It's clearly not negative,
but it's hard to know how positive it is.
Really, the key to what is going on would be the exact nature of the FDA discussions that led to the submission. There are 2 points of view here.
1) The FDA wants to find a reason to aprove, so they asked the company if they could bief up the NDA in some respect to help it out. This would obviously be very positive.
2) The FDA just routinely asked DORB if they had anything else, and DORB dropped a load of junk on them forcing the delay.
And any view in between.
The problem here is that the FDA will stay quite, so you only have the DORB view (which COULD be spun).
Given that the market valued Orbec as near DOA, the uncertainity is clearly a positive.
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