its particularly nasty characteristics.
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macgyver
Posted on: Oct 20 2018, 07:02 AM


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He’s self administering to test its effects on autism, if X-ray is to be believed that PW is indeed a savant.
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macgyver
Posted on: Oct 19 2018, 08:11 PM


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Posts: 358

Lol
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macgyver
Posted on: Oct 19 2018, 06:17 AM


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Posts: 358

I’ll be contributing to that short squeeze. As of today. I’m going all in with my SMSF on Clinuvel, and if all goes well I’ll live well till I retire and when I retire I will still be living well 😉💵💵💵

Ladies and gentlemen place your bets, the ball is spinning🎲♥️♣️♠️♦️
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macgyver
Posted on: Oct 18 2018, 04:30 PM


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Posts: 358

Nice work. I thought this was happening but I was unsure especially after the shake last week. Now we have proof. Onwards and upwards smile.gif
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macgyver
Posted on: Oct 16 2018, 07:41 PM


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Posts: 358

I see CUV9900 is breaking out and making a run to the finish line. What’s going on there??
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macgyver
Posted on: Oct 16 2018, 03:28 AM


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Posts: 358

I can’t queue higher than $25. Sad...
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macgyver
Posted on: Oct 15 2018, 07:47 PM


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Posts: 358

Outrageous, they’re selling themselves short!!
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macgyver
Posted on: Oct 15 2018, 11:34 AM


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Posts: 358

Tiddlywinks..
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macgyver
Posted on: Oct 13 2018, 09:03 PM


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“North Korea nuclear naughty boy Kim Jong Un”

“Dr Doom”.

Can someone ask who Giles Delaney is at the AGM? 🤣🤣🤣
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macgyver
Posted on: Oct 13 2018, 08:54 PM


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Posts: 358

Thank you for posting, a very interesting read. An insight into how the reimbursement was negotiated in other European countries, the first time I had seen PW mention anything directly about how the pricing was worked out regarding patient number thresholds.

And he is exactly right: if it’s good enough for the EMA then it’s good enough for NICE. What’s the point of having an EMA? (Pre-Brexit that is😈)
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macgyver
Posted on: Oct 12 2018, 03:18 PM


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Not too bad today, all things considered.
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macgyver
Posted on: Oct 12 2018, 03:32 AM


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Posts: 358

An RTF is a material event, and one that should be communicated accurately to shareholders. Clinuvel could be sued for not doing so as it could result in investors losing money no matter how short the time frame is. Clinuvel are expert at presenting information in a very grey manner at best and utterly fudging the truth at worst so I wouldn’t be surprised if this was the case on this occasion.

But as mentioned already, several statements about impending PDUFA dates and “expected information” could imply an unforeseen loophole, or perhaps since it is mostly technical information the FDA is waiting for there could be an allowance for Clinuvel to submit without affecting the status of their submission, even more so if the FDA has already accepted 80-90% of the content of the rest of the NDA which contains “ the guts” of it, so to speak..
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macgyver
Posted on: Oct 11 2018, 11:09 AM


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Posts: 358

Don’t worry too much Yolo, I have faith in Clinuvel.
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macgyver
Posted on: Oct 11 2018, 06:39 AM


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Particularly if it’s overvalued....
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macgyver
Posted on: Oct 10 2018, 08:12 PM


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Well, I’m always learning... I didn’t know what EPP was 10 years ago, and I also used to ignorantly think EPP sufferers could just “stay out of the light”. I reckon 95% of Australia’s population doesn’t know what EPP is. That’s why porphyria groups should keep fighting the good fight and educating folks, such is the rare and strange nature of this disease.
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macgyver
Posted on: Oct 10 2018, 04:42 PM


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Posts: 358

I think it’s less a corruption problem and more an education problem concerning the NICE members. While it was very poor form for that doctor to say that EPP patients could stay out of the light, it could be said that he, like many others before who have eventually come to understand this disease and the psychology of its sufferers, is just simply not up to speed with it. This means he should be chastised not once but twice: once for making a dipstick comment, and again for making an assumption without knowing the facts!
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macgyver
Posted on: Oct 10 2018, 05:23 AM


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Posts: 358

A confluence of factors may affect the share price over the next 3 weeks:

- The ASX experiencing consecutive drops to the point where it is approaching technical support,

- Continual rebalancing by certain instos,

- Volume still averaging higher compared with three months prior,

- CLVLY and UR9 opened lower yesterday but finished higher with what could be labelled fair volume. Interesting to see whether the recent spruiking of Clinuvel by PW and Co draws more attention to the these stock codes,

- Jitteryness concerning FDA NDA and when it starts,

- General economic conditions approaching similar indicators with the recession of 2008.

