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Biotech / Medical : Genentech (NYSE:DNA) formerly known as (NYSE:GNE) -- Ignore unavailable to you. Want to Upgrade?


To: west57th who wrote (77)11/9/2005 1:18:08 PM
From: DewDiligence_on_SI  Respond to of 250
 
>Later in the release they said "average patient improved". Does this mean improved in the technical definition of 15 letter improvement…<

No—this means a raw improvement, i.e. a gain of 1 or more letters, not the FDA definition of “improved vision,” which is a gain of 15+ letters relative to baseline.

I think it’s safe to infer that the mean gain relative to baseline in ANCHOR is less than the 7-letter gain seen in the MARINA study. However, the results from MARINA are more consequential because 75% of wet AMD patients fall into the subgroups tested in MARINA.

Overall, Lucentis should be close to a lock for FDA approval in 2006. DNA’s willingness to run the 5,000 SAILOR trial as a phase-3*b* sealed the deal, IMHO.