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KIadis naar de €15,00 in november

2.067 Posts
Pagina: «« 1 ... 93 94 95 96 97 ... 104 »» | Laatste | Omlaag ↓
  1. Koetjuh 24 november 2017 10:41
    quote:

    Windkracht schreef op 24 november 2017 10:25:

    pssssst......is hier nog iemand. Op het forum is het net zo stil als de koers vandaag, compleet bevroren.
    Stilte is soms ook goed, want geen nieuws is ook nieuws. Zo lang er geen slecht nieuws is, komen we iedere dag weer een stapje dichter bij de goedkeuring.
  2. Koetjuh 24 november 2017 12:22
    quote:

    Koro schreef op 24 november 2017 12:02:

    Kiadis het lachertje van de beurs. Draadje voor december.
    Nee dat is Ahold al. Koers 25% lager gezet door nieuws wat weinig impact heeft gehad op Ahold. Gevolgd door uitstekende kwartaalcijfers van Ahold, plus iedere periode wordt Ahold genoemd als favoriet. En al weken/maanden lang geen beweging in de koers te krijgen, sterker nog regelmatig dagen dat de koers wegzakt.
  3. Koetjuh 24 november 2017 14:38
    quote:

    kampie schreef op 24 november 2017 13:59:

    [...]

    Aandeel is volledig dood gemanipuleerd.Het zal nog wel even duren voor er weer nieuw leven inkomt.
    Nieuwe mijlpaal bereikt dus! Denk dat we allemaal wachten tot het punt dat er zo goed als niks meer valt te manipuleren. Ik begin nu meer vertrouwen te krijgen dat de koers snel naar boven kan. Of we gaan binnenkort zo maar hard omhoog, of we kunnen nu eens rustig wachten op het volgende nieuws.
  4. Windkracht 24 november 2017 16:44
    Wilde een verkoop doen van 1000 stuks op 8,02 (limietorder). Direct na het doorvoeren van de order, gaat de bied er op 8,021 en 8,02 er uit en vliegt omlaag naar 8,00. We mogen dus ook niet meer op de laatkoersen verkopen. Ondanks de enorme manipulatie, zou ik zeggen een heel positief signaal !
  5. PGV 24 november 2017 18:51
    quote:

    Windkracht schreef op 24 november 2017 17:17:

    Bijzonder, er gebeurt weinig en het boekje is erg onrustig.......Volgens mij zitten we allemaal te wachten op echt nieuws. Dus niet iets zoals het feit dat ze op drie events aanwezig zijn, maar een update over de ontwikkeling atir 101 dan wel een partnership.
    Zou mooi zijn.
  6. Windkracht 25 november 2017 12:46
    FDA Approves CAR T-Cell Therapy for Adults With Certain Types of Large B-Cell Lymphoma

    By The ASCO Post
    November 25, 2017


    ON OCTOBER 18, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Axicabtagene ciloleucel, a chimeric antigen receptor (CAR) T-cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma. (On August 30, 2017, the FDA approved the CAR T-cell immunotherapy, tisagenlecleucel [Kymriah], for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse.)

    A Scientific Paradigm

    “[OCTOBER 18 ] MARKS another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases. In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer,” said FDA Commissioner Scott Gottlieb, MD. “This approval demonstrates the continued momentum of this promising new area of medicine, and we’re committed to supporting and helping expedite the development of these products. [The FDA] will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine. That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR T cells and other gene therapies. We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms.”

    Axicabtagene Ciloleucel Indications

    AXICABTAGENE CILOLEUCEL is approved for use in adult patients with large B-cell lymphoma after at least two other kinds of treatment have failed, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Axicabtagene ciloleucel is not indicated for the treatment of patients with primary central nervous system lymphoma.

    Each dose of axicabtagene ciloleucel is a customized treatment created using a patient’s own immune system to help fight the lymphoma. The patient’s T cells are collected and genetically modified to include a new gene that targets and kills the lymphoma cells. Once the cells are modified, they are infused back into the patient.

    “The approval of axicabtagene ciloleucel brings this innovative class of CAR T-cell therapies to an additional group of cancer patients with few other options—those adults with certain types of lymphoma that have not responded to previous treatments,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research (CBER).

    Safety and Efficacy

    THE SAFETY AND EFFICACY of axicabtagene ciloleucel were established in a multicenter clinical trial of more than 100 adults with refractory or relapsed large B-cell lymphoma (ClinicalTrials.gov Identifier NCT03105336). The complete remission rate after treatment with axicabtagene ciloleucel was 51%.

