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CUV, CLINUVEL PHARMACEUTICALS LIMITED
macgyver
post Posted: Today, 12:24 AM
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In Reply To: FarmaZutical's post @ Yesterday, 11:40 PM

Palatin existing in an inverse universe: get FDA approval, sp plummets. Shizenhousen.

 
FarmaZutical
post Posted: Yesterday, 11:40 PM
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PTN falling like a lead coated rock with an elephant sitting on it. Now below $1 / - 18 %y

 
PunkassDerm
post Posted: Yesterday, 11:13 PM
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In Reply To: CobiV13's post @ Yesterday, 10:53 PM

If you're talking about John Harris from UMASS? I think the nexus is this: His peer in the Dermatology Dept, Dori Golberg, is doing melanocyte transplants. Maybe external motivation. Seems odd his was hot on afamelanotide before, only to go to procedures and I believe more dangerous immunosuppressives (JAK).

Abbvie research is literally across the street from UMASS, and they are heavily into JAK research. Yes.

AND...Beechwood hotel / Sonoma restaurant is owned by a rheumatologist that has done countless RA studies, including for Humira (Abbvie). Dr Charles Birbara


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PunkassDerm
post Posted: Yesterday, 11:03 PM
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In Reply To: CobiV13's post @ Yesterday, 10:53 PM

I'm strongly guessing the dance is already on, probably already decided. Just pending on October 6. Let this SP rip please.


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CobiV13
post Posted: Yesterday, 10:53 PM
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In Reply To: PunkassDerm's post @ Jul 25 2018, 02:14 AM

PAD have you perhaps gained any further insight as to Harris distancing himself from Clinuvel? Do you still think he is being biased due to where his funding is coming from?

 
NewToCli
post Posted: Yesterday, 10:42 PM
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In Reply To: PunkassDerm's post @ Yesterday, 10:25 PM

It really would perfectly fit their portfolio. Still after the merger they will miss new blockbuster drugs... why the heck is Cuv so hardly ignored? Put 3bn usd on the table and add it to the take over list!!


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PunkassDerm
post Posted: Yesterday, 10:25 PM
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In Reply To: NewToCli's post @ Yesterday, 09:57 PM

Agree...remember how smooth last rollout was. So little news on new products despite plans to share. Can only mean acquisition. Allergan/Abbvie please!


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PunkassDerm
post Posted: Yesterday, 10:20 PM
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OM-freaking-G

This is a skin and inflammatory powerhouse in the works, they NEED TO ACQUIRE PTN AND CUV!!!
I have a boner sans medicine.


AbbVie to Acquire Allergan in Transformative Move for Both Companies


https://news.abbvie.com/news/press-releases...h-companies.htm


"This is a transformational transaction for both companies and achieves unique and complementary strategic objectives," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "The combination of AbbVie and Allergan increases our ability to continue to deliver on our mission to patients and shareholders. With our enhanced growth platform to fuel industry-leading growth, this strategy allows us to diversify AbbVie's business while sustaining our focus on innovative science and the advancement of our industry-leading pipeline well into the future."

"This acquisition creates compelling value for Allergan's stakeholders, including our customers, patients and shareholders. With 2019 annual combined revenue of approximately $48 billion, scale in more than 175 countries, an industry-leading R&D pipeline and robust cash flows, our combined company will have the opportunity to make even bigger contributions to global health than either can alone," said Brent Saunders, chairman and chief executive officer, Allergan. "Our fast-growing therapeutic areas, including our world class medical aesthetics, eye care, CNS and gastrointestinal businesses, will enhance AbbVie's strong growth platform and create substantial value for shareholders of both companies."

Strategic Rationale

New growth platforms and leadership positions to diversify and expand revenue base: The combined company will consist of several attractive franchises with leadership positions across immunology, hematologic oncology, medical aesthetics, neuroscience, women's health, eye care and virology. Allergan's product portfolio will be enhanced by AbbVie's commercial strength, expertise and international infrastructure.
Immediate scale and enhanced profitability for AbbVie's growth platform: AbbVie's enhanced growth platform, comprised of growing and durable franchises across highly-attractive therapeutic areas, is expected to grow at a high-single digit annual growth rate well into the next decade, from more than $30 billion in 2020.
Financially attractive with immediate EPS accretion: This transaction is expected to be 10% accretive to adjusted earnings per share over the first full year following the close of the transaction, with peak accretion of greater than 20%.1 ROIC is expected to exceed AbbVie's cost of capital within the first full year.
Significant cash flow generation: The success and scale of the combined commercial business ensures funding capacity and flexibility for simultaneous robust pipeline investment, debt reduction and capital return to shareholders. The combined companies generated $19 billion in operating cash flow in 2018.


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NewToCli
post Posted: Yesterday, 09:57 PM
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Breme is expected to be available to women by September this year. So it’s 2-3 months from approval to roll out.

Transfered to Cuv it would mean in spring 2020 Epp would be fully covered, every patient to be treated.. 500 patients more on the revenue side immediately. That’s my expectations... wondering how many years will pass until Cuv will accomplish this. (Centers, training, reimbursement fights...). 70 aud would be fantastic after Approval, but not with this operational speed and lack of clear communication, progress and pipeline. Where are the VP results by the way???



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royco
post Posted: Yesterday, 07:23 PM
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In Reply To: macgyver's post @ Yesterday, 06:14 PM

I think cuv's days in the shadows are over.
The current sp is already bringing us in a very respectable level for what is still a company with a very small quarterly revenue (see last two quarters in Northern wintertime) but important growthlevels.
Growth if forthcoming ans with fda approval I think we have ourselves around 75-100 million in annual sales guaranteed for the next 10 years on epp only.

With the ASX200 inclusion there will be a ton of new investors that are looking into and analysing this company for the first time.
FDA approval is what will mean substantial de-risking and is needed to help unlocking the immense potential of the drug platform and also trigger a number of important actions from the company with regard to the further development of the drug SCENESSE and the other related products including cosmetics.
My guestimate would be between 50-70 AUD in the following months until the end of the year.
Towards this time next year and with further expansion according to plans I hope for 70-100AUD.

Compared to previous percentual growth levels that is not spectacular but by that time we could be a 4 bln AUD marketcap company.
I still have some hopes for a substantial take over bid or clinuvel taking over another company or announcing an important joint venture for US distribution.
Just like what happened before the ultimate EMA green light I expect this to materialise just before the US approval.
Hard to believe that clinuvel would go all alone to develop and market the drug platform in the US market and rest of the world.
It makes sense to partner up and share the burden rather than to develop what nobody else is waiting for: a completely new US sales and marketing machine.
Possibly Blijdorp and B&S are instrumental for this scenario and ideally positioned at least for the more cosmetic part of the platform.

Being a clinuvel shareholder I am very familiar with delays. It is almost natural to expect delays with anything on the path of SCENESSE and CUV. Trials, regulatory decisions, cosmetic roll outs, product developments. The only time they got something earlier than expected was the 2010 Italian early access scheme. 9 years ago, anything else was stretched to the breaking point. Longest ema review ever, two extra phase II or III trials needed in the EU... waiting endlessly for the US phase II results, waiting years for the vitiligo phase IIb results...EMA opinion delays....months and years gone.
Now just the fda has added 3 months to the longest ever fast track orphan drug, expedited and rolling review. Forgetting the delays to market in the UK...
Clinuvel people just never give up and seem to outlast the regulatory roadblocks and virtual reality.
I wonder if the US EPP community will have to go and protest at the FDA offices this month with help of the EU bunch and similar to what they did when EMA just could not decide.
glta





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