"Meeting with FDA, expected within 30 days, to discuss a potential accelerated approval with a post-approval condition for an additional study."
When you read it, the FDA could approve the treatment with the condition of an additional study. Not as bad as first presented!!!!! Could be approved soon with conditional study! that's my take on it. Buy in cheap!!!!!
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- MSB to dispute FDA finding in Type A meeting
MSB to dispute FDA finding in Type A meeting, page-38
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