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TheG1000
Posted on: Jan 31 2020, 12:18 PM


Group: Member
Posts: 36

I think the shorts were hoping Clinuvel would follow Nearmaps lead in quarterly results and their share price response.
I for one am happy with the results, it's in-line iwht what I was expecting (not to be confused with what I was hoping).

We might not have what we want (ie, expansion at anything more than a glacial pace), but compared to the negative setbacks us Clinuvel investors are used to, this report is a mere blip. It says to me "nothings actualy wrong" for once.

When your retention rate is around 95% or more, you are fooling yourself if you expect it to do anything other than go down. Retention rate is fine, the money is in expansion of sales (waiting PW....).
Still looks might fine to me.
Insurance costs should rise in line with the value of what is being insured, we should expect them to increase each renewal if we continue to grow and expand, I'm not unhappy with this.

I'd still buy at this price (if I wasn't already back to my all time high quantity of shares)
I can't find enough downside to sell below $30.

Good luck to everyone, DYOR, my opinion above is just that, opinion.
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TheG1000
Posted on: Dec 23 2019, 10:10 AM


Group: Member
Posts: 36

It's good to see more communication though and I'd expect they've learned enough from the EMA and FDA submissions to sail through with the TGA.

What we really want to see is the lodgement with the Pharmaceutical Benefits Advisory Committee (PBAC) and how that goes... Hopefully the more recent measures of clinical outcomes improves our assessment, compared to that of the useless NICE.

I'm not negative on CUV here, rather on our PBS funding.
On a positive note, Orphan Status is useful here, also makes it all pretty cheap with the fee waivers including submissions for PBS inclusion.

Good to see the SP going the right way (I've repurchased every share I sold, thank you sorters)
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TheG1000
Posted on: Oct 27 2019, 04:46 PM


Group: Member
Posts: 36

I've always loved Orthocell, but have been unable to convince myself to invest (obviously Clinuvel had a better attraction for my conservative approach), though I'll be glad to see them succeed.

Another I've finally entered a few months ago after watching from the sidelines is Paradigm PAR.ASX.
I think it's treatment profile and risk would appeal to others whom like Scenesse's profile.
It might be a tad expensive but is well funded, and you can bet if it is fully proven and approved one day it won't suffer from a lack of publicity as CUV does.
It's target market is sport (AFL, NFL) stars!

I'm no investment expert, I just like the treatment so DYOR
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TheG1000
Posted on: Oct 25 2019, 02:45 PM


Group: Member
Posts: 36

I think we'll just buy more. (read: did buy more)
$30.40 was a bargain, as is sub $33, but then again I bought at $28 before FDA approval, so 8% more for an approved drug was not much of a jump to justify.
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TheG1000
Posted on: Oct 14 2019, 12:10 AM


Group: Member
Posts: 36

I sold shares too (most above $44) however those were my "bonus shares", I had no financially sensible right to own them, essentially gambling money on CUV that is needed elsewhere.
I saw free money and grabbed it. Selling those lets me sleep like a babe.

My core bulk holding though is untouched, all the real risks (for me) just evaporated with FDA approval, I can afford to hold them for decades, though I'll sell down as logic dictates. Also, I fear my accountant may physically harm me, should I realise all those capital gains at once.

I didn't sell my core holding when the pre-FDA approval price hit $38 months ago (did sell some of the bonus ones around $35), so selling now would be madness for me.
That's personally though, congratulations to anyone selling however many to free themselves of whatever stress.
A real-world fellow CUV long friend of mine passed away without seeing this FDA approval or these prices, life matters and perspective matters.

