It all depends where you place the emphasis, here as you do
"This second, confirmatory study will be conducted in parallel with a patient population that has an identical clinical profile; approximately 600 of them using the same primary endpoint"
Or here as I would
"This second, confirmatory study will be conducted in parallel with a patient population that has an identical clinical profile; approximately 600 of them using the same primary endpoint"
Either way there is no mention as to what phase the trial is, 3 or 4.
I've looked for FDA guidances on parallel trials in the past and again today and can only find a parallel trial in relation to medical devices not drug trials. However I do find the phrase confirmatory trial and the word studies in the FDA document Accelerated Approval, second last para,
"These studies are known as phase 4 confirmatory trials."
This is the ASX announcement where the trial change was published.
PHASE 3 HEART FAILURE TRIAL SIZE TO BE SUBSTANTIALLY REDUCED FOLLOWING FDA DISCUSSIONS
Perhaps this will be clarified in the morning.
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- Ann: P3 Trial of MSB's Cell Therapy in CHF Completes Recruitment
Ann: P3 Trial of MSB's Cell Therapy in CHF Completes Recruitment, page-37
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