This is a game changer and the FDA has to study it closer than most of these. I believe the longer it takes, the decision will be more to a favorable side, than the negative. If they were leaning towards a further review, they would throw the ball back in NEPH court, not drag it out.
Rejection is a possiblity but imo approval is far more likely. This could be some eoy tax selling with some very frustrated nervous longs that are just fed up and have decided to sell and go elsewhere. If the bad news was out we would of seen more than just a slow bleed to where we are now. Some stops have been taken out also. Bottom line other than political there is no reason why approval will not be given. The worst thing is the silence, NEPH stated that approval was expected 2009. If the timeline changes they should inform the shareholders, if the FDA have contacted them or they have contacted the FDA then an update is a reasonable expectation. However these guy's could care less about the shareholders and the chance of an update is slight based on the past. 3 choices sell and take your loss, add at these prices or hold and wait till the news.
I no longer buy into the notion that approval vs rejection is 90%-10% ... Those who espouse that 510K's are rarely denied ignore the fact that this is much more than a simple device .. it's a game changer in the extremely lucrative dialysis market.. and it's rather naive to think that the major players in that segment wouldn't hesitate to influence the medical device board to deny it in order to continue their dominance of the segment.
Sound like science fiction..maybe so .. but as always be aware of all the angles.
Still long 17,000 shares (and above water on them).