Only posting as a sounding board for others mulling buying/selling, not financial advice, do your own research and hopefully you made enough to live life on your terms.
(Full disclosure: still loooong, already semi-retired for my kids sakes, financially independant of CUV but it's my favourite and I'll be unable to stop myself buying it when it dips)

Patent info looks good, management could rewrite our opinions of them in many respects if they get the next 12 months right.
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TheG1000
Posted on: Oct 13 2019, 12:48 PM


Group: Member
Posts: 36

If they achieve control of the board and enough shares, they can issue new equity to dilute the blocking stake, the size and speed of which would be determined by how much they could acquire, and what stock options they could grant the new board.
They could then compulsorily acquire.
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TheG1000
Posted on: Oct 10 2019, 10:32 AM


Group: Member
Posts: 36

Bought a few thousand this morning, forgot my wife gets the order confirmations blink.gif , think she had earmarked our funds for other things already! (Is buying CUV a medical condition?)
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TheG1000
Posted on: Oct 10 2019, 08:25 AM


Group: Member
Posts: 36

Millions of dollars worth of shares stacking the sell side so long before open, nobody with enough shares to sell all those would place their orders in such a fashion, they want it to look like it's all sell, fine smile.gif Might be a bit desperate, certainly not aimed at getting the best price like a real seller would.

I almost bought more in $35 range yesterday, but was having too good a day to trust my decision making... Which itself was obviously a bad decision.
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TheG1000
Posted on: Oct 9 2019, 11:19 PM


Group: Member
Posts: 36

So if we go above $55 per share ($2.7B AUD market cap), might we start to discuss S&P ASX100 inclusion? biggrin.gif
Yeah, maybe a bit early, but I'm in quite the good mood for some reason.
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TheG1000
Posted on: Oct 9 2019, 04:04 AM


Group: Member
Posts: 36

Congratulations to everyone!
Clinuvel Management and team (poor souls).
Epp sufferers (hope their access is speedy and delay-free)
Sharescene/Sharecafe, Google groups et Al (even Iggy, oh and the bird)

I have not had to wait as long as many of you, but today is the day we were waiting for, I honestly don't even care if the share price stands still, we have all the time in the world now, for our FDA APPROVED DRUG!
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TheG1000
Posted on: Oct 7 2019, 09:17 AM


Group: Member
Posts: 36

Yeah, no less than 3 different currencies used throughout the document. Nice and clear /s

CEO staying on is (almost) always good news for stock price though, I'm happy enough, just wondering how "exceptional" the STIs will actually be.
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TheG1000
Posted on: Oct 7 2019, 09:06 AM


Group: Member
Posts: 36

Announcement:
PW up for around $1.5 million AUD
Attached File(s)
Attached File  CLINUVEL_renews_CEO_Employment_Agreement.PDF ( 166.92K ) Number of downloads: 172

 
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TheG1000
Posted on: Oct 2 2019, 09:46 AM


Group: Member
Posts: 36

PDUFA date is now October 8th

Announcement: FDA Clarifies SCENESSE PDUFA Date
Attached File(s)
Attached File  449445njhptnmd.pdf ( 132.6K ) Number of downloads: 90

 
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TheG1000
Posted on: Sep 30 2019, 06:47 PM


Group: Member
Posts: 36

@IntiRaymi: not sure if I ever thanked you for AVH, so might as well do it now, did my own due diligence and bought a bunch, sold out for double my money and plenty left as free carry. (they looked fully priced above 0.50) Moved into Paradigm, but it's all play money compared to CUV.

@xray: I can vouch for 2000 of them today, couldn't resist sub $24.

It was only a few months ago, I was looking at $35 a share and wishing I could have bought more "back in the 20's", I thought I would never buy again, just sell... wrongo!

Buy logic is they are cheap for the odds:
What's the least they are possibly worth with full Fda rejection?
$15 is an easy case to make. So I might lose say $10 /share.
Approval is easy $40 (not on day 1 maybe, but no rush), conservative say $35, for $10 profit.

So even at 50% odds I can justify a buy, given the real odds are more like 95% approval, it is just free money.

For the record, I actually think it'll go above $50 with approval, agree it will take a few weeks or months, but what's the rush once you have approval?
As long as PW doesn't sell, I'm happy with his position if I lose $100k he loses what $8 million? Seems fair.

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TheG1000
Posted on: Aug 28 2019, 01:31 PM


Group: Member
Posts: 36

Solid results as expected. Financials is where management shines (not so much the reports).

