You could be right. But curious timing for sudden inclusion nonetheless.
Especially when there has been no further update other than "we met with FDA" in earlier ANNs and most recently, "expectations" of IDE initiation in Q216.
Anyone who knows anything knows this "expectation" is entirely unrealistic, not even achievable within the regulatory process timelines - there is currently no IDE approval, and clearly significant deficiencies, and it's May already. The very notion of obtaining IDE approval, subsequent IRB approval, and getting US trial sites trained up and formally initiated in 7 calendar weeks is ludicrous. Especially when you're down 2 x VP Reg & 1 x VP Clin Research within 6 months. You can't make 20 minute brownies in 4 minutes. History would even suggest some can't make 4 minute brownies in 20 minutes ...
Anyway, just my opinion. DYOR.
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