Word abonnee en neem Beursduivel Premium
Rode planeet als pijlen grid met hoorntjes Beursduivel
Uitgebreid zoeken

BioPharma Terug naar discussie overzicht

Clinuvel, de droom van elke belegger......

2.596 Posts
Pagina: «« 1 ... 120 121 122 123 124 ... 130 »» | Laatste | Omlaag ↓
  1. Omnius 14 juli 2016 14:02

    • Omnius

      Lid sinds: 01 jan 2000

      Laatste bezoek: 04 mei 2024

    • Aanbevelingen

      Ontvangen: 116

      Gegeven: 320

    •    Aantal posts: 1.656

    Ja begint te lopen, bijna door de meerjarige top, daarna is er geen weerstand meer. verwacht ook wel dat we dit jaar nog een stuk omhoog kunnen naar de 8 - 10 AUD, puur op EPP.

    Het is inmiddels een onverantwoordelijk groot gedeelte van mijn porto (bijna 50%), maar ik zie weinig alternatieven met zoveel ruimte omhoog en met weinig risico omlaag. dus dan hou ik ze maar gewoon vast.

    Ik ga wel stukje voor stukje positie verkleinen vanaf 6 USD of zo (ik heb CLVLY), maar dit is omdat ik nu een gedeelte van mijn VBR gebruikt heb en dit wil ik niet voor de lange termijn gebruiken.

    Ik zit er nu ongeveer 8 jaar in.
  2. [verwijderd] 14 juli 2016 14:10

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    Ik blijf er in totdat Vitiligo erin kicked. Ik heb een paar vrienden/kennissen die ik op melanotan (Scenesse) heb gewezen en die zijn lyrisch erover. Eentje is een surinamer waar het echt heel erg was en daar zie je gewoon dat het bijtrekt.

    Enige nadeel is dat hij onder de zon uit moet blijven anders wordt het een Antilliaan haha.
  4. Omnius 18 juli 2016 11:23

    • Omnius

      Lid sinds: 01 jan 2000

      Laatste bezoek: 04 mei 2024

    • Aanbevelingen

      Ontvangen: 116

      Gegeven: 320

    •    Aantal posts: 1.656

    www.clinuvel.com/en/investors/news-pu...

    Monday, 18 July 2016 13:07 FDA accepts SCENESSE® clinical data package for NDA submission
    Clinuvel's LogoClinuvel prepares New Drug Application (NDA) for the treatment of erythropoietic protoporphyria (EPP)
    Executive summary:

    FDA concludes initial review of datasets on SCENESSE® in EPP
    FDA deems datasets satisfactory for submission of New Drug Application
    Pre-NDA meeting with FDA to be scheduled to discuss timelines and procedure
    Clinuvel will request rolling review of NDA under Fast Track designation
    Clinuvel to request Priority Review to shorten review from 10 to 6 months
    Clinuvel Pharmaceuticals [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced that the US Food and Drug Administration (FDA) has concluded an initial review of Clinuvel’s clinical data package for its drug SCENESSE® (afamelanotide 16mg) in patients with the orphan (rare) genetic disorder erythropoietic protoporphyria (EPP). The FDA has deemed Clinuvel’s clinical data package satisfactory for submitting a New Drug Application (NDA).

    FDA SUBMISSION PROCESS

    In January 2016 the FDA requested that Clinuvel submit clinical datasets generated from trials of SCENESSE® in EPP conducted between 2006 and 2013. The need to understand the severity of EPP symptoms and clinical effectiveness of SCENESSE® were the basis of FDA’s request.

    After a four month review the FDA concluded that the data generated is both satisfactory and sufficient for Clinuvel to submit its NDA dossier. In accordance with 21 CFR Section 314.5 the dossier comprises seven technical sections (chemistry, manufacturing and controls, nonclinical pharmacology and toxicology, human pharmacokinetics and bioavailability, clinical data, statistics) and other pertinent information, including labelling, patents and company financials.1 A pre-NDA meeting will now be organised between the FDA and Clinuvel.

