(Total Views: 352)
Posted On: 11/26/2019 2:41:22 PM
Post# of 155130
As safety data for combo depending on what FDA will decide regarding the dose for which the BLA will be submitted. A pivotal trial for mono will definitely be required.
It is madness by the FDA not to have approved 350mg some time ago. Further safety data for 525 and 700mg could have been collected during the mono study...
It is madness by the FDA not to have approved 350mg some time ago. Further safety data for 525 and 700mg could have been collected during the mono study...
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