Eagle believes that these findings…support the expansion of the product’s label to include this indication. The Company continues to analyze the study data, and expects to discuss the full data and next steps with the FDA in the near future.
EGRX has previously stated that, given positive data in the Saudi trial (which they now have), at most one small US trial would be needed for FDA label expansion of Ryanodex to include an indication for exertional heatstroke.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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