    Clinuvel will request a rolling review of its NDA dossier under its designation of Fast Track to SCENESSE®, announced to the Australian Securities Exchange (ASX) on July 6, 2016. Clinuvel will request a Priority Review from the FDA to shorten the dossier review time from 10 months to 6 months. Data from 352 patients who participated in five trials in EPP between 2006 and 2013, as well as data from over 200 patients who received the drug during compassionate use and special access programs, will be submitted. Additional data from other patient populations who have been exposed to SCENESSE® will be part of the scientific dossier.

    The FDA has initiated an EPP workshop on October 24 to learn more about the disease and the effectiveness and safety of the proposed treatment.

    SCENESSE® was granted orphan drug designation by the FDA in 2008. As a result, the FDA will waive all PDUFA user fees usually required during the submission process.

    COMMENTARY

    “Since 2008 Clinuvel has regularly consulted with the FDA throughout Phase I, II and III of its clinical program, and we have since submitted annual reports to update the Agency on our progress,” Clinuvel’s Director of Regulatory Affairs, Nicoletta Muner said. “Today’s FDA outcome is a direct result of a decade of our team’s consistency, dedication and transparency in negotiating the best pathway with the Agency.

    “I am very much looking forward to achieving the milestone of presenting the FDA with a quality dossier. Our submission will serve for years to come as a basis for further development and new indications with SCENESSE®,” Dr Muner said.

    “The FDA Division seems to justly balance scientific data and patients’ experiences with SCENESSE®,” Clinuvel’s Chair, Stan McLiesh said. “The NDA filing will be the next significant step towards making SCENESSE® available in North America, where patients have been vocal in requesting the drug for some time.

    “After a complex and difficult journey spanning more than a decade I am proud and delighted that Clinuvel’s teams continue to meet longstanding company objectives in the development of SCENESSE®. I thank our active investors for the confidence they place in Clinuvel. Most importantly, the patients are to be commended for their participation in the US trials.”

    PUBLICATIONS OF SCENESSE® IN EPP

    A first-in-class drug, SCENESSE® activates the pigment melanin in skin, providing a barrier which protects skin cells from light (photoprotection). The drug also acts as an anti-oxidant. SCENESSE® is delivered via a subcutaneous dissolving implant approximately the size of a grain of rice. Increased pigmentation of the skin appears after two days and lasts up to two months.

    Results from three clinical trials of SCENESSE® in EPP have been peer-review published. Results from the Phase II CUV010 study were published in both the New England Journal of Medicine and Photochemisty and Photobiology in 2009. Results from the Phase III studies CUV029 (Europe) and CUV039 (USA) were published in the New England Journal of Medicine in 2015.2

    Data from ongoing use of the drug – up to eight years in some patients – from compassionate use and expanded access programs were published in the British Journal of Dermatology in 2015.3

    EUROPEAN DISTRIBUTION OF SCENESSE®

    SCENESSE® was approved by the European Medicines Agency in 2014 under EC2004/726 article 14(8) and is now commercially available for the prevention of phototoxicity in adult EPP patients.4 The drug has a positive safety profile which continues to be monitored through a strict European post-authorisation pharmacovigilance program comprising an EPP Disease Registry.

    - End –
  5. Omnius 18 juli 2016 11:24

    • Omnius

      Lid sinds: 01 jan 2000

      Laatste bezoek: 04 mei 2024

    • Aanbevelingen

      Ontvangen: 116

      Gegeven: 320

    •    Aantal posts: 1.656

    lauwe reactie van CUV, maar toch nog net boven de 5 AUD gesloten, dus dat is wel positief.
  6. uptech 18 juli 2016 18:01

    • uptech

      Lid sinds: 04 okt 2004

      Laatste bezoek: 19 jul 2022

    • Aanbevelingen

      Ontvangen: 9

      Gegeven: 3

    •    Aantal posts: 503

    Tijd voor TA? Grapje. En nee ik ben niet ajshare van sharescene. Hihi. Wel weer goed nieuws hoor.
  7. [verwijderd] 19 juli 2016 09:22

