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Clinhope
Posted on: Sep 18 2019, 04:44 PM


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Posts: 1,004

Ok, that's it. Can someone please explain to me how CUV and CLVLY are almost always in lock step. If some algorithm is playing fiddle with CUV shorting, how is it that it once again, as has been the case for years now, we have the CUV price close to within a few cents of the equivalent U.S CLVLY closing price?!

I can understand it would be within say 5% of each other would be "natural", but this is something else.
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Clinhope
Posted on: Sep 13 2019, 10:12 PM


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For what it's worth, approximately 24 days out from FDA handing down their decision, i just want to say to all the CUV long termers that we are so close to the thing we've been waiting so long for, but we still shouldn't lose sight of where we are and what it will be like post FDA decision.

America is a completely different beast compared to Europe and on top of that the company is poised to completely spread its wings. The work that remains ahead of the company is surely daunting enough even if it were just going into the US with EPP. But add on Vitiligo, paediatric, XP, OTC products, CUV9900, VLX001, Australia and Japan and you have a future that will be both turbulent and rewarding.

My point is, as frustrating as it is to see morons playing games with Clinuvel, try and appreciate the great investment you're involved in and be prepared that post October 6th, things may still be just as frustrating sitting at $50, than $23.
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Clinhope
Posted on: Sep 2 2019, 12:15 PM


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https://apple.news/AJv7CDXiLRYSyUNLeqED2Uw
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Clinhope
Posted on: Sep 1 2019, 10:09 AM


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The systemic benefits of Scenesse seem to be completely different with brem. I.e, Scenesse is still king regardless of being second to the starting line.


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Clinhope
Posted on: Aug 28 2019, 09:23 AM


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It's possible that they don't have the sh!te logo there because how would you present it without spending a lot more money. The illuminated "C" is much simpler and ties in nicely with the "light and life" conference.

SADLY...the goddess and Frilly duo may still be lurking around in the background.
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Clinhope
Posted on: Aug 26 2019, 11:38 PM


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I get your frustration, but i was relieved when i read this:

About 1% of patients treated with Vyleesi in the clinical trials reported darkening of the gums and parts of the skin, including the face and breasts, which did not go away in about half the patients after stopping treatment. Patients with dark skin were more likely to develop this side effect.

Not quite the same as Scenesse right?
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Clinhope
Posted on: Aug 23 2019, 10:33 AM


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I was looking for companies that I managed to find some other interesting cases that received an extension but are a little bit different.

Eliquis by Bristol-Myers Squibb Company and Pfizer.

In March 2012 they received the three month extension.

By late June 2012 they received a CRL!

Late September 2012 FDA accepts resubmission.

December 28th 2012 FDA approves Eliquis.

Bivigam by Adma Biologics did the same with an extension, CRL due to "FDA running out of time to review their extensive submission package."

So there are two companies that seemed to be in a very bad situation and received extensions and CRLs and went on to be approved.


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Clinhope
Posted on: Aug 21 2019, 08:31 AM


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I get your point but I’m just trying to get the attention of people that maybe aren’t as interested in this than the usual crowd.

Echo chambers are the death of truth.
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Clinhope
Posted on: Aug 20 2019, 09:30 PM


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Hopefully my post about the cash ban and the few scraps that have appeared in the MSM have got some peoples attention on this forum.

If any of you who think the "powers that be" have gone and are going too far with their monetary policies please sign this petition. It would be great if more people would contact their local members but i understand not everyone sees this the same as i do.

CASH BAN CHANGE.ORG PETITION

This is a battle against international conglomerate banks like HSBC who are petitioning the government to lower the amount to well below $10,000. They have vested interests in seeing this through.

These banks, governments and financial institutions play monopoly with real peoples livelihoods and lives. NO MORE. The next GFC will come because of these scumbags and everyday people will suffer. They are vying to set up the monetary policies around the world so that they can keep playing these games!

CASH BAN CHANGE.ORG PETITION
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Clinhope
Posted on: Aug 18 2019, 09:29 PM


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Because it is an event horizon. Our future relies so heavily on the outcome of the FDA decision that thinking beyond that point is as much speculation as trying to answer what will the world be like once General Artificial Intelligence is created? We can guess and we can prepare for likely scenarios. But ultimately, the answer to what action we take or the outcome of our future will only be unveiled when we reach the event horizon.
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Clinhope
Posted on: Aug 17 2019, 10:17 AM


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Posts: 1,004

QUOTE
Final concordant and discordant regulatory outcomes

Further to the above resubmissions and reexaminations of applications, we compared final regulatory outcomes. If an application was not resubmitted/reexamined by an agency, the initial outcome was also considered to be the final outcome. By this accounting, the proportions of applications finally approved by the EMA and the FDA were similar (93% and 92%, respectively). Resubmission/reexamination of initially nonapproved applications increased the concordance between the agencies to 98% (105/107) of applications


Very nice. Interesting that the FDA has a slightly higher non-approval vs the EMA. I'd like to see if there is a difference (probably not statistically significant) of approval ratio for those who get EMA approval 1st and vice versa.
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Clinhope
Posted on: Aug 8 2019, 03:37 PM


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Posts: 1,004

While we are all quietly suffering i want to raise a critical issue which i think affects all of us, even those who aren't in Australia. Despite my last rant only receiving the applause of crickets, here we go.

As of Monday the 12th August 2019 the Australian Government will introduce a bill said to help address illegal money laundering and tax fraud. A limit on cash transactions of $10,000 and above will be introduced January 1st 2020.

The truth is that this is the first step toward the government/RBA introducing deeply negative interest rates of -3% or more to appease the desires of the IMF who believes having a transition to mostly cashless economies with "deeply negative interest rates" on a global scale is the only way to stave off the impending global crisis. Which btw is a result of the astronomical debt bubble initiated post 2008 GFC, by major banks and governments around the world which continues to this day.

IMF:
QUOTE
The experience of the Great Recession and its aftermath revealed that a lower bound on interest rates can be a serious obstacle for fighting recessions. However, the zero lower bound is not a law of nature; it is a policy choice. The central message of this paper is that with readily available tools a central bank can enable deep negative rates whenever needed—thus maintaining the power of monetary policy in the future to end recessions within a short time. This paper demonstrates that a subset of these tools can have a big effect in enabling deep negative rates with administratively small actions on the part of the central bank. To that end, we (i) survey approaches to enable deep negative rates discussed in the literature and present new approaches; (ii) establish how a subset of these approaches allows enabling negative rates while remaining at a minimum distance from the current paper currency policy and minimizing the political costs; (iii) discuss why standard transmission mechanisms from interest rates to aggregate demand are likely to remain unchanged in deep negative rate territory; and (iv) present communication tools that central banks can use both now and in the event to facilitate broader political acceptance of negative interest rate policy at the onset of the next serious recession.
IMF FRAUD

This is exactly the same type of sneaky tactics the US, New Zealand, EU and Australian governments used to introduce the "Bail-IN" back in 2014. Both that and the "war-on-cash" that we are seeing now will be changed slowly, bit by bit, so as few people as possible are aware of the real reasons behind them.

The IMF has point blank stated that the only way to counter the next GFC is to drop interest rates into the negative territory, thereby causing banks and other institutions to drop their rates and thereby making common folk PAY TO KEEP MONEY IN THE BANK. No one in their right mind would do such a thing, so they are expecting people will increase the consumption and investments which will then stimulate the economy. Great! Except you still have banks conducting trillions of dollars of derivative gambling and governments conducting trillions of dollars of Quantitative Easing increasing the global debt further. Like putting a bandaid on an atomic bomb.

They are pretending this is an innocuous change aimed at finding the bad guys, the truth is they are setting it up so that when the system collapses, it is the common people that suffer and not the banks.

A great resource for information about this is John Adams website: John Adams submission letter

Summary videos: ScoMo Declares War On The Australian People
Cash Ban Lies

For any aussies out there, we can no longer afford to brush this kind of thing off without standing up for ourselves.
PLEASE, look into it yourself and write to your local MP and the treasury (Blackeconomy@treasury.gov.au) stating your concerns.


Please take a little bit of time to look into it and don't label this as being just another baseless conspiracy theory.
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Clinhope
Posted on: Aug 6 2019, 02:49 PM


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I hope my prediction of the whole global economy going to hell in a hand-basket just before approval wasn't right.
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Clinhope
Posted on: Aug 5 2019, 10:41 AM


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Looks like they want to and will crack the $30 mark. Wankers.
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Clinhope
Posted on: Aug 4 2019, 11:06 PM


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And these kinds of positive effect we see from a-MSH come about during systemic dosing, aka what occurs with the implant, or is it applied locally somehow?
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Clinhope
Posted on: Aug 4 2019, 10:20 AM


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Punk, a-MSH aren't Melanin injections, right? Unless that's what they're referred to as, i thought melanin injections were something else. Is it possible that even as a dermatologist she has absolutely no idea what she is talking about?
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Clinhope
Posted on: Aug 1 2019, 05:04 PM


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Clinuvel played ignorant because they never thought a plucky SC member would invoke the FOIA and uncover such critical information?
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Clinhope
Posted on: Jul 30 2019, 10:04 PM


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Anyone have an idea why the PDUFA is set for SUNDAY? Seems pretty dumb to set it for a weekend and not a work day.

