Tuesday, January 22, 2013 3:29:55 PM
ANAC a primer:
32M basic and diluted Q3
36M cash and 22M Oct offering of 4M shares
45M cash by eoy 2012, enought through NDA
will raise money after results for launch
SO WHAT IS THE BIG DEAL?
Current nail fungus FDA approved remedies consist of an oral drug with safety issues requiring liver tests
or a topical application with efficacy problems ranging from 5.5-8.5%. Anacor believes they have solved these problems
with their late phase 111 product Tavaborole.
35M people in the US have the onychomycosis infection. Anacor
believes more patients can be reached by offering a safe, topical anti-fungal with higher efficacy.
PHASE 111 TRIALS:
Quote:
In the fourth quarter of 2011, we completed enrollment in our two identical planned Phase 3 clinical trials for tavaborole in onychomycosis in the Americas. The tavaborole Phase 3 program consists of two double- blind, vehicle-controlled trials enrolling approximately 600 patients each. Vehicle refers to the formulation without the active ingredient. Two-thirds of the patients are randomized to receive tavaborole at the 5.0% concentration, or dose, compared to one-third who will receive vehicle once daily for 48 weeks. The primary efficacy endpoint will be a composite endpoint measuring complete cure of the great toenail at week 52, which is consistent with the FDA requirement for Lamisil. Complete cure requires both a mycologic cure and a completely clear nail. Mycologic cure is achieved when the fungus present in the nail plate is killed by treatment. Achieving a clear nail requires a complete elimination of the diseased portion of the nail by replacement with a new healthy growing nail and nail bed. Given the slow rate of nail growth, which is approximately one to two millimeters per month, the industry standard for conducting Phase 3 clinical trials of onychomycosis is to evaluate the nails over a 12-month period, in order to allow sufficient time for patients to grow a new nail. We expect data from the first of these trials in January 2013 and from the second trial approximately six weeks later.
http://www.clinicaltrials.gov/ct2/results?term=an2690.
CONFERENCE LINK FOR COMPANY PRESENTATION:
http://www.media-server.com/m/p/uetscjzh
Avant Technologies Engages Wired4Tech to Evaluate the Performance of Next Generation AI Server Technology • AVAI • May 23, 2024 8:00 AM
Branded Legacy, Inc. Unveils Collaboration with Celebrity Tattoo Artist Kat Tat for New Tattoo Aftercare Product • BLEG • May 22, 2024 8:30 AM
"Defo's Morning Briefing" Set to Debut for "GreenliteTV" • GRNL • May 21, 2024 2:28 PM
North Bay Resources Announces 50/50 JV at Fran Gold Project, British Columbia; Initiates NI 43-101 Resources Estimate and Bulk Sample • NBRI • May 21, 2024 9:07 AM
Greenlite Ventures Inks Deal to Acquire No Limit Technology • GRNL • May 17, 2024 3:00 PM
Music Licensing, Inc. (OTC: SONG) Subsidiary Pro Music Rights Secures Final Judgment of $114,081.30 USD, Demonstrating Strength of Licensing Agreements • SONGD • May 17, 2024 11:00 AM