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    Wat goed om na al die jaren wachten en vertrouwen houden deze doorbraak mee te maken. Zit er ook al ruim 10 jaar in. Een koersdoel van 8 a 10 dollar eind 2016 zou fantastisch zijn. Ik vind eerlijk gezegd dat we ook wel recht hebben op een split tegen die tijd. We hebben immers ook een reverse split gehad jaren geleden van 100% naar 10%. Wat denken jullie zit dat erin?
  9. frank2you 21 juli 2016 08:10

    • frank2you

      Lid sinds: 12 dec 2003

      Laatste bezoek: 26 apr 2024

    • Aanbevelingen

      Ontvangen: 128

      Gegeven: 58

    •    Aantal posts: 1.209

    Lees onderstaand verhaal van Uhohinc (google forum).

    Ik ben het volledig met hem eens, in eerste instantie lijkt het een misser van Clinuvel maar PW gaat niet door de knieen voor deze italiaanse maffia die zich er niet voor schaamt om nu te beweren dat Scenesse slechts kleine verschillen met het placebo laat zien. Ze deinzen er niet niet voor terug om leugens te verspreiden als deze kleuters van Europa hun zin niet krijgen.

    Gelukkig weten de italiaanse EPP patienten beter, weten andere landen nu wat hun te wachten staat en zal de BRD op 4 augustus NL volgen....als ze de noodkreten van alle EPP patienten in hun land serieus nemen.

    Uhohinc
    06:30 (1 uur geleden)
    Re: Italy to discontinue Scenesse due to high price
    Bericht vertalen in het Nederlands
    The Italians are just being petty and childish in my opinion. They probably feel disrespected by holding a meeting to which they would have used it to bully Clinuvel and accuse the company of greed. And they had Italian EPP patients there to ambush Clinuvel with emotional pleas. Maybe it was seen as arrogance by the Italians or Mauro by not showing, but I think Clinuvel out negotiated the guys whom make a living negotiating everyday with drug companys. But these Italians are supposed to be experienced and experts in pricing of drugs and negotiating. Clinuvel disarmed them and may have inadvertently bruised their feelings, and their reaction has imploded on them. I think it will play out favorable to Clinuvel and the Italian EPP patients maybe even before December. Or maybe Mauro is just trying to use this to justify a bigger budget.
    Clinuvel raised more capital, and Clinuvel can go on without a few countrys not reimbursing. And most importantly, in meeting any other Price and Reimbursement Committee anywhere, Clinuvel has advantage by showing it will walk and not be negotiated unfairly nor is Clinuvel bluffing. Clinuvel is now in the optimal negotiating position. The best negotiating position is where the one party as in Clinuvel does really not need to negotiate a deal, even though we all know both sides really must negotiate and come to a agreement. Clinuvel really did set it self up to where they could write off Italy.

    On Wednesday, July 20, 2016 at 9:00:51 PM UTC-7, MrPoonz1 wrote:

    Strategic mistake by PW
  10. Omnius 21 juli 2016 08:17

    • Omnius

      Lid sinds: 01 jan 2000

      Laatste bezoek: 04 mei 2024

    • Aanbevelingen

      Ontvangen: 116

      Gegeven: 320

    •    Aantal posts: 1.656

    Ik vind het ook een gemiste kans van PW en consorten. Ze hadden op zijn minst op de uitnodigingen van de landen in kunnen gaan om uit te leggen waarom ze voorheen een lagere prijs kregen etc.

    Verder zag ik laatst een linkje dat het beter is om het gratis weg te geven tijdens compasionate use, dan om een gereduceerde prijs te hanteren. Dit om dit soort discussies later te voorkomen. Voor Clinuvel was dat misschien geen optie, aangezien hun cash positie niet zo heel ruim was/is.