Rerating of PE and consecutive dividends is good and sensible in value (not that I personally want a dividend) (I wonder if they were planning a slightly higher dividend (Page 11 mentions it as $0.028))

Pity we are in a low interest rate environment, we won't get as much credit for our lack of debt as we would have otherwise.

Anyone see any particular negatives I might be overlooking?

Looking forward to October.
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TheG1000
Posted on: Aug 21 2019, 02:57 PM


Group: Member
Posts: 36

I'm not sure when lift off will occur, though around this week is as good a guess as any.
I did decide today though, that I think we have seen the bottom of this dip and so bought up a few thousand for the first time in 6 months. I didn't get the very bottom, but I'm satisfied, a few more above $28.80 (when/if it gets there) and I'm done.

This pull-back and the 3 month delay cost me a lot of money on paper, I thought it'd annoy my wife too, but she just quipped back:
"Didn't you say, when they gave the first approval date, that we should add half a year of Clinuvel time? Seems like it's ahead of schedule"

So I've felt no stress the last few months as the price dropped, CUV is doing exactly what anyone who has been around more than 4 years is used to.

I'll just buy the dip... again GLTAH
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TheG1000
Posted on: May 29 2019, 01:54 PM


Group: Member
Posts: 36

You're spot on about not having people to talk to about retirement at our (I'm early 30's) age. I've been planning it for several years and so have a plan in place, which my family and I have started.

Instead of fully retiring I've gone part-time, halving my hours, which quadruples my time with the wife and kids. I don't think I could not work, as I'd have no friends and be lonely and bored within a few years I predict. I've also got real estate properties, other amazing shares (CSL, NEA) and small business interests that diversify me a little more, otherwise I'd have to sell more CUV due to my risk aversion.

I'd recommend you work or study (a gap year in life is fine too), life is both too long and too short to do nothing and more money won't hurt (what if my next child has SMA, the drug to cure it is $3mil, I'd kick myself for taking it too easy).

That said, I love the freedom to act out my life plans thanks to CUV, though I'd live if it went to 0 tomorrow.

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TheG1000
Posted on: May 24 2019, 06:25 PM


Group: Member
Posts: 36

I'm working off $46/$17, with a non-crl delay for "unexplained Clinuvel reasons" price of $27
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TheG1000
Posted on: May 17 2019, 01:20 PM


Group: Member
Posts: 36

The only CUV relevant information is just referring to Morgan Stanley's assessment that Clinuvel is first in line/most likely to be included in the ASX200 at the June rebalance.
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TheG1000
Posted on: May 15 2019, 12:32 PM


Group: Member
Posts: 36

Nice to see Karen (Director) topping up. The announcement is for a few of the ADRs, wonder why US OTC instead of on the ASX.

https://www.asx.com.au/asx/statistics/displ...;idsId=02105818
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TheG1000
Posted on: May 14 2019, 05:29 PM


Group: Member
Posts: 36

A quick squiz over the Australian liquidity data (haven't verified what does and doesn't count, just generalising here) looking for 6 months CUV median liquidity gives:

March rebalance: 56,452 (We missed out)

June rebalance worst case: 65,930
June rebalance current: 77,031
June rebalance best case: 84,341 (if all remaining volumes exceed 85,151)

This is just interesting to me, looks good.
Not saying it means anything.
Please note S&P's inclusion criteria consider the volume in ratio to the overall market, and I haven't checked that.
DYOR
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TheG1000
Posted on: May 8 2019, 03:29 PM


Group: Member
Posts: 36

Just an FYI, the same substantial holder notification was made today for the ADR BNYMC has in place for Avita Medical (ASX:AVH)
So not CUV specific.
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TheG1000
Posted on: Apr 18 2019, 11:29 AM


Group: Member
Posts: 36

The pre-Easter sell off, glorious for those of us stockpiling cash after taking a little cream off the top. I didn't pick up many at the last pull-back, I did much better this time.
For anyone new or not looking to buy more, just don't look at the shares for a few months, take a holiday and come back later in the year to collect.
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TheG1000
Posted on: Mar 15 2019, 04:10 PM


