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Thursday, 11/21/2019 8:48:37 AM

Thursday, November 21, 2019 8:48:37 AM

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CNS Pharmaceuticals Filed Request with FDA for Pre-IND Meeting for Berubicin

 Download as PDFNOVEMBER 21, 2019 8:00AM EST

HOUSTON, Nov. 21, 2019 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, filed a Pre-IND meeting request for Berubicin for IV for the Treatment of Glioblastoma Multiforme to the US Food and Drug Administration Division of Oncology Products 2, Center for Drug Evaluation and Research.
In its request, the Company outlined its rationale for the continued investigation of the compound and detailed key questions for the FDA, including its permission to utilize the supply of Berubicin acquired from Reata Pharmaceuticals Inc. in the planned upcoming Phase II clinical trial. The company has performed a preliminary purity testing and analysis on Reata's supply of Berubicin and verified that it is 99.9% pure.
"We believe that utilizing the supply of Berubicin we acquired from Reata could offer the Company significant costs savings and eliminate the excess risk and time associated with manufacturing complex drugs," stated CEO of CNS, John M. Climaco.


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