Am i missing something or it just doesn’t matter?
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Clinhope
Posted on: Jun 13 2019, 08:47 AM


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He thinks UBER is cheap! What an idiot, it’s a massive speculative buy if UBER ever turns a profit after they get their autonomous fleet. Theyve even resorted to Elon Musk like baseless spruking with their “autonomous flying taxi service” down in melbourne. And no competition? He is demented, just every single car manufacturer that can build a fleet off the first company to achieve level 4 autonomy and sell a autonomous taxi service.

So at the very point when Uber starts clearing their massive debt with full autonomy they lose all competitive advantage because everyone will crack the code soon after.
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Clinhope
Posted on: Jun 9 2019, 01:57 PM


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I'd be in. If we get approval it will be worn with pride.
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Clinhope
Posted on: Jun 8 2019, 11:32 AM


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I’m not saying you are wrong, all i know is that the legislation leaves it open for banks to take customers money. The government guarantees to pay back the money, but this is still a highly immoral situation. It does nothing to address the real problem of banks being gambling houses and playing poker with their customers money. My understanding is that theyve done this so theres no bailouts like in 2008. Bailouts that happened because of sub-prime debt repackaging. Something which is magnitudes WORSE since 2008. Australias banks alone have ~$60 TRILLION in derivatives debt and JP Morgan alone has nearly that much!

This legislation is palmed off by most people, that will never happen they say. The truth is theyve been playing us like puppets for years.

And im not saying this because im exposed, i dont think i am. My cash deposits are minimal so unless they can sell my CUV shares and take that then i should be ok (fingers crossed).
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Clinhope
Posted on: Jun 7 2019, 10:57 PM


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Just a quick post about the totally underhanded plot to destroy any notion of a free market. Reserve banks, governments and commercial banks rape and pillage the worlds economies and leave their citizens with the charges.

The ability for banks to seize the publics deposits to stave off a collapse has been implemented more or less secretly around the world and behind our backs.

If you’re unaware of this issue, please do some reading and sign the petition.

https://cecaust.com.au/stop-bail-in-petition
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Clinhope
Posted on: Jun 7 2019, 12:08 PM


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I was just looking at the next ASX 200 rebalance, it should be on the 21st June right? Announcement being the 3rd friday of June...
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Clinhope
Posted on: Jun 4 2019, 05:50 PM


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If it ever drops below $15, maybe then.
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Clinhope
Posted on: Jun 3 2019, 05:33 PM


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Once bitten twice shy. When i read about the delay all of the feelings of old came back, paranoid conspiracies about big pharma putting the pressure on to delay a paradigm altering drug.

I understand the idea that this delay seems to bolster the chance of approval but it's still gut wrenching .

So if we get approval this will be a fast track decision of just shy of 9 months.
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Clinhope
Posted on: Jun 1 2019, 07:23 AM


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He's still around. He's got a captive audience on a remote island somewhere.
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Clinhope
Posted on: May 31 2019, 01:17 PM


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@Alaaf, thanks for sharing your story. I think you can see the appreciation for your earnest words by all the thanks from fellow Clinuvelians. It really demonstrates how lucky we all are, but especially so in your case. Not only having found a potential treatment but also having friends that respect you enough to listen to your advice and invest in Clinuvel.

Well done. All the best.
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Clinhope
Posted on: May 29 2019, 04:33 PM


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Thanks to anyone who replied to my post so far. I find it reassuring that people with such great outlooks on their fortunate positions are making similar life choices to mine.

If i start my own Investment fund in a few years i'll know where to look for backers. wink.gif
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Clinhope
Posted on: May 29 2019, 02:16 PM


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LJS, absolutely. As i've mentioned here before i didn't take the opportunity to share the money i had, to do the things with my family that i wanted to do. Now i will have that regret for the rest of my life. I don't want to repeat that again. I've planned and forecast countless times in excel the varying scenarios for share price, number of CUV shares, expenses and income (or no income) and should i play my cards right there is no NEED to work out of necessity to "survive". Having said that i realise the need to work comes from both a sense of personal achievement and giving back to society (more than just taxes).

@THEG1000, that's great to hear. It's entirely possible i'll have to go back to work in a few years if things don't turn out well. But i've got the sack of cash and I'm running with it as fast as i can. I've been studying for the last 6 years in varying ways, taken the last year off from Uni and i'm currently studying investing to try and make a small income seperate to that of CUV. Hopefully within a few years i'll be able to stop selling CUV as an income source.

@seeva22: yep i am hungry my friend. Hungry to enjoy life and hungry to not let it all go to waste. i'm using the next few years as a way to transition (why do i hate that word now i wonder....) into finding out what the rest of my life will be about. It's 50k. Small amount left on a car loan, renting an apartment. Sell a decent parcel every month to live off of and help family when i can.
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Clinhope
Posted on: May 29 2019, 11:44 AM


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Just because i have no one else to talk to about this and you guys are the only ones who can relate to my situation, I'm wondering if anyone hear is considering early retirement?

I was walking through my "retirement village" AKA sleepy Sydney suburb and got a few questions as to why i wasn't working. My studies are on hold for this year but that is the only answer i could give. Being in my mid 30's i don't know if I'm shooting my future self in the face.

Most people here would have near the amount of shares i have. The smallest i've seen mentioned was 20,000 shares. Still a fortune even at todays s.p.

As we talk about taking profits, has anyone else given up their day job to live off the CUV fruit?
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Clinhope
Posted on: May 28 2019, 05:59 PM


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It is a positive "event horizon" for me. All i know is that the outcome will more than likely be positive. What that positive will look like exactly is completely unknown for so many factors like "Newtocli" just mentioned.

In general we all know the broad investor market buy and sell on rumours which could work for or against us. The s.p might shoot up to $70 for arguments sake and then drop down to $45 on rumours of slow implementation (as a made up example). Or it could be pushed up to $150 on news of specialist clinics ready to go, vitiligo, Australia, Japan not far behind and paediatric and topicals coming online in the next year or so.

WHO KNOWS. It's all a dream.
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Clinhope
Posted on: May 24 2019, 10:57 AM


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Yeah baby $33.04!!!
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Clinhope
Posted on: May 20 2019, 11:24 AM


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VLRX001 (a topical) is touted as being a treatment initially used in combination with Scenesse for the treatment of vitiligo. Suggesting to me that the topical is mostly localised in effect.

Clinuvel also alludes to the 2nd generation melanocortins as systemic and topical. If topicals turned out to be systemic in any major way then it's a strange distinction in the way i see it.

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Clinhope
Posted on: May 20 2019, 10:03 AM


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Strong start out of the gates.

Attached Image

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Clinhope
Posted on: May 20 2019, 09:06 AM


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In regards to the implant, a majority is absorbed by 48 hrs, 90% in 5 days, plasma levels undetectable by day 10.

Should be an interesting day of trade!!!

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Clinhope
Posted on: May 17 2019, 09:58 PM


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A small bit of coverage on yahoo finance.

https://au.finance.yahoo.com/news/insiders-...-040459461.html
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Clinhope
Posted on: May 17 2019, 09:20 PM


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The other one ive taken a small position in is Allegra Orthopaedics. Mentioned on this board a while ago, i looked into it and it looks very promising. Though the stock barely trades and news is none existent. But the results ive seen look quite promising.

Thanks Telix, I’ll have a look.
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Clinhope
Posted on: May 17 2019, 10:31 AM


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$31.405

And yes i will be posting the highs when i catch them.
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Clinhope
Posted on: May 17 2019, 10:15 AM


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Just hit $31.3 biggrin.gif
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Clinhope
Posted on: May 14 2019, 08:01 PM


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Some of the people Clinuvel follows are a bit disconcerting:

https://twitter.com/Licuwangxiaoyua
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Clinhope
Posted on: May 8 2019, 08:56 AM


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QUOTE
The EUMelanin stimulated by Scenesse is literally the most effective and efficient “sunscreen” that we know of. Chemical creams for photo protection are ancient technology and the health risks (many are only just coming to light) that are associated with using them are outrageous in comparison to our safe and effective implant.


Absolutely. What I'm saying is that while that is true, from a public health organisation perspective such as the FDA or the Cancer Coucil in Australia is will be a decade or more before they ever ease off on the sunscreen and clothing message to prevent UV damage. It is also likely that Clinuvel will therefore support such a message, hopefully with their own OTC products with sunscreen incorporated.

QUOTE
It might seem crazy in 2019 that chemical suncreams will be rejected for Afamelanotide patches creams implants pills even, but why would you lather yourself in these ineffective chemical soups that have the potential to cause all sorts of issues within the body if you had a super safe and effective alternative? ]


I think Scenesse shouldn't be relied upon as the stand-alone sun protectant. Yes it is light years ahead of anything we currently have, but sunscreens will still have a time and place to be used in conjunction with Clinuvels other products. In that article it said that sunscreens were initially popular for use on holidays and for certain peak times of sun, whereas now it is encouraged everyday all day. Maybe those patients using Scenesse will go back to using sunscreens at the peak UV index and sun exposure periods.

It's all very speculative to forecast peoples behaviour but that's how i see it playing out at the moment.
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Clinhope
Posted on: May 7 2019, 07:10 PM


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Posts: 1,004

I agree with what you’ve said, possible conspiracies and all. But in addition to what’s been said today about sunscreens i want to say that Scenesse will not be the end of sunscreens whatsoever.

