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macgyver
Posted on: Today, 11:47 AM


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This pretty much puts the question of whether PASS is still in play or not to bed. Scenesse still authorised under exceptional circumstances (updated 26/04/19), therefore just the renewal with unlimited validity to come.

Sorry peeps sad.gif

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macgyver
Posted on: Today, 09:22 AM


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Johnny H was on the right track regarding the possibility of up to 10 years or more post-authorisation monitoring. The screenshot below shows the drug Atryn having received positive opinions for both the annual reassessment and the 5 year renewal with unlimited validity. Atryn has had marketing authorisation under exceptional circumstances for 10 years having first been rejected early 2006 after which it was subsequently approved. That’s not to say PW isn’t pushing for a standard MA, but my expectations are tempered somewhat.

Curiously, Atryn has been withdrawn from the European market by the owner.

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macgyver
Posted on: Today, 07:27 AM


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QUOTE
Exceptionally, the CHMP may consider that all specific obligations have been fulfilled and comprehensive data on the efficacy and safety of the product is available. In such cases the CHMP may recommend granting a Marketing Authorisation not subject to specific obligations


I’m hopeful.
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macgyver
Posted on: Today, 02:33 AM


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Yes, I did jump the gun on that one🙋‍♂️
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macgyver
Posted on: Today, 02:30 AM


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I can’t say for sure whether Scenesse would have the PASS protocol removed, but since PW was seeking to abolish it and Clinuvel has applied for unlimited validity then it’s reasonable to assume this represents movements towards that outcome.

When a market authorisation is due to expire, the renewal application is submitted at least 7-9 months prior to expiration date. In the annex B2.2.2 there is no mention of an EMA request for supplementary information which I view positively (After all, what more could the EMA ask for after 5 years of PASS?).

Since reading in EMA literature itself about MAs under exceptional circumstances not normally receiving a standard MA, perhaps through the rapporteur was Clinuvel able to ascertain that Scenesse was a suitable candidate for a standard MA. Whatever the case, this is where Clinuvel is at so it’s remarkable to say the least.
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macgyver
Posted on: Yesterday, 09:58 PM


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Scenesse is no longer classed as having a marketing authorisation under exceptional circumstances, instead it has obtained standard market authorisation

By rights, Clinuvel should now be unencumbered of obligations concerning collection of data and monitoring of patients concerning the PASS protocol. I believe PW was pushing to drop PASS because of costs and burden on the company, but acknowledges the invaluable data collected having intrinsic value for the company especially concerning the FDA NDA.

I wonder if this allows Clinuvel to now push 6 doses a year for EPP patients?

The surprising thing was that market authorisation under exceptional circumstances normally doesn't receive an "upgrade" to a standard market authorisation. The data and patient feedback must be overwhelmingly positive, which bodes well for the FDA...
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macgyver
Posted on: Jul 22 2019, 08:42 PM


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edit
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macgyver
Posted on: Jul 22 2019, 08:58 AM


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$500??? Sweet nothings will get you everywhere wub.gif
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macgyver
Posted on: Jul 19 2019, 02:02 PM


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A large number of the sell side orders have been above at least $36 for 2-3 weeks, so it’s not indicative of a sell off. However, in the last few days the sell side has increased so some retail investors are possibly stepping out for the time being. With shorts increasing substantially over the past few days we know where this is going.

I find it inconceivable that a big player is selling off altogether, though nothing surprises me concerning Clinuvel...
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macgyver
Posted on: Jul 16 2019, 10:31 AM


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I think the average increase across the last four (possibly 3 quarters, it was a while ago I tried to do an average increase calc) was something like 63-65%. I’m expecting the same this time around, which will be very pleasing and point to increasing patient registrations.

Edit: That’s yoy, relative to its own quarter which was still in the average mentioned above.
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macgyver
Posted on: Jul 14 2019, 12:02 PM


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Two documents concerning legislated improved approval timeframes for TGA (Australian drug authority) and actual reported (TGA report 2018).

The TGA has a pathway to accept comparable overseas regulator dossiers (FDA Clinuvel dossier).

https://www.tga.gov.au/sites/default/files/...7-june-2018.pdf

https://camargopharma.com/resources/blog/ex...roval-australia

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macgyver
Posted on: Jul 12 2019, 02:34 PM


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Agreed, we had a good run there for a while. But now thumbdown.gif
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macgyver
Posted on: Jul 12 2019, 10:16 AM


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Looking at how quickly new indications may be approved for an existing drug. The time varies considerably with different classes of drugs. Duxipent (by Sanofi and Regeneron) was approved for four indications in quick succession (March 4th 2017 - June 26th 2019). However two of them were for moderate to severe dermatitis (for adults with adolescents being granted 2019).

I noted the surprising speed with which this drug was able to go from Phase 2 trials to approval, with multiple indications following shortly after. This could point to the power of big pharmaceutical companies such as Sanofi and Regeneron with the FDA. Makes you think about Clinuvel's journey to date and how long its taken.

I think Clinuvel still has a part to play with dermatitis treatment. If their topicals prove to be sustaining. these could be priced cheaper (in good time) than Duxipent, not affect the immune system, and not require injecting.

https://www.drugs.com/history/dupixent.html
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macgyver
Posted on: Jul 11 2019, 11:42 AM


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I take it PW was only referring to the European data and the protocol in place there as a reference point for the FDA to analyse data from patient usage history

He doesn't say that FDA will initiate a similar patient monitoring scheme, just that Clinuvel has reams of safety data in the European scheme that the FDA has access to which bolsters the dossier (and is taking the FDA a lot longer to assess based on sheer volume of information).

