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Re: QuidWilson post# 77913

Thursday, 10/04/2018 10:55:40 AM

Thursday, October 04, 2018 10:55:40 AM

Post# of 140475
I have been thinking that for a while, or at least CE filing mid-year and FDA to follow. My suspicion is that when they announced the delay last fall, they pushed everything out further than necessary to give them a buffer and make it more realistic to hit the rest of the milestones. Very few complex medical device projects come in without delays; it is virtually impossible to predict a show-stopping snag when the program is in early design phases (or they would just be part of the initial plan). Delays are always a little disappointing but extremely common - just ask Medtronic. Easiest way to avoid future delays is to build in enough cushion in the schedule to deal with setbacks and still meet scheduled milestones, and if no issues come up, you look like heroes.


Message in reply to:

Best part of the release...q filings 1 year ahead of schedule...

"Filed three Q-submissions containing detailed protocols for animal, cadaver and human confirmatory studies for review by the U.S. Food and Drug Administration ("FDA"), approximately one year ahead of plan"

Encouraging that my suspicion that Mac is ahead of his stated milestones is correct. May submit for 510 mid 2019 rather than end?