Negative, negative, negative again! CE Mark & IDE. Whilst there are deadlines with the latter, the simple matter is if it rejected the FDA simply publish a rejection, same goes for the former. Guess what, no rejection notices have been made! As you would expect, regulators can do their job and ask more questions. Delays are run of the mill, like traffic on a road and particularly around festive time. I think its positive that dialogue is ongoing, without rejection.
Fair point there are delays no doubt and it disappoints is holders, but the direction looks on track and I'm sure Mt Roberts has done better dd and is happy with the progress than the guesswork on this forum.
Personally I think we'll be closer to $1 by year end than $0. That's a fair rise in a market like this and better % than any bank share will give you. Its also been less volatile!
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