Re: Resverlogix Reaches Agreement With FDA for Key Aspects of Apabetalone Registration Enabling Study
posted on
Jun 22, 2020 06:27PM
Keep in mind the data we have from BoM. I'll almost state this wrong, but I think our RRR was 18% with a study powered for 30%. I would think this will be one of the inputs to the trial design and power calculations. Of course all of this will take into account the new target population including the SOC they are on. But if that 18% has any bearing on the power I think it will need to be a big trial. I guess the good news as far as I could understand it (not far ... hahaha) I recall that apabetalone's impact in BoM started very quickly???
I must say I'm glad the enthusiasm is back but I have my rose coloured glasses off at this stage. I want to actually see some science and progress at Zenith.
Just some thoughts. Slay me if I'm way off track here.
Toinv