RE: Welease Wodger21 Dec 2022 16:37
Regulatory approval by the FDA, MHRA, EMA, etc will require proof that drug is efficacious for particular indications, specifying dose(s), route(s) and rate(s) of administration and dosing frequency. This is for Avacta's protection as much as anything since medical litigation is about the fastest way to ruin a small company.
Proof will be by comparison with standard of care for each indication (cancer type) and there will be lots of thought going into what is the best dose and rate of IV infusion (or possibly directly into tumours? - possible slow release formulation in the future?) and how often AVA6000 should be administered. If efficacy is good and side effects are minimal then, because doxorubicin is so well characterised, hopefully these Phase 2 trials will be 'a formality', particularly if AVA6000 is in Accelerated Approval.