Milestones
LINC Pharmaceuticals intends to conduct early proof-of-principle pre-
clinical experiments then initiate clinical studies. The company will first
formulate proven PTHrP analogs and PPAR-gamma agonists for
administration to the lung. LINC will then test these formulas using in
appropriate vivo models of lung fibrosis to establish the efficacy and
safety of these novel treatments on the inhibition of pulmonary fibrosis
progression.
Near Term Objectives - Keys to Success in 2004
• Obtain funding from government sources (SBIR and related programs)
• Obtain additional funds from private sources
• Complete the management team
• Establish the Board of Directors and Scientific Advisory Board
• Complete additional key proof-of-concept in vivo experiments
• Define a clear regulatory path to FDA approval
• Identify potential corporate partners
• Establish the physical infrastructure including leased office/lab space
Mid-Term Objectives – Years 2 through 4, Product Development
• Establish research laboratory capability
• Formulate target compounds for pulmonary use
• Complete contracts with CROs for testing and cGMP manufacturing
• Conduct preclinical research program in support of an IND
• File an IND for the initial indication
• Conduct clinical research program
• Submit additional INDs for follow-on indications
Long-Term Objectives – Beyond Year 4, Market Development
• Obtain FDA approval
• Launch the prodct
• Continue commercialization and expand product sales
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