NetworkNewsBreaks – Silo Pharma Inc. (NASDAQ: SI
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Posted On: 10/03/2022 4:45:11 PM
NetworkNewsBreaks – Silo Pharma Inc. (NASDAQ: SILO) Preparing for Ketamine Tech FDA Pre-Investigational New Drug Package
Silo Pharma (NASDAQ: SILO), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, is collaborating with Premier Consulting to prepare a pre-investigational new drug (“IND”) package and meeting request with the United States Food and Drug Administration (FDA) for SPC-26, the company’s novel topical formulation of ketamine for the treatment of fibromyalgia. The company is planning to pursue a 505(b)(2) regulatory pathway for novel topical formulation of ketamine. According to the company, Premier Consulting will assist with the development of SILO’s nonclinical, clinical, clinical pharmacology, and biopharmaceutics strategy and program to be proposed to the FDA. Silo is planning to submit the pre-IND meeting request for collaborative discussions with the FDA in anticipation of the filing a clinical IND package. “We are confident that our highly constructive preclinical work on SP-26 will offer strong support for our pre-IND package as we seek to advance our time-released ketamine delivery system into the clinic,” said Silo Pharma CEO Eric Weisblum in the press release. “We intend to pursue the 505(b)(2) regulatory pathway and have engaged Premier Consulting as a true strategic partner to pave the way for productive discussions and alignment with the FDA.”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
Silo Pharma (NASDAQ: SILO), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, is collaborating with Premier Consulting to prepare a pre-investigational new drug (“IND”) package and meeting request with the United States Food and Drug Administration (FDA) for SPC-26, the company’s novel topical formulation of ketamine for the treatment of fibromyalgia. The company is planning to pursue a 505(b)(2) regulatory pathway for novel topical formulation of ketamine. According to the company, Premier Consulting will assist with the development of SILO’s nonclinical, clinical, clinical pharmacology, and biopharmaceutics strategy and program to be proposed to the FDA. Silo is planning to submit the pre-IND meeting request for collaborative discussions with the FDA in anticipation of the filing a clinical IND package. “We are confident that our highly constructive preclinical work on SP-26 will offer strong support for our pre-IND package as we seek to advance our time-released ketamine delivery system into the clinic,” said Silo Pharma CEO Eric Weisblum in the press release. “We intend to pursue the 505(b)(2) regulatory pathway and have engaged Premier Consulting as a true strategic partner to pave the way for productive discussions and alignment with the FDA.”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
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