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CUV - CLINUVEL PHARMACEUTICALS LIMITED


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I dont have the figures but from what i read , epp is diagnosed in most cases in adulthood .. With the unfortunate few children , so we can assume 99% of the epp patients ( quoted) are adults .

Note , sorry iggy i accidently thanked your negative post , fat fingers and iphone ....

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In module 1 they specify that they are talking about

only adult patients and that they expect between 450 and 900

in year 2030.

 

Tabelle 1-13: Jahrestherapiekosten fÃÆâ€â„¢ÃƒÆ’ƒâ€Â ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒ¢Ã¢â‚¬Å¾Ã‚¢ÃƒÆ’ƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¼r das zu bewertende Arzneimittel ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã¢â‚¬Å“ Patientengruppen mit therapeutisch bedeutsamem Zusatznutzen (Angabe je Anwendungsgebiet)

Anwendungsgebiet

Bezeichnung der Patientengruppe

Jahresthera piekosten pro Patient in Euro

 

Jahrestherapiekosten GKV insgesamt in Euro

 

Kodierunga

Kurzbezeichnung

A

EPP

Erwachsene Patienten mit EPP

ab

65.945,94

bis

87.959,75

450 Patienten: ab

29.675.673,00

bis

39.581.887,50

 

max 900 Patienten:

ab

59.351.346,00

bis

79.163.775,00

 

 

a: Angabe der im Dossier verwendeten Kodierung.

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German Health Authority - Assessment of Scenesse

 

Dossier evaluation G16-01 version 1.0 Afamelanotide - assessment according to ÃÆâ€â„¢ÃƒÆ’ƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚§ 35a para 1 sentence 10 SGB V. 05/10/2016 Institute for Quality and Efficiency in Health Care (IQWiG) - 4 - 3 cost of therapy 3.1 comment on the number of patients with therapeutically bedeutsamem Added value (module 3, section 3.2) The details of the pU to the number of patients with therapeutically bedeutsamem additional benefits located in Module 3 A (Section 3.2) of the dossier. 3.1.1 Description of the disease and characterize the target population The erythropoietic Protoporphyrie provides the pU is comprehensible and plausible. The Target population characterizes the pU correctly in accordance with the authorization of Afamelanotide as adult patients with erythropoietic Protoporphyrie [ 2] . 3.1.2 SHI patients in the target population The pU assumes based on extrapolations 5 Expert centers in Germany that a maximum of 900 patients with erythropoietic Protoporphyrie live in Germany. He estimates, that about 50% of these patients due to age, immobility and lack of confidence in a new treatment, are currently untreated. The pU continues to believe that all Patients are insured in the GKV. This gives a SHI target population 450-900 Patients.

 

The details of pU the duration of treatment are traceable and plausible and comply with the authorization of Afamelanotide [2 ]. Depending on the duration of protection required recommended 3 to a maximum of 4 implants per year.

 

4.4 cost of therapy for the statutory health insurance Table 2: annual treatment costs for SHI to be evaluated drugs per patient description of therapy description of patient group Jahrestherapie- cost per patient in ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’‚¡ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¬ a comment afamelanotide adult patients with erythropoietic Protoporphyrie 65 945.94 to 87 959.75 The details of the pU to the cost total traceable. A: Gives the pU GKV: statutory health insurance; pU: pharmaceutical company

 

 

Dossier evaluation G16-01 version 1.0 Afamelanotide - assessment according to ÃÆâ€â„¢ÃƒÆ’ƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚§ 35a para 1 sentence 10 SGB V. 05/10/2016 Institute for Quality and Efficiency in Health Care (IQWiG) - 6 - Protoporphyrie the order plausible. Since this information but also children and Includes young people, is not approved for that Afamelanotide, the target population is Total overestimated. Additional uncertainty is the adoption of pU that all Patients of the target population in SHI are insured. The annual treatment costs for Afamelanotide total traceable.

 

 

Looks like $22,000 EU per implant? Is this accurate?

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The question now is will Clinuvel release this news tonight? I can see this as a positive news release for Clinuvel to continue negotiations with other EU health agencies - no reason to hide the info. If the German's feel the price is justified, wouldn't you think other countries would feel the pressure to approve as well? I can't think of a reason Clinuvel would not want to release this news. Unless of course there is a reason to continue to hold the share price down.

 

Do we get news later today?

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I hear you Farma, but I still have to believe that PW is a smart man and understands how the stock market works. I still believe he knows where the company is at, and has a strategic plan to share this with the general public when the time is right. If this is a 3 - 5 year hold for PW, then I believe he does not care about the share price today, and will put the marketing machine in motion when the company, and share price, will benefit the most. No reason to tell the world we will be great soon, it will be more beneficial to tell the world WE ARE GREAT TODAY, and here is why!
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Personally, i think Clinuvel doesn't want to release news of one more country coming online...I believe they would like to have 3 more members of the EU consortium announce marketing commencement together. I believe many investors were falsely under the assumption that once CUV gets approval to market Scenesse in the EU, than all member countries would qualify. That won't happen. The current trickle in approach will strongly influence the perception and reality of revenues coming in for the near term and over the coming 12-18 months. I think this company will be fortunate if it can get 1000 patients being treated with scenesse at whatever the final fixed point price may be in the coming year. Even at max, this could be a $10 million annual rev stream...leaving the company at current prices with a p/s of 14 and p/e range a total ????. This is more a process of turtlelike accretion versus ripping a band-aid off of a wound. Speculation abounds...information is absent.
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