Tuesday, December 15, 2009 11:22:10 AM
NEPH.ob has not been waiting as long as we have but, it is somewhat similar... being that they resubmitted their response to the FDA in the Spring '09. and got a clearance for only 1 of their 3 510Ks -- but only two products essentially. one being a water filter and the other being a filter for hemodiafiltration. interestingly, if they approve/clear the latter, then it'll be a first going into the U.S. for a paradigm shift from hemodialysis treatment to hemodiafiltration treatments. many thought that would need a PMA (i.e., a class 3), or may be a class 2 to with clinicals (again, essentially the same).
thus, we wait for our 510k -- class 2 -- clearance as well.
meantime, what you have at the FDA this year is a change in administration and a change in location, yes the medical devices division moved during the summer time...
so, be this as it may/is... we wait... meanwhile traders do what they do...
i've got a little more dry powder to go toward either.
*****
then as someone else stated, as reading recent posts, could be a short attack on the CT data news... those buggers. or just people that don't really understand.
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