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Posted On: 02/17/2021 10:25:29 PM
Post# of 145882
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Re: ombowstring #78448
Thanks Owbowstring. I appreciate the feedback. As an ex executive I look at all options on the table.the worst possible outcome would be the preliminary stat from unblinding without the reports is the data says the results are borderline .that puts me in a bind and what do I have to release to the public with a potential questionable outcome. My answer was , take the extra time to see the complete breakdown of the results which put me in a position to have a discussion with the fda should they see the results as negative. The ultimate issue here is time to get an EauA so I will do things in parallel so the time constraint is reduced and take my chances with the complete report
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