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08:02 EDTOPTR
theflyonthewall.com: Optimer Pharm completes enrollment in Fidaxomicin Phase 3 trial
Optimer Pharmaceuticals has completed enrollment in the second of two pivotal Phase 3 clinical trials evaluating the safety and efficacy of fidaxomicin for the treatment of Clostridium difficile infection, or CDI. The Company previously reported positive data from the first Phase 3 trial which showed that fidaxomicin met its primary endpoint of non-inferiority of clinical cure compared to Vancocin. The second Phase 3 trial is a multi-center, randomized, double-blind clinical trial comparing the safety and efficacy of fidaxomicin to that of oral vancomycin in subjects suffering from CDI. This study, which enrolled 536 adult subjects providing 90% power to assess the primary endpoint of clinical cure, was conducted in approximately 100 clinical sites throughout North America and Europe. The study is designed to evaluate safety and compare the response to treatment by subjects during and after a 10-day course of therapy for cure, which is the primary endpoint. If cured, subjects are followed for a subsequent four-week period to evaluate recurrence, which is a secondary endpoint. Global cure, defined as cure with no recurrence, is also a secondary endpoint. :theflyonthewall.com



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February 5, 2010
09:44 EDTOPTR
theflyonthewall.com: Gappers report: Bullish gaps
This is a list of stocks making unusual moves on the open versus the prior day close. Gapping stocks often have excessive movements during the day and in the days thereafter. We use 5% for filter criteria and scanned for stocks that traded above $10 the prior day. GAPPING UP: TCI 5.56%, CTCT 5.86%, TSN 5.93%, HAIN 6.61%, RMD 7.99%, PKI 8.48%, LMNX 8.85%, ALKS 10.36%, FARO 10.86%, SFLY 12.30%, LRN 12.66%, OPTR 13.83%, ARG 43.92%. :theflyonthewall.com
09:27 EDTOPTR
theflyonthewall.com: Pre-market top 5 gainers

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February 4, 2010
16:31 EDTOPTR
theflyonthewall.com: Optimer Pharm announces results from second Fidaxomicin Phase 3 study
Optimer Pharmaceuticals announced positive top-line results from the second of two pivotal Phase 3 trials evaluating the safety and efficacy of fidaxomicin, or OPT-80, in patients with Clostridium difficile Infection. The trial met the primary endpoint of non-inferiority with 91.7% of patients treated with fidaxomicin achieving clinical cure vs. 90.6% for Vancocin, the only FDA-approved therapy for CDI. Importantly, fidaxomicin also had significantly lower recurrence rates and higher global cure rates compared to Vancocin. :theflyonthewall.com