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Posted On: 07/11/2021 12:40:25 PM
Post# of 148902
Swordman, You're fixated on the RTF, man. I have to ask, since I have no knowledge or experience: Is an RTF letter really a Lego, paint-by-number school teacher analysis of the BLA?
"Hey Johnny, great effort, but here's the list of things you did wrong, and here's how you need to correct them."
Maybe they are like this. Do you know?
Or maybe the FDA says 'No, here's your RTF. If you'd like to discuss details, you can request a meeting by filling out preliminary meeting request form 4590. Someone will review and may send you the final meeting request form. Please keep in mind, well, you know, Covid....'
"Hey Johnny, great effort, but here's the list of things you did wrong, and here's how you need to correct them."
Maybe they are like this. Do you know?
Or maybe the FDA says 'No, here's your RTF. If you'd like to discuss details, you can request a meeting by filling out preliminary meeting request form 4590. Someone will review and may send you the final meeting request form. Please keep in mind, well, you know, Covid....'
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