US DoD Naval Medical Research Center Receives FDA Guidance on the clinical development plans for new oral therapeutic
The FDA were recently provided a Pre- Investigational New Drug (IND) package for the new Hyper-immune therapeutic which specifically targets Campylobacter jejuni capsule and Enterotoxigenic Escherichia coli (ETEC) colonization factor antigen 1.
- The FDA were recently provided a Pre- Investigational New Drug (IND) package for the new Hyper-immune therapeutic which specifically targets Campylobacter jejuni capsule and Enterotoxigenic Escherichia coli (ETEC) colonization factor antigen 1.
- Following FDA review the agency provided a written response to the non-clinical questions posed in the briefing documentation as well as providing additional guidance and comments to support the planned IND submission.
- This is an important milestone in the development of any new drug for therapeutic evaluation.
- The company is also please to inform shareholders that the manufacturing program is proceeding as planned.