G'Day ma420,
A couple of considerations that are relevant to the quesitons you have posed:
1. There is no "Phase 2" and then "Phase 3" - it's a combined Phase 2/3.
2. We need tabs for this trial.
3. The tabs from the Phase 1 trial were developed to allow for a small dose in cohort 1, rising to the largest dose in cohort 4, for the purpose of identifying the optimum dose. Turns out, that's 10mg/kg. Going forward, expect all patients to be treated at that rate. This means the tablets will contain more API than those used for the Phase 1.
4. All tabs used in human trials have been and will be manufactured to cGMP standards.
Hope this is useful.
Cheers
Densy
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