Group: Member
Posts: 36

A great week for all shareholders, I guess we found the buy pressure.
Just wanted to point out that the massive trade won't help with ASX200 inclusion as much as you'd hope. It's not a mean average liquidity they use, it's a median (the middle number of all numbers in order).
I still think we will make it though.
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TheG1000
Posted on: Mar 12 2019, 10:27 PM


Group: Member
Posts: 36

Clinuvel may not have made the S&P ASX200, but we did sneak into the Chi-X Australia 200 indices.
This doesn't mean much to me personally, no idea whether this has any material impact on the share price.
Attached File(s)
Attached File  CXA070319001.pdf ( 227.73K ) Number of downloads: 84

 
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TheG1000
Posted on: Mar 8 2019, 08:24 AM


Group: Member
Posts: 36

Ugh, might have made it more confusing.
I should clarify that what I said Regards to funds buying Clinuvel was in regards to topping up and buying 'more'. Their initial buy for inclusion will of course be large and dependant on the market Cap we reach by inclusion date. But once they have them they don't usually have to buy much more.

Also Asx300 inclusion only required 30% relative liquidity, so a fair bit higher for Asx200 with 50%. It's also a median liquidity, not a mean liquidity, so very high volume days and very low volume days don't really count for much.
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TheG1000
Posted on: Mar 8 2019, 07:54 AM


Group: Member
Posts: 36

Liquidity is an eligibility criteria, while there is always some wiggle room, if you don't meet the 50% minimum relative liquidity (VS the All Ordinaries) then your market cap never gets a look in.
PNI for example has almost double our liquidity.

Also, in regards to discussions of how many shares the index funds/ETFs must buy, there is some confusion about them needing to buy more as Clinuvel price increases. There are different methods to weight a funds holdings (equal weight VS Cap weight) but a Cap weighted fund will not need to buy more shares unless people put more money into the fund. If Clinuvel doubles in price, so does the funds $ of Clinuvel, so no need to buy more.
It is of course not quite that simple, but for our purposes let's pretend it is.

I'm still long (took some profits then bought it all back at the $17 bargain price in December) . GLTA
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TheG1000
Posted on: Sep 16 2018, 09:01 PM


Group: Member
Posts: 36

With $2.88 billion tracking the asx300 by relative market cap weighting, I'm guessing they only really need Max $1.4 million in Clinuvel. Which is still excellent.
I've reviewed quite a few of the FDA SOPPs and Industry Guidance documents to try and determine the exact situation the NDA is in (SOPP8401 is useful for those looking to understand the whole process).
An RTF would surely require an announcement to market, so is it an IR? If there is to be determination of PR once queries are answered , is the review clock somehow paused mid validation by an IR, which I thought only came post validation, once accepted for review.

More fun might be that the final module submitted under rolling review needed more work, as such the Nda has not truly been submitted under the review clock. Rather it's still in the rolling review stage, as the announcement on FDA progress was at pains to point out, mentioning the "rolling review" multiple times. That'd be embarrassing, but not as embarrassing as an RTF.

I'm enjoying the ride, have gone free carry as of the $15 mark (sorry, but tax and stuff guys)

(All the above is my opinion, don't rely on it for investment decisions and please feel free to have your own)
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TheG1000
Posted on: Jun 23 2018, 01:28 AM


Group: Member
Posts: 36

Finally we will get some real news, good or bad. My gut says good, my head says bad (RTF, as some have already highlighted and historical CUV pessimism).
I imagine the bump in ADR price on the volumes we see over in the USA is likely to close out short positions, unlikely to reflect whether the news will be negative or positive.

I'm hoping for the best, but even at the worst I'll still be holding long for years to come, like most of us here I suspect.
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TheG1000
Posted on: Oct 18 2016, 08:06 PM


Group: Member
Posts: 36

Some thoughts on the announcement of NICE STA recommendation:

Simplifying for those who don't want to read up too much on all the aspects, being appropriate for STA instead of HST is BAD news.

