Navigation Links
BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Third Quarter 2013 Financials
Date:11/12/2013

in the outcome of this clinical program, and we believe the market opportunities continue to expand for a novel Schedule 3 opioid like buprenorphine."

"Finally, with our BUNAVAIL clinical program complete and our BEMA Buprenorphine chronic pain program winding down, we anticipate that our research and development spending for the remainder of 2013 and for 2014 will be reduced substantially.  This spending reduction, along with the guaranteed Endo milestones, will give us sufficient cash runway to reach BUNAVAIL revenue, which would be expected in the third quarter of 2014 assuming a June 2014 approval.  This would leave us cash flow positive at the end of 2014.  Needless to say, we have a very exciting 12 months in front of us with some very important catalysts," concluded Dr. Sirgo.

Anticipated 2013/2014 Milestones

BDSI is focusing its resources on achievement of the following key milestones:

  • BUNAVAIL NDA. Based on timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the BUNAVAIL NDA is expected to be completed by June 7, 2014.
  • Milestone Payments and Phase 3 study results for BEMA Buprenorphine.  BDSI and Endo expect data from the opioid naive Phase 3 study to report out in early-2014 with the opioid experienced trial to report out in mid-2014.  Upon completion of study enrollment and database lock for each trial and the acceptance of filing of the NDA with the FDA, BDSI is expected to receive milestone payments from Endo totaling $30 million. 
  • Initiation of Confirmatory Phase 2B Study for Clonidine Topical Gel.  BDSI plans to initiate a Phase 2B study of Clonidine Topical Gel for the treatment of painful diabetic neuropathy in the first quarter of 2014.   This study could complete in 2014.

