Update on Oncopeptides’ appeal of U.S. withdrawal
On Monday, October 2, Oncopeptides participated in a joint meeting with the Center for Drug Evaluation and Research’s (CDER’s) hosted by Dr. Peter Marks. The meeting presented an opportunity for both parties to present their view on the issue. The materials used, including meeting notes, will be posted in the public docket in the future, we don´t have information on when.
You will be able access the materials through the following link: https://www.regulations.gov/docket/FDA-2023-N-3167
There is currently no new and concrete information to share regarding next steps.
Oncopeptides look forward to the continued dialogue.
Investor Q&A
What does this mean for Oncopeptides?
The meeting was an opportunity for both Oncopeptides and CDER to present their view on the issue. The presentations in essence reflected the documents previously presented. The foundational fact remains the same: the FDA is looking to withdraw the approval of Pepaxto from the U.S. market, a decision which we have appealed. We look forward to seeing the process through.
Could you estimate the chance of success of this appeal?
We don´t want to speculate on that. While our strong confidence in the product and its ability to help patients suffering from Multiple Myeloma also in the U.S. remains, we need to remember that we currently don´t market Pepaxto in the U.S.
Oncopeptides’ full strategic focus is on the product roll-out in Europe, where we have a marketing authorization and an established marketing company.
I have questions about the contents of the appeal document that you have filed
Reach out to David Augustsson, Director of Corporate Affairs at david.augustsson@oncopeptides.com
I have questions about the continued FDA appeal process
At this time we cannot share any more details or information other than what is made public by the FDA through the following links:
https://www.regulations.gov/docket/FDA-2023-N-3167
We aim to keep the market and other key stakeholders informed as far as possible while still respecting the formal process.