SPECTRUM PHARMA Forum: Community User: AdlerX8

https://investor.sppirx.com/index.php/news-releases/news-release-details/spectrum-pharmaceuticals-presents-late-breaker-oral-presentation

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👎 https://investor.sppirx.com/index.php/news-releases/news-release-details/spectrum-pharmaceuticals-receives-complete-response-letter-fda-1

https://investor.sppirx.com/index.php/news-releases/news-release-details/spectrum-pharmaceuticals-report-second-quarter-2021-financial

Es ist ziemlich still geworden

https://www.smarteranalyst.com/new-blurbs/spectrum-pharmaceuticals-sppi-gets-a-buy-rating-from-h-c-wainwright-5/ 12$ Target 💪

https://investor.sppirx.com/index.php/news-releases/news-release-details/spectrum-pharmaceuticals-announces-rolontisr-eflapegrastim-pre

https://investor.sppirx.com/index.php/news-releases/news-release-details/spectrum-pharmaceuticals-reports-first-quarter-2021-financial

Nach Phase 3 kommt ja noch nda filing und pdufa. Also diese Zeitspanne würde mich interessieren....

Hallo. Hat jemand von Euch auf dem Schirm wie lange es nach Vollendung der Phase 3 bis fda im Mai zeitlich gedauert hat?

HENDERSON, Nev.--(BUSINESS WIRE)--Mar. 16, 2021-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has scheduled the pre-approval inspection at the ROLONTIS® (eflapegrastim) manufacturing site in May 2021. In October 2020, the company received notification from the agency that it would defer its decision on the BLA because an inspection of the Hanmi Bioplant in South Korea could not be conducted during the review cycle due to restrictions on travel related to the COVID-19 pandemic. “I am thrilled that the FDA informed us that they will be conducting a pre-approval inspection of the ROLONTIS manufacturing facility in May,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “We believe the pre-approval inspection marks the final step in the ROLONTIS review process.” https://investor.sppirx.com/index.php/news-releases/news-release-details/spectrum-pharmaceuticals-provides-update-rolontisr-eflapegrastim

Ok dann schauen wir mal

Mal abwarten was so ab 15:30Uhr losgeht....

Spectrum Pharmaceuticals (NasdaqGS: SPPI), ein biopharmazeutisches Unternehmen, das sich auf neuartige und zielgerichtete onkologische Therapien konzentriert, gab heute bekannt, dass die US-amerikanische Food and Drug Administration (FDA) die Fast-Track-Kennzeichnung für Poziotinib erteilt hat zur Behandlung von nicht-kleinzelligem Lungenkrebs (NSCLC) bei zuvor behandelten Patienten mit HER2-Exon-20-Mutationen. Spectrum plant, noch in diesem Jahr einen neuen Arzneimittelantrag (NDA) für Poziotinib einzureichen

Ja gute News

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