Monday, January 08, 2018 4:38:17 PM
This literally means nothing.
He said ASAP for CE app in EMEA and it was withdrawn.
That word gives him every escape route - the fact that he is not ready to talk about why he decided to skip CE mark app was never given (in one conf it seemed it slipped as the mfg GMP issue)
Now he is not giving reason for withdrawing 510k app at such late stage
Normally this is unacceptable behavior as he is keeping SH in dark and putting their investment at risk.
Every question from fda is addressable but how and whether in realistic timeline is the key question.
N is playing the investors and being dishonest.
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