While the Company anticipates receiving the FDA’s formal letter in the near future, the Company is currently unable to provide more specific guidance regarding the timing. The Company plans to make a public announcement shortly following receipt of formal communication from the FDA, and expects to make no further public comments on the subject until such announcement.
Source: http://www.sec.gov/Archives/edgar/data/1138400/000114420411056401/v236549_8k.htm
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