The answer to the question of when will approval be granted is "imminent".
The board members & management of SMN do not know when approval will be granted but obviously, they have an idea that it may be very soon. If they do know, they would not be in a position to publicise the fact.
The hiring of specialised staff by Anodyne & the manufacture of sensors surely must be an indication that they are expecting the approval very shortly. This is their way of telling investors that they expect approval shortly without going into print.
Take the hint. Buy, do not sell.
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