Anyone here an expert with Rolling Reviews... I
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Posted On: 02/26/2020 10:43:07 AM
Anyone here an expert with Rolling Reviews...
I emailed Nader earlier with below. If anyone exactly understand how Rolling Review works, it will be appreciated if they can help me and Nader understand what is the best play for HIV BLA.
parts of what I emailed>>
But if Rolling Review means, FDA cannot give a CRL on part 2 of the submission, it might be worth considering only submitting part 2 when ready and purposely delay part 3.
Again, a) I don't understand if there are timelines associated with it, b) how the rolling review can help in not receiving a CRL, and c) if there is a short timeline for the to respond for each part, but it is worth understanding all their options, before making the next move and submitting part 3.
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I emailed Nader earlier with below. If anyone exactly understand how Rolling Review works, it will be appreciated if they can help me and Nader understand what is the best play for HIV BLA.
parts of what I emailed>>
But if Rolling Review means, FDA cannot give a CRL on part 2 of the submission, it might be worth considering only submitting part 2 when ready and purposely delay part 3.
Again, a) I don't understand if there are timelines associated with it, b) how the rolling review can help in not receiving a CRL, and c) if there is a short timeline for the to respond for each part, but it is worth understanding all their options, before making the next move and submitting part 3.
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