    Treatment with axicabtagene ciloleucel has the potential to cause severe side effects. It carries a boxed warning for cytokine-release syndrome, which is a systemic response to the activation and proliferation of CAR T cells causing high fever and flu-like symptoms, and for neurologic toxicities. Both cytokine-release syndrome and neurologic toxicities can be fatal or life-threatening. Other side effects include serious infections, low blood cell counts, and a weakened axicabtagene ciloleucel usually appear within the first 1 to 2 weeks, but some side effects may occur later.

    Because of the risk of cytokine-release syndrome and neurologic toxicities, axicabtagene ciloleucel is being approved with a risk evaluation and mitigation strategy, which includes elements to assure safe use. The FDA is requiring that hospitals and their associated clinics that dispense axicabtagene ciloleucel be specially certified. As part of that certification, staff involved in the prescribing, dispensing, or administering of axicabtagene ciloleucel are required to be trained to recognize and manage cytokine-release syndrome and nervous system toxicities. Also, patients must be informed of the potential serious side effects and of the importance of promptly returning to the treatment site if side effects develop.

    To further evaluate the drug’s long-term safety, the FDA is also requiring the manufacturer to conduct a postmarketing observational study involving patients treated with axicabtagene ciloleucel.
  7. Windkracht 25 november 2017 13:00
    www.nsf.org/newsroom/regulatory-radar...

    The criteria to meet RMAT designation are:

    The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under section 361 of the PHS Act and 21 CFR Part 1271.
    The drug is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition.
    Preliminary clinical evidence to indicate that the drug has the potential to address unmet medical needs for such a disease or condition.
    The advantages of RMAT designation include eligibility for increased and earlier interactions with the FDA, eligibility for priority review and accelerated approval which allows for approval based on surrogate or intermediate endpoints. In addition, the sponsor can satisfy its licensing requirements through commitment to post-approval clinical studies and from real-world data such as those obtained from patient registries and health record analysis.

    A request for RMAT designation must be made at the time of an Investigational New Drug (IND) application or as an amendment to an existing IND. If an IND is on hold or is placed on hold during the designation review, the RMAT designation cannot be granted.

    The request does not need to contain data sets (primary data) but should provide preliminary clinical evidence that is available, plus brief descriptions of a) any available therapies for the disease or condition, the study design, the population studied and the endpoint(s) used and b) the study results and statistical analyses (e.g. subgroup analyses).

    As of May, 17 RMAT submissions were received and four were granted. Two examples of therapies that have been issued RMAT designation are:

    ATIR101 (Kiadis Pharma N.V.), an adjunctive immunotherapeutic for human stem cell transplantation consisting of a single dose donor lymphocyte infusion with immune cells from a partially-matched family member that contain potential cancer killing T-cells and have been depleted of graft versus host disease (GVHD) causing lymphocytes

    Ixmyelocel-T (Vericel Corporation), an autologous expanded multicellular therapy for the treatment of a serious cardiovascular disease, dilated cardiomyopathy
  8. [verwijderd] 25 november 2017 14:10
    quote:

    Gelano schreef op 25 november 2017 13:58:

    En haalt ze die 15 nog?
    Niet serieus te nemen toch dit aandeel?
    Doe maar interessant praten met feiten e.d., resultaat is om te huilen. Niet eens de 8 euro.
    Lees je eens in. De koers van 8 euro is logisch.
    Het stijgingspotentieel is enorm.
    Nu is het wachten op een aanleiding die de koers hoger gaat zetten.
  9. Gelano 25 november 2017 14:19
    quote:

    BassieNL schreef op 25 november 2017 14:10:

    [...]
    Lees je eens in. De koers van 8 euro is logisch.
    Het stijgingspotentieel is enorm.
    Nu is het wachten op een aanleiding die de koers hoger gaat zetten.
    Je snapt het niet helemaal volgens mij.
    Lees nogmaals het onderwerp van dit draadje.
    Ja, nog 4 dagen te gaan knul.
  10. forum rang 6 Chiddix 25 november 2017 15:57
    De kop van dit draadje is identiek aan die van October. De realiteit is, Kiadis gaat niet naar 15 euro tenzij een farmaceut een bod uitbrengt(260 miljoen). Dat is goedkoper voor een farmaceut dan wachten totdat de EMA zijn oordeel geeft over het medicijn. Als je een bod uitbrengt voordat er gekeurd is, dan moet je wel zeker van je zaak zijn , dat het middel door de keuring komt.
    Ken geen voorbeelden maar incidenteel zal het misschien voorkomen. Vooralsnog zitten beleggers in het wachtlokaal. Z on beetje dezelfde situatie als bij de Pharming Group (2008-2012). Wachten op nieuws, wachten op een overname en wachten op goedkeuring. Binnen nu en een jaar wordt alles duidelijk.
2.067 Posts
Pagina: «« 1 ... 93 94 95 96 97 ... 104 »» | Laatste |Omhoog ↑

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