GENERAL	12 Months Ended
Dec. 31, 2017
GENERAL
GENERAL	NOTE 1:—GENERAL a. Nature of the business: SteadyMed Ltd. (the "Company") was incorporated and is located in Israel, commenced its operations on June 15, 2005 and, together with its wholly-owned subsidiary, SteadyMed Therapeutics, Inc. ("Inc."), and Inc.'s wholly-owned subsidiary, SteadyMed U.S. Holdings, Inc. ("Holdings"), is a specialty pharmaceutical company focused on the development and commercialization of therapeutic product candidates that address the limitations of market-leading products for certain orphan indications and in other well-defined, high-margin specialty markets. The Company's primary focus is to obtain approval for the sale of Trevyent®, its lead product candidate for the treatment of pulmonary arterial hypertension ("PAH") in the United States The Company submitted a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") for Trevyent for the treatment of PAH on June 30, 2017. On August 28, 2017, the Company received a Refusal to File Letter from the FDA. Based on its preliminary review, the FDA determined that the NDA was not sufficiently complete to permit a substantive review. Specifically, the FDA requested further information on certain device specifications and performance testing and also requested additional design verification and validation testing on the final, to-be-marketed Trevyent product. On November 1, 2017, the Company held a Type A meeting with the FDA to gain clarification on these requests. Company management believes the meeting was constructive. Following its receipt and review of the minutes from this meeting, the Company finalized its revised operating plan and now expects to resubmit the NDA for the subcutaneous administration of Trevyent in the fourth quarter of 2018. The Company have also finalized a revised spending plan, to allow its current cash and cash equivalents to fund operations through the third quarter of 2019, when it believes it will receive FDA approval of the Trevyent NDA. The Company is also at an earlier stage of development with two products for the treatment of post-surgical and acute pain in the home setting. Its product candidates are enabled by its proprietary PatchPump®, which is a discreet, water resistant and disposable drug administration technology that is aseptically prefilled with liquid drug at the site of manufacture and pre-programmed to deliver an accurate, steady flow of drug to a patient, either subcutaneously or intravenously. Inc. and Holdings are located in the United States, and commenced operations on January 1, 2012 and March 25, 2015, respectively. The principal executive officers of the Company are located in the offices of Inc. and Holdings, and Inc.'s and Holdings' principal business activities are to provide executive management, treasury and administrative support functions to the Company. b. Liquidity: The Company is devoting substantially all of its efforts toward research, development, regulatory approvals and marketing of Trevyent®. In the course of such activities, the Company expects operating losses for the foreseeable future. For the year ended December 31, 2017, the Company incurred operating losses of $20,435 and negative cash flows from operating activities of $22,243. Until the Company has positive cash flows from operating activities, it will need to raise significant additional capital by way of the exercise of the remaining outstanding warrants issued in the 2016 and 2017 private placements, another private placement of debt and/or equity and/or a secondary public offering to allow the Company to continue as a going concern. These factors raise substantial doubt about the Company's ability to continue as a going concern. There is no assurance, however, that the Company will be successful in obtaining an adequate level of financing for its long-term needs, and therefore, there is a substantial doubt in the Company's ability to continue as a going concern. The accompanying financial statements in this annual report do not include any adjustments to reflect the possible future effects on recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty. c. On June 28, 2015, the Company entered into an Exclusive License and Supply Agreement (the "Agreement") with Cardiome Pharma Corp. and Correvio International Sárl (hereinafter collectively referred to as "Cardiome") pursuant to which an exclusive royalty bearing license to certain of the Company's patents relating to Trevyent® ("License") was granted to Cardiome in order to develop and commercialize Trevyent, if approved for the treatment of PAH, in certain regions outside the United States, specifically, Europe, Canada and the Middle East (the "Regions"). The Company provided certain services for Cardiome through the fourth quarter of 2017. Cardiome is responsible for the regulatory submissions and approvals and commercialization of Trevyent in the Regions. In addition, the Company has agreed to supply Trevyent as finished goods to Cardiome upon commercialization of Trevyent® in the Regions ("Supply Services"). Cardiome made a $3,000 upfront payment to the Company (the "Upfront") and the Agreement provides for future regulatory, third-party payor reimbursement approval and commercialization milestone payments to be achieved by Cardiome of up to $9,250 and a scaling royalty ranging from the low teens to mid-teens percent on future Trevyent sales by Cardiome in the Regions. In addition, there is a fixed price on finished goods to be supplied by the Company as part of the Supply Services.

