Genmab — Maj 2021
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Har slettet.
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Svar fra Genmab : "Hej Helge, Vi har ikke kommunikeret noget om en eventuel milepælsbetaling i forbindelse med godkendelsen, så såfremt der er en sådan, vil den fremgå af vores Q2 regnskab 11. august"
. God pinse Nicolai Søberg-Hansen -
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Jeg ser på det i morgen. Skal se dyner.. Godnat herfra.
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Øh...'Såfremt' der er en 'eventuel' milestone, så fortæller vi det først om tre måneder. Ikke at en milestone nødvendigvis er voldsomt afgørende, og når de ikke meddeler det, er der jo nok ikkenogen, men det er der så måske eventuelt alligevel, hvis det viser sig...
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This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, the FDA collaborated with the Brazilian Health Regulatory Agency and United Kingdom’s Medicines and Healthcare products Regulatory Agency.
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I øvrigt nævner Janssen ikke Genmab eller Duobody med så meget som et halvt ord https://www.janssen.com/us/sites/www_janssen_com_usa/files/rybrevanttm_amivantamab-vmjw_receives_fda_approval_as_the_first_targeted_treatment_for_patients_with_non-small_cell_lung_cancer_with_egfr_exon_20_insertion_mutations.pdf
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God morgen.
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En subkutan version af amivantamab på vej https://meetinglibrary.asco.org/record/201164/abstract
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Sukker, ja det store Mariposa studie med 1000 pts har primary completion april 24. https://clinicaltrials.gov/ct2/show/NCT04487080?term=Amivantamab&draw=2&rank=4
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Gentogen, i ansøgningen fra 3. dec nævner de dog genmab. https://www.jnj.com/janssen-submits-application-to-u-s-fda-seeking-approval-of-amivantamab-for-the-treatment-of-patients-with-metastatic-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations
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Phase I study investigating the safety of stereotactic body radiotherapy (SBRT) with anti-PD-1 and anti-IL-8 for the treatment of multiple metastases in advanced solid tumors. https://meetinglibrary.asco.org/record/201166/abstract
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