To clarify, I'm not getting the impression that Clinvuel will repeat in America what has been done in Europe regarding the PASS protocol. In fact, I see PW's reference to the labelling e.g "black box or black triangle" as contributing to control of the product somewhat, but not placing strict controls on it such as distribution and select centres for administration.
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macgyver
Posted on: Jul 10 2019, 08:46 AM


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Clinuvel website is back up. No changes were made as far as I know.
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macgyver
Posted on: Jul 9 2019, 08:31 AM


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Expect some stern dressing down from PW in the newsletter when he finds out an intrepid investor has gone directly to the FDA to find out what went wrong. This occurred a few years ago when someone had contacted NICE and/or UK patients seeking news about anything Clinuvel. The totally appropriate methods punters resort to seeking information that rightfully should be in the public domain. Too bad Pierre...
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macgyver
Posted on: Jul 9 2019, 12:34 AM


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Yes, anything is possible. Refusal, nuclear war, meteorite hitting the earth. If there is another regulatory delay, there’ll be more than shorters to worry about. You’ll be asking yourself financial existential questions such as “How long am I?”, followed by “Am I too long?”

Billy Boots will be beside himself if that happens🤣🤣🤣
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macgyver
Posted on: Jul 8 2019, 08:01 PM


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Probably not. Not sure what it means, but just thinking back to the day before Clinuvel went up to the ASX200. The volume traded was large yet a large percentage was shorts. Today’s finish in the auction saw orders pile up quickly, but in the end the amount settled was negligible.

If the price goes down during the course of the week it’s shorts playing with themselves. If the price goes up then the stock could be shorted heavily again in a month or so. However, it starts getting a bit risky closer to PDUFA date with shorters less willing to put their neck on the line. There’s also the possibility of an early PDUFA with FDA completing their review before Oct 6th. Plus there is labelling info forthcoming from the FDA
which will send a signal to the market that approval is imminent (I think). Fun and games to be had no doubt...
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macgyver
Posted on: Jul 8 2019, 04:04 PM


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What's this, another short set up? Too many orders on the buy side appearing out of nowhere..

Edit: Only 30-40k odd traded after 4pm.

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macgyver
Posted on: Jul 4 2019, 12:53 PM


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Agreed. I should've led my post with the info transfer from the EMA to FDA plus PASS data as the main reason for why the FDA skipped on having an advisory committee for Scenesse. Safety is established. Patient retention rates placate efficacy concerns somewhat.

My guess concerning exceptional circumstances regarding efficacy and non blind trials is based around the experience with the EMA, in that it was difficult to measure these. Therefore the agency had to give the benefit of the doubt based on expert and EPP patient testimony. In this sense it would be an exercise in futility for the FDA to hold an advisory committee based on the regulatory journey of the drug to date.

I think Dr Wally may be right about the first meeting held with EPP patients, APF and others in Sliverwater 2016? where it was perhaps determined early that conventional methods of proving efficacy to the FDA's satisfaction would be difficult/onerous.

Respectfully, I don't agree with Dr Wally's opinion that the FDA bailed on having a second meeting because of perceived bad publicity and the like. Just look at odi01's post about the FDA approving the cancer drug with 8 out of 13 advisors recommending against it. That's shifty, and symptomatic of the misguided policy of the Trump administration. On one hand Trump wants more drugs to be approved so patients have access to potential life saving treatment regardless of efficacy yet wants to lower drug prices. The dodgy cancer drug in question is $22,000. 61% of the advisors in that committee said no, the FDA said yes. Very bad optics...

Looks like we're headed down to $33 again. rolleyes.gif
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macgyver
Posted on: Jul 4 2019, 08:36 AM


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I don't think the FDA is concerned with "optics" so to speak. I'm guessing the main reasons for not holding an advisory committee is due to exceptional circumstances i.e. difficulty validating efficacy or having a truly blind trial because of tanning. Plus I've seen an article back in 2014-15 about a new protocol for sharing of information between the EMA and FDA. I have no doubt this transferring of information would have occurred, tied with the PASS data from Europe convincing the FDA that no such committee was needed.

I have no idea about how FDA approval relates to possible approval in Japan and Australia. PW certainly thinks having FDA approval bolsters Clinuvel's position in those jurisdictions. I'm curious as to whether sharing of information occurs here. No committees here hopefully...

odi01's post was interesting. I hate to say this but shouldn't this bode well for Clinuvel? ph34r.gif
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macgyver
Posted on: Jul 3 2019, 02:59 PM


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Nice to see a sensible, level headed post. The last 48 hours were dire...
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macgyver
Posted on: Jul 2 2019, 11:59 AM


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Recovery underway? I had a look at the chart dating back to September 2018. The large retractions in sp averaged about $6 so we might’ve hit the bottom. Interesting to see whether the sp will break $40 and actually get up to $50 odd with anticipation leading into October more heightened than ever before.
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macgyver
Posted on: Jul 1 2019, 07:52 AM


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This was interesting, particularly since these two gentleman have been bought out with Clinuvel shares (one received 33k odd shares?). Not a hell of a lot of shares in the scheme of things but certainly worth their weight in gold in the medium term. I found it interesting also that they were bought out relatively early. Vallaurix was barely operating as a business entity before Clinuvel took over full ownership.

