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Re: None

Tuesday, 12/15/2009 11:22:10 AM

Tuesday, December 15, 2009 11:22:10 AM

Post# of 59550
As far as strictly pps only, a comparable is NEPH.ob, look at them, they too have dropped in the past 5 trading days or so... likely, due to prolonged FDA clearance decision... similar to here... imo, i don't really see it more than anything but that...

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.