My understanding of the FDA's stance is that the approval of the Registration study will hinge on the outcomes and data from the Phase 2 study. SYC has indicated that results from the study will be consistently disclosed, and that extensive preparations, including the manufacturing processes required for Registration approval, have been undertaken.
Ann: March 2024 Quarterly Update and Appendix 4C, page-19
-
- There are more pages in this discussion • 7 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