Any person of any skin type that is on Scenesse will still need to apply sunscreen, from both health organization and personal perspectives. I can see Scenesse as being another layer of protection from sun damage and i believe that Clinuvels OTC products will have sunscreen qualities in them.

62 DAYS AND COUNTING!!!!
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Clinhope
Posted on: May 6 2019, 09:29 AM


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Posts: 1,004

Approval after a second rejection seems unlikely even if it is only based on production facility processes and not clinical data. The fact they got a second rejection takes the risk into a whole new level.

https://www.raps.org/regulatory-focus™/ne...-approval-times
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Clinhope
Posted on: Apr 28 2019, 09:36 AM


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Posts: 1,004

Hey guys,

I was going to write a reply last night but thought better of telling others what to do. This morning i can't hold back.

I think everyone here is in a relatively great financial position as the s.p currently stands. I realise wealth can be a fleeting, fickle thing, one stupid move and it will be gone in a flash. But i just want to illuminate the other side of the "every dollar i spend now is so much i won't have down the road".

The last 5 years has been the toughest i've ever faced, life just throwing one thing after another. It's taken people from me that i can never get back and will never have the chance do the things i dreamed of doing with them. I had the money, i thought i had time on my side too. But it turns out i didn't.

Don't make the same mistake. Hold two ideas in your mind, 1. don't waste money 2. don't waste time holding off on things that really mean something to you.

Cheers.

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Clinhope
Posted on: Apr 26 2019, 07:16 PM


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Posts: 1,004

Thanks for asking that. This is first hand evidence of how i thought the non-believers see Clinuvel. A high risk company, over-valued and little potential of an upside with so few people to treat. LMFAO.
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Clinhope
Posted on: Apr 19 2019, 04:09 PM


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This coming Monday and Thursday the ASX is closed.
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Clinhope
Posted on: Apr 17 2019, 12:06 PM


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@johnny, at the moment I’d have to sell some CLINUVEL shares to pay for it which really seems counterproductive.

@hamster, well said. Here and Uho on GG has all the bases covered.
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Clinhope
Posted on: Apr 17 2019, 09:45 AM


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I guess you applied for access and are waiting for a reply?
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Clinhope
Posted on: Apr 16 2019, 02:14 PM


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Yes we have yolo. It’s mostly an unknown and unlikely to be a threat to Clinuvel anytime soon.
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Clinhope
Posted on: Apr 14 2019, 10:28 AM


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I think some of the more knowledgable investors here have spoken about this before, but judging by the current price, where we are at the moment relative to some of the highest share prices in Aus then there will need to be a share split soon otherwise the s.p when fully fledged will dwarf even the largest companies.

Is that basically right?
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Clinhope
Posted on: Apr 11 2019, 12:21 PM


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So we should all write to him when the sp reaches double again shortly after July 8th.
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Clinhope
Posted on: Apr 11 2019, 08:35 AM


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Could be! That would be one cheeky "Easter Egg".
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Clinhope
Posted on: Apr 4 2019, 02:52 PM


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If i remember correctly it did quite well for AK and organ transplant recipients?
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Clinhope
Posted on: Mar 28 2019, 07:22 AM


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https://twitter.com/ClinuvelNews

"Each silicon atom is connected by 4 strong bonds, keeping electrons in place so current can't flow. A silicon #SolarCell uses 2 types of silicon that are either of negative (-) or positive (+) charge, the latter are also known as holes."

For all we know they could be updating the website to branch out into solar panels.
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Clinhope
Posted on: Mar 24 2019, 02:35 PM


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Yep i agree. I guess I’m just really concerned about the ramifications of the worldwide QE for the last 9 years and how inflated the derivatives, real estate and stock market is. Chances are I’m being overly paranoid when it comes to thinking the financial system will be turned upside down when the tsunami of debt comes crashing. Putting my paranoia aside things will be go south for a bit and then the fed will just alleviate the worlds debt addiction with QE to levels unprecedented even by todays standards.

Anyway! By 2020 we should still be right to get the Porsches and Mansions, and if you live in Australia maybe a tidy 3 bedroom house 30 minutes outside of the cbd.
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Clinhope
Posted on: Mar 23 2019, 01:37 PM


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Seemingly spanked just ahead of the rest of the US market. This is what worries me the most. That we get approval and then the next crisis comes steaming through.

Not to be an alarmist, Clinuvel looks to be a safeguard against whatever is coming. But we will need to be prepared for some hard hits. CUV, GOLD, CASH. .
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Clinhope
Posted on: Mar 21 2019, 04:57 PM


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Sometimes. If the mass of monkeys (mostly professional traders) out there inflate the PRICE well beyond the VALUE, or undervalue a stock from fear that's when I've made good returns, think VW diesel gate and possibly now with Boeing.

So the only reason i can imagine Clinuvel currently not being overvalued as a single drug biopharma ahead of FDA approval is that it, for whatever reason, hasn't caught the attention of the monkeys, they don't see the scope of potential. All they are seeing is "EPP-SMALL POPULATION-EXPENSIVE-POSSIBLY VITILIGO-NOT MUCH ROOM TO GROW" and i put that down to the understated tone CUV has put forward for the last 10 years or so.

It feels like we are the lucky few to see the truth, i hope that turns out to be true come July 8th.
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Clinhope
Posted on: Mar 21 2019, 04:17 PM


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That is the logic which underpins over 90% of the international stock markets. "Modern portfolio theory" is responsible for us having gone under the radar for the last 5 years or so and allows people like us to pick up once-in-a-lifetime stocks for what will hopefully turn out to be dirt cheap.
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Clinhope
Posted on: Mar 21 2019, 12:50 PM


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Don't worry i wasn't far off $29, buying in last week. And probably a few more to add to the pile next week.
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Clinhope
Posted on: Mar 20 2019, 11:33 AM


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It would be a lengthy process to reverse surely? I would've thought it would be a case of "tough titties" i.e bad luck!
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Clinhope
Posted on: Mar 2 2019, 07:56 AM


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I almost thought it said #psychedelics for a second. Which would've explained the post thoroughly.
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Clinhope
Posted on: Feb 16 2019, 01:41 PM


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"and meeting orphan disease needs I would say that it is riskier to not hold Clinuvel than it is to hold it. "

I agree, which is why it is the only stock i'm holding on to, despite my dire fears for what may come for international economies.

@seeva222, i had a look back at some biopharma stocks during the 2008 GFC , Allergan for example, but none seem to be an adequate comparison for CUV. Any ideas?
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Clinhope
Posted on: Feb 15 2019, 09:09 AM


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Hey guys,

I thought I’d raise a subject which I haven’t seen on this board before, one that I think will be one of the only obvious things to have any negative effect on the mid-term trajectory of the CUV sp and possibly (but hopefully not) the roll-out of the drug.

I raise this issue here out of respect and curiosity for the opinion and experience of the fellow CUV longs.

Strong speculation ahead!

Surely everyone here has heard of the possible looming economic crisis. The markets shook from October to December last year only to turn 180* over the last couple of months and recover much of what was lost. Clearly CUV/CLVLY are detached for various reasons from the wider market speculations and fluctuations. Yet there may be a storm on the horizon with the potential to land a few blows to our ship.

I’m no economic expert, yet to me, the current global economic systems that have risen since the GFC are the equivalent of real world Monopoly. With the Reserve Banks acting as the banker and everyone else as the pieces on the board. The vast majority of European countries have levels of debt they will never be able to pay off, the same goes for China, the US and Japan. The core functions are broken and the Fed continues to play puppet master attempting to continually stoke the markets flame by adjusting rates and taking on banks bonds-assets-debts.

As the U.S bond yield curve flattens and surely inverts, Italy implodes dragging the rest of Europe with it, and countries around the world continue with “Quantitative Easing” I will be shocked if the next global economic crisis doesn’t appear within the next two years.

It’s an unfortunate scenario, one I’m sure many think won’t happen. And some who think it’s people like me that bring it about. But my question to those here is, if or when it does happen, how do you think it might affect Clinuvel?

Personally I think we will see this the collapse happen in the second half of 2019. The markets and Feds may be able to bluff their way into a continuing Bull market for now, but not for long. The possible crisis would only blunt the Clinuvel s.p and possibly delay the current potential by a year or two. Approval will go ahead, but I could see trouble with insurers willing to fork out the money if the crisis is as bad as I think it will be.

I look forward to hearing others thoughts on this.
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Clinhope
Posted on: Feb 13 2019, 03:12 PM


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Nicely done Punk. My first guilty pleasure was a bit more subdued than yours for the time being (some high end audio gear) but the first big guilty pleasure will be POST APPROVAL haha. Can't take the leap just yet.
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Clinhope
Posted on: Feb 7 2019, 04:59 PM


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@waz, yep that should be an interesting week assuming we make the new listing.

No one is surprised by the closing price?! $23.45
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Clinhope
Posted on: Feb 7 2019, 03:11 PM


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So the ASX top listings are calculated on the third Friday of a given month after closing, the next specified month being March. Does that mean we can expect the new listing to be posted first thing monday morning on the 18th March?
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Clinhope
Posted on: Feb 2 2019, 01:35 PM


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Is there some way we can see your comment? I had a look but couldn't see where it is. I'm sure you'll keep us posted regardless.
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Clinhope
Posted on: Feb 2 2019, 11:40 AM


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I was just watching a Joe Rogan podcast with David Sinclair where they talked about various molecules and drugs being developed. At one point David talks about some molecule that treats psoriasis through anti-inflammatory actions. Joe asks if all immune disorders are inflammatory based to which David says he believes so. To which Joe says ohh, because i have vitiligo. He then proceeds to write down the name of this pre-clinical drug which has no actual evidence related to treating vitiligo in the hope it might do something.

