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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)

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To: Mkilloran who wrote (12645)8/5/1998 8:49:00 AM
From: DaiS  Read Replies (2) of 23519
 
>>If Vivus took that approach it could have been hung up in committe for way too long.>>

No I think you are wrong. The Mutual Recognition process appears to require 90 days. Since muse was introduced in UK in February, 90 days have clearly elapsed since then. I received this from Astra this am and have requested clarification which I await.

"The reason why Muse has not been approved throughout the EC is because there have been some changes regarding, for instance, analysis methods, packaging, and production units since the file was originally sent in to the authorities. These changes have to be submitted to the authorities before Mutual Recognition (MR) procedure can start. This work is in progress at this very moment."

Astra are excellent in responding - perhaps if we bombard Astra they might be forced to embarass Vivus IR inot action.
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