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... patentable 24 Peter Kolchinsky, PhD The Entrepreneur’s Guide to a Biotech Startup A patent may describe a new way to manufacture DNA microarrays If you want to start a company that will make and... status to a drug for a very small market and may assign Fast Track, Priority Review, and/or Accelerated Approval status to a drug that addresses an important unmet medical need Orphan status offers... plan should include a listing of assumptions used to prepare the financials, a balance sheet, an income statement, and a statement of cash flows Historical data should be prepared as annual totals