Thanks for this. If true, 90 days is a very attra
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Posted On: 10/27/2020 6:01:16 PM
Thanks for this. If true, 90 days is a very attractive interval to wait for authorization by the UK MHRA.
Regarding the EU EMA, filing and approval with that regulatory body have always been discussed by Dr.NP as being distinct and separate from the UK MHRA.
Looking forward to the outcome of the Canada meeting on November 9, and the scheduling of an EU EMA meeting (hopefully) shortly thereafter.
Too bad positive HIV traction in these ex-US countries won't embarrass the US FDA enough to accelerate any part of our Combo HIV BLA acceptance/PDUFA date, or approval.
Notwithstanding, the potential of multiple ex-US Combo HIV approvals, with the possibility of Mono Label Expansions, will be a nice adjunct to a COVID approval in Q1-2021.
Regarding the EU EMA, filing and approval with that regulatory body have always been discussed by Dr.NP as being distinct and separate from the UK MHRA.
Looking forward to the outcome of the Canada meeting on November 9, and the scheduling of an EU EMA meeting (hopefully) shortly thereafter.
Too bad positive HIV traction in these ex-US countries won't embarrass the US FDA enough to accelerate any part of our Combo HIV BLA acceptance/PDUFA date, or approval.
Notwithstanding, the potential of multiple ex-US Combo HIV approvals, with the possibility of Mono Label Expansions, will be a nice adjunct to a COVID approval in Q1-2021.
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