Post by
hilles on Oct 17, 2024 12:50pm
I need Info
Will Theralase get this designation once approved?
With FDA Orphan Drug Designation (which means it gets 7 years of exclusive marketing rights once it’s approved) and Fast Track Status (which speeds up the review process because it addresses a serious unmet medical need), Tecarfarin has significant market potential due to its ability to solve key issues associated with Warfarin, including its complex metabolism and kidney-related complications.
Comment by
DJDawg on Oct 17, 2024 1:32pm
Regrets. Not applicable for this situation. Goal is BTD and then AA folllowed by Full Approval. In a wishful perfect scenario.