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Re: read_this_n0w post# 4547

Saturday, 02/17/2007 12:41:08 AM

Saturday, February 17, 2007 12:41:08 AM

Post# of 6489
TRCA agreeing to a delay makes me wonder...

1. TRCA not confident they'll get an injunction or maybe they're worried about their chances with judge (ie they're not so confident of case and what judge may do)

2. TRCA wrangling with INSM to provide delay to wait for an EMEA decision or "approvable letter" type delay (like they got). If INSM gets EU marketing nod early that changes everything for TRCA and would increase strength of INSM bargaining position tremendously.

One thing is for sure INSM desparately needs to get EU approval before TRCA does. That would change the whole dynamic to this situation. I believe its possible, I think TRCA (with same retrospective application) could face some issues with approval. I never thought they would get US approval first (was wrong there). I think INSM must have a cleaner more current and compliant data package than TRCA's retrospective / licensed one.
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