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Biodel Inc. (BIOD) Message Board

  • freewillybird freewillybird Oct 30, 2010 3:16 PM Flag

    Burlington facility probably cleared by now

    When contacted today the Sept 8th, 2010, Albany Molecular Research, Inc. stated that it intends to respond to the FDA today in regard to the recent warning letter it received, dated August 17, 2010, from the U.S. Food and Drug Administration (the "FDA") in connection with the FDA's inspection of AMRI's pharmaceutical manufacturing facility located in Burlington, Massachusetts. AMRI’s Director of Investor Relations, Peter Jerome stated “We intend to submit our response to the FDA today, September 8th.

    AMRI has already informed Biodel (NASDAQ: BIOD) that the FDA inspection that resulted in this warning letter was unrelated to the review of Biodel's NDA for Linjeta (Previously known as VIAJect), but rather was related to the review of another sponsor's product candidate. It should also be noted that Biodel has also previously disclosed that it is working with Wockhardt Ltd., its second contract manufacturer producing finished Linjeta product, to develop the disposable pen for use with Linjeta and that it intends to conduct the majority of its future Linjeta manufacturing with Wockhardt Ltd.

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