I’m expecting a PR concerning the NDA and the requested information within or at the end of the next 3 weeks (60 days total from date of request/relevant PR). I do expect the sp to be volatile regardless of PDUFA being announced especially if priority review is not granted. Overall I do expect the sp to climb gradually towards PDUFA date, this stock is not overvalued yet.

NICE is proving to be a pain in the neck and I have compartmentalised it already as being lost to Clinuvel. Bigger fish to fry somewhere else.
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macgyver
Posted on: Oct 9 2018, 02:51 PM


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I think you're spot on.
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macgyver
Posted on: Oct 9 2018, 02:36 PM


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On further reading, it remains to be seen whether the appeals upheld will be enough for NICE to approve.

Appeal by International Porphyria Patient Network (IPPN)
Appeal point Ground 2.1: The committee failed to act fairly by not acknowledging the evidence provided in patient testimonies and by expert physicians on the overwhelming clinical benefit.

- Appeal point was not upheld. A somewhat critical factor considering patient testimonies were used in the EMA's approval decision.

- Not sure how Clinuvel could capitalise on the fact that NICE was unreasonable by stating afamelanotide provides small benefits. If Clinuvel were to be successful in the final NICE decision, I think their argument hangs tentatively on this aspect. Patient testimonies no longer play a part moving forward.

- The other possibility for Clinuvel is the discrimination aspect against EPP sufferers, in that there is no other treatment available and NICE's decisions/behaviour denies EPP patients access to treatment. With this I guess NICE and Clinuvel could come to an agreement with the managed access scheme, however NICE would negotiate the hell out of the pricing way down to a level that Clinuvel possibly won't accept.

- The appeal panel's judgements seem fairly weighted without further analysis. Two options then: Agree on a lower price for Scenesse with full discretion possibly lower than the lower end of the pricing band agree in Germany OR straight to the High Court.
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macgyver
Posted on: Oct 9 2018, 02:09 PM


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Posts: 358

edit
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macgyver
Posted on: Oct 9 2018, 10:37 AM


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Posts: 358

Still waiting on one for going too fast to $22🤣
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macgyver
Posted on: Oct 9 2018, 10:28 AM


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Posts: 358

Instos giving themselves some headroom to offload post haste, could still be a few weeks left of this kind of action.
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macgyver
Posted on: Oct 9 2018, 09:33 AM


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Posts: 358

Tree shake...
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macgyver
Posted on: Oct 8 2018, 04:08 PM


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Posts: 358

Its a problem I have with the current strategy. Regardless of whether Clinuvel obtains FDA approval, they still have work to do in Europe. This intense singular focus on the FDA blindsides Clinuvel to anything else. FDA approval is not contingent on keeping a low profile across the globe. It's approved in Europe for God's sake!

I understand meeting requirements to list on the NASDAQ, but like I mentioned before, theres a whole lot of money burning a hole in Clinuvel's bank account that needs to be put to work. Otherwise I'm going to give my crusty old friend Carl Ichan a call and get him down to the AGM to agitate for change!!!
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macgyver
Posted on: Oct 8 2018, 02:22 PM


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Including the requisite increase in share price of course Mr LevelHeaded....
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macgyver
Posted on: Oct 8 2018, 08:59 AM


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Copy that, makes sense now.
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macgyver
Posted on: Oct 8 2018, 08:59 AM


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Posts: 358

Investor presentation Sachs 18th Biotech in Europe

https://www.asx.com.au/asxpdf/20181008/pdf/...1lz45q14r6h.pdf
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macgyver
Posted on: Oct 8 2018, 08:54 AM


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Edit: 2.7 % of shares not 2.7 million.
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macgyver
Posted on: Oct 8 2018, 08:39 AM


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I'm curious about the status of ACN 108 768 896 Pty Ltd. This entity is supposed to be a subsidiary of Clinuvel, formerly known as EpiPharm (the original Epitan holding company?). It holds 8% of Clinuvel's shares. How does a subsidiary hold shares in a parent or holding company? I take it some legal gymnastics has taken place.

