Navidea Biopharmaceuticals Inc (NAVB)

[DDbuyer]

Dutton update report - 07/01/2008

Neoprobe Introduces Enhanced Gamma Detection System And Confirms Phase III Clinical Trial Progress Of Lymphoseek.

Neoprobe announced last week that it has introduced an enhanced gamma detection control unit, the Neoprobe GDS (model 2300). This is the first device to be introduced under the development collaboration with marketing/distribution partner Ethicon Endo-Surgery that was announced last December. The Neoprobe GDS unit contains internal circuitry that enables it to communicate with the Company's new family of wireless probes without the necessity of an external adapter.

This new control unit is intended as an upgrade to and replacement for, the installed base of older generation control units (models 2000, 2100 and 2200), some of which have have been in service for more than ten years. We expect the collaboration to result in both new product flow and additional product enhancements in the future.

The first Phase III trial for Lymphoseek in breast cancer and melanoma was initiated on June 9, well within the time frame we anticipated in our June 6 Update Report. Management confirmed that at least five clinics were enrolling patients as of yesterday, and that a number of others will begin enrolling patients over the next two months. Approximately 18-20 total clinic sites are expected to participate in this ~200 patient trial, which is expected to complete enrollment by the end of this year. We anticipate launch of the second Phase III trial for Lymphoseek in head and neck squamous cell carcinoma (~150 patients, with the potential for early stoppage) over the next few weeks. In our opinion, Neoprobe appears on track for a first half 2009 NDA filing for Lymphoseek and we anticipate commercialization of this first in class compound late next year.

link: http://www.duttonassociates.com/research/neop/notes/neop_note_070108.pdf

tonoos... thanks. I've bookmarked it. I always like Kevin's commentary.

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