"Clarification" from the company. Not what the Street wanted to hear, so I bought back the calls I wrote on the dead cat bounce. Hoping it can bounce twice.
>>WALTHAM, Mass., June 14 /PRNewswire/ -- PRAECIS PHARMACEUTICALS INCORPORATED (Nasdaq: PRCS - news) said today, in response to various inquiries, and to clarify statements made by or attributed to the company, that, as previously announced, it would seek to respond promptly to the deficiencies cited in the letter it received from the U.S. Food and Drug Administration (FDA) with respect to the company's New Drug Application (NDA) for PLENAXIS(TM) (previously referred to as abarelix depot). The company emphasized that, in view of the nature of these deficiencies, it could not predict when its response could be completed, and could give no assurance as to when or if its application would be approved.
Separately, and unrelated to the company's receipt of the FDA letter regarding PLENAXIS, the company also said that, in accordance with its agreement with Amgen and as previously announced, the Investigational New Drug (IND) application for abarelix depot for the treatment of endometriosis has been transferred to Amgen. A phase II/III study is ongoing, and decisions regarding the future development of abarelix depot for the treatment of endometriosis have not been made.<<
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Real helpful, huh?
Cheers, Tuck |
