Note 2 - Significant Accounting Policies

3 Months Ended

Mar. 31, 2021

Notes to Financial Statements

Significant Accounting Policies [Text Block]

( 2 ) Significant Accounting Policies

(a)

Basis of Preparation

The accompanying condensed consolidated balance sheets, statements of operations, stockholders' equity, and cash flows as of March 31, 2021 and for the three months ended March 31, 2021 and 2020 are unaudited. The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information and on a basis consistent with the annual financial statements and, in the opinion of management, reflect all adjustments which include only normal recurring adjustments, necessary to present fairly its financial position as of March 31, 2021, results of operations for the three months ended March 31, 2021 and 2020, and cash flows for the three months ended March 31, 2021 and 2020. The results for the three months ended March 31, 2021 are not necessarily indicative of the results to be expected for the year ended December 31, 2021 or for any other interim period or for any other future year. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in the Company's Annual Report on Form 10 -K for the year ended December 31, 2020, filed with the SEC on March 30, 2021.

(b)

Liquidity and Other Risks and Uncertainties

Liquidity -  The Company has incurred net losses and negative cash flows from operations since its inception and had an accumulated deficit of $119.0 million as of March 31, 2021. Management expects operating losses and negative cash flows to continue through at least the next several years. The Company expects to incur increasing costs as it advances its trials and development activities. Management believes cash and cash equivalents of $21.5 million as of March 31, 2021 are sufficient to fund the Company's planned expenditures and meet its obligations for at least 12 months following the filing of this form 10 -Q.

(c)

Use of Estimates

The preparation of the financial statements in accordance with U.S. GAAP requires management to make certain estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. Significant items subject to such estimates and assumptions include share-based compensation, the useful lives of property and equipment, right-of-use assets and related liabilities, incremental borrowing rate, allowances for doubtful accounts and sales returns, derivative instruments, clinical accruals, inventory valuation, and assumptions used for revenue recognition.

(d)	Principles of Consolidation
	The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany accounts and transactions have been eliminated during the consolidation process.

(e)	Changes to Significant Accounting Policies
	The Company's significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in its Annual Report on Form 10 -K filed March 30, 2021 for the year ended December 31, 2020. There have been no changes to those policies.

(f)	Recent Accounting Pronouncements
	Recent accounting pronouncements issued by the Financial Accounting Standards Board (FASB), including its Emerging Issues Task Force did not or are not believed by management to have a material impact on the Company's financial statement presentation or disclosures.