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Monday, April 18, 2022 9:08:01 AM
I am not as sure they have submitted, at least not completely, though I know the length of time that has elapsed would lead me to believe they have at least prepared it and quite probably submitted it or possibly well along in the midst of a rolling submission process now. I was trying to figure out based on any labeling clues whether there was more evidence of a submission being in process or being completed.
Some of the new regulatory pathways may lead to some changes to the steps of the BLA review process by engaged RA's as we know mfg readiness has climbed some in approval importance and it may be at least in shorter review timelines that labeling discussions come up sooner as well. Things are lining up for sure and it would be wonderful to find out the BLA submission has occurred, I am not as sure yet, still trying to confirm but I think getting closer.
GLTA
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