NO Whytee - I'm actually embarrased for you.
Heading refers to a pathway
Si's comments refer to an outcome after pathway completion which may be accelerated approval.
How about you provide negatives on the actual FDA comments as stated in the announcement
" the presented results may support a reasonable likelihood of clinical benefit......in LVAD patients, consistent with the criteria for accelerated approval"
When you are going to correct someone and give them a dressing down please be accurate.
Reg
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-446
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