phase 3 trials, page-4

Eddy, Cortina etc al - hi new here.

My read of information disclosed is that existing cohorts are continuing into the Ph.III trials - remember the significance of ACT is that it's a 2nd/3rd line of treatment - meaning it provides therapy for those who are non-compliant/resistent to existing 1st-line ARV therapies.

As I understand there are now 2 parts to the Ph.III trials - i. what has now commenced which is effectively an extension of the Phase IIb trials, and ii) a combination trial with existing therapies which was ordered by the authorities to determine the most effective combinations and interactions. My understading is also that it's about a two year process.

All in all two key things strike me:

1. Phase III trials are really not about "if" it works, but rather how to maximise therapeutic outcomes and extend the reach and targeting of the trial. I think I read somewhere there will be extension studies for e.g. on ACT and children etc.

2. My understanding is that there are few therapies of this nature which complete positive Phase IIb trials that do not make it market - think we need to see Phase III not as a static exercise but as an alternative line of treatment as the trial is working through clinics, and as a concurrent pathway to commercialisation.

There may be some research scientists out there that can add more or correct me if I am wrong.

Cheers, Donna