Successful Applicaton for EMA Paediatric Waiver
Filed with ASX · · 3 pages · English
• Argenica has been successful in its application to the European Medicines Agency (EMA) seeking a full waiver to develop ARG-007 in paediatric acute ischaemic stroke (AIS), which is an uncommon condition in children. • Argenica’s Product-Specific Waiver to submit a Paediatric Investigational Plan (PIP) for all subsets of the paediatric population removes the regulatory obligation to conduct paedi
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Earlier from Argenica Therapeutics
- Quarterly Activities/Appendix 4C Cash Flow Report
- AI Analysis Reveals Efficacy In Severe Stroke Patients
- Positive TNK Study Results Fulfil Key FDA Requirement
- ARG-007 Efficacious Dose Validated in New Preclinical Study
- Phase 2 Trial Promising Improvements in Functional Outcomes
Later from Argenica Therapeutics
- Half Yearly Report and Accounts
- Argenica Receives $3.97m R&D Tax Incentive Cash Rebate
- Presentations at European Stroke Organisation Conference
- Clinical Advisory Committee Established to Advance Phase 2b
- IND Application Advanced With Successful Completion of Assay
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