Have you overlooked one major significant difference? The clinical oversight committee has formally issued a statement confirming insufficient clinical benefit to recommend approval.
The ultimate notified body PFO.
In over 40 years working in medical device companies across the globe, including working with BSI and several other NB's, I've never seen it happen. Even the dumbest companies out there knew to withdraw their submission to avoid such an outcome.
OSL Price at posting:
5.4¢ Sentiment: Sell Disclosure: Not Held
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