Think was wrong thread...
Database lock was dated 15th Nov....analysis done.2 big pointsRemembering its only the result from Rotator cuff trial, still recruiting for Tennis elbow 92% completed last 4c, pending full recruitment CY2021.
- There are currently no proven long-term, non-surgical solutions to repair chronic shoulder tendoninjuries
- Ortho-ATI® is well positioned to become the first FDA approved injectable cell therapy in orthopaedics for the treatment of chronic tendon injuries
"The Company remains on track to complete data analysis for the RC Study with data expected to beavailable in Q4, 2021. The Company will provide further updates in relation to the market opportunityfor Ortho-ATI®, the regulatory strategy to be pursued to enable rapid approval by FDA and also thestudy design to facilitate the first global approval of a cell therapy for tendon injuries. Plans for thedevelopment of a US commercial and development team are well advanced and are pendingsuccessful outcomes from this important study".....going it alone in US??
Huge prospects for Nerve repair unmet need.....The Company continues to work closely with the Experien Group, headquartered in Silicon Valley asthe Company’s US regulatory advisers to evaluate opportunities for expedited approval of Remplirfor nerve regeneration. The team is now finalising the US FDA submission to confirm the mostappropriate US regulatory pathway, potential for inclusion in expedited programs and what this willmean for reimbursement value for the product.
End the year with a BANG...yep sure. gltah cept Lopez
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Think was wrong thread...Database lock was dated 15th...
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