I now think these two gentlemen don’t have any more interest in Vallaurix other than the Clinuvel shares and that they were directors of Vallaurix (though Louis Phun possibly still managing the labs and the Captain involved in some capacity. No sharing of IP for these guys? Then I think the plan all along was to establish Vallaurix with local help, dissolve the partnership after Vallaurix was established, compensate the two gentlemen with Clinuvel shares, yet still have them involved in some capacity for their business connections and experience.
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macgyver
Posted on: Jul 1 2019, 12:23 AM


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One of the businessmen PW partnered with in Vallaurix before Clinivel took full ownership. It appears he established the lab at the aforementioned science park.
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macgyver
Posted on: Jun 30 2019, 11:57 PM


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Yeah I agree, we can only surmise or guess at certain things. Interesting to note that Vallaurix’s partner Biotech Lab Singapore Pte Ltd had its address down at North Bridge Rd as well. Clinivel went into partnership with two Singaporean businessmen who established Bio Tech Lab. My feeling is this was to satisfy the requirements of either establishing a business entity in Singapore in which you have to partner with a local business or some sort of entrepreneur visa specifically for PW so he could obtain permanent residence and eventually Singaporean citizenship if he so desired. (For tax minimisation purposes)

Given the hasty deal for Vallaurix with minimal information and the shoddy website put up for Biotech Lab, it appears the bare minimum to establish a presence in Singapore was achieved. The address for the Vallaurix labs is situated in a science park which is clearly seperate from their corporate headquarters. This could be an empty building for all we know. I’m passing through Singapore next January, if I have a stopover of a few hours I might take a look and report back.

I think the fellow working at Vallaurix as a chemist for 1 year and five months gives me confidence that something is well underway, I have seen job adverts posted either here or on Google Groups for Vallaurix a while back so this is promising as well.

The address at North Bridge Rd is most definitely an accountant.
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macgyver
Posted on: Jun 30 2019, 09:09 PM


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Not sure if this has been mentioned before, Vallaurix has moved from North Bridge Road (I think this was an accountant acting as secretary/director for the shell company for Clinuvel before they set up shop proper in Singapore) to Tower 15 which looks a significantly more corporate environment. Vallaurix has research labs too?

Former address for Vallaurix (North Bridge Rd, Singapore)
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New digs at Tower 15, Hoe Chiang Rd Singapore
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Address of Vallaurix labs
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And one of the Vallaurix chemists:
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I don’t want to assume too much but I think we possibly have a bona fide operation running in Singapore👍
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macgyver
Posted on: Jun 27 2019, 10:50 AM


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$2000 a share. Optimistic to say the least.

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macgyver
Posted on: Jun 27 2019, 10:15 AM


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Manipulated much?

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macgyver
Posted on: Jun 26 2019, 11:43 PM


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I think Dr Wally is a bit harsh Johnny, I haven’t seen you get THAT many thanks devilsmiley.gif
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macgyver
Posted on: Jun 26 2019, 11:39 AM


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AbbieVie most definitely getting a discount on what Pfizer was prepared to pay for Allergan ($126 billion) before they walked away. Its up there with Jerry Yang's monumental failure to accept Microsoft's $44 billion bid for Yahoo! which later sold for $4.5 billion.

It's a sign of the times for the pharmaceutical industry currently, with super mergers increasing in cadence over the last few years. Takeda's CEO seems hell bent on acquiring anything and lumbering his organisation with massive debt. wacko.gif

It's only a matter of time before someone looks at Clinuvel. Interesting to think about takeover numbers. If AbbieVie is paying a 45% premium and Clinuvel does crack $70, that's $100 a share straight up. Not a scientific estimation I grant you, but it does illustrate how much and how quickly the share price could rise in the event of a bid from a suitor unwanted or otherwise.

In that case, I hope a takeover bid doesn't eventuate till after 2020/21. $200 anyone?
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macgyver
Posted on: Jun 26 2019, 12:24 AM


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Palatin existing in an inverse universe: get FDA approval, sp plummets. Shizenhousen.
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macgyver
Posted on: Jun 25 2019, 06:14 PM


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$70 for FDA/EPP approval would be impressive. Hard to say how the market will respond, I think it will be different to EMA approval though. The market may respond more favourably and be inclined to factor in revenues beyond EPP i.e. vitiligo, XP in short order.
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macgyver
Posted on: Jun 25 2019, 07:57 AM


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Wow, you really took the romance out of the experience 🤣🤣🤣
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macgyver
Posted on: Jun 22 2019, 08:02 PM


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My sentiments exactly. Five years this October since EMA approval. I can only hope the spigot opens fully after FDA approval and PW is less guarded and more adventurous. Procedural obsequience is pretty passé these days and most of us here roll our eyes in disbelief and resignation anytime a PR comes out which has the substance of a wet tissue. But yea, our time is near.
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macgyver
Posted on: Jun 22 2019, 12:35 PM


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Just goes to show that Palatin’s approach to how they’ve brought Vyleesi to market with regular comments by their CEO and newsletters means Clinuvel doesn’t have to fly under the radar constantly or be deliberately vague with investors. Competition is one thing, and they aren’t waiting . They’re getting on with it.
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macgyver
Posted on: Jun 22 2019, 12:12 PM


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https://www.sec.gov/Archives/edgar/data/911...55/ptn_ex11.htm

Dilution coming for Palatin. $40 million placement. How convenient.
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macgyver
Posted on: Jun 22 2019, 10:23 AM


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I agree with yours and NewToCli’s assessment of Vyleesi. While I absolutely believe women affected by this problem deserve treatment, I think the path to market for bremelanotide could have taken on a different class of afflictions, much in the same way Clinuvel is treating skin disorders. I feel this was very opportunistic by Palatin, however the point is to make money so I can’t begrudge them that.

