"FDA approval for surgical therapies requires concomitant improvement in both pain and function" (per previous MSB info).
1st time 24 months results presented re 100 patient trial... quite significant IMO ( we previously knew 12 months only).
Based on the 24 month results - FDA approves Phase III commencement.
Good Luck Holders.
Ann: P3 trial initiated, positive 24 mth P2 results in back pain, page-4
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