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Re: Dufresda post# 92307

Sunday, 01/15/2017 4:55:14 AM

Sunday, January 15, 2017 4:55:14 AM

Post# of 332439
I wouldn't be surprised if the FDA needed another year to evaluate the RWD, focusing on pro and contra of clearance based on the available data, and then taking another year to decide, while "forgetting" about the available clinical data on foot and knee.
I have been working for 4 different public services till now, albeit european.
Wouldn't it be better for BIEL to take control, forcing a decision on foot and knee?
That way they are half way,while they prepare to go the whole way.
Also I would check with BRAUN whether some pre-operation clinical data regarding the hip could be useful to convince the FDA.
I had excellent and consistent results with Actipatch for my hips.
The back is far more complex.RWD is certainly the way to go but before you realise it we will be unpacking the next christmas presents without Actipatch.