This message was posted by a user wishing to remain anonymous
If you are asking about basis, there could be several based on your preclinical proof of efficacy/safety to do a combo development! I think your question is more like can we or is it possible to do a combination therapy study under mono NBE IND with an approved biologic. Correct?
Original Message:
Sent: 13-Feb-2024 09:28
From: Anonymous Member
Subject: Conducting combination study under monotherapy IND
This message was posted by a user wishing to remain anonymous
Hi
What is the basis for conducting a study combining an approved biologic with an NME biologic under the NME biologic monotherapy IND?
Thank you