Two things, how in the hell can a guy as worldly and information hungry as Joe not have heard of an effective vitiligo treatment on the cusp of approval?
And, how can we best get the message to him? Anyone here know how to actually use twitter?
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Clinhope
Posted on: Feb 1 2019, 10:43 AM


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With 7.4 millions views and counting the moderators of Sharecafe CUV forum have a strong interest in keeping the peace. No one needed to say anything.

Does anyone think this could effect us? https://www.statnews.com/2019/01/31/in-bold...n-drug-rebates/
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Clinhope
Posted on: Jan 30 2019, 03:32 PM


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Has anyone considered the micro needle patch as a delivery method? Would this be a tidy work-around for large molecule penetration?
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Clinhope
Posted on: Jan 25 2019, 02:22 PM


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Just for my reputation sake i did not mean to thank iggy for that post. It was meant for Johnnytechs post instead.
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Clinhope
Posted on: Jan 25 2019, 08:53 AM


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Two or three indications, 3+ years of top notch safety, tens of thousands getting treatment in the U.S and then it will be time to LOOK at allowing off-label for specific cases to expand the scope of treatment. Unless PW is looking to only ever allow treatment for approved indications even after he's gone, which would be unfathomable in the history of pharmaceuticals at this level.

What really annoys me about this discussion, and it's fine and expected for PW to establish a tight control over distribution and prescribing, but for us here on a FORUM to be that shit-scared that we can't discuss the expansion of treatment for things that aren't cosmetic is ridiculous. We have all seen the potential of this treatment for everything from AK, potent antioxidant, to acne. https://rosacea-support.org/scenesse-shows-...e-for-acne.html

A nice little write-up on Scenesse. https://www.dermnetnz.org/topics/afamelanotide/

Fellow Aussies have a good long wknd.
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Clinhope
Posted on: Jan 16 2019, 05:24 PM


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PW responds to our conversation on Twitter?

CEO, Dr Philippe Wolgen: ‘Controlled-use of novel technology is central in our thinking’.

Awesome, the wonders of technology.
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Clinhope
Posted on: Jan 16 2019, 09:32 AM


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Seems like a bit of an over-reaction to say that Scenesse shouldnt be used for a population that it may help without adverse affects after it has been approved. We know that when being used for any various indication it will likely be effective and definitely safe.
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Clinhope
Posted on: Jan 15 2019, 07:33 PM


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Can anyone speak confidently about the limitations of prescribing if we get approval. I’ve heard it mentioned before that FDA can limit/ban off label use but haven’t heard in what circumstances they make such a choice.

Surely limiting the off label usage when the potential benefit to help so many other patient indications with an extremely safe drug is unfounded in this case.
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Clinhope
Posted on: Jan 15 2019, 10:27 AM


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Sorry can you repeat that. I don’t understand what you mean. biggrin.gif
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Clinhope
Posted on: Jan 15 2019, 10:27 AM


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Sorry can you repeat that. I don’t understand what you mean. biggrin.gif
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Clinhope
Posted on: Jan 12 2019, 07:13 PM


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Hey Iggy, i hope you had a good Christmas and New year! I'm pretty sure majority of the people here have not only taken tax into account for when they do sell some shares, but most will likely make enough money post tax that there will be a divorce fighting over the money and how to best spend it instead of the tax bill.

Funnily enough i'm doing my tax now for 17-18 and found out that more than half of my Clinuvel shares were bought at 18cents. That sure is bitter sweet.
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Clinhope
Posted on: Jan 12 2019, 06:42 PM


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Up till last week i would've said Celgene was a strong buy certain of making a decent return. Yet a takeover deal has sprung up, yes also causing CELG to shoot up 30% in a week but has also as far as i can tell put a leash on CELG's future prospects as a respectable Biopharma.

Apart from that i would hold off on the re-investing, the 2000 trillion $ global debt (yes that is 2 QUADRILLION DOLLARS) tells me a storm is brewing on the horizon. Clinuvel should be a safe harbour for some of your money.
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Clinhope
Posted on: Jan 12 2019, 02:17 PM


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I've tried to share the potential of this company with everyone from close family and friends to my accountant and even a podcast that covers Biotech every Wednesday. I've even written longgggg emails to friends to try and describe the past present and possible future to no avail. The light just doesn't turn on for them. For all of us i think the light turned on pretty quick.

They either couldn't see the potential or couldn't see that what had been achieved to that point was only the beginning of much bigger things to come.

Friend:"What did you buy in at?"

Me: "$3".

Friend:"Where is it now?"

Me:"$18"

Friend:"Ohh well that's good for you"

Me:"..... stun.gif "

Of course well done to everyone who's held on through the silence and missed targets. I just hope that when the rubber hits the road in the second half of 2019 that the road is already paved well ahead to get Scenesse to the people in need, ASAP.
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Clinhope
Posted on: Jan 9 2019, 09:03 AM


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Seems like a huge benefit to Clinuvels plight. Can we foreward that to NICE and the Norway agency?
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Clinhope
Posted on: Jan 8 2019, 07:08 AM


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Theyve clearly taken a leaf out of NICES book and used the same rhetoric to reduce costs to the national scheme.
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Clinhope
Posted on: Jan 3 2019, 06:51 AM


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A new scientific communique. I find it interesting that over 90% of the communique is about stuff other than Afamelanotide and that 90% sets up a vague summary of what potential Afamelanotide (not Scenesse for whatever reason) might have. Don't get me wrong, it is informative about the disease and current treatments which i appreciate. But who are these communiques written for....


The 10%
Afamelanotide: an analogue of α-MSH designed to assist in vitiligo repigmentation


Significant advances in the understanding of the factors which influence melanocytes and their stem cells have lead to improved clinical care for patients with vitiligo. The potential of α-MSH and its analogues to further stimulate these developing melanocytes following ultraviolet therapy, to aid in repigmentation of the vitiliginous skin, is an exciting prospect.

Patient responses to NB-UVB are hugely variable. It is impossible to predict whether vitiligo will improve as a result of the treatment, and if so, to what extent. Considerable time and resources are required to reach a clinical conclusion as to whether NB-UVB therapy is effective and there are potential long term risks associated with repeated exposure to UV radiation, a known carcinogen. Thus, there is a clear argument for the exploration of potential combination therapies with NB-UVB which could reduce the number of clinical visits required to achieve repigmentation.

Based on knowledge of the processes involved in repigmenting vitiliginous skin with NB-UVB, there are clear scientific grounds for the combined use of this light therapy with α-MSH analogues. Afamelanotide, the most clinically advanced α-MSH analogue, is thus a natural therapeutic candidate. It has a greater binding affinity with the MC1R on melanocytes than natural α-MSH and is therefore able to more readily activate melanin to repigment skin. It is hoped that treatment with afamelanotide, in conjunction with NB-UVB therapy, will produce faster, more consistent repigmentation of vitiliginous skin.
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Clinhope
Posted on: Dec 27 2018, 12:33 PM


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Pediatric formula.
Australia and Japan “TGA” applications.

Both seem important enough to be on your list biggrin.gif

Merry Christmas and Happy New year to you all. 2019 will be the start of a new era.
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Clinhope
Posted on: Dec 23 2018, 09:10 PM


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I don’t speak german/dutch, whichever that was. Was it more of the typical coverage or something unique?
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Clinhope
Posted on: Dec 19 2018, 10:50 AM


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Did you guys know the vitiligo results are out?!!’ 😆

Thank goodness for that. The results seem good all round. 21 people in the study, 3 withdrew for negative cultural associations with skin darkening, worked everywhere but the feet, pigmentation maintained for 3 months after treatment.

Would have appreciated a couple of photos though.
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Clinhope
Posted on: Dec 18 2018, 11:53 AM


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As it stands it looks like PW won’t be getting an early Christmas present. So assuming PDUFA is announced 1st qtr 2019, we’d still be looking at FDA decision before 2020, right?
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Clinhope
Posted on: Dec 10 2018, 03:08 PM


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Quite often you’ll see the price post approval shoot up due to hype and then drop once the first few qtrs results come in.

Although I don’t think that will be the case here. Unless there are unforseen snags in regards to regulations, insurances, clinics etc the hype and sales will push the price up and up post approval once the cat is out of the bag.
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Clinhope
Posted on: Dec 6 2018, 06:30 AM


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Quite an informative presentation on the inspection process.

https://www.fda.gov/downloads/drugs/develop...e/ucm466481.pdf
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Clinhope
Posted on: Nov 30 2018, 04:02 PM


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You don't watch the closing trades that often do you? biggrin.gif

Just in relation to the FDA inspection of the production facility/ies i don't think i view it with the same pessimism as other here.

I don't know the history of these inspections, but to me it is a sign that the FDA is in the final stages of assessing the application and this would be one of the last hurdles for them to undergo.

I think we are still on track for PDUFA early 2019 and approval mid 2019. I don't see why this inspection would delay things.
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Clinhope
Posted on: Nov 24 2018, 06:58 AM


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Speculated by us and logical but I’ve never seen it specified by Clinuvel as transdermal or self administered.

