Ann: LVAD Results Webcast Presentation, page-4

Yes and the FDA set a target re: GI Bleeding and this was achieved so hence BLA meeting being organised .... I cant see the FDA pursuing something they believe to have failed ?

I also don’t see that the NIH would throw more $ at an additional trial if they think it was a complete waste of time / failure ?

The pump thrombosis problem with the LVAD device made assessment of weaning difficult and I would anticipate that is why they are keen to undertake a new trial with the newer model LVAD this time around ... costs for these trials are enormous so again I cannot see NIH going to such expense if they weren’t of the opinion that it was worthwhile ?

GLTAH