Re: INFORM-1 trial design
Yes that is my understanding from the webcast. If your interest is just HCV the first 20 minutes or so are Pirfenidone related and then Dan Welch gets onto 191.
By no means exhaustive but some notes from the Cowen Conference presentation (not much new info):
Pirfenidone
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. No new analysis on why one study showed significance and other did not. Continue to say both show evidence of treatment effect with CAP-1 supportive of CAP-2. Main emphasis is Repeated Measures Analysis (this is an exploratory analysis Rank ANCOVA was prespecified).
. Target to Submit NDA in Summer '09, MAA end of '09
. Reaffirmed partnering interest on Pirfenidone. Discussions to continue over next couple months.
. Prelaunch preparations ongoing
HCV
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. Phase 2B to start in Summer. Roche Milestone of 20 million. 12/24 Week treatment; Q8&Q12 dosing, dose TBD
. Confirmed late-breaker presentation of INFORM-1 at EASL
. Q4 present all cohorts from INFORM-1 (AASLD)
. Q4 '09/Q1 '10 Estimated RVR data from Phase 2B.
Financials
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~200 million in Cash (~2 years burn). 155 million 12/08 + 63.5 million from 2/09 offering.
