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Downrampers Fail, page-10

  1. 322 Posts.
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    From that I take a delay is possible as further list of OS questions although oral submission would at least get to the heart of the matter but would still be a delay and CR would need to be done with uncertainty.

    I wouldn't think BSI would deviate from EMA opinion as if approve after neg opinion they would be wide open if something went wrong and if they rejected after positive opinion it would indicate they are 'not open for business' for other approvals from other drug companies (ie overly cautious).

    Still leaves three main possible outcomes to my thinking, thanks for your input.
 
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