HNY all.
An update to the trial registration for the HEALEY Platform Trial Master Protocol has been posted:
https://tinyurl.com/yc7yyxd8As you will see from the link (which takes you to a comparison panel showing the changes made) key updates to the protocol include:
- Simplified outcome measures.
- Trial duration moves from 24 to 36 weeks.
- Eligibility criteria, most importantly time since onset shifting from 36 months to 24 months at the screening visit (so more newly diagnosed pax).
A further update to the master protocol will be required to include NUZ-001 once we have the green light from the FDA.
Cheers
Densy
(20min delay)