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Posted On: 11/04/2021 1:59:34 PM
Post# of 148876
Aaron11 minutes ago
An other good post from Aaron (YMB)
Quote
"From RTF page 8
"Following the January 2019 MPPRC meeting, DAV communicated the following comment: "members of the council asked about the CCR5 Receptor Occupancy data for the 350mg, 525mg and 700mg doses. Please submit this data With your BLA.".
DAV reiterated this request in our December 16th, 2019 correspondence.
Despite this advice, the BLA only includes representative data..."
So Amarex feels that NP rushed them into a submission. Let me get this straight, the FDA reviewer points out in January, 2019 that RO data be submitted, asks again for it in December 2019, notes that in May of 2020 it's still not submitted with the BLA and that's because NP rushed them?
endquote
An other good post from Aaron (YMB)
Quote
"From RTF page 8
"Following the January 2019 MPPRC meeting, DAV communicated the following comment: "members of the council asked about the CCR5 Receptor Occupancy data for the 350mg, 525mg and 700mg doses. Please submit this data With your BLA.".
DAV reiterated this request in our December 16th, 2019 correspondence.
Despite this advice, the BLA only includes representative data..."
So Amarex feels that NP rushed them into a submission. Let me get this straight, the FDA reviewer points out in January, 2019 that RO data be submitted, asks again for it in December 2019, notes that in May of 2020 it's still not submitted with the BLA and that's because NP rushed them?
endquote
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