BioDelivery Sciences (BDSI) to Meet with FDA to Routinely Finalize Proposed Risk Strategy
Source: http://Blog.QualityStocks.net/?p=13757Posted on Monday, November 10th, 2008 | In Small & Micro Cap
BioDelivery Sciences International, inc. (NASDAQ: BDSI) remains on schedule to meet with the Food And Drug Administration, on Nov. 17 to discuss its Risk Evaluation and Mitigation Strategy for ONSOLIS, its main cancer pain treatment drug.
The company said it has already sent the FDA the information it needs, in advance preparation for the meeting. ONSOLIS (formerly known as BEMA Fentanyl) is for patients who are opoid tolerant. It’s the company’s lead development product.
“Our proposed REMS program will be an important step in helping to assure that prescribers and patients get the benefits of ONSOLIS while minimizing the risks of improper or inappropriate use,” said Dr. Mark A. Sirgo, BDSI president and CEO.
Quality Stocks has kept its eye on BDSi for a while. Biodelivery Sciences is a specialty pharmaceutical company focused on developing products to address growing market opportunities, including conditions such as pain.
In August, The FDA requested conversion of the submitted risk minimization action plan (RiskMAP) to a REMS and told BioDelivery Sciences all other aspects of its New Drug Application were complete.
“We are confident that our proposed REMS program is consistent with the advice we received in our Complete Response letter,’ Dr. Sirgo said, “and we are hopeful that this will allow for a quick submission following what we anticipate will be a productive meeting with FDA.”
After the meeting, BDSI expects to resubmit its application in December and receive approval in the first half of 2009.
Let us hear your thoughts below:
Last 5 posts by QualityStocks
- Omnicity Corp. (OMCY.OB) Announces Addition of New Board Member - November 20th, 2009
- Muscle Flex, Inc. (MFLI.PK) Announces Release Time for the BUDDY Tablet Caddy Two-Minute Commercial and Landing Page - November 20th, 2009
- Artfest International, Inc. (ARTS.OB) Announces Revenue Profit Jumps - November 20th, 2009
- Omnicity Corp.’s (OMCY.OB) Recently-Issued Corporate Update - November 20th, 2009
- Soligenix Inc. (SNGX.OB) Taking Steps to Meet Challenges of Vaccine Technology and Biological Warfare - November 20th, 2009
BDSI;, BioDelivery Sciences International;, cancer, development product;, Fda, Fentanyl;, Food And Drug Administration, Mark A. Sirgo;, ONSOLIS;, pain, Pharmaceutical, Small & Micro Cap
 About QualityStocks (http://QualityStocks.net)
Our name, QualityStocks, emphasizes our commitment to connect subscribers with companies that have huge potential to succeed in the short and long-term future. We believe strong management and vision for the future are crucial for any company to be successful. Timing is everything and we help investors succeed by providing an objective, broad-based view of the SmallCap markets on a daily basis. Please see disclaimer on QualityStocks website: http://disclaimer.qualitystocks.net |
No recommendations, either expressed or implied, are being made to buy, sell, hold or short any of the mentioned stocks. No legal, tax or accounting advice is expressed or implied. Always contact your attorney, CPA, or tax advisor before acting on any legal or tax issues. StraightStocks.com is not responsible for the content, products, or services of any of the advertisers on this site. StraightStocks.com receives compensation from advertisers on this blog. Services and products referred to herein are trademarks, registered trademarks, servicemarks, and/or registered servicemarks of their respective trademark or servicemark owners.