Clinuvel

[stmccallum]

Not to pile on, but another member drew my attention to a post on another investment forum.

On September 5th, 2023, Clinuvel announced that they were conducting a PK trial on 12 patients in order to receive a label extension from the EMA for adolescent EPP patients.

View attachment 5218
Clinuvel very conspicuously uses the term "Upon scientific review", leading the reader to believe that the EMA has only recently reached this conclusion, and has just informed Clinuvel of their decision.

I recently criticized Clinuvel for not seeing this coming, and my opinion was that they should have known this a year earlier and should have already completed the trial (CUV 052)

I was wrong.

Clinuvel was actually informed of and agreed to the need for this trial 9 YEARS AGO, and in fact, it was a condition of EMA approval.

View attachment 5219

Original here.

If that's not enough, the EMA again requested the study in January 2018, and Clinuvel deferred it.
View attachment 5220

Original here.

So, in summary, in spite of it being a condition of approval 9 years ago, and receiving subsequent reminders from the EMA that it needed to be done, Clinuvel went ahead and applied for an adolescent extension without having conducted the trial. Unsurprisingly, the EMA said no. I suspect that the EMA said no at the outset of the application, but for whatever reason, Clinuvel waited a year to inform investors of their lack of progress.

This level of arrogance, incompetence, and deceit is just stunning.

Vote accordingly.

The FDA and EMA make pediatric studies PK and sometimes efficacy studies requirements of approval to ensure that sponsors are held to their commitments
PIPs pediatric investigational plans are agreed to at time of approval
This is pharma 101 not something that can be ignored

 

[stmccallum]

The FDA and EMA make pediatric studies PK and sometimes efficacy studies requirements of approval to ensure that sponsors are held to their commitments
PIPs pediatric investigational plans are agreed to at time of approval
This is pharma 101 not something that can be ignored

Or in this case their pharamacovigilance plan
Wow oh wow

 

[mrdax]

Not to pile on, but another member drew my attention to a post on another investment forum.

On September 5th, 2023, Clinuvel announced that they were conducting a PK trial on 12 patients in order to receive a label extension from the EMA for adolescent EPP patients.

View attachment 5218
Clinuvel very conspicuously uses the term "Upon scientific review", leading the reader to believe that the EMA has only recently reached this conclusion, and has just informed Clinuvel of their decision.

I recently criticized Clinuvel for not seeing this coming, and my opinion was that they should have known this a year earlier and should have already completed the trial (CUV 052)

I was wrong.

Clinuvel was actually informed of and agreed to the need for this trial 9 YEARS AGO, and in fact, it was a condition of EMA approval.

View attachment 5219

Original here.

If that's not enough, the EMA again requested the study in January 2018, and Clinuvel deferred it.
View attachment 5220

Original here.

So, in summary, in spite of it being a condition of approval 9 years ago, and receiving subsequent reminders from the EMA that it needed to be done, Clinuvel went ahead and applied for an adolescent extension without having conducted the trial. Unsurprisingly, the EMA said no. I suspect that the EMA said no at the outset of the application, but for whatever reason, Clinuvel waited a year to inform investors of their lack of progress.

This level of arrogance, incompetence, and deceit is just stunning.

Vote accordingly.

I just vomited all over the place.

That basically means:
if they can't even get the most simple thing done in or after 9 years, what should be expected for the rest of the game plan?

 

[Merchant of Venice]

I just vomited all over the place.
That basically means:
if they can't even get the most simple thing done in or after 9 years, what should be expected for the rest of the game plan?

(As long as you are on moderator status, I can't put your posts on ignore. It's pretty stressful for me because I can't stand your constant whining).

If you don't have confidence you have to sell I've been telling you for a really long time now - your embarrassing vote at the AGM won't change anything like every year so go with it or get out.
Just grow up.

 

[FarmaZutical]

(As long as you are on moderator status, I can't put your posts on ignore. It's pretty stressful for me because I can't stand your constant whining).

If you don't have confidence you have to sell I've been telling you for a really long time now - your embarrassing vote at the AGM won't change anything like every year so go with it or get out.
Just grow up.

Honest question: Do you just love everything about your investment in Clinuvel or are there tiny fractions of the way they conduct business that you find a tad off?

 

[CUV88]

(As long as you are on moderator status, I can't put your posts on ignore. It's pretty stressful for me because I can't stand your constant whining).

If you don't have confidence you have to sell I've been telling you for a really long time now - your embarrassing vote at the AGM won't change anything like every year so go with it or get out.
Just grow up.

Your vote is a fart in the wind

 

[Effector]

(As long as you are on moderator status, I can't put your posts on ignore. It's pretty stressful for me because I can't stand your constant whining).

If you don't have confidence you have to sell I've been telling you for a really long time now - your embarrassing vote at the AGM won't change anything like every year so go with it or get out.
Just grow up.

All right, let's stick to the facts then. True or not true?

So, in summary, in spite of it being a condition of approval 9 years ago, and receiving subsequent reminders from the EMA that it needed to be done, Clinuvel went ahead and applied for an adolescent extension without having conducted the trial. Unsurprisingly, the EMA said no. I suspect that the EMA said no at the outset of the application, but for whatever reason, Clinuvel waited a year to inform investors of their lack of progress.

 

[Merchant of Venice]

Honest question: Do you just love everything about your investment in Clinuvel or are there tiny fractions of the way they conduct business that you find a tad off?

I am an investor.
I do not make my decisions based on wild speculations or accusations which are not verifiable and not provable.
I see increasing sales, stable balance sheet, increasing dividend, strong margin, low valuation and currently no acute competitors at EPP.
The plan for further diversification and growth are clearly communicated. If they deliver only 10% of this in the next 2 years I will go with high profits.
After that, I will recoil and I always think in terms of risk-reward ratio and do not give in to irrational bullshit! Here it is only about believe and hope. The wildest speculations and manipulation before the Annual General Meeting. I'm not going along with that.

 

[Effector]

I am an investor.
I do not make my decisions based on wild speculations or accusations which are not verifiable and not provable.
I see increasing sales, stable balance sheet, increasing dividend, strong margin, low valuation and currently no acute competitors at EPP.
The plan for further diversification and growth are clearly communicated. If they deliver only 10% of this in the next 2 years I will go with high profits.
After that, I will recoil and I always think in terms of risk-reward ratio and do not give in to irrational bullshit! Here it is only about believe and hope. The wildest speculations and manipulation before the Annual General Meeting. I'm not going along with that.

So, all wild speculation or true? A simple yes or no will do. If true, a bunch of incompetent amateurs are running the show. Grow up or better hire qualified staff.
The only thing I want that this company is managed by professionals and not trainees.

So, in summary, in spite of it being a condition of approval 9 years ago, and receiving subsequent reminders from the EMA that it needed to be done, Clinuvel went ahead and applied for an adolescent extension without having conducted the trial. Unsurprisingly, the EMA said no. I suspect that the EMA said no at the outset of the application, but for whatever reason, Clinuvel waited a year to inform investors of their lack of progress.

 

[fozz]

Not to pile on, but another member drew my attention to a post on another investment forum.

On September 5th, 2023, Clinuvel announced that they were conducting a PK trial on 12 patients in order to receive a label extension from the EMA for adolescent EPP patients.

View attachment 5218
Clinuvel very conspicuously uses the term "Upon scientific review", leading the reader to believe that the EMA has only recently reached this conclusion, and has just informed Clinuvel of their decision.

I recently criticized Clinuvel for not seeing this coming, and my opinion was that they should have known this a year earlier and should have already completed the trial (CUV 052)

I was wrong.

Clinuvel was actually informed of and agreed to the need for this trial 9 YEARS AGO, and in fact, it was a condition of EMA approval.

View attachment 5219

Original here.

If that's not enough, the EMA again requested the study in January 2018, and Clinuvel deferred it.
View attachment 5220

Original here.

So, in summary, in spite of it being a condition of approval 9 years ago, and receiving subsequent reminders from the EMA that it needed to be done, Clinuvel went ahead and applied for an adolescent extension without having conducted the trial. Unsurprisingly, the EMA said no. I suspect that the EMA said no at the outset of the application, but for whatever reason, Clinuvel waited a year to inform investors of their lack of progress.

This level of arrogance, incompetence, and deceit is just stunning.

Vote accordingly.

"So, in summary, in spite of it being a condition of approval 9 years ago, and receiving subsequent reminders from the EMA that it needed to be done, Clinuvel went ahead and applied for an adolescent extension without having conducted the trial. Unsurprisingly, the EMA said no. I suspect that the EMA said no at the outset of the application, but for whatever reason, Clinuvel waited a year to inform investors of their lack of progress.

This level of arrogance, incompetence, and deceit is just stunning"

IF the above information is all true then the company needs to respond, children are the victims in this they could be under systematic treatment already not ad hoc... epp is really shit and painful disease and children should be #1 priority with lots of $$ and resources directed to them so what is the plan for children in US, Israel and Australia???

 

[macgyver]

Great analysis and a lot unpacked from the newsletter.
I don’t follow as closely as I used to as I took the chairman’s advice and sold out 80% of my holdings over the past couple of years.

The reasons were pretty simple - zero progress with CUV9900 and OTC’s etc after 5-10 years of promises, and an inability to execute the go-it-alone strategy.

Sure, they have $85m of EPP sales now, but it’s been how long since approval? Market penetration is dismal, but CEO and CFO keep crowing each year about exceeding expectations! How low can you set the bar!

Maybe they should have a look at the NEU strategy when benchmarking. Drug approved in April and sales running at $45m per qtr within 3-4 months.

Sure, they only get a royalty %, but they also get decent upfront payments, not waiting 7 years then worrying about patent expiry and competition.

https://announcements.asx.com.au/asxpdf/20230727/pdf/05s0ssrw25d2l8.pdf

I think one of the fundamental differences between Clinuvel and Neuren (Acadia as the partner in the US) is Clinuvel not having a dedicated sales force or no strategy to raise awareness of Scenesse amongst the EPP community. Acadia is doing a lot of work in the Retts syndrome community to raise awareness, something I've always thought was lacking in Clinuvel's approach.

Analysts predict only 4% of the EPP market has been captured. Clinuvel has relied on the goodwill of patient groups such as the APF to spread the word, but I’ve never seen any kind of outreach program or an elevated level of sponsoring related events to raise awareness (one or two perhaps but never a continual presence in related spheres).

Perhaps given the rarity of the disease and the lower end pricing for Scenesse when compared with other orphan drugs Clinuvel has been content to let EPP sales grow organically through word of mouth via the APF rather than get a low ROI on spending for awareness campaigns. But I've always found it curious that Clinuvel seems aloof towards this community, it's their bread and butter but they don't engage with them like other pharmaceutical companies do with their respective patients.

I guess if vitiligo is successful then Clinuvel might see a need to institute a sales force or raise awareness of the drug. Clinuvel is not Tesla, I don't think having 100+ specialty centres alone will achieve a high level of market penetration because their strategy hasn't been that effective to date if only 4% of the EPP market has been captured. There needs to be some push from the company.

 

[macgyver]

"Meanwhile, behind the facade of this innocent looking bookstore.."

Wolgen stumps up $29,813.86 to buy Clinuvel shares. He doesnt have a lot of cash lying around this dude