High Probability of Success
The advanced status of this technology provides an excellent chance of
meeting the goals outlined in this plan. The viability of scientific
concepts has been demonstrated using laboratory techniques, and
additional animal studies are planned to confirm the efficacy of target
compounds.
Regulatory Success
For the therapeutic drug opportunity, the pathway to an initial IND with
the FDA is clear, and the estimated development time to filing is
approximately 18 months, with an estimated cost of $2.75 million if
existing approved drugs are available (and 36 months and $5 million if
unique compounds are used).
Market Success
Viability of the LINC technology has been demonstrated in the laboratory
setting using study designs and evaluation criteria appropriate for the
target disease (including current FDA requirements). In addition,
because no other therapy is currently available to effectively inhibit the
progression of damaging fibrosis in these pulmonary diseases, the LINC
technology is expected to be readily adopted by the medical community.
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