I don’t foresee blockbuster sales for this drug at all. Regarding the article posted here in recent days about womens’ sexuality and Vyleesi, it’s a very different and complex problem as opposed to Viagra and what that alleviates😆

Talk of $1 billion in sales is complete rubbish. All this is is a foot in the door and a now more significant threat to Clinuvel: another melanocortin already in the market and a 3 month headstart. Let the race to CNS disorders begin..

P.S: Congrats to those who have invested in Palatin and have an interest in Clinuvel, your heads must be spinning after such a heady week. It’s moments like these that makes the wait and anguish all worthwhile👍
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macgyver
Posted on: Jun 21 2019, 04:29 PM


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The Fix huh? Terrible track..
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macgyver
Posted on: Jun 21 2019, 04:04 PM


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Come on $40 fuck ya!
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macgyver
Posted on: Jun 21 2019, 04:00 PM


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Churn baby churn...
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macgyver
Posted on: Jun 21 2019, 02:57 PM


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Anyone have their stop losses triggered this morning? Conniving S.O.Bs devilsmiley.gif
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macgyver
Posted on: Jun 20 2019, 01:31 PM


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Great analogy : FDA denial = Death weirdsmiley.gif
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macgyver
Posted on: Jun 20 2019, 10:10 AM


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I wouldn't say fake, its just we're not in the big boys' club (instos and investment banks).
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macgyver
Posted on: Jun 20 2019, 09:30 AM


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Indicative price looks dodgy this morning. Sell side significant but more than half volume above $40, though it can be said with confidence that doesn't mean shit. I'm expecting another 200k under $39 while ETFs get their fill. (Hope I'm wrong)
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macgyver
Posted on: Jun 19 2019, 02:56 PM


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Watching today's trading there was 200k shares traded for the first 3 hours and now the turnover has come down a bit. Bids and offers from behind the scenes have a hold on the trading. 89k shares on offer?? More like 300k or more...

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macgyver
Posted on: Jun 18 2019, 02:51 PM


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Oh well, I’ll take the good with the bad😜
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macgyver
Posted on: Jun 18 2019, 01:41 PM


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I appreciate it greatly Dr Wally, if only because its an extremely rare event devilsmiley.gif
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macgyver
Posted on: Jun 18 2019, 11:19 AM


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I’d think it an absolute disgrace if we didn’t get to $40 today... devilsmiley.gif

(Hands up who’s greedy?) 🙋‍♂️
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macgyver
Posted on: Jun 18 2019, 08:50 AM


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First time I’ve seen Jimmy the Flip-Flopper mention CSL and Clinuvel in the same breath. He must be high.
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macgyver
Posted on: Jun 15 2019, 11:03 PM


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I have EPP sales for Europe and America at $200 million with 1500 patients in America and the current patient numbers in Europe (with 6 implants in USA) roughing out at $3.25 per share. Use 20 as a multiple based on Sphene Capital’s 2020/21 estimation and the sp is $65, or conversely using a multiple of 12 (average for established Pharma companies) = $39.

To me $40 seems an appropriate target before FDA approval. And then there’s Japan and Australia to contend with. Japan will have some material effect concerning profit but I don’t see Australia being significant in the scheme of things (although every dollar helps the bottom line of course and the added benefit of having Scenesse in the Australian market for the next indications).

This is a pure stab in the dark but over the next 18 months I don’t picture the sp going higher than $55-70. Of course with all the expectations concerning Scenesse for future revenue, a somewhat exorbitantly high P/E ratio could be a possibility for the next 2-3 years. If that’s the case then the sky is the limit and perhaps $100 per share is coming in relatively short order.
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macgyver
Posted on: Jun 14 2019, 08:08 AM


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macgyver
Posted on: Jun 14 2019, 07:44 AM


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https://www.marketindex.com.au/sites/defaul...alance-june.pdf

I spotted this PDF which said the changes were effective today. It came out on the 8th June. Am I mistaken?

Sorry wrong year!! weirdsmiley.gif
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macgyver
Posted on: Jun 13 2019, 12:03 PM


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Thank you Waz, cheers for your good work. Here’s hoping we go up🤟
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macgyver
Posted on: Jun 12 2019, 01:07 AM


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Conservative market saturation figure of 1500 X $96,000 = $144 million. Not bad.
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macgyver
Posted on: Jun 11 2019, 08:58 PM


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Thanks for this. I disagree with their projected revenue for end 2020. It's just a guess on my part but I'd reckon revenue will easily exceed $36 million given rollout in the US should be a lot smoother than Europe.
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macgyver
Posted on: Jun 11 2019, 02:09 PM


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?
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macgyver
Posted on: Jun 11 2019, 10:16 AM


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I love it, missing Frilly somewhat. It was a great logo, much better than than the Microsoft Paint stitch~together we currently have. This would look very snazzy if it was a black T-shirt with white font and picture😉


By the way I found a depiction of Dr Wolgen:

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macgyver
Posted on: Jun 7 2019, 10:43 AM


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Presentation looks consistent with the last 1000 presentations.

