Biotech Values

[DewDiligence]

FDA CMA:

[The Continuous Marketing Application (CMA) should not be confused with the Special Protocol Assessment (SPA) described in message #51.]:

http://biz.yahoo.com/bw/040206/65354_1.html

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NeoPharm's IL13-PE38QQR Drug Development Program Selected to Participate in New FDA Continuous Marketing Application Pilot 2 Program

LAKE FOREST, Ill.--(BUSINESS WIRE)--Feb. 6, 2004--NeoPharm, Inc. (Nasdaq/NM:NEOL - News) today announced that its IL13-PE38QQR development program has been accepted for inclusion in the U.S. Food & Drug Administration's (FDA) new Continuous Marketing Application (CMA) Pilot 2 program. NeoPharm will work with the FDA over the next several weeks to finalize an agreement on NeoPharm's participation in the program. The objective for this exploratory program is to test the CMA concept during the Investigational New Drug (IND) phase of new drug and biological product development to determine whether such activity can improve the efficiency of the drug development and review process and shorten review time. Under the CMA Pilot 2 program, the FDA and Fast Track drug applicants enter into an agreement to engage in frequent scientific feedback and interactions during the IND phase of product development. According to FDA guidelines, the CMA Pilot 2 program will evaluate the cost of such enhanced interaction between the FDA and applicants and whether it improves the efficiency and effectiveness of development programs, and will be limited to no more than one Fast Track product for each of 20 participating FDA review divisions. For more information on CMA Pilot 2, visit http://www.fda.gov/cber/gdlns/pdufa2.htm.
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According to the FDA guidelines, CMA Pilot 2 applications are evaluated based on FDA's overall assessment of (1) the potential value of enhanced interaction, emphasizing the potential public health benefit resulting from development of the product, (2) the likelihood that concentrated scientific dialogue will facilitate the availability of a promising novel therapy, and (3) the applicant's demonstration of commitment to product development as evidenced by a thorough consideration of the rationale for participation in CMA Pilot 2.
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