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Replies to post #225249 on Biotech Values
10/02/19 7:10 PM
In the written response received by Savara on October 1, the FDA indicated that the data provided in the briefing package do not provide sufficient evidence of efficacy and safety and did not recommend that the Company submit a Biologics License Application (BLA). The Company is working to determine the next steps for the Molgradex development program.
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