$heff's $tation of $tocks & $olid DD

[trade2much]

CHTP a delay- PDUFA Clock now extended- Jan appears no longer a valid date, perhaps later in the spring of 2014? - http://finance.yahoo.com/marketupdate/inplay


7:32AM Chelsea Therapeutics announces update to NORTHERA (Droxidopa) NDA Filing; FDA identified certain technical deficiencies (CHTP) 3.07 : Co announced that the FDA, upon further review of the Company's resubmitted New Drug Application (NDA) for NORTHERA (droxidopa), has identified certain technical deficiencies in the resubmission that will require resolution prior to the resubmission being deemed a complete response. As previously announced on July 17, 2013, Chelsea had received written confirmation from the FDA that the resubmission was deemed to be a complete response to its March 28, 2012 Complete Response Letter and was assigned a new PDUFA date of January 3, 2014. However, the FDA has now notified the Company that they have noted deficiencies that relate primarily to the formatting of certain submitted electronic datasets and statistical programs describing the methods used to generate tables and listings. The deficiencies are unrelated to study conduct, interpretability of study results, or validity of study conclusions. The Company believes that the matter can be resolved quickly, and expects to submit the necessary response in August. Until the response is received by FDA, the Agency has informed Chelsea that the six month review clock for the NDA specified under the Prescription Drug User Fee Act (PDUFA) will not start. Therefore, upon a successful resubmission with the currently requested changes sought by the FDA, a new PDUFA date will be set by the Agency.