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Re: TheHound post# 6013

Thursday, 01/04/2018 9:56:30 PM

Thursday, January 04, 2018 9:56:30 PM

Post# of 6305
While the INSPIRE trial will not enroll another patient, this does not mean that the company will not file for HDE approval. It simply means they will most likely submit the HDE application with the data they have on the 16 evaluable patients.

It's been a brutal year or so, but I think folks need to understand that the most recent PR still shows the company plans to submit the HDE application, its just in a manner different then what we've been hearing all these years (with control arm + INSPIRE data for 16 patients).