TechGuru, thanks for writing the road map. I boo
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Posted On: 04/19/2020 2:58:45 PM
TechGuru, thanks for writing the road map. I bookmarked it, will be instructive to compare with the real process. I have a question about the BLA for combo. You wrote:
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BLA files probably next week. Is a rolling application and the clinical part has been iterated few times with FDA.
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I asked this question the other day but received no answer.
Under the rolling BLA, Nader can submit any portion separately and he did so with the first part in March of 2019. I recall that during one of the CCs in March of 2020 he announced that he had two separate clinical BLAs and will let the FDA decide which to accept: the original one and one on the additional larger group of patients the FDA had suddenly requested in the end of December 19/early January 20. My question is: did he actually submit these clinical parts to the FDA? I can find no official PR about this.
Thank you for clarifying this.
_________________________
BLA files probably next week. Is a rolling application and the clinical part has been iterated few times with FDA.
_________________________
I asked this question the other day but received no answer.
Under the rolling BLA, Nader can submit any portion separately and he did so with the first part in March of 2019. I recall that during one of the CCs in March of 2020 he announced that he had two separate clinical BLAs and will let the FDA decide which to accept: the original one and one on the additional larger group of patients the FDA had suddenly requested in the end of December 19/early January 20. My question is: did he actually submit these clinical parts to the FDA? I can find no official PR about this.
Thank you for clarifying this.
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