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Die Presentation wurde vorgestern im vorfeld der Needham konferenz die am mittwoch stattfindet geupdated .Diese Biotechfirma ist wohl eines der günstigsten die ich je gesehen habe . Financial guidance: Recent financing extends estimated cash runway into the first quarter of 2019. Präsentation 31.März http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9N… AXS-05 Treatment Resistant Depression in Phase 3 -(Only 1 approved drug for TRD = unmet medical need. 3M patients in the U.S.) AXS-05 Agitation in Alzheimer’s Disease in Phase 2/3 -(No approved medication = unmet medical need. 2M patients in the U.S.) AXS-02 Complex Regional Pain Syndrome (CRPS) in Phase 3 (Orphan+Fast Track Status) -(No approved drug = high unmet need. 80,000 new cases per year in the U.S.) AXS-02 Knee Osteoarthritis (OA) with Bone Marrow Lesions (BMLs) in Phase 3 (SPA & Fast Track) -(7M patients in the U.S.) AXS-02 Chronic Low Back Pain(CLBP) with Modic Changes (MCs) in Phase 3 -(1.6M patients in the U.S.) Vice President, Clinical and Regulatory Dr. Niecestro has served as our Head of Regulatory since October 2012. In addition, since 2004, Dr. Niecestro has served as a consultant to a variety of biopharmaceutical companies, including Keryx Biopharmaceuticals, Inc. and TG Therapeutics, Inc. Prior to 2004, Dr. Niecestro held numerous senior management positions including serving as Vice President of Clinical Development for Andrx Laboratories, Senior Director, Clinical Development and Therapeutic Head for Gastrointestinal, Oncology and Stroke at Eisai Inc., and Director, Clinical Operations and NDA Planning for Organon Inc. While at Andrx, Dr. Niecestro was part of the team that developed the following approved drugs: extended-release metformin, extended-release lovastatin, and valproic acid. At Eisai, Dr. Niecestro played a pivotal role in the development and commercialization of Aciphex (rabeprazole sodium) and the post-NDA program for Aricept (donepezil sodium), and was involved in the launch of both the oncology and neurology franchises in the United States. While at Organon Dr. Niecestro was part of the team that developed and commercialized the following drugs: Zemuron (rocuronium bromide), Orgaran (danaparoid sodium), Humegon (FSH/LH), Follistim (recombinant FSH beta), and Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol). Dr. Niecestro has been involved in the filing of over 45 INDs, has over 60 peer-reviewed publications, and holds 3 patents. Dr. Niecestro completed his graduate and post-graduate work at the University of Illinois at Chicago. |
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| aus der Diskussion: | AXSM (Mkap $83 M) (Cash $40 M) 4 x Phase 3 Studien /erste Daten im 2H 2017 |
| Autor (Datum des Eintrages): | Biohero (03.04.17 00:00:07) |
| Beitrag: | 28 von 268 (ID:54662105) |
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