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
Ann: LVAD Results Webcast Presentation, page-4
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