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Re: 10nisman post# 31594

Friday, 07/30/2021 12:56:01 PM

Friday, July 30, 2021 12:56:01 PM

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it means they need more/better data to support approval.


They wouldn't ask for more if they didn't like what they already see. The government has no problem shutting down trials that they are funding when data isn't good.

A BLA requires more than one trial. A 200 patient trial is tiny. It makes sense to make it bigger for the BLA.
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