The process takes longer (a good 10-20 weeks longer) and that's only AFTER doing a whole new scoping process for STA and the one for HST doesn't seem to count if reading Clinuvel's announcement correctly. So our 37 weeks can't even begin yet (I don't think scoping can be less than 5 weeks from memory, 12?).

The STA assessment is on cost effectiveness (HST was not, only really clinical effect), it relies heavily on the cost per QALY gained compared to alternatives (ICER), not cost per year.
- the 30k GBP upper ICER boundary is not 30k spent on Scenesse per year
- QALYs are hard to calculate (brush up on EQ-5D... bring calculus skills and a fortune teller), and I'm just doing this to illustrate but say 3 x Scenesse/year counts for 0.3 ICER/year, that's 10k worth per year, or 3300 GBP per implant. Also, you cannot just get 1 implant, as using 1 does not produce the same ICER as the 3, it would drop and you'd just get 3300GBP per year instead of 10k.


The STA process does not consider benefits/costs beyond the health budgets, meaning they wont consider economic benefits or the reduction in other costs, compared to the HST process which is appraised on benefits beyond just health.

One bright light is that there is some consideration (in a different manner to HST) of "no alternative treatments" in the STA in some manner, even if not on the face of it all.
I can't wait to see how they apply a reference case in comparison to Scenesse, as that is a requirement for STA.

Also the STA decision doesn't qualify more people as EPP, they point out they have not redefined the treatment population as that would cost them more, a little having and eating of the cake on their part. So just because their EPP patient population estimate put forward is high enough to ruin HST for Scenesse, it is of no benefit in reality, as the number would be the same for sales either way.

Now that I've vented on NICE I'd like to point out it's the English EPP sufferers getting shafted here. The effect on us (longs) shouldn't be significant in the scheme of things, a few delays, pricing issues and hoping the system changes in our favour in the meantime (that last sentence in Clinuvels announcement gave me a chuckle). If (hopefully) there's a pullback is SP I'll just keep topping up, surprised the news wasn't taken worse by the market though, go figure.

Footnote: My knowledge on the English system is a little outdated and patchy, I may have missed things. You are welcome to disagree or correct any errors or oversights on my part, no offence taken.
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TheG1000
Posted on: Oct 10 2016, 08:52 AM


Group: Member
Posts: 36

$8.07 AUD

Assumed Key Factor: $16 million revenues for FY17.
Wildcards/Outliers: Date FDA submission announced or trial commencement or takeover offer(s).

The 5 day volume weighted price would be more relevant, given the volume based price volatility... but much less fun.
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TheG1000
Posted on: May 18 2016, 11:08 PM


Group: Member
Posts: 36

.... And the countdown clock disappeared, as though it was never really there at all...?

As I rarely post, might as well throw in that I'm surprised at the 25K price, pleasantly for at least the short term. I had been working off a price around the 18K mark.

I had finished my buying with my final order filled yesterday, will reconsider whether to go a little further, if a little more uP info comes in near that of the Germans.

I was also surprised by the price rise today. I expect a rather gradual price increase towards $8 by the years end as the breakeven point becomes calculable (excluding increased research costs of paediatric formulation and US direction/vitiligo). I assume it was eager SS informed buyers running up, but that is simply a guess/hope, as I'd appreciate the price staying below $5 in case I would like some more.

One thing I can tell you is that 'somebody' at least is selling, I have not had to chase the Offer price, they've come down to my bid on the majority of trades, so not all sneaky bots and cross-trades. Though keep in mind cross trades have several uses.

It would be nice to know more of the Singapore side, but at least they are hiring, so something must be getting done.
Use in children has many 'scarier' unknown outcomes to deal with. I've noticed many discussions on the myriad of possible diseases this molecule might be useful for. In a child that potential range of effects is a risk to their development physically, as opposed to the lifestyle/mental health weighted benefits (which, lets face it, still come in second to their more measurable, tangible cousins). Is there financial reward to cover that risk? The EMA presumably thinks not, so they chose to nudge it along.

