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Posted On: 12/09/2021 7:30:53 PM
Post# of 148883
I still wish we weren't doing the 50 patient interim analysis in Brazil - and still not sure why we are - unless we just don't believe we can meet full enrollment. although that goes counter to NP's mention of a coming expected surge in Brazil.
My point is that our achilles heel has been the lack of solid, deep / robust data set. and it's clear we'll never get the "benefit of the doubt" from the FDA. my fear is that even if we have good results, the smaller sample size will be used against us - or worse, the smaller sample size simply yields a lesser result.
trust me - i want data as soon as possible like everyone. but we need to get strong data on a big trial to show everyone (especially the FDA) what a mistake they made, and finally get us to approval.
My point is that our achilles heel has been the lack of solid, deep / robust data set. and it's clear we'll never get the "benefit of the doubt" from the FDA. my fear is that even if we have good results, the smaller sample size will be used against us - or worse, the smaller sample size simply yields a lesser result.
trust me - i want data as soon as possible like everyone. but we need to get strong data on a big trial to show everyone (especially the FDA) what a mistake they made, and finally get us to approval.
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