Jan A. Alfheim CEO
• •
• • • Dr. Sara Westrøm, Ph.D. has joined the Oncoinvent R&D team as Senior Research Scientist
SPECIALLY DESIGNED CaCO 3 microparticles • Carriers for the alpha-emitting isotope • Degradable and non-toxic • Good regional retention, low systemic exposure A NEW alpha-emitting radioisotope Ra-224 • High energetic radiation for efficient tumor cell kill • Local deposition of radiation • Therapeutic relevant temporal and spatial window • Low probability of unintended radiation damage
• •
Submissions to ethics Submissions to Radiation Safety Study Country committees Submissions to regulatory authorities Authorities (LEC/CEC) Initial submission approved To be submitted: Norway Amendment to be submitted to Approved by DSA Re-submission to NoMA CEC Application for FANC licenses submitted To be submitted (Site, import, clinical study) Belgium To be submitted to CEC to FAHMP To be submitted: response to questions To be submitted Oct 2019: To be submitted to BfS after CEC Germany to LEC and CEC Submitted to BfArM approval Initial submission approved To be submitted: Norway Amendment to be submitted to Approved by DSA Re-submission to NoMA CEC To be submitted to CEC Sweden (Biobank application after CEC To be submitted to MPA NA approval)
Tina Bønsdorff, CSO
• •
• • •
Recommend
More recommend