Editing Openai/6931b6bf-ceb4-8001-ad1d-faa66f3cf0b8 (section)

=== ✅ Estimated Odds That ALA-002 Reaches Phase 3 ===

Because ALA-002 is an NCE in psychiatry, the best benchmark is the historical probability that an NCE entering Phase 2 will successfully advance to Phase 3.

===== Industry Probability: Phase 2 → Phase 3 =====

Across all therapeutic areas:
* ~30% – 35% For CNS/psychiatry drugs:
* ~20% – 30%

===== For Novel Psychoactive Compounds (MDMA-like analogues) =====

There is very limited historical data, because almost no MDMA analogues have made it through formal pharmaceutical trials.
But drugs in psychiatry, especially psychoplastogens, psychedelics, and serotonin-modulating agents, generally fall on the lower end of the progression range due to:
* high placebo response
* regulatory uncertainty
* complex trial design
* difficulty showing effect size consistency

===== ⭐ Realistic Estimated Probability for ALA-002 =====

➡️ 20% to 30% chance of reaching Phase 3
(assuming it begins a Phase 2 trial and completes it)

This estimate reflects:
* It’s an NCE (which historically reduces success rate vs reformulated drugs).
* It’s in mental health, a category with ~25% Phase 2 → 3 transition rate.
* ALA-002 is aiming to replicate MDMA-like therapeutic effects, but MDMA-assisted therapy itself has had regulatory headwinds in 2024–2025.