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Posted On: 09/28/2020 2:59:22 PM
Post# of 154722
CrazyRon,
I've not gotten a clear and definitive answer to the same question; however, my reading indicates that if the FDA and drug sponsor effectively communicate within the prescribed timeline (30-day) with a "Type A meeting" that it is just a "stopped clock" situation. That would hopefully put Leronlimab back at the 75-day milestone of the BLA process. But who knows what the FDA will do....
See Appendix A of this FDA doc.
https://www.fda.gov/media/78941/download
Now...the question is...is it still Expedited (6-month) or Standard Review (10-month) timeline. I'm thinking still Expedited with no refiling fee.
I've not gotten a clear and definitive answer to the same question; however, my reading indicates that if the FDA and drug sponsor effectively communicate within the prescribed timeline (30-day) with a "Type A meeting" that it is just a "stopped clock" situation. That would hopefully put Leronlimab back at the 75-day milestone of the BLA process. But who knows what the FDA will do....
See Appendix A of this FDA doc.
https://www.fda.gov/media/78941/download
Now...the question is...is it still Expedited (6-month) or Standard Review (10-month) timeline. I'm thinking still Expedited with no refiling fee.
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