About BioDelivery Sciences International

BioDelivery Sciences Inte
'/>"/>

SOURCE BioDelivery Sciences International, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. BioDelivery Sciences to Present at the Stifel Nicolaus 2013 Healthcare Conference
2. Endo and BioDelivery Sciences Provide Update on BEMA Buprenorphine Phase III Development Program
3. BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Second Quarter 2013 Financials
4. BioDelivery Sciences Announces Submission of NDA for BUNAVAIL
5. BioDelivery Sciences Announces the Hiring of Adrian Hepner, M.D. as Vice President of Clinical Research & Regulatory Affairs
6. BioDelivery Sciences to Present at the William Blair 33rd Annual Growth Stock Conference
7. BioDelivery Sciences to Present at the Jefferies 2013 Global Healthcare Conference
8. BioDelivery Sciences to Present at the Bank of America Merrill Lynch 2013 Health Care Conference
9. BioDelivery Sciences Appoints Thomas W. DAlonzo to Board of Directors
10. BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of its 2012 Annual Report
11. BioDelivery Sciences to Present at the 25th Annual ROTH Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)...  Humberto C. Antunes,  Galderma  worldwide CEO, will receive a ... of Drugs in Dermatology (JDD) at the upcoming ... is January 17-20, 2014, at the Omni Orlando Resort at ChampionsGate ... The ODAC is a distinguished event that delivers a ...
(Date:1/15/2014)... R.I. , Jan. 15, 2014 MultiCell Technologies, ... filed a U.S. provisional patent application concerning composition of ... to achieve targeted tumor cell death.  ... small noncoding double stranded RNA molecules (VSRNAs) which interfere ...
(Date:1/15/2014)... YORK , Jan. 15, 2014 ... report is available in its catalogue: ... India Drug Forecast and Market Analysis to ... PharmaPoint: Atopic Dermatitis - India Drug ...
Breaking Medicine Technology:Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 2Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 3Galderma's global leader honored with a "Lifetime in Dermatology Achievement Award" by Journal of Drugs in Dermatology 4MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 2MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 3PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 2PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 3PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 4PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 5
... 15, 2011 Echo Therapeutics, Inc. (OTC Bulletin Board: ... tCGM System as a non-invasive, wireless, transdermal continuous glucose ... transdermal drug delivery, today announced the appointment of William ... of Directors.  Echo,s Board now has a majority of ...
... 2011 Joyant Pharmaceuticals Inc. ("Joyant"), a privately-held pharmaceutical ... covering an entire class of anti-cancer therapeutics based upon ... targeting the apoptotic pathway and have broad potential for ... malignancies. The United States Patent and Trademark ...
Cached Medicine Technology:Echo Therapeutics Announces Appointments to Board of Directors 2Echo Therapeutics Announces Appointments to Board of Directors 3
(Date:4/17/2014)... MAYWOOD, Il. (April 17, 2014) Doctors who ... disease called lymphangioleiomyomatosis (LAM) can face an agonizing ... progression of the disease and help relieve shortness ... lung transplants, and sirolimus can cause potentially fatal ... said pulmonologist Dr. Daniel Dilling, medical director of ...
(Date:4/17/2014)... 2014-- Colic affects about one in five infants in ... visits during the first several months after birth. Research ... showing promise; however, the April 1, 2014 issue of ... reported on a study, "Probiotics and Infant Colic," concluding ... for infant colic did not reduce crying ...
(Date:4/17/2014)... EcoHealth Alliance, a nonprofit organization that focuses on conservation ... today examining the current state of knowledge of the ... improved global surveillance strategies to combat the emergence of ... in West Africa that has claimed the lives of ... According to the World Health Organization (WHO), the ...
(Date:4/17/2014)... Arias, M.D., Ph.D., at The University of Texas Health ... superbug that caused a bloodstream infection in a Brazilian ... of The New England Journal of Medicine . ... of highly-resistant bacteria known as methicillin-resistant Staphylococcus aureus ... hospital and community-associated infections. The superbug has also acquired ...
(Date:4/17/2014)... April 17, 2014 Meaningful long-term survival is ... of the abdomen when treated with cytoreductive surgery ... a first-of-its-size analysis by physicians at Wake Forest ... the largest reported, single-center experience with cytoreductive surgery ... M.D., and analysis of 20 years, worth of ...
Breaking Medicine News(10 mins):Health News:Patients with rare lung disease face agonizing treatment dilemma 2Health News:Patients with rare lung disease face agonizing treatment dilemma 3Health News:New study says probiotic use for infant colic is not effective in reducing symptoms 2Health News:Re-emergence of Ebola focuses need for global surveillance strategies 2Health News:Re-emergence of Ebola focuses need for global surveillance strategies 3Health News:New MRSA superbug emerges in Brazil 2Health News:20 years of data shows treatment technique improvement for advanced abdominal cancer 2
... of the 1000 Genomes Project announced today that three ... have joined the international effort to build the most ... a tool for medical research. The new participants are: ... Biosystems, an Applera Corp. business, Foster City, Calif.; and ...
... Science,(Nasdaq: CSCX ), a global leader ... products, announced today,that it completed certification for ... Electronic Health Record (EHR)., (Logo: ... player in electronic health systems, with more,than ...
... children may have an impact on cardiovascular functioning equivalent ... to a research abstract that will be presented Wednesday ... Associated Professional Sleep Societies (APSS). , The study, authored ... Melbourne and Monash University, Melbourne, Victoria, Australia, focused on ...
... Ill. Widowed seniors are more likely to have disrupted ... event, according to a research abstract that will be presented ... the Associated Professional Sleep Societies (APSS). , The study, authored ... focused on 28 spousally bereaved seniors aged 60 years and ...
... insomnia delivered via the Internet can significantly improve insomnia ... be presented on Wednesday at SLEEP 2008, the 22nd ... , The study, authored by Lee Ritterband, PhD, of ... female) with an average age of 45 years. ...
... DaVita Inc., a leading,provider of kidney care ... disease (CKD), recently announced that Debbie Benner, MA, ... and Mary,Burgess, RD, Grant Program Manager for DaVita ... at the XIV International Congress on,Nutrition and Metabolism ...
Cached Medicine News:Health News:3 sequencing companies join 1000 Genomes Project 2Health News:3 sequencing companies join 1000 Genomes Project 3Health News:3 sequencing companies join 1000 Genomes Project 4Health News:3 sequencing companies join 1000 Genomes Project 5Health News:HeartCentrix Informatics Solution from Cardiac Science Now Certified with Allscripts Electronic Health Records 2Health News:HeartCentrix Informatics Solution from Cardiac Science Now Certified with Allscripts Electronic Health Records 3Health News:Primary snoring in children impacts cardiovascular functioning 2Health News:Primary snoring in children impacts cardiovascular functioning 3Health News:Disturbed sleep is prevalent in widowed seniors 2Health News:A self-help program delivered online can improve insomnia in adults 2Health News:DaVita Dietitians to Speak at the International Congress on Nutrition and Metabolism in Renal Disease in France 2
... 10% Ash: 1.6% Gel ... Gel pH (1.5%): 5.0 7.0 Gel Point (1.5%): ... A (430 nm, 1.5%): 0.150 Resistance ... 25,000 Ohms EEO (-m r ): ...
... easy and economical generation of a hypoxic ... Chamber utilizes a surface-type seal where all ... by a stainless steel ring clamp for ... and semi-spherical top and bottom provide minimum ...
... of miniTHERM incubators is available, ensuring the ... for their specific requirements. miniTHERM incubators have ... and extremely space saving. Their size corresponds ... is possible to stack up to three ...
In microbiological laboratories and for in vitro fertilization, as well as in cancer research or tissue engineering, the Heraeus CO2 incubator BBD 6220 provides the best contamination protection and ...
Medicine Products: