(Total Views: 779)
Posted On: 10/27/2020 6:29:18 PM
Post# of 154377
Re: Riztheinvestor #63508
Perhaps relevant to note that the UK and US BLAs are not the same.
UK is weekly 350mg dose.
US is weekly 700mg dose.
If fsoalex's schedule is correct as to the 90 day disposition of the UK BLA, then the MHRA will almost certainly dispostion the 350 mg BLA before the FDA dispositions the 700mg BLA.
Pourhassan intentionally played this gambit: MHRA deliberations at 350mg will be much shorter than FDA deliberations at 700mg because the 350mg data is already 100% complete. The gambit looks good so far.
UK is weekly 350mg dose.
US is weekly 700mg dose.
If fsoalex's schedule is correct as to the 90 day disposition of the UK BLA, then the MHRA will almost certainly dispostion the 350 mg BLA before the FDA dispositions the 700mg BLA.
Pourhassan intentionally played this gambit: MHRA deliberations at 350mg will be much shorter than FDA deliberations at 700mg because the 350mg data is already 100% complete. The gambit looks good so far.
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