    Ik ga ervan uit dat langzaam toch meer landen online gaan komen en dat Italië en Zwitserland vroeg of laat toch mee gaan, onder druk van patiëntenverenigingen. Wat dat betreft steun ik de harde lijn van PW wel.
  11. frank2you 21 juli 2016 13:51

    • frank2you

      Lid sinds: 12 dec 2003

      Laatste bezoek: 26 apr 2024

    • Aanbevelingen

      Ontvangen: 128

      Gegeven: 58

    •    Aantal posts: 1.209

    Van sharescene...het kan verkeren...

    if you weren't confused already, prepare to be so after reading this article.
    Good news. But what a mess.

    ----------

    Afamelanotide available again. The sun shines for patients with Protoporphyria
    OF INSALUTENEWS · July 21, 2016

    logo-ire-isg

    First plant of the year this morning at San Gallicano, Reference Center for Porphyria leaders. Branca: "Thanks to AIFA and to the Region for having authorized the release of the drug distribution to patients of Lazio and also for the sick outside the region"

    torque-guys-scaleRoma, July 21, 2016 - Good news for patients suffering from Protoporphyria Erythropoietic (EPP): green light to the use of this medicine "Afamelanotide". So far this year, in fact, the distribution of the drug had been blocked. A price four times higher than established by AIFA was asked by the manufacturer to each individual system, and this has caused an objective difficulty for patients in getting the therapy.

    Now, thanks to the commitment of the General Directorate of the IFO Institute Regina Elena and San Gallicano, and the Lazio Region has obtained the rights to the rig, at the San Gallicano, for 21 patients living in the Region. But not limited to, the Lazio Region has authorized, by agreement with other regions, also treat patients outside the region. There are at least 140 in Italy those affected by the disease.

    It is so that finally this morning at the Porphyria Centre Rare Diseases and ISG, directed by Giovanni Leone, was made the first plant of the season on a patient with EPP.

    The Protoporphyria Erythropoietic is a rare disease that prevents the sun exposure, and is especially debilitating in the summer, it can also result after a few minutes of sun exposure the erythema and burns all over his body. The one and only existing cure for the disease is the subcutaneous implantation of Afamelanotide drug.

    "I am very proud - said Marta Branca, special commissioner IFO - with the result. I want to express gratitude to AIFA and the Lazio Region for having authorized the release of the valuable drug distribution. With the plant this morning at the San Gallicano it puts an end to the ordeal and suffering of these our patients' rare ''.

    A rare disease, unknown even to many medical specialists who often mistake the symptoms for trivial photosensitivity, urticaria or special solar erythema. Until 2008 there were no cures for Protoporphyria Erythropoietic (EPP). The patients did not respond to steroid therapy, to antihistamine therapy, it 'to painkillers and had to settle for simple compresses of cool water for relief. But in 2008 its San Gallicano Institute was held the trial of the new drug Afamelanotide, now available in a few centers in the world and in only three centers in Italy including the San Gallicano, one of the Old South.

    It is to administer a subcutaneous implant the size of a grain of rice that stimulates the production of melanin and make sure that these parties take symptoms, at least until they are covered by the drug. From here you understand the importance of not deprive patients of the therapy, which would force them to not have a normal life in the open air.

    In an effort to solve the problem of the drug block, because of the price quadrupled by the manufacturer, the extraordinary Marta Branca Commissioner has promoted since early this year to AIFA meeting, with the participation of the Institution San Gallicano, the doctors involved and the patients association, to find a solution to the problem.

    "The association of the EPP patients - declares Branca- has also played a key role in informing all patients residing in different regions about their rights and to create a coordination. Today, after so much trouble and thanks to the support of the Lazio Region, we can claim to have won the battle, being able to re-administered to our patients the drug saves - quality of life ".