NOTE 1:—GENERAL

a. Nature of the business:

SteadyMed Ltd. (the "Company") was incorporated and is located in Israel, commenced its operations on June 15, 2005 and, together with its wholly-owned subsidiary, SteadyMed Therapeutics, Inc. ("Inc."), and Inc.'s wholly-owned subsidiary, SteadyMed U.S. Holdings, Inc. ("Holdings"), is a specialty pharmaceutical company focused on the development and commercialization of therapeutic product candidates that address the limitations of market-leading products for certain orphan indications and in other well-defined, high-margin specialty markets. The Company's primary focus is to obtain approval for the sale of Trevyent®, its lead product candidate for the treatment of pulmonary arterial hypertension ("PAH") in the United States

The Company submitted a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") for Trevyent for the treatment of PAH on June 30, 2017. On August 28, 2017, the Company received a Refusal to File Letter from the FDA. Based on its preliminary review, the FDA determined that the NDA was not sufficiently complete to permit a substantive review. Specifically, the FDA requested further information on certain device specifications and performance testing and also requested additional design verification and validation testing on the final, to-be-marketed Trevyent product. On November 1, 2017, the Company held a Type A meeting with the FDA to gain clarification on these requests. Company management believes the meeting was constructive. Following its receipt and review of the minutes from this meeting, the Company finalized its revised operating plan and now expects to resubmit the NDA for the subcutaneous administration of Trevyent in the fourth quarter of 2018. The Company have also finalized a revised spending plan, to allow its current cash and cash equivalents to fund operations through the third quarter of 2019, when it believes it will receive FDA approval of the Trevyent NDA.

The Company is also at an earlier stage of development with two products for the treatment of post-surgical and acute pain in the home setting. Its product candidates are enabled by its proprietary PatchPump®, which is a discreet, water resistant and disposable drug administration technology that is aseptically prefilled with liquid drug at the site of manufacture and pre-programmed to deliver an accurate, steady flow of drug to a patient, either subcutaneously or intravenously.

Inc. and Holdings are located in the United States, and commenced operations on January 1, 2012 and March 25, 2015, respectively. The principal executive officers of the Company are located in the offices of Inc. and Holdings, and Inc.'s and Holdings' principal business activities are to provide executive management, treasury and administrative support functions to the Company.

b. Liquidity:

The Company is devoting substantially all of its efforts toward research, development, regulatory approvals and marketing of Trevyent®. In the course of such activities, the Company expects operating losses for the foreseeable future. For the year ended December 31, 2017, the Company incurred operating losses of $20,435 and negative cash flows from operating activities of $22,243.

Until the Company has positive cash flows from operating activities, it will need to raise significant additional capital by way of the exercise of the remaining outstanding warrants issued in the 2016 and 2017 private placements, another private placement of debt and/or equity and/or a secondary public offering to allow the Company to continue as a going concern. These factors raise substantial doubt about the Company's ability to continue as a going concern. There is no assurance, however, that the Company will be successful in obtaining an adequate level of financing for its long-term needs, and therefore, there is a substantial doubt in the Company's ability to continue as a going concern.

The accompanying financial statements in this annual report do not include any adjustments to reflect the possible future effects on recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.

c. On June 28, 2015, the Company entered into an Exclusive License and Supply Agreement (the "Agreement") with Cardiome Pharma Corp. and Correvio International Sárl (hereinafter collectively referred to as "Cardiome") pursuant to which an exclusive royalty bearing license to certain of the Company's patents relating to Trevyent® ("License") was granted to Cardiome in order to develop and commercialize Trevyent, if approved for the treatment of PAH, in certain regions outside the United States, specifically, Europe, Canada and the Middle East (the "Regions"). The Company provided certain services for Cardiome through the fourth quarter of 2017. Cardiome is responsible for the regulatory submissions and approvals and commercialization of Trevyent in the Regions. In addition, the Company has agreed to supply Trevyent as finished goods to Cardiome upon commercialization of Trevyent® in the Regions ("Supply Services"). Cardiome made a $3,000 upfront payment to the Company (the "Upfront") and the Agreement provides for future regulatory, third-party payor reimbursement approval and commercialization milestone payments to be achieved by Cardiome of up to $9,250 and a scaling royalty ranging from the low teens to mid-teens percent on future Trevyent sales by Cardiome in the Regions. In addition, there is a fixed price on finished goods to be supplied by the Company as part of the Supply Services.