When we look at the upcoming milestones for NAVB one thing that stands
out is only one is binary, the EU approval. PERSONALLY I think in terms of a binary the risk/reward is excellent. Nothing like the ARNA adcom for example.
A reminder, a direct monetary event begins-- C-code is billed and reimbursed outside of, and in
addition to, the current procedure code which should significantly increase adoption. (from Life Capital)
Company said, "Navidea anticipates that the billing code, which will become effective on October 1, 2013, will streamline the billing and reimbursement process for hospital providers who use Lymphoseek and support its fair and equitable reimbursement."
I am adding Phase 11 Alz data collection as it is a timeline event and I think we will get a PR.
• October 2013 – Pass-through C code for Lymphoseek begins.
• 2H 2013 – Initiate Phase IIb trial for NAV5001 in dementia with Lewy bodies.
• 2H 2013 – Supplemental NDA filed for label expansion of Lymphoseek to head and neck
cancer.
• 2H 2013 – Rest-of-world partnerships for Lymphoseek.
• 2H 2013 – Potential European MAA approval for Lymphoseek.
• 2H 2013 – Initiate Phase III trial for NAV5001 in Parkinson’s disease.
*My add-Phase 11 Alzheimer NAV4694 safty/efficacy data collection December 2013, per ClinicalTrials.gov
