Ann: Positive EMA Meeting For Phase 3 Disc Repair Program, page-10

"How do you rate the reimbursement involvement which is a separate process which they are now including as part of the one process in the pilot program? Irrelevant I suppose?"

Of course it's not irrelevant. Speaking as someone who has previously tried to get a clinical data square peg into a reimbursement round hole, such engagement feeding into trial design is essential. Notwithstanding the SEED process, I can never understand why more companies don't think this stuff through.

My simple point is: the expression "fast-tracking" implies a truncated or expedited process, which this isn't. To imply otherwise is not correct.

Nonetheless, it is accurate to say that this is an important and meaningful contribution to this trial programme - especially in an area like back pain, where the health economic outcomes have the potential to be significant, if the clinical data is supportive.