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ghmm

02/16/11 3:58 PM

#114912 RE: biomaven0 #114911

I am long LGND and probably biased :-) but I think the trial has an extremely high chance of success. To me the risk was safety and they should be done treatment period (or very nearly so) so the major risk is gone. They talked about the powering and Phase 2 results at their analyst day last year and they are way over powered for success. The trials needed the number of patients for safety.

My concern is longer term and if HCV therapies lose the Interferon then what use would be there (in HCV). I actually thought oncology may be a better long-term use. Ligand licensed a follow-on to GSK that has some better characteristics and there is also Nplate from Amgen.
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DewDiligence

02/16/11 4:08 PM

#114914 RE: biomaven0 #114911

Phase II data showed a substantial increase in number of patients completing therapy (claim is 65% vs 6%).

What do those numbers represent? The HCV patients who received Promacta in phase-2 were required to have a raised platelet count before starting antiviral therapy.
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DewDiligence

07/26/11 8:15 AM

#123921 RE: biomaven0 #114911

(LGND)—GSK reported today that the first of two phase-3 trials testing SoC ± Promacta in HCV patients with thrombocytopenia, called ENABLE-1, hit its primary endpoint by showing a statsig increase in SVR (http://www.gsk.com/investors/reports/q22011/q22011.pdf page 4).

ENABLE-2, a clone of ENABLE-1, is due to report data any day. The clinicaltrials.gov entries for these trials are in http://www.clinicaltrials.gov/ct2/show/NCT00516321 and http://www.clinicaltrials.gov/ct2/show/NCT00529568 .