But you’re probably right, it would’ve been there since the new site went up i just never noticed.
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Clinhope
Posted on: Nov 23 2018, 06:41 PM


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FDA GMP inspection pg 12 of the AGM slideshow.

Also, i was just browsing the Clinuvel site and read something i haven't seen specified or maybe i just remember:

"VLRX001 is an addition to the family of melanocortin analogues which provoke increased and prolonged cellular activity. It contains a specific peptide sequence, designed to make it less susceptible to degradation than physiologic (natural) alpha-melanocyte stimulating hormone (α-MSH).

The VLRX001 development work was undertaken through CLINUVEL’s Singaporean subsidiary, VALLAURIX and has leveraged the knowledge gained from long term experience with the clinical use of SCENESSE®. Formulation work will focus on the development of VLRX001 for topical self-administration by patients. The transdermal product will initially be evaluated as adjuvant maintenance therapy in the depigmentation disorder vitiligo."

I can remember discussion here about the two new products potentially being topical a-MSH's, as the regular peptide molecule is too large (?) to be readily absorbed, they would need a smaller peptide but no one had come up with a solution.

So did you all know about this?!
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Clinhope
Posted on: Nov 21 2018, 02:15 PM


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None! No more crumbs. What a surprise grrr.gif
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Clinhope
Posted on: Nov 21 2018, 12:47 PM


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I'm just going through the presentation now and noticed something a little interesting. Did anyone notice the two small pictures of a spray and a cream on page 26 in relation to "world's first locoregional photoprotection"?

They could just be pictures for the sake of putting something there, or they could be showing that the 2 forthcoming products cuv9900 and vlrx001, one is a spray and one is a cream.

What other crumbs can we find.
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Clinhope
Posted on: Nov 21 2018, 06:27 AM


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Iggy, im a bit shocked at your post...

Anyway here’s an excerpt that seems timely after yesterday:

“DNA damage, in the form of thymine dimer formation, was also shown to be reduced by 59% (P < .0033) in the basal layer of the epidermis of this group of subjects. This study has shown for the first time the potential ability of a synthetic hormone that augments melanin production to provide photoprotection to people who normally burn in direct sunlight.”
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Clinhope
Posted on: Nov 20 2018, 06:10 PM


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Finally I’m all-in at a decent average. Sellers were teasing me, holding at $17.6 all of yesterday when my bid was 17.5 only to have it drop to $16.78 today.

I didn’t mean to summon the demon about the instagram comment.

Scenesse is safe, the tanning from Scenesse does not cause DNA damage and in fact it probably reverses or minimises it.

Again, i think it silly that Clinuvel has started a public record of them stating the flawed idea “there is no such thing as a safe tan” that will clearly be in direct conflict to the message they will be spruking post approval and can be quoted by anyone with an agenda against them.
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Clinhope
Posted on: Nov 20 2018, 06:44 AM


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Yeh i did know that. My point was it seems completely stupid for Clinuvel to say tanning=Skin damage, yet made no effort to say why the tan Scenesse brings on is different.
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Clinhope
Posted on: Nov 19 2018, 09:41 PM


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Right, thats a relief then. Didn’t expect royco to be quite so pessimistic.
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Clinhope
Posted on: Nov 19 2018, 06:48 PM


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So you attended the AGM royco? Haha if that’s what they didn’t talk about, them what in the hell DID they actually talk about?

Meanwhile, Clinuvel reminds everyone that “tanning is a response to skin damage from UV radiation”. UMMMM....sooooo When Scenesse tanns the skin it’s doing what exactly?

I feel sick.
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Clinhope
Posted on: Nov 17 2018, 07:20 AM


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He’s referring to FDA approval in early 2019, or his commemt could be taken to say at its worst that anytime before christmas 2019 which we all know is well within FDAs guidelines for approval.

As the interviewer says “fda approval in early FY19 is what we’re hearing”.

And then PW says: “well we hope we’ll have an early Christmas present of 2019”.
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Clinhope
Posted on: Nov 15 2018, 08:32 PM


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After blackm3’s possibly most liked post ever on SS, here is the link to the yourmoney video only posted today.

https://www.google.com.au/amp/s/www.yourmon...rading-day/amp/
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Clinhope
Posted on: Nov 13 2018, 09:18 AM


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This instagram post actually annoyed me a little:
https://www.instagram.com/p/BqFja1Fns63/?ut...d=1hcefkosn5yz5

How about instead of educating us about “how clinical trials work” you educate us on how YOUR clinical trials worked or otherwise!
I guess to be fair, i think it’s likely the reason they haven’t spoken about the Singapore vitiligo trial is because they are waiting for the FDA NDA decision. When they said trial results would be forthcoming they didn’t expect the delay we are currently in.
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Clinhope
Posted on: Oct 30 2018, 09:25 AM


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@macgyver: I have to say that’s the way I’ve seen this stock trade for the last 5 years or so. Clearly manipulated to a price someone deems necessary and the small number of real investors and traders play along none the wiser and mostly powerless.
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Clinhope
Posted on: Oct 21 2018, 03:44 PM


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Dont think ive was Ive seen this posted before:

http://www.porphyriafoundation.com/sites/d...d%20implant.pdf
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Clinhope
Posted on: Oct 17 2018, 08:39 AM


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Interesting.

https://www.instagram.com/p/Bo_x7vQDyXU/?ut...id=qlqw4smmkx5m
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Clinhope
Posted on: Oct 13 2018, 07:17 AM


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https://social.eyeforpharma.com/patients-an...changed-my-life

Just another person with EPP whose life has been positively transformed by Scenesse. Nothing to see, move along.

Rocco also appeared on tv recently talking about his story.
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Clinhope
Posted on: Oct 10 2018, 10:04 AM


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18th Annual Biotech in Europe Forum.

https://yourir.info/resources/fee77b1d1a878...urope_Forum.pdf

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Clinhope
Posted on: Oct 8 2018, 09:59 AM


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Fantastic idea investek, i gave my details a bit late but when i recieve it ill make a donation.
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Clinhope
Posted on: Oct 5 2018, 10:29 AM


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Hey Punk, have you seen anything about the followup of people with vitiligo? Say the treatment is a success where does their condition stand 12 months down the road?

Would be interesting to know something about how long the improvement lasts.
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Clinhope
Posted on: Oct 4 2018, 09:41 AM


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Punk can probably soeak ti this with authority, but the lighter parts of the skin should darken at a much faster rate than the normal parts of skin.
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Clinhope
Posted on: Oct 3 2018, 08:45 AM


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Don’t apologize for such great information integral to helping form a picture of the hidden world of Clinuvel.

A very interesting post.
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Clinhope
Posted on: Sep 30 2018, 02:06 PM


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Also being used for treating vitiligo. I stumbled across this while looking into recell. http://3af4pk1d7ktnf8ieb2pl91t1.wpengine.n...es-in-China.pdf
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Clinhope
Posted on: Sep 27 2018, 05:53 PM


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Motley fool has some great podcasts, one in particular being "Industry Focus" that often talks about the latest Biotech stocks doing something cool. I would've contacted them already to suggest they look into Clinuvel if i wasn't selfish and didn't want to keep this all to myself up to FDA decision.

The fact that the broader market has taken this long to catch on and there are still people who look at Clinuvel and are hesitant about its future boggles my mind. Am i missing something or are they?

$70 for a takeover. This is a once in a lifetime opportunity. We could easily see $70+ before 2020 arrives.
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Clinhope
Posted on: Sep 27 2018, 03:36 PM


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A bit more coverage in a Motley fool article, though he says he wouldn’t buy now, but will keep an eye on it :

https://au.finance.yahoo.com/news/too-buy-m...-015430294.html
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Clinhope
Posted on: Sep 26 2018, 10:10 AM


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I’ve been a bit distracted by other things for the last few months amd in the tsunami of info about Clinuvel haven’t kept up to date as i have for the last decade.

Can someone clarify that Clinuvel only stated there would be two new indications without saying what they are? So they could be vitiligo and XP but we’re not sure?
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Clinhope
Posted on: Sep 25 2018, 04:41 PM


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I think there are two ways to look at our current sp.

One is to say yeh it’s a true indication of the core value of Clinvel we’ve all known about for years. Only now the hoard is aware as well.

The other way to look at it is that nothing definite has happened to take us from $12 to $21 in less than a month amd we are like Seligmans dogs cowerinng in a corner waiting to be shocked yet again.

Anyway it is a true win/win scenario whether it goes up or down from here.
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Clinhope
Posted on: Sep 25 2018, 03:37 PM


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Posts: 1,004

Does anyone think we will retrace back down again to sub $18? This growth seems artificial after such a long wait.

And to state the obvious i wouldn’t mind it going back down to pick up a few more as ive said many times before.
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Clinhope
Posted on: Sep 21 2018, 10:27 AM


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Posts: 1,004

Yeh I’ve been watching it go from 50 sigs a day to one and then none. I find it perplexing that the epp community isn’t able to gain more interest from the general puplic and friends. I’m not judging them harshly, I don’t have a clue what the reality is over in the uk. But if it were me i would take my ipad down to local school and businesses, family, friends and ask if they can sign a petition for an amazingly positive cause.

