Vion Pharmaceuticals Inc. (VION.OB)'s investigational anticancer agent Onrigin is scheduled to face FDA decision on December 12. The company is seeking approval of Onrigin Injection as a treatment for elderly, poor-risk patients with acute myeloid leukemia.
In September, the FDA's Oncologic Drugs Advisory Committee, voted unanimously against approval of Onrigin. The panel required Vion to complete a randomized study defining the efficacy and safety of Onrigin prior to receiving regulatory approval from the FDA. Following the FDA panel's decision, shares of Vion, which trade over-the-counter, plunged 57% to close at $1.12 on September 2.
Vion currently does not have the funds to conduct such a randomized trial. Though not mandatory, the regulatory agency usually follows the recommendations of its panels.
On October 12, Vion announced it had hired the investment banking firm Merriman Curhan Ford & Co. to assist in evaluating its strategic alternatives that include a restructuring of the company and its debt and sale of the company or its assets. The strategic review is expected to be completed in a few more days.
Last month, Vion announced it is reducing its workforce by 19 employees, which represent approximately 48% of the company's workforce. The reduction in the workforce represents annual cash savings to the company of about $2.7 million.
Vion ended the third quarter of 2009 with cash and cash equivalents totaling $18.9 million. According to the company, without additional financing, the cash and cash equivalents will not be adequate to fund operations for the next twelve months.
VION.OB, which traded in the range of $0.25-$6.54 in the last twelve months, closed Tuesday's trade at $0.95.
Will Vion continue operations or will it curtail or cease operations, liquidate its assets and/or file for bankruptcy? ... The impending FDA decision and the outcome of the company's strategic review will determine the company's future.
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