Regulatory update from US Food and Drug Administration
The Company has an ongoing dialogue with the FDA and will provide updated information as soon as more information becomes available.
- The Company has an ongoing dialogue with the FDA and will provide updated information as soon as more information becomes available.
- The Company plans to submit complete data from the OCEAN-study to the International Myeloma Workshop meeting in Vienna on September 8-11, 2021.
- The information was submitted for publication, through the agency of the contact persons above, on July 28, 2021, at 16:30 (CET).
- They have all developed resistance to their last line of therapy, and within 18 months from the study start to lenalidomide, the most used drug in multiple myeloma.