Heartbreaking.
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Clinhope
Posted on: Aug 29 2018, 05:44 PM


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I get the feeling i've lost my chance to buy a few more at a good price. Having said that if the manipulators stay their course i still might have a chance :D
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Clinhope
Posted on: Aug 17 2018, 09:57 PM


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They will easily reach 10000 by feb 2019.
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Clinhope
Posted on: Aug 17 2018, 08:31 AM


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There seems to be quite a few people here interested in Palatins Bremelanotide. As an investment opportunity surely you’d be looking at AMAG instead of PTN as AMAG will take exclusive rights of the drug and PTN only recieving royalties...
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Clinhope
Posted on: Aug 6 2018, 06:49 PM


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Because Iggy this is the only drug that fucken works well and doesnt have disastrous side effects. (Unnecessary swearing is a side effect of being from Australia.😆)
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Clinhope
Posted on: Aug 4 2018, 06:25 PM


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Did he say what his firm is waiting on before they buy in?
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Clinhope
Posted on: Aug 4 2018, 12:45 PM


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Mrdax, "In the whole document I don't find the non-approvd drugs; especially because I was also searching the total number of drug filings in 2017 earlier, to calculate the approval rate."

So you're saying that there might've been 200 novel drugs for eg that were up for approval but only 46 were granted. The pdf then goes on to detail the approval rates of those 46 and ignore the rejected novel drugs. In which case of course they'd all be approved and i see your point. But wording like this suggests to me that there were only 46 novel drugs and all of them were approved. Pg 14 "In 2017, CDER met its PDUFA goal dates for 100% of the novel drugs approved (46 of 46)."

Then the only really relevant part is to focus on 46 of the 35 novel drugs were approved (85%) in the first cycle. Leaving 11 novel drugs which had insufficient submissions, missing information etc but were able to still achieve approval on the second cycle as we know all 46 were approved. Right? wacko.gif

Whatever the details the stats are good for what title in the review process Scenesse has currently gained. Priority review will be the next title im sure.

I like the graph that shows the novel drugs with one or more expedited pathways had the highest chance of getting approval/equal with priority review @ 61% (yes i know 100% gained approval ):
Attached Image

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Clinhope
Posted on: Aug 3 2018, 09:51 AM


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Posts: 1,004

Hahaha it does too. I'll be going there in a few months i'll keep an eye out for approved FDA towns.

Facebook thought it appropriate to place a safe tanning pill advert on my feed and i had to share it: https://dr-viton.com/product/dr-viton-bronzan/

The comments on FB (e.g "ohh wow i can't wait to take one pill and get tanned for summer!!!!!!!!!!" biggrin.gif biggrin.gif biggrin.gif )and the list of active ingredients makes me feel sick.
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Clinhope
Posted on: Aug 3 2018, 09:21 AM


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Posts: 1,004

Just to reiterate (because i hate when people post vague information here), the companies (from seeva22) in 2017 which had fast track were all approved, no rejections:

1. Aliqopa - Approved -
2. Bavencio - Approved -
3. Baxdela - Approved -
4. Bevyxxa - Approved -
5. Emflaza - Approved -
6. Idhifa - Approved -
7. Ingrezza - Approved -
8. Mavyret - Approved -
9. Mepsevii - Approved -
10. Ocrevus - Approved -
11. Prevymis - Approved -
12. Rydapt - Approved -
13. Solosec - Approved -
14. Vabomere - Approved -
15. Verzenio - Approved -
16. Vosevi- Approved -
17. Xermelo - Approved -
18. Zejula - Approved -

Pretty good record i'd say.
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Clinhope
Posted on: Aug 2 2018, 10:12 PM


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In 2017 all were approved that had fast track status.

See previous discussion: http://www.sharescene.com/index.php?showtopic=27&st=610

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Clinhope
Posted on: Aug 1 2018, 09:25 AM


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Posts: 1,004

Just out of interest how far do you think $30 is from its 10 yr potential, say ~2028? See my guesstimate is that a year or two after approval we’ll be close to if not past 30. At which point I’d be better of selling small parcels as needed than sell prematurely with a takeover.
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Clinhope
Posted on: Jul 22 2018, 07:49 AM


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Posts: 1,004

I was just watching a youtube channel called Veritasium and it uncovered for me, why it is that melanin and therefore Scenesse is so effective for various purposes. I always thought the melanin was simply a super effective UV shield, but apparently the melanin actually forms a protective cap around the nucleus of each cell. I guess the more melanin the more complete and robust the protective cap around more of the cells nucleus'.

Watch for about 30s to see the relevant part: https://youtu.be/V9K6gjR07Po?t=5m15s
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Clinhope
Posted on: Jul 19 2018, 08:42 PM


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Possibly an attempt to drop the price as much as possible before FDA priority review decision and limit the following run upward?
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Clinhope
Posted on: Jul 19 2018, 11:31 AM


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What gives you that idea?
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Clinhope
Posted on: Jul 2 2018, 05:15 PM


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Can anyone think of a reason why that large trade wouldn’t show up on my commsec sales?
Attached Image

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Clinhope
Posted on: Jun 22 2018, 06:06 AM


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Posts: 1,004

Does anyone understand why someone would apparently go through the trouble of spending millions developing a drug for an indication already taken in Europe and likely to soon be taken in the US?

It seems too risky to me, the chance of the drug working is low in general, it takes at least a decade to develop (30 in clinuvels case), costs a lot, and in this case you have a proven and approved competitor.

Anyone have a decent reason?
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Clinhope
Posted on: Jun 14 2018, 04:42 PM


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Known to cause serious side effects?! What a blatant lie. Even the illegal MT1 isn't associated with serious side effects, nor is the MT2 which is much more potent and has considerably harsher sides (darkened moles, increased libido, hyper pigmentation for eg). What fool wrote that article?

And i struggle to imagine anyone would be silly enough to risk the tens of millions of dollars taking a new drug through clinical trials when Clinuvel is likely to beat them to the finish line by at least 5 years considering the current pace.
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Clinhope
Posted on: Jun 13 2018, 09:25 PM


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They patent the a-MSH and the use of said molecule in a specific process or treatment. Eg a-MSH for treatment of vitiligo.
So someone would have to come up with an alternative molecule and then go through the same hurdles as clinuvel has which may not take as long but will still take around 10 years of development.
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Clinhope
Posted on: Jun 11 2018, 10:16 AM


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What is that list of drugs? EDIT: Ohhh those on fast track wink.gif

The percentage of approval depends, if you meant Emflaza instead of Em aza, then 100% of those are approved. If you did actually mean Em aza then i have no idea what that is and 94.44% of those drugs were approved.
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Clinhope
Posted on: Jun 10 2018, 04:42 PM


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https://giphy.com/gifs/mindblown-TlK63EWmJD...s&utm_term=

The potential is huge, a step-change from the implant, much improved ease-of-use, even better safety. I wonder if this is truly applicable to Scenesse.
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Clinhope
Posted on: Jun 9 2018, 12:10 PM


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Posts: 1,004

I found the original study and can’t make heads or tails of it. I think that as others have said, the trick to getting a topical to work in humans is getting it to penetrate the dermis, not sure they’ve acheived that and even if they have, there’d be a long road ahead to market.

https://www.cell.com/cell-reports/fulltext/...1247(17)30684-8
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Clinhope
Posted on: Jun 2 2018, 09:44 AM


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Posts: 1,004

To put a figure on it the monthly searches for "clinuvel" have gone from 2900 in December 2017 to 3100 per month in May 2018.
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Clinhope
Posted on: May 30 2018, 08:57 PM


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Posts: 1,004

Not sure about you waz but i am scared shitless (aussie slang) for the day the skincare range is released. Amateur hour seems to be managements modus operandi.
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Clinhope
Posted on: May 30 2018, 05:56 PM


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Posts: 1,004

Did anyone notice the Skincare range tab on Clinuvel.com is gone?

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Clinhope
Posted on: May 29 2018, 10:43 PM


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Who.

The hell.

Writes an.

Article with two.

Lines.

Per paragraph.

Are you $%&*#ing KIDDING.

Me?

Attached Image

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Clinhope
Posted on: May 29 2018, 03:32 PM


Group: Member
Posts: 1,004

Darren Keamy huh, CFO. Must be a dope. Can’t you start hiring competent people Royco! This is a billion dollar company in the making.

Internet disclaimer: the above comment contains sarcasm and is in no way meant to be taken seriously or to insult the people mentioned in said comment.
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Clinhope
Posted on: May 27 2018, 04:43 PM


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Posts: 1,004

Reading the paragraph you quoted seems as though it suggests a-MSH has been tested and is effective in treating humans with neurodegenerative diseases when it doesn't seem to have been trialled at all in humans. Browsing the report from Sphene capital page 20 i found something i found very interesting about the potential mechanism i guess of why it may be effective in treating such diseases:

"With treatment of demyelinating diseases, however, addressable market could get substantially bigger
In 2016, researchers at the University of Münster investigated possible effects and applications outside of pigment excitation to better understand the mode of action in demyelinating disorders by explicitly using afamelanotide. A demyelinating disease is any disease of the nervous system in which the myelin sheath of neurons is damaged. This damage impairs the conduction of signals in the affected nerves. In turn, the reduction in conduction ability causes deficiency in sensation, movement, cognition, or other functions depending on which nerves are involved.
The results of the study showed long-lasting neuroprotective and anti- inflammatory properties of α-MSH in the central nervous system of mice. It was demonstrated, that inflammatory reactions to multiple sclerosis (MS) had been significantly reduced by using afamelanotide. Even a complete decline in MS in the mouse model was shown. In addition, side effects seem minor, since afamelanotide is well tolerated.
Afamelanotide blockades inflammatory immune cells in the bloodstream. Due to its neuroprotective effect, afamelanotide also counteracts the degeneration of nerve cells which can be monitored in Alzheimer's disease.
Clinical studies in humans are still pending. However, the pre-clinical studies in the mouse model provide a good basis for a clinical phase 1 study and encourage to further investigate the potential of afamelanotide in humans for neurodegenerative diseases, in our view."
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Clinhope
Posted on: May 22 2018, 04:55 PM


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In what way could it apply to Scenesse?

