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Monday, July 01, 2024 5:35:43 PM
if they do bypass the RFI process…the extra time it took might make it worth the lengthy time it took.
RFI response time is 60 days.
You gain 60 days max by avoiding an RFI.
The “extra time” they took was way more than 60 days. It’s not “worth it” to avoid an RFI.
Now, you could make the argument the MAA needed to be water tight and bullet proof because of the immunotherapy implications, and the extra time could absolutely be justified through that route, I don’t know.
But to say the extra time was taken to avoid an RFI seems silly.
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