Yes absolutely it can be used for the BLA. I t
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Posted On: 02/26/2025 8:32:51 PM
Yes absolutely it can be used for the BLA.
I think the better questions, is if they decide to file the BLA again, since they now have the data from last year. Can they use the publication to support the Integrated Summary of Safety (ISS) that was required to be completed?
The answer to that is also a yes. 1,600 patients sounds like it could be an external, peer-reviewed version of the ISS. Extra eyes to make sure everything is good to go.
The hold was for the ISS. It was a hold for safety specifically the ISS part that is being addressed. The hold was never on the Integrated Summary of Efficacy ISE section of the BLA.
Now the question I ask. Did we need to do this in order to satisfy the requirements to start the CRC trial. My guess is most likely. So that means this doesn’t have anything to do with the BLA.
I’m not going to answer that.
I think the better questions, is if they decide to file the BLA again, since they now have the data from last year. Can they use the publication to support the Integrated Summary of Safety (ISS) that was required to be completed?
The answer to that is also a yes. 1,600 patients sounds like it could be an external, peer-reviewed version of the ISS. Extra eyes to make sure everything is good to go.
The hold was for the ISS. It was a hold for safety specifically the ISS part that is being addressed. The hold was never on the Integrated Summary of Efficacy ISE section of the BLA.
Now the question I ask. Did we need to do this in order to satisfy the requirements to start the CRC trial. My guess is most likely. So that means this doesn’t have anything to do with the BLA.
I’m not going to answer that.
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