Afamelanotide would have to be on the OTC drug monograph.
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Clinhope
Posted on: May 15 2018, 07:26 PM


Group: Member
Posts: 1,004

Can any Aussies recommend a good brokerage account? I'm with Commsec and get charged $30 per transaction which i think is a little high?

Cheers.
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Clinhope
Posted on: May 14 2018, 08:28 PM


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And if we travel at 99.99% the speed of light we stand still in time and space. Approval takes infinity.
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Clinhope
Posted on: May 14 2018, 07:08 PM


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Posts: 1,004

I'm jealous of your math and graphing skills.

So that would put decision time around April to June 2019?
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Clinhope
Posted on: May 14 2018, 06:52 AM


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Posts: 1,004

Charlie, best guesses fall between December 2018 and February 2019 i believe.

But things will be happening in the next few months that will confirm or deny that estimate and give more accurate estimations.
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Clinhope
Posted on: May 13 2018, 05:49 PM


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Posts: 1,004

Make no mistake Iggy sure as shit has Clinuvel shares.
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Clinhope
Posted on: May 13 2018, 01:56 PM


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Posts: 1,004

Both.

Post your number Iggy!
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Clinhope
Posted on: May 13 2018, 08:16 AM


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Haha some of these numbers are making me drool.

44.2k for me with a little more to come. 😅
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Clinhope
Posted on: May 12 2018, 07:24 PM


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Posts: 1,004

Yeh now that you say it, by the 20th rings a bell. Just every time it's been mentioned i guess it was shortened to 20th May.

So hopefully next week we'll hear some news, exciting.
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Clinhope
Posted on: May 12 2018, 06:43 PM


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Posts: 1,004

I had to double check that May 20th (release day of the mystical skincare range) is actually on a Sunday! So it will more likely be May 21st?
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Clinhope
Posted on: May 12 2018, 11:39 AM


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Posts: 1,004

Just a guess Dr, but based on comments over the last 5 years of SS members giving clues about their holdings. I'm not sure how long you've been on SS but a member called madman was said to have 1 million odd shares (might not have been that number) but he said at one point he sold 80,000 shares to take a small profit.

I would say many members have in the tens of thousands of shares, having bought in when the sp was a few dollars or better.
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Clinhope
Posted on: May 12 2018, 10:41 AM


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Posts: 1,004

Ok so ive been a bit negative of late and I’m going to continue that theme with this post.

What’s the big deal of other instos coming on board if the majority of SS members hold close to as many if not more than the 3rd to 8th biggest insto holders?

Are we expecting these small holders to rapidly increase their holdings on good news thereby sending the sp up. Whereas the members here are mostly all in with their current holdings and don’t have much effect on the sp?
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Clinhope
Posted on: May 10 2018, 04:48 PM


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Posts: 1,004

Scary that we could have as little as 7 years protection for scenesse. But like i asked last week, how is it that there are companies that get 14 odd years of patent protection for an approved drug? It was from 2018-2032.

We may be able to extend the protection by 5 year intervals with new indications for Scenesse but that's an unknown for now.

Ohhhhh look...it settled on $13.000 by pure luck.

Attached Image
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Clinhope
Posted on: May 9 2018, 06:30 PM


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Posts: 1,004

And at the end of it have the sp sit on or as close to $13? By who and for what reason?

There's been numerous people on SS saying it's heavily manipulated for a good 4 or 5 years now.

I've noticed the trading behaviour you just outlined at $6, $8, $9, whatever it was last week and now $13.
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Clinhope
Posted on: May 9 2018, 12:39 PM


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Posts: 1,004

@Johnny The sp being news in itself did occur to me. I'll be expecting Clinuvel to be mentioned on a great podcast called "The investor podcast". They do picks each quarter and Tobias e Carlile, writer of the Enquirers Multiple is an Aussie. If he hasn't picked up this company by now or in the next few months i'd be extremely surprised.

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Clinhope
Posted on: May 9 2018, 11:59 AM


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Posts: 1,004

As far as we know this price rise is off no news, essentially speculation. Possibly a mix of new investos getting word of Clinuvels potential and existing investors getting excited about the upcoming skincare and NDA application announcements.

It throws a spanner in the works. I'm excited about the rise, but i think this changes what i thought would happen running toward approval. I thought the sp would be at $12-13 POST skincare announcement assuming it was good news. Being solidly at $13 for now, does that mean a good skincare announcement takes us to $15-$17....pre FDA announcement $20-25? Insanity.

If i was all in it wouldn't be insanity. But im not all in and have more to accumulate, so it is insanity sleep.gif

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Clinhope
Posted on: May 8 2018, 06:10 AM


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Posts: 1,004

I have a bad quote? Im not sure what that exactly means Dax. If it means it’s my fault they didnt invest i think that’s mostly true. I tend to lay the information on thick and be overly honest. Most people aren’t use to it so it puts them off.

I tried my best to share the love. Hopefully i can do well enough out of this to help my family for the rest of their lives.
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Clinhope
Posted on: May 7 2018, 08:53 PM


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Posts: 1,004

In the last 10 years i've told 10 people about this company. Friends, family and strangers. Out of those 10, one could see the matrix. Early 2019 is the time we either wake up and realise we've been in the matrix the whole time or realise our world for the last 10+ years has been the truth and everyone else has been in the matrix.

IF Scenesse is not approved by the FDA on completion of the NDA process in late 2018 early 2019, it is confirmation to me that there are some truly dark powers that work behind closed doors.
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Clinhope
Posted on: May 3 2018, 10:28 AM


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Posts: 1,004

Anyone????

Attached Image

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Clinhope
Posted on: May 1 2018, 10:53 AM


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Posts: 1,004

How has Starpharma gained patent protection for Vivagel till 2032?
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Clinhope
Posted on: Apr 29 2018, 08:35 PM


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I can't help but see Tsumoil and get the same awful feeling as when i see the Artemis logo. Is this a sign that i'm in a nightmare? A glitch in this utopian dream of Clinuvel?

How in the world can they make the name Tsumoil marketable in the cosmetic sector. Unless of course Afamelanotide is a good lubricant, then the name makes complete sense.
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Clinhope
Posted on: Apr 24 2018, 10:20 PM


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Posts: 1,004

Just a heads up for those outside Australia, tomorrow the 25th is ANZAC day so the ASX will be closed.

To all Aussies and Kiwis here, have fun, be safe.
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Clinhope
Posted on: Apr 23 2018, 02:37 PM


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Posts: 1,004

We’ve been talking about a takeover for a few weeks now. Do common shareholders have any say to accept or reject a takeover bid?
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Clinhope
Posted on: Apr 23 2018, 12:21 PM


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Posts: 1,004

Wow. I am very suspicious Johnny.
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Clinhope
Posted on: Apr 22 2018, 08:59 AM


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I believe all the Artemis speculation on this board comes from a combination of the new logo with Artemis goddess and things said by Clinuvel of a skincare launch/announcement in the coming months.

My understanding is that there are two different companies, Artemis Skincare from Sweden and Artemis pharmceuticals from germany that are potential candidates. My bet would be on Artmemis Skincare. They have an extensive range, good product reviews from the little i can find and a somewhat premium type brand.
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Clinhope
Posted on: Apr 20 2018, 05:46 PM


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$40 would be a minimum for not being short-changed of Clinuvel mid term potential. However, having said that i think any business would be crazy to pay that much for a company that is make or break on a single decision by the FDA. There may be takeover bids pre-FDA, but the first genuine bid will come post approval.

Personally i'm hoping we stay lone rangers.
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Clinhope
Posted on: Apr 20 2018, 04:15 PM


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Posts: 1,004

The higher the sp goes the more sane i feel and justified in many decisions I’ve made in the last 10 years.
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Clinhope
Posted on: Apr 8 2018, 10:27 PM


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@Johny H and here i was thinking you was Heckek, silly me....
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Clinhope
Posted on: Apr 4 2018, 03:44 PM


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Surely no company would be dumb enough to waste precious time and money trying to get a molecule approved for an indication that Clinuvel will most likely get approval for, 10 years ahead of anyone else? Even if they could do it as cheaply as Clinuvel, why would you take the risk going after Vitiligo or EPP?
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Clinhope
Posted on: Apr 3 2018, 01:04 PM


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Posts: 1,004

Why do you guys persist in feeding the last troll on this board? I admit Iggy is my favorite of the trolls, his posts are creative and play an interesting devils advocate making me ask the hard questions that might shine light on my delusions of grandure. But as we say here in Aus, “he’s taking the piss”. Meaning he is playing games at your expense.
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Clinhope
Posted on: Apr 2 2018, 11:50 AM


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There's no requirement to expose them to sunlight Igg. Firstly i would imagine that benefits of Scenesse such as the anti-inflammatory and anti-oxident properties other than melanogenesis would be beneficial to people with XP but there are other people on this board with more knowledge on that.

