said Tuesday it will sell its assets because it's unable to comply with government standards to resurrect its operations.
The Cranbury, N.J., generic-drug company has collapsed since late May when it announced it was
halting all manufacturing and withdrawing its products from the marketplace. The company, which said it couldn't guarantee the integrity of data used to support product applications, subsequently filed for bankruptcy protection and was delisted from
Tuesday's news sent the stock down 82 cents, or 72.6%, to 31 cents. The stock, which now trades as a "Pink Sheets" equity, reached a high of $25.65 on May 9, two weeks before Able revealed its manufacturing problems.
Able told investors Tuesday that the stock will probably be worthless because any proceeds from the sale of assets will be "insufficient" to pay all creditors.
Able had been talking with the Food and Drug Administration about how it could return products to the market and restore the agency's confidence in its manufacturing activities, laboratory work and record-keeping.
Able wanted to take a shortcut, which the FDA rejected. The company proposed relaunching drugs "without the need for full FDA review and approval of all of the data supporting each
product application," the company said. "The proposal represented a departure from long-standing FDA policy in situations involving questions of data integrity, which Able felt was justified by its extraordinary voluntary actions."
The agency insisted that Able resubmit applications for each product with new test data. The FDA's decision killed any chance for a corporate reorganization because Able was counting on "obtaining significant external financing," which it could only get if it could reintroduce products to the market quickly.