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jq1234

11/02/13 3:01 PM

#169190 RE: iandy #169160

There is a difference between ph1 dose finding study to dose titration dosing schedule I am talking about. Many drugs use dose titration in ph3. Gleevec actually uses dose titration. The idea is to put everyone on an effective dose first, then up the dose only for those needed, thus not to put everyone to riskier high dose at the beginning. Based on FDA release, FDA hasn't been convinced what dose should patients be on first, 15mg? Unless FDA is comfortable with a dose guidance, it is unlikely to put the drug back on market IMO.

By the way, your posting about how BIIB dealt with Tysabri withdrawal the other day was really on target. That's the route ARIA should follow, go hostile and whine like Roche about Avastin withdrawal from MBC indication goes nowhere because data are not on their side!