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Ann: Positive Results from Australian Adult Clinical Study, page-318

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507 Posts.

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12/06/19

01:48

Post #: 39010342
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Originally posted by ScrimpyCat: ↑

CE can take 6-9 months (for the notified body review process), and seeing as we filed it back at the start of the year, we're only just now in the 6th month. So you might be checking for awhile haha.

My gut feeling is that we may see it closer to September. Since the De Novo FDA filing was only done in April (review can take 150 days unless they make a request for more information), it makes me think the team are trying to time both approval processes so they can be received within a similar window of time (both could be received around September).

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please advise where did you get the info that notify body takes 6 to 9 months for CE clearance ?

I can't find any info from BSI website.

RAP Price at posting: 17.5¢ Sentiment: Buy Disclosure: Held
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