dt and btt trials running together, page-4

Hi dma,

Yeah i read this before. I don't agree with your interpretation mate. I have a total of 273 Ventrassist implants for US Trials. See my calcs below:

DT TRIAL:
Module A: 180 patients with 2:1 randomisation with control arm that doesn't get the implant. i.e 120 Ventrassist implants and 60 patients without. To see who fares better.

Module B: 45 patients randomised with another LVAD (maybe Thoratec 2nd gen device?). It doesn't say the ratio here. Assuming it is also 2:1, then we have 30 Ventrassist implants and 15 other commercial approved LVAD.

Therefore total Ventrassist implants for DT trial =

120 (module A) + 30 (module B) = 150

BTT Trial:
Total of 140 patients from a previous announcement. Not sure of the randomisation ratio, anyone know? Again assuming a reasonable balance of 2:1 to the control arm, that is 93 total Ventrassist implants.

Therefore total Ventrassist implants for US trials =

150 (DT trial) + 93 (BTT trial) + 30 (feasibility study) =

273

At $100k each that's just over $27 mil. These are only rough numbers of course depending on how many control participants there are. Could be less, could be more. Whichever way, it's a heck of a lot of implants.

And yeah dma you're correct in saying that the trials will run concurrently.

Cheers