Multiple Catalyst Update for Navidea PDUFA da
Post# of 47
Posted On: 08/22/2014 3:20:15 PM
Multiple Catalyst Update for Navidea
PDUFA date 16 Oct, 2014 for broadening Lymphoseek
In March 2014, the FDA accepted for review the second sNDA to support broader and more flexible use of Lymphoseek in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other product capabilities. Under PDUFA, the FDA has set a target review date for the second sNDA of October 16, 2014.
EU expansion of Lymphoseek
In April 2014, the Company announced its expectation that the CHMP would convene a meeting of the Scientific Advisory Group on Oncology (SAG-O) to discuss additional elements of the Lymphoseek clinical study in patients with head and neck cancer to provide an opportunity for Navidea and independent experts in head and neck cancer surgery to review clinical data in the MAA filing and discuss broad aspects of care for patients with head and neck cancer in Europe. Navidea expects that the SAG-O's opinion, though not binding, will be considered by the CHMP when it meets to review the Lymphoseek MAA later this year.
Pipeline expansion with R-NAV
In July 2014, Navidea announced that it has formed a joint enterprise with Essex Woodlands-backed Rheumco, LLC, to develop and commercialize radiolabeled diagnostics and therapeutics for rheumatologic and arthritic diseases. The joint enterprise, called R-NAV, LLC, will combine Navidea’s proprietary Manocept CD206 macrophage targeting platform and Rheumco’s proprietary Tin-117m radioisotope technology to focus on leveraging the platforms across several indications with high unmet medical need:
1) Detection of RA initially using Tc-99m tilmanocept, commercially known as Lymphoseek,
2) Combination of the Manocept platform with Tin-117m for detection and treatment of RA,
3) Detection and treatment of human and veterinary osteoarthritis (OA) using the Tin-117m technology, and
4) Treatment of pediatric hemophilic arthropathy (PHA), a rare rheumatologic condition.
Cost reduction aiming for cash flow positive in 2015
In May 2014, the Board of Directors made the decision to refocus the Company's resources to better align the funding of our pipeline programs with the expected growth in Lymphoseek revenue. This realignment primarily involves reducing our near-term support for our neurological product candidates, including NAV4694, as we seek to secure a development partner or partners for these programs.
http://www.sec.gov/Archives/edgar/data/810509...01410q.htm
PDUFA date 16 Oct, 2014 for broadening Lymphoseek
In March 2014, the FDA accepted for review the second sNDA to support broader and more flexible use of Lymphoseek in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other product capabilities. Under PDUFA, the FDA has set a target review date for the second sNDA of October 16, 2014.
EU expansion of Lymphoseek
In April 2014, the Company announced its expectation that the CHMP would convene a meeting of the Scientific Advisory Group on Oncology (SAG-O) to discuss additional elements of the Lymphoseek clinical study in patients with head and neck cancer to provide an opportunity for Navidea and independent experts in head and neck cancer surgery to review clinical data in the MAA filing and discuss broad aspects of care for patients with head and neck cancer in Europe. Navidea expects that the SAG-O's opinion, though not binding, will be considered by the CHMP when it meets to review the Lymphoseek MAA later this year.
Pipeline expansion with R-NAV
In July 2014, Navidea announced that it has formed a joint enterprise with Essex Woodlands-backed Rheumco, LLC, to develop and commercialize radiolabeled diagnostics and therapeutics for rheumatologic and arthritic diseases. The joint enterprise, called R-NAV, LLC, will combine Navidea’s proprietary Manocept CD206 macrophage targeting platform and Rheumco’s proprietary Tin-117m radioisotope technology to focus on leveraging the platforms across several indications with high unmet medical need:
1) Detection of RA initially using Tc-99m tilmanocept, commercially known as Lymphoseek,
2) Combination of the Manocept platform with Tin-117m for detection and treatment of RA,
3) Detection and treatment of human and veterinary osteoarthritis (OA) using the Tin-117m technology, and
4) Treatment of pediatric hemophilic arthropathy (PHA), a rare rheumatologic condition.
Cost reduction aiming for cash flow positive in 2015
In May 2014, the Board of Directors made the decision to refocus the Company's resources to better align the funding of our pipeline programs with the expected growth in Lymphoseek revenue. This realignment primarily involves reducing our near-term support for our neurological product candidates, including NAV4694, as we seek to secure a development partner or partners for these programs.
http://www.sec.gov/Archives/edgar/data/810509...01410q.htm
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