Explore the latest developments in Expanded Access for ALS research in this informative webinar presented by Dr. Suma Babu from Massachusetts General Hospital. Gain insights into ongoing and upcoming Expanded Access Protocols (EAPs), including the Pridopidine EAP and RAPA-501 EAP. Learn about the distinctions between EAPs and clinical trials, understand the FDA's stance on expanded access, and discover the current status and progress of multicenter EAPs. Delve into comparisons with other trials and examine the Rapa EAP for more advanced disease cases. Engage with the Q&A session to address your queries about ALS research and expanded access opportunities. Register for future webinars and stay informed about the HEALEY ALS Platform Trial through provided links.
Overview
Syllabus
Introduction
What is Expanded Access Pathway EAP
EAPs are not clinical trials
Should we have an EAP
What does FDA say
Clinical Trial Development
Study Updates
Expanded Access Protocol EAP
Study Status
Study Progress
Multicenter EAPs
Comparison to other trials
Rapa EAP
More advanced disease
QA
Taught by
MassGeneralHospital
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