|China-Biotics Inc. Receives NASDAQ Delisting Notification. Shire Announces FDA Approval For FIRAZYR.|
|By Staff and Wire Reports|
|Thursday, 23 June 2011 19:05|
China-Biotics Inc. (NASDAQ:CHBT), announced the Company received a letter from the NASDAQ Listing Qualification staff asserting that, because the Company has not yet filed its Annual Report on Form 10-K for the fiscal year ended March 31, 2011, and based upon disclosures made by the Company in its recently filed Form 12b-25 and additional information provided to NASDAQ, the Company no longer complies with the NASDAQ Listing Rules for continued listing.
In addition, the NASDAQ Letter requested that the Company provide to NASDAQ a formal plan of compliance setting forth the steps that the Company proposes to take to regain compliance for continued listing of the Company's common stock on the NASDAQ, as well as certain other information relevant to NASDAQ's evaluation of the plan of compliance. NASDAQ has established an expedited schedule for the Company to submit its plan of compliance and related information.
The Company's response is due no later than July 5, 2011. The Company will use its best efforts to submit a plan of compliance to NASDAQ, together with the other information requested, on or before July 5, 2011. There can be no assurance that the Company will be able to meet this deadline or that the Company's plan of compliance and other related information will sufficiently satisfy NASDAQ to avoid delisting.
Shire plc (NASDAQ:SHPGY) announced the Pulmonary-Allergy Drugs Advisory Committee to the FDA recommended, by a vote of twelve to one, that the efficacy and safety data provides substantial evidence to support approval of FIRAZYR (icatibant) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 18 years and older.
In addition, by a vote of eleven to one, with one abstention, the Committee recommended self-administration of the drug by patients. The Committee's input will be considered by the FDA in its review of the New Drug Application for FIRAZYR.
The Company has been assigned an action date of August 25, 2011 under the Prescription Drug User Fee Act. In considering whether FIRAZYR is safe and effective, the Committee considered data from three double-blind, randomized, controlled phase III trials, known as the FAST-1, FAST-2, and FAST-3 studies.
The results from these trials, which included patients with cutaneous, abdominal, and laryngeal attacks, provided substantial and convincing evidence of clinically meaningful benefit of FIRAZYR for the treatment of acute HAE attacks in adults. Treatment of acute attacks with 30 mg of FIRAZYR administered under the skin was generally well tolerated with a consistent safety profile across all clinical studies.
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