This is what ChatGPT says,
which very sounds like what Imugene has to me.
In general, a registration trial (or pivotal trial) is typically required to demonstrate the safety and efficacy of a drug or treatment before it can be submitted to the FDA for approval. These trials are usually part of Phase 3 of clinical development. However, the FDA can approve a drug based on data from earlier phases, including Phase 1, or in some cases, Phase 2, if the data is robust enough to demonstrate safety and efficacy for the intended population.
In certain situations, a company may request approval through alternative pathways like:
- Accelerated Approval: If early-stage trials show promising results, the FDA might grant approval based on surrogate endpoints or early-phase data, especially for serious conditions where there are no other treatments available.
- Breakthrough Therapy Designation: This allows faster development and review processes if the drug shows substantial improvement over existing treatments, which may include approval based on Phase 1 or Phase 2 trials.
- Orphan Drug Designation: This is for rare diseases, where the FDA may approve drugs based on less comprehensive evidence if the disease is very rare and there are no effective treatments.
So while Phase 3 trials are often the standard before registration trials, in exceptional cases, a drug may proceed to registration with Phase 1 or Phase 2 data, particularly if the disease being treated is severe, and the treatment is showing significant promise. However, these situations are exceptions rather than the rule.
(20min delay)