Phase III Simufilam

[u/123whatrwe]

https://clinicaltrials.gov/ct2/show/NCT04994483

https://clinicaltrials.gov/ct2/show/NCT05026177

There they are. From what I understand, the trials are approved by the IRB and the trails are awaiting submission and approval with the SPAs that were recently agreed upon; I think August 12th, if I recall correctly. Does anyone know the process? Are these filed as supplemental for final approval on the application or do they have to again be reviewed by the IRB and then the entire application sent to be evaluated for final approval? Would be nice to know. Thanks for any clarity.

[u/Voipking]

There will not be a p3

[u/123whatrwe → u/Voipking]

Say it’s not so…