RE: Food for thought21 Aug 2020 12:39
To me, it's encouraging and its means they are happy that the internal signal they have seen means they can make the trial bigger and commit resources to it. Scientific language is deliberately nuanced.
For those wanting an idea of the aims of the different phases of trial:
Phase 1 = Mainly to establish what is the right dose along with safety. Generally very small number of patients. Cannot register with FDA etc with Phase 1
Phase 2=Using the dose established from Phase 1 in a larger number of patients. Main aim is to look at safety with some look at signal. In a rare disease (very small numbers (IBS is not one) ) they can register if there is an unmet need (no other treatment available) they can register with FDA etc if there is a treatment response and has acceptable safety.
Phase 3= This is the gold standard for registering a treatment. Large numbers of patients randomised against what the standard of care is.