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August 12, 2014
07:11 EDTBDSIBioDelivery Sciences and Endo Pharmaceuticals report on BEMA Buprenorphine NDA
BioDelivery Sciences International announced that along with its commercial partner, Endo Pharmaceuticals, engaged in a positive pre-New Drug Application, or NDA, meeting with the FDA regarding BEMA Buprenorphine for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. The positive outcome of the pre-NDA meeting allows BDSI and Endo to maintain expectations of an NDA filing with FDA for BEMA Buprenorphine in late 2014 or early 2015 as planned.
News For BDSI From The Last 14 Days
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March 31, 2015
11:37 EDTBDSIBioDelivery Sciences management to meet with Jefferies
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10:36 EDTBDSIOptions with decreasing implied volatility
Options with decreasing implied volatility: BDSI FIVE NSR LULU RHT RH CTRX BBRY GME APOL
March 30, 2015
12:22 EDTBDSIOn The Fly: Midday Wrap
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10:22 EDTBDSIOptions with decreasing implied volatility
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09:27 EDTBDSIOn The Fly: Pre-market Movers
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09:04 EDTBDSISorrento Therapeutics appoints George Ng as Chief Legal Officer
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06:39 EDTBDSIBioDelivery primary endpoint in Clonidine study not statistically significant
BioDelivery Sciences announced that the primary efficacy endpoint in the Phase 3 clinical study of Clonidine Topical Gel compared to placebo for the treatment of painful diabetic neuropathy did not meet statistical significance, although certain secondary endpoints showed statistically significant improvement over placebo. In addition, a strong safety profile for the product was observed. The results of this trial provide data that will allow the company to better refine the protocol criteria to capture a more "enriched" patient population and target site selection. Secondary efficacy endpoints statistically significant.
March 27, 2015
09:37 EDTBDSIActive equity options trading on open
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March 26, 2015
13:46 EDTBDSIBioDelivery Sciences volatility elevated
BioDelivery Sciences April call option implied volatility is at 126, May is at 101, June is at 82; compared to its 26-week average of 78 according to Track Data, suggesting large near term price movement.
March 20, 2015
15:16 EDTBDSIBioDelivery Sciences April volatility elevated
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