FDA Plays

[mathijs22]

yeah just read so, company didn't hear anything so far from fda

5:27:58 PM
UPDATE: Avanir Says It Hasn't Heard From FDA On Drug Decision

By Thomas Gryta

Of DOW JONES NEWSWIRES

NEW YORK -(Dow Jones)- Avanir Pharmaceuticals Inc. (AVNR) said it hasn't heard from the U.S. Food and Drug Administration on an expected decision on its AVP- 923 drug Friday, and doesn't know why its stock suddenly dropped.

Shares of the Aliso Viejo, Calif., drug developer plummeted more than 50% to $ 1.31 shortly after 3 p.m. EDT before recovering. The stock was trading above Thursday's $2.81 close Friday before the move. The stock closed down 14% to $ 2.42 on more than 12 time its average trading volume.

In after-hours trading, it recently traded up 13.6% from Friday's close to $ 2.75.

The company is expecting a decision from the FDA on its AVP-923 drug for pseudobulbar affect, which is marked by episodes of uncontrollable laughing or crying suffered by people with certain diseases. The decision deadline is Saturday, which means a decision could come Friday at some point.

A spokeswoman for Avanir said the company hasn't heard from the agency, hadn't seen any news, and wasn't aware of any reason for the stock to drop.

She added that, as far as the company is aware, the FDA hasn't issued an announcement. FDA officials weren't immediately available to comment.

The news, when it comes, is expected to move the stock. Canaccord Genuity analyst Ritu Baral recently estimates a 75% chance of approval with a $9 price target, but notes that any serious delay or safety issues would be very negative for the stock.

A minor label-related delay could still give a boost to the stock, he said.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; [e-mail]




http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=201010291716dowjonesdjonline000627&title=update-avanir-says-it-hasnt-heard-from-fda-on-drug-decision