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Stock impact report

scPharmaceuticals Inc. Announces Results of Type A End-of-Review Meeting with FDA Regarding FUROSCIX® NDA

scPharmaceuticals, Inc (SCPH)  More Company Research Source: GlobeNewswire
Last scpharmaceuticals, inc earnings: 3/24 07:00 am Check Earnings Report
US:NASDAQ Investor Relations: scpharmaceuticals.com
PDF No additional clinical efficacy, PK or safety data required December 31, 2020 cash, cash equivalents, restricted cash and investments estimated to be $105 million, sufficient to fund operations through potential FUROSCIX® approval and launch and into 2023 BURLINGTON, Mass., Feb. 23, 2021 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that on February 19, 2021, the Company received the official Type A meeting minutes from the U.S. Food and Drug Administration (FDA) regarding the requirements for resubmission of the FUROSCIX® 505(b)(2) New Drug Application (NDA) following the Complete Response Letter (CRL) received on December 3, 2020. The outstanding questions are primarily focused on Pre-Approval Inspections and bench testing. The Company will run additiona [Read more]
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