The stock has fallen recently on news:
UPDATE - Nexia's spider silk will need clinical tests
TORONTO, June 18 (Reuters) - The U.S. Food and Drug Administration (News - Websites) has decided that Nexia Biotechnologies's (Toronto:NXB.TO - News) spider-silk sutures must undergo clinical trials before being approved, the company said on Wednesday, which may delay commercialization of its lead product.
Nexia chief executive Jeffrey Turner said he did not know how long it would take to bring the sutures to market or what the cost of clinical trials would be. But he said the FDA's decision was not a setback for Nexia, which has enough cash to cover operations until November 2005.
Last month the Montreal-based company said it would lay off about 30 of its about 100 employees as it tried to cut costs by about 40 percent to C$600,000 a month.
Nexia stock fell 4 percent on the Toronto Stock Exchange (News - Websites) on Wednesday as more than 106,000 shares changed hands. Over the previous 10 days average daily trading volume had been about 72,000 shares.
The company had hoped the FDA would give the sutures the green light without clinical tests under a fast-track program that approves, without testing, new products that are similar to existing devices.
Nexia said on Wednesday the FDA had told the company that its silk sutures, which are threads used to stitch wounds, and the way they are made "raised questions" that had not been previously considered for such material.
Nexia's spider silk, called BioSteel, is made from milk from goats that have a spider-silk gene. The manufacturing process isolates the spider silk proteins from the milk and spins them into a fine fiber stronger than steel.
The company said the FDA will require Nexia to test its BioSteel sutures to close wounds before approving them.
"This is not like falling off a cliff or something like that," Turner said in an interview about the FDA's decision. "We are at a point where we have additional clarity but not total clarity (from the FDA)."
Nexia's shares closed down 4 Canadian cents at 96 Canadian cents in Toronto. They have fallen 45 percent this year.
($1=$1.34 Canadian)
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