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Posted On: 05/20/2020 7:21:18 PM
Post# of 155794
“We have a rolling review for Combo HIV which entitles us to a ruling within 6 months of the acceptance of the BLA.”
I’m not sure that this is correct. According to the FDA, a product that has received fast track designation “could be eligible for priority review if supported by clinical data at the time of BLA, NDA, or efficacy supplement submission (see section VIII).”
But this is a separate designation. So, unless the FDA has specifically indicated that we have been given “priority review” (and not just “fast track”), we should not expect it.
What’s more, even with a priority review, the timeline is only reduced to 6 months (from 10).
Again, I’m no expert, so I could be wrong about all of this. But my information comes from here:
https://www.fda.gov/files/drugs/published/Exp...logics.pdf
I’m not sure that this is correct. According to the FDA, a product that has received fast track designation “could be eligible for priority review if supported by clinical data at the time of BLA, NDA, or efficacy supplement submission (see section VIII).”
But this is a separate designation. So, unless the FDA has specifically indicated that we have been given “priority review” (and not just “fast track”), we should not expect it.
What’s more, even with a priority review, the timeline is only reduced to 6 months (from 10).
Again, I’m no expert, so I could be wrong about all of this. But my information comes from here:
https://www.fda.gov/files/drugs/published/Exp...logics.pdf
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