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  1. TDA
    11,411 Posts.
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    Resourced, forever finding something to whine about:)

    What that statement means is that if they are asking specific questions about manufacturing processes (for example) and nothing else, then all data submitted to do with previous trials etc has more than likely been enough as no additional information has been requested.

    Everything is a process and they "could" be asking for additional information regarding clinical results, if that were the case I doubt SM would be saying all looks to be on track for planned sales.

    imo


 
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