I'd like to see some emphasis on projected revenues.They are trying to entice new investors after all. I want to see BILLIONS on the next presentation. devilsmiley.gif
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macgyver
Posted on: Jun 5 2019, 05:38 PM


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I’m dead.
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macgyver
Posted on: Jun 5 2019, 05:00 PM


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Sorry its actually Malcolm Bull biggrin.gif
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macgyver
Posted on: Jun 5 2019, 04:50 PM


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John Bull.
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macgyver
Posted on: Jun 5 2019, 04:04 PM


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Is your post directed at me? No trolling here brother, except for the ones that play for Queens Park Rangers...
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macgyver
Posted on: Jun 5 2019, 01:07 PM


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I don’t think it’s an issue. I get what you’re saying and most of us would agree about the smoke and mirrors Clinuvel sometimes employs, but Clinuvel has Nasdaq designation? Something might have been said to management to correct this lest they lose the designation.

Besides, with Clinuvel being domiciled in Australia (with subsidiaries around the world), they only have to answer to the ASX of which there’s been no complaints from them as far as we know. I agree 100% that Clinuvel will have to tighten up their reporting when Nasdaq comes knocking.
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macgyver
Posted on: Jun 4 2019, 03:32 PM


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Are you suggesting Dr Wally is hysterical? Please refrain from such insinuations good sir... devilsmiley.gif

All jokes aside, the good Doctor is right on the money about....safety profile.
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macgyver
Posted on: Jun 4 2019, 02:53 PM


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Dr Wally, are you the penguin? devilsmiley.gif

If you mention safety profile one more time..... puke.gif
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macgyver
Posted on: Jun 4 2019, 12:15 PM


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I am very cynical and I’m not surprised if last Tuesday’s massive short was connected to yesterday’s news. Who would short that much this close to July? Suspicious. But then again, if we heading towards $40, then I’d think nothing of it. Someone’s to blame always!!
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macgyver
Posted on: Jun 4 2019, 09:29 AM


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I don’t see anything in this post about the safety profile Dr Wally but I’ll take your word for it👍
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macgyver
Posted on: Jun 3 2019, 10:33 PM


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I don’t believe you’ve told me about the safety profile of Scenesse before. Please tell me more.. devilsmiley.gif
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macgyver
Posted on: Jun 3 2019, 03:15 PM


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Thanks, my seer ring me back to postpone my appointment due to lack of animal entrails.
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macgyver
Posted on: Jun 3 2019, 02:18 PM


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Frustrating I know. I'm not too miffed, except for that second PR release which basically stated what was mentioned in the first one. Why bother? There must be some hidden message in there somewhere.

I'm calling my seer now to see what she makes of the PR....
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macgyver
Posted on: Jun 3 2019, 10:11 AM


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This is a bit of a long shot, but I wouldn’t be surprised if the sp finished higher than last Friday’s close.🤷🏽‍♂️
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macgyver
Posted on: Jun 3 2019, 09:42 AM


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No surprises there. According to Frogster’s post, the reasons for the extensions solicited or otherwise don’t seem overly critical, as in they’re not requesting more trials etc. I’m assuming it was a solicited extension? The only reason I can think of for an unsolicited extension would be for Clinuvel to provide more data from Europe to bolster the dossier.
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macgyver
Posted on: Jun 3 2019, 09:31 AM


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What’s a three month extension in the scheme of things? I’m thinking it’s not a big deal, just that the FDA is flat out overall.
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macgyver
Posted on: May 31 2019, 04:01 PM


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Battle of the Bots.
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macgyver
Posted on: May 30 2019, 11:32 PM


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The IRS clamped down on this in the US (shorting the box). They now treat as a CGT event regardless, but there other methods (collars) to try to get around this. Not sure about the ATO’s approach to this.
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macgyver
Posted on: May 29 2019, 04:55 PM


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Is a takeover a chicken? devilsmiley.gif
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macgyver
Posted on: May 29 2019, 03:59 PM


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I’ve been on sabbatical for nearly a year now, it’s the first time in my working career (started working at 11 years old doing the local paper run, and having one job or another as I went through high school) that I’ve had a break longer than 3 months. Travelled overseas for three months in anticipation that the share price would rise, and it’s worked out perfectly.

Very shortly I think I’d be in a position to retire early. Although I’ve enjoyed my time off from working and really just taken a long overdue breather for the first time in many years, even if I was close to being comfortable or I could retire early, the time off has made me realise that instead of working for the man, I need to accomplish something for myself, be it in business or academia. To retire early and travel the world on a reserved budget is fine, and believe me travelling is very satisfying, the satisfaction derived from building a business from scratch and have it be successful would be enormously rewarding.

Ironically it took having time off to stand back and see the bigger picture. However, I’m clear now that, even with pockets stuffed with cash, I’d be restless. Soon it will be time to build on that money and start out on my own. It’s no wonder the tycoons (Buffet, Bill Gates, Jeff Bezos et al) still go to work. Money is no object, so what do you do to fill the time? Build.
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macgyver
Posted on: May 28 2019, 04:21 PM


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Schlitzo wont be disappointed with today’s effort..
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macgyver
Posted on: May 27 2019, 10:05 PM


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I put takeover at 0.01%. X-Ray would dispute this.
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macgyver
Posted on: May 27 2019, 05:27 PM


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Lol that’s exactly what it’s come to for me. I’m getting greedy and nervous🤷🏽‍♂️
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macgyver
Posted on: May 24 2019, 01:30 PM


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$48/18
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macgyver
Posted on: May 24 2019, 10:22 AM


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David Gilmour’s guitar says that as well🤣
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macgyver
Posted on: May 23 2019, 03:33 PM


