Biotech Values

[DewDiligence]

Biofield falls 53% on negative FDA letter:

[The FDA is saying that a 510(k) device clearance does not suffice and that BZET must instead submit a PMA, which is a device submission that roughly corresponds to an NDA for a drug.

At one time, BZET was one of the largest holdings in the H&Q Healthcare and H&Q Life Sciences closed-ends funds (twin funds that I used to own when they could be bought at a discount to NAV). BZET has been a disaster for these funds and today’s drubbing obviously doesn’t help.]

http://biz.yahoo.com/prnews/050309/nyw145_2.html

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FDA Responds to Biofield's Request for Reclassification of New Breast Proliferation Rate Detection System

Wednesday March 9, 12:49 pm ET

ATLANTA, March 9 /PRNewswire-FirstCall/ -- Biofield Corp. (OTC Bulletin Board: BZET), announced today that the U.S. Food and Drug Administration (FDA) has conducted a review of the Company's request for reclassification of the Biofield Breast Proliferation Rate Detection System that is intended as an adjunct that may support other modalities such as mammography, clinical breast exam, sonography, and MRI used in breast cancer diagnosis.

The FDA determined that the Biofield device does not meet the criteria for class I (General Controls) or class II (Special Controls) classification and therefore falls into Class III, for which 510(k) clearance does not apply, but rather approval must be sought through a PreMarket Approval (PMA).

David M. Long, Jr., MD, PhD, Chairman and CEO of Biofield Corp. stated, "The Company intends to meet shortly with the FDA to discuss regulatory pathways and data requirements. The Company plans to cooperate with the FDA in this process of moving forward under the format of a PreMarket Approval (PMA)."
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