    "This EPP - precise Giovanni Leone - represents the limiting case as regards the treatment of pathologies induced by exposure to sunlight, which include less severe and less rare, affecting a wide segment of the population and for which it is operating the clinic dedicated to the diagnosis and treatment of photodermatosis active this year at the Porphyria Centre of the San Gallicano "
  18. frank2you 5 augustus 2016 08:07

    • frank2you

      Lid sinds: 12 dec 2003

      Laatste bezoek: 26 apr 2024

    • Aanbevelingen

      Ontvangen: 128

      Gegeven: 58

    •    Aantal posts: 1.209

    quote:

    Omnius schreef op 4 augustus 2016 20:51:

    Ja ongelofelijk dat de koers hier niets op doet.
    Ja....inderdaad....het aandeel, bedrijf, medicijn blijft onbekend, het volume is nagenoeg niets. We moeten afwachten tot de volgende kwartaalcijfers of tot de wereld wakker wordt.
2.596 Posts
Pagina: «« 1 ... 120 121 122 123 124 ... 130 »» | Laatste |Omhoog ↑

Neem deel aan de discussie

Word nu gratis lid van Beursduivel.be

Al abonnee? Log in

Direct naar Forum

Zoek alfabetisch op forum

  1. A
  2. B
  3. C
  4. D
  5. E
  6. F
  7. G
  8. H
  9. I
  10. J
  11. K
  12. L
  13. M
  14. N
  15. O
  16. P
  17. Q
  18. R
  19. S
  20. T
  21. U
  22. V
  23. W
  24. X
  25. Y
  26. Z
Forum # Topics # Posts
Aalberts 465 6.843
AB InBev 2 5.292
Abionyx Pharma 2 29
Ablynx 43 13.356
ABN AMRO 1.580 46.550
ABO-Group 1 19
Acacia Pharma 9 24.692
Accell Group 151 4.129
Accentis 2 253
Accsys Technologies 22 8.993
ACCSYS TECHNOLOGIES PLC 218 11.686
Ackermans & van Haaren 1 160
ADMA Biologics 1 31
Adomos 1 126
AdUX 2 457
Adyen 13 16.546
Aedifica 2 832
Aegon 3.257 320.159
AFC Ajax 537 7.020
Affimed NV 2 5.766
ageas 5.843 109.779
Agfa-Gevaert 13 1.865
Ahold 3.536 74.004
Air France - KLM 1.024 34.365
Airspray 511 1.258
Akka Technologies 1 18
AkzoNobel 466 12.774
Alfen 12 16.629
Allfunds Group 3 1.223
Almunda Professionals (vh Novisource) 651 4.247
Alpha Pro Tech 1 17
Alphabet Inc. 1 339
Altice 106 51.196
Alumexx ((Voorheen Phelix (voorheen Inverko)) 8.485 114.768
AM 228 684
Amarin Corporation 1 133
Amerikaanse aandelen 3.821 240.407
AMG 965 126.239
AMS 3 73
Amsterdam Commodities 303 6.524
AMT Holding 199 7.047
Anavex Life Sciences Corp 2 382
Antonov 22.632 153.605
Aperam 91 14.175
Apollo Alternative Assets 1 17
Apple 5 322
Arcadis 251 8.626
Arcelor Mittal 2.024 318.716
Archos 1 1
Arcona Property Fund 1 267
arGEN-X 15 9.150
Aroundtown SA 1 183
Arrowhead Research 5 9.284
Ascencio 1 20
ASIT biotech 2 697
ASMI 4.107 37.730
ASML 1.762 77.223
ASR Nederland 18 4.132
ATAI Life Sciences 1 7
Atenor Group 1 333
Athlon Group 121 176
Atrium European Real Estate 2 199
Auplata 1 55
Avantium 29 10.695
Axsome Therapeutics 1 177
Azelis Group 1 49
Azerion 7 2.681

Beleggingsideeën van onze partners

Macro & Bedrijfsagenda

  1. 10 mei

    1. Eurocommercial Q1-cijfers
    2. VK economische groei eerste kwartaal
    3. VK handelsbalans maart
    4. VK industriële productie maart
    5. Wolters Kluwer €1,36 ex-dividend
    6. Aperam €0,50 ex-dividend
    7. AMG €0,20 ex-dividend
    8. Arcadis €0,85 ex-dividend
    9. VS consumentenvertrouwen (Universiteit Michigan) mei (vlp) 77

  2. 13 mei

    1. NL faillissementen april
de volitaliteit verwacht indicator betekend: Market moving event/hoge(re) volatiliteit verwacht
Naar de hele agenda