https://ipscell.com/rmat-list/
Mesoblast is the only RMAT recipient for back pain
Mesoblast RMAT for heart failure shared with Vericel ( autologous) and Athersys ( not doing to well )
On another subject- the FDA reps at the ODAC meeting that overturned the 9-1 decision.
Wilson Bryan Head of OTAT ---------------- Gone , see ya Wilson
Steven Bauer Branch Chief------------------Bon Voyage Steve
Philip Hoffman Chairperson, FDA medical officer ---------- Enjoying that rather large grant - well done Phil
Kristin Baird FDA medical officer - Baird concluded by reiterating that the primary end point results for Study GVD001/002 were statistically significant and the response measured was durable; moreover, the study data were consistent across subgroups, as well as secondary efficacy end points. Farewell KB
Bitter much , me ----- yes
Reg
Onwards and upwards blasters!
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Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-500
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