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Posted On: 05/03/2021 11:21:39 AM
Post# of 145254
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Re: Evil Rabbit #88854
It does sound that way, but we do have rolling review and 2 of the 3 sections of the BLA are already submitted. I am guessing the final section will be submitted in July. not sure why it is worded this way, because the FDA clearly states that rolling submission means each of the 3 sections can be submitted as they are done instead of all 3 at one. nothing says that they can sub-divide the sections and submit those in smaller chunks.
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