Excellent recap - thank you! Question on the cl
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Posted On: 03/05/2020 7:19:27 PM
Excellent recap - thank you!
Question on the clinical section of the BLA. Did he say they could submit within 3 days after receiving the response from the FDA, or did he say they were expecting a response within 3 days? I would really be surprised if it was the latter because the FDA doesn't normally set deadlines for itself.
Also on the manufacturing section, I think he said they were expecting the final documentation within 10 days, and it would then take another week or two to do the paperwork that's required for submittal. Do you know if I heard that correctly?
Sorry for all for all of the questions but I was driving and unable to take notes.
Thanks!
Question on the clinical section of the BLA. Did he say they could submit within 3 days after receiving the response from the FDA, or did he say they were expecting a response within 3 days? I would really be surprised if it was the latter because the FDA doesn't normally set deadlines for itself.
Also on the manufacturing section, I think he said they were expecting the final documentation within 10 days, and it would then take another week or two to do the paperwork that's required for submittal. Do you know if I heard that correctly?
Sorry for all for all of the questions but I was driving and unable to take notes.
Thanks!
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