Press - Wall Street JournalTORONTO (Dow Jones)--Food and Drug Administration approval for Isotechnika Pharma Inc.'s (ISA.T) lead drug appeared uncertain Wednesday after the FDA canceled an advisory hearing to review the company's data.
Isotechnika's stock fell sharply on the news, which means the company must wait until a formal review meeting is held Aug. 3.
Advisory committees review results of a company's tests on a new drug and make recommendations. Drugs are rarely approved without an advisory committee hearing.
The FDA sometimes delays committee meetings to give companies more time to assemble data, but the vague wording of this announcement causes concern, according to an industry observer.
The FDA said in a posting on its website the meeting was "canceled to allow time for the resolution of several outstanding issues." Usually the FDA specifies that it's awaiting data, so the failure in this case to give a reason is worrisome, said the observer.
Adding to the uncertainty, the FDA said it "may reschedule an advisory committee meeting in the future." In other cases it said it "will reschedule," the observer noted.
The FDA said it will continue to review the drug.
Dr. Launa Aspesl, chief operating officer for Isotechnika, said the company doesn't know why the agency canceled the meeting. "It was going through the typical process," Aspesl said. "They were reviewing it and asking questions as it went."