The cream would presumably have local effects, interesting to see whether a particular delivery method has been licensed at all, probably not that far along. Most are aware of the cons of a simple peptide, the cream might make use of the pros, a little less costly R&D wise.

My thoughts, probably more suited to a blog, as an investor/speculator/believer long CUV.
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TheG1000
Posted on: Mar 16 2016, 11:43 PM


Group: Member
Posts: 36

That order actually has the opposite effect, protecting the price from dropping too far. The indicative price could only go below the 2.50 if a sell order had more volume than that order and all those above it. So say the only other order was 10 shares buy at 3.00, I could place a sell order for 11 shares at 1.00, the attempt to lower the price to 1.00 would fail as I run into the brick wall at 2.50. So my ploy to convice you the sky is falling would require a solid 120,011 in volume.
If that order was on the sell side pre-open and dissappeared before open, you could presume it may supress the price.
(I apologise if my explanation is talking down, or I've misunderstood your question)
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TheG1000
Posted on: Sep 22 2015, 12:10 AM


Group: Member
Posts: 36

Just expanding on this information a little for anyone interested in these numbers. The current prices per year for these treatments (Enbrel, Humira, Stelara) comes in more around the AUD$22,000 per year mark, at least in Australia.

Also the pricing is a lot to do with the cost to quality of life ratio. These drugs were priced around the improvements to quality of life for those with rheumatoid arthritis, a progressive disease that until the advent of such medicines we could only hope to slow or delay. Drawing links between these treatments then onto psoriasis then onto afamelanotide, is not a good way to determine the pricing. As an opinion, rheumatoid arthritis has a far greater impact on quality of life as compared to EPP, as such afamelanotide would not achieve the same price on that single factor.

That said, being a first in class, the void in treatment options bodes very well for pricing. Just wanted to help with the info in regard to correlation between those drugs and our favourite afamelanotide. I'm not saying the projected pricing is wrong, just the use of these drugs as comparison.
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TheG1000
Posted on: Feb 26 2015, 09:04 PM


Group: Member
Posts: 36

Can someone with a little more accounting know-how than I, please confirm (for my interest) that there are some 1.1 million performance rights to be expensed as a share based payment in a future report. If so will these be expensed for the expected value of $2860365?

Is this value subject to change based on market movements or is it already accounted for in there somewhere, mixed in with other unlisted performance rights?
Just trying to determine my actual loss per share.

@ignoramus: I do believe I have some of those shares you off loaded at $4.20 (They hurt my average buy price so), care to swap back?
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TheG1000
Posted on: Oct 31 2014, 08:42 AM


Group: Member
Posts: 36

"If" Scenesse were covered by the PBS in Australia, the cost per script would be $6 for concession/benefits holders and $36.90 for general patients (These figures increase slightly each year). That is of course, only for those with the specific condition and meeting any other government restrictions (other drugs/ degree of severity).

If someone did not meet those requirements, but still filled the script, most would pay full price. As far as insurance in Australia goes they cover varying amounts, the best insurance is likely to cover anything above say $40 but only to a maximum payout usually in the order of less than $800 per year, more than half of the insurers are worse than that though.

My opinion is that PBS approval is not likely at the current costs, as the drug is cost-tested for improvement in quality of life, and I don't see it coming in high enough on the scale compared to other approvals. There is an orphan-disease style system, but approvals seem to have ground to a bit of a halt, though I haven't had a proper look in 6 months. The PBS approval process is likely to take 1-2 years, then if the costs come in higher than 20 million per year to the system, the minister will review the advice of the Pharmaceutical Benefits Advisory Committee (shouldn't happen with Scenesse).

Before that happens the drug will have to be listed on the Australian Register of Therapeutic Goods (after which a non-PBS prescription could be written and filled). FDA approval is an excellent lead in to approval in Australia, I see Scenesse having few issues getting listed by the TGA. PBS listing is the hard one.

(long on CUV)
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