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Broken through $32 resistance?
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macgyver
Posted on: May 23 2019, 09:23 AM


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Prince is a better guitarist than Clapton. Even Slowhand will admit that. Long live SRV🎸
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macgyver
Posted on: May 21 2019, 06:40 PM


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No news coming before PDUFA I reckon. Afterwards you’d expect a torrent of news, otherwise the IR manager is sacked. Again!
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macgyver
Posted on: May 21 2019, 10:50 AM


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That must have been painful. I endured Wiggles torture just this morning with my boy. The things we do....
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macgyver
Posted on: May 20 2019, 06:35 AM


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Good point. Irrespective of potential benefits that a Clinuvel topical might bring relating to skin cancer and whatnot, it shouldn’t be viewed as a magic bullet. Common sense should prevail concerning UV exposure.
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macgyver
Posted on: May 17 2019, 11:34 PM


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Apologies. Edited.
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macgyver
Posted on: May 17 2019, 10:01 AM


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Vale Bob Hawke, the greatest Australian who ever lived.

Let’s go Clinuvel!!
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macgyver
Posted on: May 16 2019, 10:11 AM


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Attached Image

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macgyver
Posted on: May 16 2019, 10:05 AM


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Fine start this morning👍

Attached Image

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macgyver
Posted on: May 15 2019, 03:38 PM


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That’s a very good question, and one which I’ve been trying to figure out myself. I’m guessing that instos/traders are taking advantage of increased volume to make small profits or looking for cheaper shares as if they are churning their own stock over and over. Like panning for gold, adding your stock to the churn hoping to get some tiny profit or cheap shares along the way.

Behind that is a genuine driver behind the price with other punters diving into the stock, especially given the positive aspects surrounding Clinuvel at the moment. A theory no less....
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macgyver
Posted on: May 13 2019, 04:53 PM


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Farma, you really need to start firing up that CLVLY IHub board now with imminent FDA approval. Your time is coming, educate the Americans about Clinuvel!
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macgyver
Posted on: May 10 2019, 09:20 AM


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Attached Image



Couple of early starters.
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macgyver
Posted on: May 8 2019, 03:23 PM


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You always know something, spill the beans!!

This stock is some crazy shit.
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macgyver
Posted on: May 8 2019, 11:12 AM


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The shortseller evisceration barbecue has started.
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macgyver
Posted on: May 7 2019, 09:59 PM


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BLOCKBUSTER.
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macgyver
Posted on: May 7 2019, 04:13 PM


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Have you heard of waterboarding?🤷🏽‍♂️🤣🤣
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macgyver
Posted on: May 7 2019, 09:36 AM


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The Tesla Network will rule them all...
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macgyver
Posted on: May 2 2019, 08:36 PM


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Preparation is key for a good starting run in the U.S if and when the FDA approval arrives. Insurances being negotiated, manufacturers in hand, centres ready to administer, allocation of funds ready to deploy. Not too sure about distribution of the drug though I suspect with the U.S there is sufficient logistics ready to go at a moments notice. Certainly experience gained from the rollout in Europe will bode well for the company.

I took the general gist of the newsletter today as a ‘steady as she goes’ reminder. And probably more to do with appeasing the FDA than warning exisiting and new investors about the folly of assuming FDA approval is a given. The flurry of activity lately suggests confidence to me, though it can be said it is due diligence that would be expected of any company in such situations.
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macgyver
Posted on: May 2 2019, 10:33 AM


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Agreed. A timely reminder that we're not quite there yet.

A NASDAQ listing will probably not occur until after approval, which might be delayed. Yet PW is pressing the flesh with institutional investors abroad, I assume in anticipation of listing.
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macgyver
Posted on: Apr 30 2019, 07:28 PM


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$1.8 mil production/manufacturing costs estimated for the next quarter compared with $1.9 mil total for the last 3 quarters. For 4Q 2018 it was $445,000. That’s significant even allowing for a possible 40% increase in European operations, and a clue to the progression of the NDA...

Approx. $700k earmarked for U.S operations?
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macgyver
Posted on: Apr 30 2019, 02:42 PM


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This stock has been artificially depressed for quite a long time, going back as far as 2016-2017 IMHO. There always seemed to be a tight rein on the share price when all of a sudden, the share price would move up a buck or two inexplicably at a time. It was as if the powers that be had kept a lid on it allowing it to rise according to a predetermined calendar.

Far fetched? Probably. 70% pop? I’ve been expecting a doubling of the share price to at least $50-55 post FDA approval, with a retrace back down to the low $40s sometime after. So yes, 70% is definitely achieveable.
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macgyver
Posted on: Apr 28 2019, 11:39 AM


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Totally agree with your comments. Time to cash in some shares this year. GLTA
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macgyver
Posted on: Apr 26 2019, 07:39 PM


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He’s right on the money about not knowing enough, which will be his bad luck when it takes off. I suggested Clinuvel to a work colleague and he looked it up and discovered that EPP has a limited number of patients in Europe. I told him about the price of the drug and what there future plans were. He was extremely doubtful about the company and decided to plough his money (life savings, super and maxed out credit cards) into a WA oil exploration company looking for oil in the Alaskan North Shelf. That stock went down by 70% and our’s went up a damn sight more. Too many stories to post here about trying to spread the gospel of Clinuvel to friends and family, with mostly everyone turning their nose up at the stock and investing in something else that has since had paltry returns or are in the negative.

