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Posted On: 01/10/2020 6:19:49 PM
Post# of 149412
Re: ClosetInvestor #14742
This trial was an investigative trial to explore responses at different dosages; safety data from this trial are used for the COMBO BLA for 700mg.
FDA has signalled that they will require a PIVOTAL phase 3 trial for monotherapy (although 525mg and 700mg were good); the protocol had been filed in July? last year, but FDA required some changes, and the protocol should be finalized this quarter... As soon as it is finalized, the investigational trial will be shut down and pivotal will be initiated (pending enough funding).
FDA has signalled that they will require a PIVOTAL phase 3 trial for monotherapy (although 525mg and 700mg were good); the protocol had been filed in July? last year, but FDA required some changes, and the protocol should be finalized this quarter... As soon as it is finalized, the investigational trial will be shut down and pivotal will be initiated (pending enough funding).
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