Edit: Epipharm was divested back in 2006 by Clinuvel, which possibly means GenePharm Australasia Ltd. is a major shareholder in Clinuvel. However, ACN 108 768 896 Pty Ltd is still registered in Melbourne 3000. Curious....
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macgyver
Posted on: Oct 8 2018, 08:30 AM


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Posts: 358

I think it's high time Madman was given a seat on the board should Biljdorp move up to Chairman, his stake plus his superfund puts him up there not far behind PW at 2.7 million shares. Would be good to have another Melburnian on the board besides Ms Shanahan. After all it is a Melbourne company not a European one....
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macgyver
Posted on: Oct 5 2018, 02:56 PM


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Posts: 358

Interesting. I wonder if they know something about Priority Review already and they’re setting the stage for Stan’s exit.
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macgyver
Posted on: Oct 5 2018, 11:37 AM


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Posts: 358

I knew it was too early🤷🏽‍♂️
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macgyver
Posted on: Oct 5 2018, 10:25 AM


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Correct me if I’m wrong but I’m guessing you have vitiligo?🤷🏽‍♂️
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macgyver
Posted on: Oct 4 2018, 05:35 PM


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Posts: 358

Adieu $22, we only knew you for a short while.

Delicious finish today.

Its too early isn't it? Sorry....
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macgyver
Posted on: Oct 4 2018, 01:55 PM


Group: Member
Posts: 358

Lagoda no longer a substantial holder. See announcements.

We’re moving up.
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macgyver
Posted on: Oct 3 2018, 10:09 PM


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Posts: 358

I prefer consolation to consolidation, or constellation for that matter🤷🏽‍♂️
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macgyver
Posted on: Oct 3 2018, 05:15 PM


Group: Member
Posts: 358

I’m not a fan of sideways action.
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macgyver
Posted on: Oct 3 2018, 06:30 AM


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Posts: 358

Maybe they’re counting on patient testimony for this indication as well...
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macgyver
Posted on: Oct 2 2018, 05:49 PM


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Posts: 358

Waiting for someone to burn the shorts.
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macgyver
Posted on: Oct 2 2018, 09:56 AM


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Posts: 358

Out of napkins.
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macgyver
Posted on: Oct 2 2018, 01:57 AM


Group: Member
Posts: 358

Never won lotto, too hard.
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macgyver
Posted on: Oct 1 2018, 05:00 PM


Group: Member
Posts: 358

I completely agree with your assessment, particularly with vitiligo and also running parallel indications. Getting over the line with the FDA is key to everything, hopefully it might snowball from there...

Farma I think the U.S for EPP is already starting to factor into the share price. Interesting to see where it ends up by time of FDA approval.

The family of porphyrias to be treated by Scenesse, what is the total number of potential patients? Mind-boggling.

100k shares shifted in the last 13 minutes of open market trade today? 700k or less to go in my napkin calc before the price moves up from $22.
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macgyver
Posted on: Oct 1 2018, 02:33 PM


Group: Member
Posts: 358

Another high quality post, cheers Farma and Levelheaded😄
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macgyver
Posted on: Oct 1 2018, 10:18 AM


Group: Member
Posts: 358

Is this THE second indication?
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macgyver
Posted on: Oct 1 2018, 05:29 AM


Group: Member
Posts: 358

$120?
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macgyver
Posted on: Sep 30 2018, 03:12 PM


Group: Member
Posts: 358

I’m ready for no PR, I expect it actually. Preferably PR is ideal but I can wait. The only thing that would be irritating is dragging out the NDA past it’s 10-12 month timeline as what happened in Europe. This time around there is no excuse to drag it out, there are very clear guidelines that the reviewers follow and the benefit of the doubt should be given to Clinuvel concerning efficacy due to patient retention and safety profile. To go beyond the timeframe is inexcusable.

The odds are not in favour of Clinuvel due to zero percentage of PRs issued from the FDA’s Dermatology and Dental department. Though in saying that, I couldn’t tell you what kind of indications and their severity PR was applied for previously. EPP might very well be a first due to the severity of it but I would be surprised if it was the first of its kind to gain PR. Opportunity for research...

If PR is granted, I’d take that as an approval and I think the market will respond accordingly in the positive.
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macgyver
Posted on: Sep 28 2018, 05:58 PM


Group: Member
Posts: 358

From Commsec: Not sure if its up to date regarding Fidelity going below 5% threshold.

Morningstar rates Clinuvel as overvalued, even though they have updated their values upwards as the stock price climbs...

Attached Image

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macgyver
Posted on: Sep 28 2018, 03:48 PM


Group: Member
Posts: 358

I’m predicting a $22 finish today.
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macgyver
Posted on: Sep 28 2018, 02:58 AM


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Posts: 358

Whoops excuse the language....
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macgyver
Posted on: Sep 28 2018, 02:38 AM


Group: Member
Posts: 358

You've never been here before....

Fuck vitiligo bro.

It'a a 5 year dream....