I feel a certain satisfaction knowing I was right about investing in Clinuvel, though I’d feel a lot more satisfied if my friends, colleagues and family had come along for the ride...
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macgyver
Posted on: Apr 26 2019, 02:11 PM


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devilsmiley.gif
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macgyver
Posted on: Apr 25 2019, 07:32 AM


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It’s a conversation we’re having. And yours is a theory. The FDA doesn’t reject a drug based on speculation. That would undermine the whole process and invite accusations of corruption and incompetence. I’m ok with the discussion, and I see no threat to my investment from it. Not even 5%.
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macgyver
Posted on: Apr 25 2019, 04:17 AM


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Another conspiracy theorist. Proof? Or you heard from someone else? If you think the FDA will deny approval because off label is mentioned on ShareCafe then the whole approval system is detrimentally flawed, and the hard work, trials and treasure spent to get to this point will have been for nothing. That doesn’t make sense. I think it beneath you if you demean the people at Clinuvel and their hard work by insinuating that just the mere mention of off- label can destroy their efforts. I know your investment is precious to you but don’t let money cloud your sense of reality.
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macgyver
Posted on: Apr 24 2019, 09:06 PM


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That’s interesting, I never thought about the doctor’s prerogative in prescribing medication and how the First Amendment might apply to that. I tend to view it the other way in that the drug company would have final say in how or where it’s drugs are distributed. However, it’s certainly possible that Clinuvel could set up the patient safety register and have the drug be available for doctors to prescribe off-label. It just doesn’t seem to gel with me though because of PW’s insistence on strict adherence to non-off label use.
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macgyver
Posted on: Apr 24 2019, 04:31 PM


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You missed a key sentence at the end of your quote which was:

QUOTE
Literally around the clock, our teams are collaborating with the FDA to answer the frequent queries arising from the scientific review process, such that a controlled post- licensing (post-marketing) follow-up of patients is put in place in the US.


Controlled post licensing follow-up? It seems to me that approval is imminent, of which the FDA accepted PW's proposal for the patient monitoring scheme a la "PASS" in Europe to get this either over the line or expedited for market release.

I'm not staking my reputation on it such as it is, but I think this drug will not be made available off-label. We'll see.
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macgyver
Posted on: Apr 24 2019, 12:44 PM


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So that’s approx minimum $218 per share. I’m satisfied...
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macgyver
Posted on: Apr 24 2019, 10:51 AM


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Good call, I like it.

I’d like to know what order of magnitude he’s talking. 10?😜
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macgyver
Posted on: Apr 23 2019, 04:31 PM


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A lot of shares traded in the end of trading auction. Similar to what happened when Vanguard was hoovering up shares.
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macgyver
Posted on: Apr 20 2019, 11:17 AM


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Mr Delaney, given the quality of your blogs that you write for Clinuvel and what you have written here, I was convinced you are who you say you are. I became suspicious when I saw your middle name.
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macgyver
Posted on: Apr 20 2019, 09:45 AM


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Knowing PW’s penchant for secrecy, I would think this scenario is most plausible. I do feel Clinuvel’s foray into CNS and anti-inflammatory indications would be extremely nascent considering they have focused their energies and money on the FDA approval. I think I’ve seen one or two job advertisements for scientists for the operation in Singapore in the last two years, which I would guess is solely concentrating on dermal applications.

That said, this is the second mention via social media concerning DNA repair/anti-inflammatory/CNS neuronal type conditions so perhaps there is something in it. If not, it would be uncharacteristic of PW to start planting seeds about indications that are way off in the future. He is the polar opposite of Palatin’s CEO...
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macgyver
Posted on: Apr 18 2019, 04:05 PM


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Nope.
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macgyver
Posted on: Apr 18 2019, 03:59 PM


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I wonder if we will see large amounts of shares in the auction after 4pm....
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macgyver
Posted on: Apr 18 2019, 09:49 AM


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Thanks to you, Johnny H and others regarding comments concerning CUV and the ASX200. We have some commited Clinuvelians doing great detective work👍

Is it possible that CUV may not may move up to ASX200 in June because CUV wasn’t No. 2 in the last ASX200 rebalance? If that’s the case then September if any date would be the earliest possible date to be included in the ASX200?
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macgyver
Posted on: Apr 15 2019, 09:51 AM


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Last push coming from Fidelity over the next few weeks. Interesting to see how much of a restraint it’s been. Does Vanguard purchase more when Clinuvel cracks ASX 200?
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macgyver
Posted on: Apr 4 2019, 04:50 PM


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That’s what I was thinking, that perhaps the 2nd indication is a stepping stone to branching out to other dermatological problems requiring DNA repair and such. AK and similar ailments could fall under the 2nd indication ‘family’ as it were. I’m not sure about timeframes for label extensions with the FDA, but if Clinuvel keeps a tight rein on off label use, then these will take years to come to fruition. It will be interesting to see what the FDA’s stance is on this situation. My understanding is is that the FDA have not bridled off label use on any other drug, and for PW to request as such would be anathema to an American or big Pharma company. Curious....
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macgyver
Posted on: Apr 4 2019, 12:57 PM


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The progress pyramid in the Goldman presentation shows 2nd indication with the words “photoprotection and DNA repair”. While most of us are guessing it will be XP, does anyone else figure the follow on from this could cover a wide range of ailments that can be alleviated with photoprotection and DNA repair? The setting of a platform perhaps through the 2nd indication pathway seperate from vitiligo?
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macgyver
Posted on: Apr 2 2019, 12:29 PM


