Just to translate the (as usual) misleading PR the company gave. The PDUFA was almost certainly extended because additional materials were submitted during the review and FDA labeled them as a major amendment.
Don't think one can read too much into it beyond that as to a positive or negative outcome for the final decision.
Yes, good times. Not that I’m really surprised. But nice to see that we’re getting up there
Not really. A good friend of mine who is real sharp at TA did a model where we’d be at $14 in 2021 before going to +$30.
When you know all the catalysts that about to catapult this stock higher, such a TA model seems absurd.
What drives this stock is future earnings and they are massive.
You a Technical Analysis supporter? Resistance at $20 becomes support. Lets see if we can hold it. Jest
Almost at a $1B Market Cap. That is amazing!
+/-50 million O/S
Fantastic!!! Saw that earlier and wondered if you would post on the matter! Thanks Farma!
PDUFA date secured with priority review: July 8th. 2019.
This is a significant milestone and the fact that the FDA doesn't plan to hold an ADCOM meeting is both surprising and reassuring.
For new investors:
Clinuvel's lead compound, Scenesse, is already approved in Europe by the EMA. It's marketed in numerous EU countries and in high demand by patients. Great Britain (NICE) is reluctant to pay the price but everyone with knowledge about GB knows that the system is broken and that tary are trying to curb expences in any way possible. Clinuvel won an appeal, though, and I assume NICE will cave in March at the final meeting.
New indications are also underway. Vitiligo is headed to Phase 3, a POC in VP is underway in Europe and a 3rd indication will be announced soon.
The Company is also develloping new products. A cosmetic line that will probably be launched soon. It was due last year. And several lotions that are being develloped in Clinuvel's Singaporean lab, Vallaurix.
Moreover, a move to Nasdaq is planned in 2019.
This is a remarkable Company with no debt, loads of cash on hand, strong Growth, big institutional backing and loyal top 20 owners. A brilliant CEO with a vested interest. And soon: FDA approval wich will only be a foot in the door and the beginning of the real growth adventure.
I see that Xeljanz (arthritis treatment) combined with UVB is having solid results as well for those suffering with Vitiligo. Wonder how the combination of the two would work.
Some prelim Xeljanz research suggests some potential side effects from use.
Choosing VP as the new orphan indication is a brilliant move. I was expecting XP, but this makes much more sense from a business perspective.
First, they will use the established framework of the EPP centers in Europe to conduct the trial(s). Likely, they will do the same in the US for the pivotal
phase 2/3 or 3 that will follow the initial 2a. This is less costly and scientifically easier than stating all over in XP where they have
no network yet. If they follow the same strategy, they will probably initiate XP trials in Japan once Scenesse
is approved for EPP there in a year to two.
Also prevalence is much higher for VP than in XP. VP = 1:100.000 (much higher in South Africa) and XP 1:1.000.000.
That gives us at least app. 6000 patients in Europe and 3000 in the US. 15.000 in South Africa.
They will dose VP patients every 28 days mirroring the dosing cycle in treating Vitiligo. It seems they plan to use
the data collected during the upcoming VP trials to also support the future NDA for Vitiligo. Smart move using synergies.
Even if they cut the price per implant down to $6000 that’s a very significant business case. We don’t know how many implants
they plan to administer yearly to VP patients but let’s assume 6 to be conservative.
Uptake will probably be fairly high since there is no alternative, so let’s assume we can treat 4000 patients in Europe and 2000 in the US
which is probably still conservative.
6000 patients paying 6000 USD 6 times a year = 216 m. USD. In my book that represents <60 USD pps. Add South Africa and that number
explodes but I will leave that out for now. Also, they may not lower the price per implant at all and then my numbers double (!).
Add EPP at the new lower price per implant administered 6 times a year (which is probably coming up) to 3000 patients coming up
and that’s 108 m. USD = < 30 USD. Add Australia and Japan and the number is even higher.
VP and EPP combined represents a future share price of 100 USD at the very least. 150 - 200 USD if they don’t lower the implant price.
The FDA and EMA are very likely to approve an sNDA and I expect the best possible scenario is a PDUFA for VP sometime in 2021 but
already now it should represent a risk weighted value of somewhere between 10-30 %. If they show good results in the phase 2a
which I expect they will the value will be higher also given the fact that the likelyhood of regulatory approval is extremely high for
a second indication.
At the current price per implant stand by my previous calculations and think that EPP is worth at least
50 USD in Europe and the US combined short to medium term. That number will go down if they lower the price per implant, of course.
I’d say that neither Vitiligo nor any of the other opportunities are reflected in today’s pps. Enfance, topicals etc. Right now, the pps
merely reflects the opportunity for EPP in Europe and we’re still on the very low side. VP ought to add a few Bucks today and 5-10 USD when the market realizes that it’s
a less risky endeavor than gaining regulatory approval for a new drug.
