Sunday, September 03, 2017 10:06:34 AM
My point is - the primary end point was clearly defined with % patients reaching the viral load reduction - Dr P was very confidence of meeting those numbers very easily.
FDA does not know how the trial is going. So it seems the results from 30 patient was not as expected which only company knew - based on these results, company was not confident that FDA will accept the results for NDA filing so they decided to keep the recruitment going till and got a meeting with FDA to discuss it.
So while the fda meeting was expected, the non-final top-line results and language of the PR makes me believe that the situation is not as clean/clear as it is made out to be.
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