I hope you had a good Easter break.
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Clinhope
Posted on: Apr 2 2018, 08:38 AM


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For anyone outside Aus the ASX is closed today2nd April for Easter long wknd.

Great first post Kboy.
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Clinhope
Posted on: Mar 30 2018, 02:04 PM


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Posts: 1,004

Thanks for posting information about another interesting company. I've done a couple of hours browsing about Setmelanotide and the studies done with it. From what i can see, going off the studies (among others) posted by Rhythm the studies are in their infancy for establishing it as a go to drug for childhood obesity. Trial groups were very small and i haven't come across a double blind controlled study and understandably so.

It looks promising for sure. But the small amount of information i've gleaned so far is concerning. i'd really like to see in the studies where the impressive amounts of fat were lost whilst on Setmelanotide, what were the changes in diet and energy expenditure. Surely diet and exercise did not stay the same and as such, the question is how much of an improvement does setmelanotide cause vs diet and exercise alone? I can't find it.

At $20 a share the hype is real. A long journey ahead of it, will probably turn out to be better than any weight loss drug previously seen.
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Clinhope
Posted on: Mar 29 2018, 09:39 AM


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Posts: 1,004

Surely approving an indication for an approved drug is not in the same league of difficulty (especially Clinuvel difficulty) compared to getting a new drug approved. Could it take a relatively long time for an indication approval...yeh. But assuming FDA approval comes through this year that is the fuel that will motivate the company for the first few years and hopefully the company expands enough with recruiting experts to implement Scenesse and get other indications approved simultaneously.

Without new indications the company will struggle post 2025.
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Clinhope
Posted on: Mar 28 2018, 02:53 PM


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Posts: 1,004

For years we cried at being left in the dark because management didn't communicate. Now they communicate people complain the letters lack anything note-worthy.....ahhh that doesn't really make sense to me.
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Clinhope
Posted on: Mar 27 2018, 09:25 AM


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Some interesting diseases in the clinuvel website, an indication of future diseases? This disease looks devastating: http://clinuvel.com/photoprotection-expert...vacciniforme-hv
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Clinhope
Posted on: Mar 26 2018, 04:57 AM


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Always happy when i can stimulate a good discussion on this board biggrin.gif
Some really great posts.
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Clinhope
Posted on: Mar 25 2018, 07:53 PM


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Yeh i wouldn't be surprised if it dropped down to those prices. But long term over 5 years or so i think sales in the rest of the world and the development of skin care range, paediatric dose, and research into other indications would still make it a great company making a lot of money.

Even with just Scenesse alone in Europe i think we can safely say nearly everyone hear will double their money by 2025. Which isn't what we hope for but that's a damn good worst case scenario.
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Clinhope
Posted on: Mar 25 2018, 03:46 PM


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Posts: 1,004

With the possible rejection in Wales (yet to be absolutely confirmed?) would anyone care to share with me their thoughts on our dooms-day scenario of a rejection by the FDA?

As i usually do, i will say this as a disclaimer: i am 95% sure the FDA will approve. But i like to be prepared for the worst case scenario that is foreseeable. If we are rejected i think there is still a decent company to be invested in considering the potential across Asia and Europe. However it wouldn't even be half of what it could be given success in the US. I would imagine a potential of $20-$30 in this situation.

What do you guys think?
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Clinhope
Posted on: Mar 24 2018, 10:15 AM


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Posts: 1,004

They dug their heels in and don't want to lose face.
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Clinhope
Posted on: Mar 23 2018, 02:47 PM


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Posts: 1,004

Yeh "small molecules RX" when referring to the CUV9900 and VLRX001.

But what would the first point "topical Rx skin INFLAMMATORY D." refer to? I thought these were all anti-inflammatory...

Attached Image



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Clinhope
Posted on: Mar 23 2018, 02:17 PM


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I don’t think they would’ve bought any existing products. The key to the Clinuvel product line will be the “small molecule” peptide i think they referred to them as in the AGM presentation. Which is interesting considering what some guys here have said about afamelanotide being way too big to penetrate the skin.
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Clinhope
Posted on: Mar 22 2018, 10:13 AM


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Posts: 1,004

Did we all miss Homm's video on the 19th of March? https://www.youtube.com/watch?v=T5a1kDqoq3k

Yes i did listen to all 7 minutes of him talking waiting for the word Clinuvel to come out but no luck. Someone in the comments does say "Clinuvel Pharmaceuticals geht gerade schön ab, Danke für den Tipp:)"

Any Dutch speakers kind enough to translate any news or otherwise about Clinuvel in homes video?
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Clinhope
Posted on: Mar 20 2018, 08:36 PM


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Posts: 1,004

I've spent a day doing forecasts on Excel and damn has it has been fun (disclaimer that i am someone who always reminds myself this could all disappear).

And the thought just occurred to me after reading the justifiably optimistic valuations, how many billion dollar markets Scenesse alone has access to.

1. Actinic Keratosis, as was pointed out is a $9 billion market.

2. Vitiligo, surely a multibillion dollar market that Clinuvel is at the forefront of and is likely to remain that way for at least a decade.

3. EPP, as above.

4. #2 and #3 for paediatric care.

Is it ridiculous to say we have at least 4 multi-billion dollar markets (#2,3,4 i'm quite sure of) ready to be addressed in the next 5 years?

As we stand now a price of $50 would be understandable. What PW unveils for the skin care products will show us the type of company Clinuvel will grow up to be. What the FDA decides on the NDA will show us how big that company will grow up to be. In which case circa $100 in 5 years is not delusional.
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Clinhope
Posted on: Mar 20 2018, 09:43 AM


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Attached Image

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Clinhope
Posted on: Mar 19 2018, 04:41 PM


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Sell at $40 and semi-retire? Haha. God knows i will!

So we close at $9.99...a bit of a joke by someone clever me thinks.
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Clinhope
Posted on: Mar 19 2018, 03:37 PM


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Posts: 1,004

I don't haha. Because pre-NDA approval is the last chance to top up the laundry basket with CUV. Some people play this game with selling in and out to improve their position. I just look at all this in a much simpler way. I.e, find a business i like (i like this one very much) buy, buy, buy, buy some more, buy and buy then hold for 10+ years.

There was a recent lawsuit between two pharmas, where one had started making the generic version of the other companies patented drug. The company sued and now the generic company can't produce it until sometime in 2027. I wonder why they got close to 10 years protection....interesting. Because god knows what will happen to Clinuvel post 2025.
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Clinhope
Posted on: Mar 19 2018, 02:42 PM


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Posts: 1,004

Whatever happens to the sp in the short term i still say congratulations to all of us here.

But i have a question, does this jump make sense on the back of todays news? I mean it's great news no doubt, but simply confirming information that has been established for quite a few years now. If it continues at this rate we'll be pushing $20 before NDA decision.
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Clinhope
Posted on: Mar 19 2018, 12:20 PM


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Posts: 1,004

I’m here due to A Current Affair when i was maybe 16. I didn’t invest at that time obviously but knew i would.
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Clinhope
Posted on: Mar 19 2018, 09:34 AM


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Posts: 1,004

A bit late on that one. Ahhh derrrrrr. graduated.gif
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Clinhope
Posted on: Mar 19 2018, 09:17 AM


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Posts: 1,004

CLINUVEL HOLDS EUROPEAN ERYTHROPOIETIC PROTOPORPHYRIA (EPP) EXPERT MEETING

Sadly i cant post the link.
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Clinhope
Posted on: Mar 18 2018, 06:28 PM


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Posts: 1,004

I've just looked at my purchase history of CUV and got a shock that 70% of my portfolio was purchased at 18 cents per share in 2010. I feel both grateful and stupefied that i didn't buy more sooner.

Let's see if we can find who has the lowest purchase price on SS. Who can beat 18 cents?
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Clinhope
Posted on: Mar 16 2018, 05:26 PM


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Posts: 1,004

So the actual decision will finally be revealed 18th April 2018.
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Clinhope
Posted on: Mar 15 2018, 05:15 PM


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Posts: 1,004

Sadly i have to sell a small portion of mine at the moment to keep my head above water. Only a few hundred at a time, but still, we all know i am selling $10 bills for $2 and that does suck.
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Clinhope
Posted on: Mar 14 2018, 10:42 AM


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Posts: 1,004

Mac, even on the news we know will happen this year the sp could easily double. The mysterious product line is one key factor but also the run up to FDA decision there will be increased speculation before the decision and possibly a drop thereafter as people cut and run. But, i hope you're right, i will be a happy man if the stock stays under $12 till late 2018.

Clinuvel just flashed us at $9.19.
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Clinhope
Posted on: Mar 11 2018, 07:31 PM


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Posts: 1,004

Your last comment triggered a realisation for me. That the launch of Clinuvel's product line is a massive step change in the company direction.

I guess we will have to wait to see whether the product line is mostly tied down to the current applications for Scenesse (EPP, Vitiligo) or if they can be effectively used by anyone. If it's the latter then i have to drastically change where i see this company headed and i'm not sure how a biopharmaceutical-cosmetic Frankenstein would look.
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