There’s still a lot of work to be done and it will be interesting to follow the work with VP and hopefully soon also Vitiligo.
My 12-18 months target is 50 USD. By then, we are either approved in the US or very close to be approved. VP trials
have hopefully been successful in Europe, the cosmetic line is underway, Vitiligo is revived, regulatory approval in Australia and
Japan is underway and Enfance for treating the pediatric population is hopefully also moving along.
I look forward to the day you’ll benefit from Scenesse and be able to enjoy the sun.
Just outstanding!! It is truly exciting to have the patience and persistence enough to see this move the way I (we) always knew it would. I admit freely that the vitiligo aspect is above and beyond my expectations from back in the mid 90s...
Still, I need the prophylactic benefits to protect me from painful burns that even the strongest lotions (SPF50+) cannot help with. The dread that goes along with trying to enjoy an outdoor existence could be minimized with this product. It IS the sole reason I discovered it. Looking for help. Epitan.
I appreciate that we cannot approve off-label use. Safety first.
Happy with Progress!
Fair value for EPP Europe is $20-25. <$50 when the US is added.
XP is at least as valuable as EPP and when added as the next indication it will have to be reflected in the share price.
Vitiligo is a potential blockbuster and even with a low, risk weighted value is should represent $10 when it’s taken to phase 3.
The new cosmetic line will also represent a value and then there is Enfance and the new products that albeit at an early stage still represent a value. Especially because it’s increasingly clear that management actually delivers.
$100 is not unrealistic within 2-5 years.
Absolutely!!! Talk about your green day. Wow!
There are controls in place to absolutely prevent off-label use.... at least for now. I am betting that these controls will ease after (if) vitiligo use is approved.
I thought Martina Adams on TV show "Botched" this weekend may have been the cause of today's jump!
On the show they mentioned her using "Melanotan" but then corrected to say it was a related drug she had injected to turn so dark...
She could be a BIG promoter of the off-label use...
Yes, very nice. Seems like folks are beginning to notice us.
Now that is impressive!! Jest
Nice move. Spotlight on us.
Welcome to the CLVLY board. You’ve probably heard about the company or the product and found your way to this board to get more information.
The best way to start is by reading this independent analyst report by Sphene Capital:
CLVLY and CLVLF are ADRs of the Australian listed stock, CUV. The stock is also traded on the German stock exchange; in Frankfurt under UR9.
The company already has a Nasdaq International Designation but plans to list “on a foreign exchange” before July, 2019 according to the latest PR. The best would be a Nasdaq listing and a relocation of the company’s headquarter to the US. Currently, it’s located in Melbourne, Australia with its main operations in Switzerland and London, GB.
The stock is extremely tightly held by institutional investors and long time believers who have been here for more than 10 years.
Happy reading and don’t hesitate to ask questions.
I’m pretty sure that other one will make a come back. In the mean time I’m very happy about the steady progress CLVLY is making.
There are so many catalysts coming up and FDA approval could easily double the sp.
Validation of the NDA next week and possible priority review.
Inclusion in the ASX300 index coming up.
Launch of cosmetic line probably before EOY.
NDA approval sometime in 2019.
Nasdaq listing before Q3 2019
Start Vitiligo ph3 2019
And much more.
Fingers crossed for more steady progress.
you are the man!
I got kicked off of IPIX board couldn’t take it (them) bashers any longer
I bought another 400 shares yesterday of your Australian drug and I’m pissed because I could’ve bought 800
last night was fun watching this stock
that you recommended to me
We all get a dividend. Also the ADRs.
Do CLVLY or CLVLF ADR's get dividends?
The dividend is specified as per CUV share. As I understand it CLVLY shares are non-voting shares while CLVLF shares can vote. Is there any other difference - such as getting dividends or not? Is one CLVLY share equal to one CUV share?
Not that $.02 AUD will make a huge difference, but just wondering. I suppose I should know this, but I bought this ADR way back in 2006 and never looked into these details.
Approaching fair price based on current sales in Europe. FDA approval will more than double the current potential and, hence, a doubling of the sp is warranted. FDA approval = $15-20. Fully rolled out in the EU and the USA $40+.
Then comes cosmetics, new indications and acquisitions of new products / companies.
Non-executive director acquires 1,3 mio. shares at a price of AUD $10 through a deal with institutional investor Lagoda. Very bullish.
I think it’s more and more likely that Willem Blijdorp and his company B&S International will be
instrumental in distributing Clinuvel’s new cosmetic line and that it will
probably be through tax free retailers in airports; mainly or partly in the Asia Pacific.
