Traws Pharma (TRAW) said Monday it has started developing an updated toxicology data package for the planned phase 2a human influenza challenge study of tivoxavir marboxil in response to information requirements from the UK's Medicines and Healthcare Products Regulatory Agency.
Traws said it expects to resubmit the updated data package to the MHRA during Q3 to enable the human challenge study to proceed and provide proof of concept data for the use of tivoxavir marboxil as an oral prophylaxis medicine.
The company said it expects a formal response from the regulator within 30 days of the resubmission.
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