Gensia Pharmaceuticals has reported that an outside panel monitoring a Phase III trial of its protara heart drug in the prevention of complications in cardiac surgery has advised the company to halt the trial as its analysis has revealed definite evidence as to whether the drug is efficacious or not. A company spokeswoman said that the halting of the trial is not thought to be due to any serious adverse reactions in the patients.
The firm said that it will announce the results some time in October, following a review of the data. There was, however, a great deal of confusion in the market, with the company's shares dropping $3 following the announcement, then recovering most of their lost value to end 5% down at $9.50. More than 2.3 million shares changed hands, 12 times the average daily volume for the stock.
It appears that the company itself does not know what the result will be as the study is not yet unblinded. Prior to the announcement, Gensia had reported that the US Food and Drug Administration had notified it that it required successful results from the ongoing trial prior to any potential approval to market the drug in the USA.
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