Friday, September 10, 2010 12:07:14 PM
Nephros has engaged King & Spalding LLP as its regulatory counsel and has scheduled a meeting with the FDA on September 10, 2010, to discuss the issues raised in the FDA's letter as well as the process for moving forward. As previously stated, based upon the meeting with the FDA reviewers, the company will determine the appropriate course of action, which could include filing a new 510(k) application with additional information or filing an appeal related to the current application," continued Dr. Mieyal.
hopefully we will know soon enough. maybe a conditional approval is imminent. approved and slight modifications have to be made.
we will know soon enuff. any good news and this will fly. too many nervous investors nowadays u cant blame em. we are all shook of mr market.
suprised there is no runup, maybe it will all come at once. GLTA
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