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Yes I believe that was the count at their last ‘ceasing to be a substantial owner’ announcement a few months back. Speculation on my part about whether Lagoda has unloaded. Either ways, there will be plenty of buying coming up ready to take Fidelity or Lagoda’s shares.
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macgyver
Posted on: Apr 2 2019, 11:09 AM


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Posts: 493

Lagoda ceased to hold for a few clients on Oct 2018 approx 1 million shares whilst still managing 2.1 million shares approx. Its possible they ceased to hold all remaining shares and redistributed to their clients. If they are still managing these shares, and they maintained their disposal frequency, its possible they have 1 million shares or less now. Coupled with Fidelity's 900k odd shares, I would suggest that either these will be sold within the next 3 months or less if Laogda is not managing these anymore. It will be interesting to see if once the sell pressure is off how quickly the cadence will run combined with FDA approval anticipation plus new into investors coming onboard after the Clinuvel roadshow has taken place. Exciting times..
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macgyver
Posted on: Apr 1 2019, 04:59 PM


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edited
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macgyver
Posted on: Apr 1 2019, 07:14 AM


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Yes, how dare he undervalue Clinuvel! Be gone downramper!!
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macgyver
Posted on: Mar 26 2019, 10:52 PM


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55+ in short order would be both dramatic and realistic rolleyes.gif
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macgyver
Posted on: Mar 26 2019, 10:51 PM


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Brenda Shanahan deserves it by a long shot. She’s been with Clinuvel for a while now, and she’s not getting any younger. And she’s a Melbourne girl as well so it’s only fitting. Keep it Aussie.
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macgyver
Posted on: Mar 26 2019, 09:29 AM


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Posts: 493

The shorts.... Large trades like the one yesterday exist in a parallel universe alongside the current shenanigans...
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macgyver
Posted on: Mar 26 2019, 07:39 AM


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Agreed. Remember July 2018 release of skincare products? Shelved until FDA process over. That said, I expect a torrent/flurry of PRs and significant events to occur. Hopefully this sustains the cadence in share price over second half 2019;)
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macgyver
Posted on: Mar 22 2019, 04:33 PM


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Mr Spock would be impressed with your logic. Levelheaded by name, Levelheaded by nature🤟😉
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macgyver
Posted on: Mar 21 2019, 11:26 AM


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I'd like to see an ASX query into the good Dr Wally's post, still deciphering...
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macgyver
Posted on: Mar 21 2019, 11:14 AM


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?
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macgyver
Posted on: Mar 20 2019, 03:59 PM


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

Looking to break $30 tomorrow, or something...
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macgyver
Posted on: Mar 20 2019, 01:34 PM


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I’m glad about the focus on the US rollout. Experience gained in Europe with experienced managers facilitating the US rollout should bode well regards expedition and execution. Speaks to confidence in the submission though I’d guess it’s S.O.P as well. Can’t wait for them to hit the ground running the day after approval😜
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macgyver
Posted on: Mar 20 2019, 01:31 PM


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Posts: 493

I thought the comments made by someone just after market open about pushing through $30 by midday and the wild drop in price around that time was more than coincidental IMHO. Beware of falsehoods in this forum. Hang on for dear life...
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macgyver
Posted on: Mar 19 2019, 01:42 PM


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Ooh maybe, fascinating isn’t it? Is there another lid at $30 I wonder?...
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macgyver
Posted on: Mar 19 2019, 10:23 AM


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$432? Thats a very friendly takeover wub.gif
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macgyver
Posted on: Mar 19 2019, 10:07 AM


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


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Attached Image

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


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


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


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Posts: 493

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


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WTF just happened??

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


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


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


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

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


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


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


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


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Posts: 493

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

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

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


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

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

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


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Posts: 493

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

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


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Posts: 493

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


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Posts: 493

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

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


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Posts: 493

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


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


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


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

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

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


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We going to $25?
  Forum: By Share Code

macgyver
Posted on: Feb 13 2019, 03:44 PM


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Posts: 493

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


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


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Posts: 493

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


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


Group: Member
Posts: 493

Nice find Sharelooker wink.gif

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

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

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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

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


Group: Member
Posts: 493

Yahoo huh?

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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

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

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

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

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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

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


Group: Member
Posts: 493

Apologies for my ignorance but can somebody clarify the following:

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

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

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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

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


Group: Member
Posts: 493

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

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

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

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

Wow!!!!

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


Group: Member
Posts: 493

Run up to $24, or beyond?😀
  Forum: By Share Code

macgyver
Posted on: Jan 4 2019, 12:36 PM


Group: Member
Posts: 493

Haha, a thorough retort. What say you heathen Ignoramus?
  Forum: By Share Code

macgyver
Posted on: Jan 3 2019, 10:59 PM


Group: Member
Posts: 493

You have to move over to Sharecafe and login there. It’s fully functional.
  Forum: By Share Code

macgyver
Posted on: Jan 3 2019, 10:20 AM


Group: Member
Posts: 493

They can’t take Clinuvel’s fee? Doesn’t seem that bad. Shutdown won’t last much longer.
  Forum: By Share Code

macgyver
Posted on: Jan 3 2019, 09:54 AM


Group: Member
Posts: 493

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

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

Nice action just before Xmas...
  Forum: By Share Code

macgyver
Posted on: Dec 19 2018, 03:56 PM


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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


Group: Member
Posts: 493

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

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

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

Scenesse is not a niche drug, it is a panacea drug.
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