dt and btt trials running together, page-8

Vyking,

I should add that my interpretation of:

“The target clinical performance of the VentrAssist in the BTT trial is for 75 percent of the patients to either have a heart transplant or still be listed for heart transplant at 180 days after implant of the VentrAssist."

...is that the 75% is the survival rate, not the number of implants. They will still have to do the full quota of implants. Happy to be corrected if you have further info though.

Also i believe an earlier announcement stated that the 30 implants of the feasiblity trial will be used as 'additional data' if needed. Therefore my take on this is that they are additional to the numbers in the BTT and DT trials, so if FDA calls on more data then they will be able to provide it and it will then count towards the total results of the BTT/DT trial.

Cheers