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BIIB Files Tysabri sBLA

By Johns Wu on Sep 26, 2005

Today ELN and BIIB filed a sBLA to the FDA, an action that they promised last week. I expect more to be discussed about the results of the safety reviews in a few days (edited for correction) at the ECTRIMS conference in Greece.

What is bothering me is the 6 month timetable for a priority sBLA filing discussed in the press release. I'm not sure how the FDA handles sBLA filings, but 6 months is a really long time considering that Tysabri has already been pulled for over 6 months. One thing I want to know is the likelyhood of hearing a ruling from the FDA in Q4 2005.

The after-hours market is responding only moderately well to this news.

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This entry was posted on Monday, September 26th, 2005 at 10:58 pm and is filed under Market News. You can leave a response, or trackback from your own site.


One Response to “BIIB Files Tysabri sBLA”


By Anonymous on September 26th, 2005 at 3:01 pm

The ECTRIMS conference doesn’t start until Wednesday the 28th. There are presentations specifically addressing Tysabri starting on the 29th. http://www.akm.ch/ectrims2005/
Hopefully we get some safety data at this conference.

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