XP is where its at. Jump on before the Japanese leave you behind....
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macgyver
Posted on: Sep 27 2018, 06:00 PM


Group: Member
Posts: 358

Today’s trading pattern similar to last 2-3 weeks, before trading begins someone has a price in mind they would like to finish at by the end of the day whilst moving a ton of shares. Uncanny how we land on $22, someone was sniffing around that number all day😝

Maybe Mammon will let it go up tomorrow🤷🏽‍♂️
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macgyver
Posted on: Sep 27 2018, 01:35 PM


Group: Member
Posts: 358

Anyone got the latest insto shareholding numbers?
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macgyver
Posted on: Sep 27 2018, 01:18 PM


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Posts: 358

$120
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macgyver
Posted on: Sep 27 2018, 10:44 AM


Group: Member
Posts: 358

Volume is up considerably within the first 45 mins of trading (128k)

Big day coming up, this stock is hitting critical mass.
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macgyver
Posted on: Sep 27 2018, 12:06 AM


Group: Member
Posts: 358

Hell yeah.
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macgyver
Posted on: Sep 26 2018, 10:10 PM


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Posts: 358

Sphene is probably more on the money with their napkin calcs, $40 AUD seems quite high based on European EPP. Cobi has pencilled in end of June 2019 so certainly doable👍
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macgyver
Posted on: Sep 26 2018, 04:05 AM


Group: Member
Posts: 358

A long time I take it😥 Even EPP has some way to go before revenue streams have matured in the four markets Clinuvel is targeting. Reinvestment of profits into further development and trials simultaneously in different regions once EPP approvals are established is the only way to go in my opinion.

It’s in PWs interest to take a leaf out of Jeff Bezos’ book and increase expenditure to reach a point where approvals for other indications in different regions are happening in quick succession (I know, this is the pharma industry. Nothing is quick). If we continue at the current rate of progress (regulator obsfucation, lobbying from powerful competitors etc notwithstanding) then PW will be an old man by the time Clinuvel is well entrenched in the industry.

I don’t need dividends (though they are greatly appreciated), I just need $200 a share 5 years from now🤷🏽‍♂️😝
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macgyver
Posted on: Sep 26 2018, 03:49 AM


Group: Member
Posts: 358

A mix of both. Currently the share price is surging in anticapation of FDA approval sometime next year. I foresee similar circumstances occurring with the other indications. Having approval in Europe and the US sets up solid fundamentals for the company to drive expansion expeditiously if not already. The napkin doesn’t take into account CNS indications either.

For the longest time the share price responded only to positive quarterly results and material information. Now investors are anticipating future revenue streams. So I think this will be the case in the near future with other indications. Similarly with oncology drugs and other potentially highly profitable indications, some companies have share prices that the layman would consider unjustifiable given no revenue or the drug in question is only at Phase 2. However the anticapation is there and reflected in a crazy share price. This type of behaviour might drive Clinuvel share price to continual new heights, albeit over a period of time.
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macgyver
Posted on: Sep 26 2018, 02:08 AM


Group: Member
Posts: 358

Based on XP, EPP, vitiligo and cosmetics, this stock is worth in excess of $200 per share. I think recent activity suggests new investors and instos are waking up to this potential. Monolithic....
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macgyver
Posted on: Sep 26 2018, 01:50 AM


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Posts: 358

My napkin has conservatively calculated XP to be worth $3.8 billion over ten years from start of sales.

Japan = 1/22,000 prevalence. Pop: 127 million/22,000 = 5772 patients approx. (round down to 5700)

Europe/USA = 1/250,000 prevalence (more for Europe). Combined pop: approx 1 billion/250,000 = 4000 patients approx

(5700 + 4000)/2 = 4850 (divide by half for conservative estimate).

4850 patients at $80k AUD per annum = $388 million AUD per annum.

Exclusivity extended in Europe? Not sure. If not then the $3.8 billion figure comes down considerably. However, experience gained in the rollout in Europe should expedite rollout in the U.S thus leading to a second indication being granted with substantial exclusivity in the U.S and limited exclusivity in Europe. (Another two years minimum before receiving XP approval in Europe leaving 4 years or less. 3-4 years exclusivity in Europe is not to be dismissed and is still rewarding by any measure.)