Cosmetic giants like Estée Lauder, L’Oréal, Unilever & Procter and Gamble are all very focused
on travel retail, according to this article: http://sc.mp/fJ7SDs
The market is huge and travel retail is exactly what B&S International are experts in.
The article mentions the TFWA international summit in Cannes and how the Tax Free Works Association gathers the
Global travel retail industry in France for this 5 days summit. I’d never heard about TFWA but
apparently Clinuvel attended the 2018 TFWA Asia Pacific conference in Singapore in May: http://clinuvel.com/2007-announcements/ite...gory/776-events
Scenesse isn’t exactly a product for the travel retail market so when Clinuvel attends this
conference it has to be with a different product and scope in mind. Chivere and t’Sumoyle seem
like products that could be a shoe in for this market.
About the billionaire Mr. Blijdorp:
"Mr Blijdorp is the founding member, majority shareholder and a current supervisory Director of B&S International NV, a privately owned Dutch group focused on the wholesale and international trading of luxury and fast moving consumer goods and pharmaceutical products. He managed B&S International for 27 years as CEO and remains actively involved in the company’s expansion strategy, helping it to become one of the largest trading houses globally with a compounded annual growth rate of 10% for the past decade. Being recognised for his expertise in merger and acquisitions and leadership, in 2014 Mr Blijdorp was awarded the Ernst & Young Entrepreneur of the Year in the Netherlands."
Good news overall. ;)
In Reply to 'FarmaZutical'
Very odd that they chose to do trading halt just because of the NDA submission. But very positive that the ball is now rolling in the US. I hope for a March PDUFA. $20 by Q1 19.
Is this about when it was expected for the US FDA filing?
Unfortunately I'm not sure this will be such a big deal. Here in the US we have a very anti-business administration. I'd expect the gov't to insist on much lower prices than Clinuvel thinks they will get. The current political environment coming from the White House is that no company should make a profit. Especially drug companies or companies that are owned or manufacture outside the US.
Will they be making Scenesse in the US and retaining profits here? That would help.
It’s very strange. Perhaps it’s considered material that they meet a deadline for the first time ever.
It is up a bit today. I'm not finding any news here except a request for a trading halt. It does not seem to be halted here in the US yet. Up $1.91 (24%) so far.
Pursuant to Listing Rule 17.1, Clinuvel Pharmaceuticals Ltd (CUV) requests an immediate trading halt with respect to its ordinary shares listed on the ASX. The trading halt is necessary as CUV proposes to make an announcement to the market regarding a regulatory submission for its drug SCENESSE®.
CUV requests that trading in its securities be halted until after the expected announcement is made or until the commencement of trade on Tuesday 26th June 2018, whichever is the earlier.
CUV is not aware of any reason why the trading halt should not be granted by the ASX nor is it aware of any other information that is necessary to inform the market about the trading halt.
Agreed. I am here as a loyal investor for the long haul. I discovered "Epitan" after an exceptional sun poisoning event over a decade ago. Fair skinned, I still need the prophylactic benefits... will never come. I still see the tremendous benefits to EPP patients... who I sympathize with after my battles with the sun.
Good luck to us!
Per diligentiam sinceritatemque progredimur et populum servimus,’
Luckily, they translated it to English most places:
‘Through diligence and integrity we advance and serve the people.’
Yes, the stock has done good and pretty much as I was hoping for. If they file the last module of the NDA within a few months we should see the next leg up.
Approval is more than likely in the USA and that more than doubles the potential.
Add the cosmetic line that we still know nothing about and the renewed focus on Vitiligo and there is a huge potential. I expect $20 USD within the next 12-18 months.
Where on the site are you seeing Latin? I haven't run across it.
Overall, the stock has done very well over the past year. Wish I'd held onto my position.
In Reply to 'FarmaZutical'
The new logo is absolutely horrible. And the website is overloaded and difficult to navigate. Not to mention the Latin crap.
But the product is still the same and it’s a winner.
It seems, Vitiligo is still in their radar. They post a lot about it on FB and Instagram.
Down the road we might see Scenesse being trial for a range of CNS disorders. In a recent patent filing they mention Multiple Sclerosis, Alzheimer's Disease and other dementias, Parkinson's Disease, Amyotrophic Lateral Sclerosis (ALS) and which is also called Lou Gehrig's Disease, Huntington's Disease, Degenerative Nerve Diseases, Encephalitis, Epilepsy, Genetic Brain Disorders, Head and Brain Malformations, Hydrocephalus, Stroke, and Prion Diseases.
Here and now focus is on the NDA for EPP and then probably Vitiligo.
EPP alone warrants a much higher pps.