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Posted On: 09/21/2020 4:36:55 PM
Post# of 148936
Re: invisioner #57222
There are multiple steps in the HIV process that have been debated so it's best to break them out IMO
Step 1: Amarex to Prepare Updated BLA Analysis/Data
- 30 days?
Step 2: FDA Multidisciplinary Review
- we know it's a min of 30 days, so perhaps 45 days?
Step 3: Rework Based on Review Results
- no rework would be a few days just to resubmit but rework may take 15 days?
Step 4: Submission and Wait for PDUFA Date
- some believe we do not reset the 60 day clock, others believe we do so maybe 15-60 days depending on how that part plays out?
These are all very rough estimates. They specifically didn't respond to the question about dates on the CC so it comes down to best guesses. I would be happy to get other's estimates/comments.
Step 1: Amarex to Prepare Updated BLA Analysis/Data
- 30 days?
Step 2: FDA Multidisciplinary Review
- we know it's a min of 30 days, so perhaps 45 days?
Step 3: Rework Based on Review Results
- no rework would be a few days just to resubmit but rework may take 15 days?
Step 4: Submission and Wait for PDUFA Date
- some believe we do not reset the 60 day clock, others believe we do so maybe 15-60 days depending on how that part plays out?
These are all very rough estimates. They specifically didn't respond to the question about dates on the CC so it comes down to best guesses. I would be happy to get other's estimates/comments.
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