(Total Views: 605)
Posted On: 07/13/2020 12:23:44 PM
Post# of 145890
Agree! We need full disclosure. But this is not unusual for BLAs to get questions back, this happens more than not. What worries and troubles me the most is they need additional data for "substantive" review. Makes me think something major is missing. Sort of like turning in a 4000 word essay knowing you were substantially less when you turn it in. I hope this not the case! But the word "substantive" concerns me!
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