scPharmaceuticals : Receives Complete Response Letter from the FDA for FUROSCIX
The CRL indicated the need for additional human factors studies, device modifications, and potentially a clinical validation study. scPharmaceuticals intends to request a meeting with the FDA to further evaluate the deficiencies raised.
While we are disappointed with the outcome of the review, we are committed to addressing the issues of the CRL and bringing this important product to market, commented
About scPharmaceuticals scPharmaceuticals is a clinical-stage pharmaceutical company focused on developing and commercializing products that reduce healthcare costs and improve health outcomes. The Companydevelops products for the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease.scPharmaceuticals is headquartered in Burlington, MA.For more information, please visit scPharmaceuticals.com.
Forward-Looking StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to statements regarding the Companys plans to meet with the FDA to discuss the Furoscix CRL, plans to resubmit the NDA for Furoscix, the timing of the FDA review process and the Companys expectations with regard to its discussions with the FDA are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, without limitation, risks associated with the Company conducting human factors studies, device modifications and potentially an additional clinical validation study, the ability of our device to appropriately deliver therapy, our ability to appropriately identify patients and implement risk assessment and mitigation strategies, whether the Company will be able to address the deficiencies raised in the CRL and the receipt of regulatory approval for Furoscix, as well as other risks set forth under the caption Risk Factors in the Companys Annual Report on Form 10-K for the year ended
Contacts:Troy Ignelzi, CFO, scPharmaceuticals [email protected]
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