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Replies to post #137435 on Biotech Values

Replies to #137435 on Biotech Values
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DewDiligence

02/20/12 7:23 PM

#137436 RE: jq1234 #137435

Teva decided not to file Laquinimod NDA for relapsing remitting multiple sclerosis (RRMS) after discussion with FDA. No surprise there.

None whatsoever.

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genisi

03/01/12 2:21 PM

#138123 RE: jq1234 #137435

TEVA: According to FDA News, Teva decided not to file Laquinimod NDA for relapsing remitting multiple sclerosis (RRMS) after discussion with FDA.

According to Teva's presentation at RBC, the FDA has agreed to an EDSS score primary endpoint for a new phase III study for Laquinimod (the BRAVO study, which failed to show statsig had an ARR primary endpoint).