Europe should be first off the rank concerning XP trials, if only because EPP is already approved and a second indication less difficult to obtain. However, Clinuvel may be required to market Scenesse Enfance first. If so, then I guess the US following FDA approval can commence XP trials. Alternatively, Japan with its higher prevalence of XP patients, smaller geography and developed economy, may be better suited to participating in XP trials because of higher number of available patients.
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macgyver
Posted on: Sep 25 2018, 03:19 PM


Group: Member
Posts: 358

Attached Image
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macgyver
Posted on: Sep 25 2018, 02:53 PM


Group: Member
Posts: 358

I’m hearing ya. Long and strong brother💪🏻
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macgyver
Posted on: Sep 25 2018, 02:39 PM


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Posts: 358

What’s to know? We’re going to $30 today mate!🤣🤣🤣


In all seriousness, it’s making me nervous. Anyone derisking?
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macgyver
Posted on: Sep 25 2018, 01:10 PM


Group: Member
Posts: 358

I don’t see why you couldn’t attend the AGM being a CLVLY holder. Doesn’t seem right to deny entry to our fraternal brothers, and sisters of course🤝✊
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macgyver
Posted on: Sep 25 2018, 12:14 PM


Group: Member
Posts: 358

Healthy appetite for shares still showing....
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macgyver
Posted on: Sep 24 2018, 12:29 PM


Group: Member
Posts: 358

Making fortunes by the minute seems so passé now... devilsmiley.gif
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macgyver
Posted on: Sep 24 2018, 12:13 PM


Group: Member
Posts: 358

Well, I was premature by two weeks rolleyes.gif

What is happening is exactly how Johnny H predicted it would go. Supply becoming very tight and the potential for substantial gains to be made in a short period of time. Expecting some volatility along the way, however if the share price surges more then it should build up a nice buffer should Clinuvel not get a priority review or some other issue occurs.
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macgyver
Posted on: Sep 21 2018, 04:47 PM


Group: Member
Posts: 358

As Verhaven posted this morning, CLVLY and UR9 made gains last night. I was expecting an announcement this morning but nothing came of it.
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macgyver
Posted on: Sep 21 2018, 04:33 PM


Group: Member
Posts: 358

I think FIL still offloading (no reason to think they are not) If it was their 1 million shares dumped on the market then the volume for this week might bring their holding down to less than a million, provided the 500k gets absorbed quickly on Monday.

Not long until they’re out then.
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macgyver
Posted on: Sep 21 2018, 04:13 PM


Group: Member
Posts: 358

FIL pushing through the last tranche sub $19 before Monday perhaps.

Tipping point.
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macgyver
Posted on: Sep 21 2018, 04:04 PM


Group: Member
Posts: 358

What the...???

Attached Image



1m shares bid for in aftermarket? 👀
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macgyver
Posted on: Sep 21 2018, 11:20 AM


Group: Member
Posts: 358

Mammon is allowing the stock to rise today. Did someone sacrifice a lamb at the altar?


Edit: Scrub that, someone is pulling it down🙄
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macgyver
Posted on: Sep 20 2018, 10:32 AM


Group: Member
Posts: 358

I’ve been thinking about the shift in strategy to XP indication/ DNA repair related indication before commencing with vitiligo. Any clues as to why this is the case?

- Maintain higher pricing per implant? (Shouldn’t be an issue given prevalence of vitiligo patients, even at reduced price per implant)

- OR vitiligo trial results less than adequate or waiting on new delivery method to improve pigementaion such as Vallaurix topicals?

- Easier to obtain approval for XP indication?

- Or is XP a launch platform to treating similar DNA repair- related indications, which maintains higher pricing whilst treating very large pool of potential patients leading to more profitability in the interim versus treating vitiligo?
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macgyver
Posted on: Sep 20 2018, 10:03 AM


Group: Member
Posts: 358

This page is unavailable, or needs updating. An old link perhaps?
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macgyver
Posted on: Sep 18 2018, 06:32 PM


Group: Member
Posts: 358

Past few days definitely increasing incrementally. Possibly more than 2-3 cents at a time.

Attached Image



Not going backwards? Wonderful.
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macgyver
Posted on: Sep 18 2018, 12:38 PM


Group: Member
Posts: 358

I tried to sell some shares this morning at $100 before the open on the off chance that some idiot had a bid in for $100. I knew it was a long shot😁😁😁

How controlled is the sp rise the last few days?? Are we only moving up in 2-3 cent increments per day?? 🤣🤣🤣
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macgyver
Posted on: Sep 15 2018, 11:03 PM


Group: Member
Posts: 358

This may be relevant. Not sure if Scenesse falls within the five classes. I assume since the U.S health insurers are paying they may have a lawful obligation to front up.

[attachment=50463:998ECD68...07D8DA2C.png]

https://bcht.berkeley.edu/sites/default/fil...ma%20120914.pdf
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