Akela Pharma Inc said it received a letter from the U.S. Food and Drug Administration that its six-month inhalation toxicology studies for its lead product were deemed invalid due to GLP (Good Laboratory Practice) deviations.
The drug developer said no toxicological reasons were cited and is evaluating several alternative remedies. It said it is confident that the submission for regulatory approval will not be delayed by more than six months.
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The drug developer said no toxicological reasons were cited and is evaluating several alternative remedies. It said it is confident that the submission for regulatory approval will not be delayed by more than six months.
Discuss Add this link to... Bury
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