(Total Views: 652)
Posted On: 02/10/2020 11:17:46 AM
Post# of 149086
I disagree.
The very fact that FDA keeps changing the goal posts and how they handled the BLA process makes me highly suspicious.
There is no rational reason for not accepting a 350mg BLA back in March: combo was tested for 350mg, showed superior efficacy and safety to ibalizumab and maraviroc in a unmet medical need population.
Dosage could have been optimized AFTER approval...
Something doesn't feel right here...
The very fact that FDA keeps changing the goal posts and how they handled the BLA process makes me highly suspicious.
There is no rational reason for not accepting a 350mg BLA back in March: combo was tested for 350mg, showed superior efficacy and safety to ibalizumab and maraviroc in a unmet medical need population.
Dosage could have been optimized AFTER approval...
Something doesn't feel right here...
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