Valproic Acid for the Treatment of Significant Hemorrhage
Awarded Limited / Sole Source Justification Posted
See the award notice from .
- Solicitation number
- W81XWH20VPA
- Agency
-
Medical Command
Department of the Army, Department of Defense
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- W81XWH20C0122 Federal contract award
- Awardee
- Westat, Inc.
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- USA
Notice details come from SAM.gov. Updated .
About this opportunity
This Limited/Sole Source Justification Notice from the Department of the Army Medical Command supports awarding an estimated $13.2 million sole source contract to Westat, Inc. for management of a phase 2 clinical trial from September 2020 to September 2023 to further research valproic acid's potential as a treatment for significant hemorrhage. As the current IND holder who has completed prerequisite pre-clinical studies and FDA discussions under a prior $10 million contract, Westat is the only company capable of satisfying the agency's requirement to mitigate the leading preventable cause of death for military personnel by executing GCP-compliant clinical trials for a new indication for this investigational drug within the necessary timeframe.
Notice text
Sole source contract for the research and development to procure services of an investigational new drug (IND) sponsor for the performance of good clinical practice (GCP) compliant clinical trials leading to a new indication for valproic acid (VPA) for the treatment of patients with significant hemorrhage.
Awarded contract W81XWH20C0122 to unknown vendor for unknown amount on 2020-09-24.
Files
| File | Type | Posted |
|---|---|---|
| JA_W81XWH20C0122_Redacted_Final.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Valproic Acid for the Treatment of Significant Hemorrhage | Award Notice | |
| This notice | Limited / Sole Source Justification | |
| Valproic Acid for the Treatment of Significant Hemorrhage | Special Notice | |
| Valproic Acid for the Treatment of Significant Hemorrhage | Pre-Solicitation |
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