On 29 Jun the FDA granted approval for Biomarin’s gene therapy for the treatment of hemophilia A, a serious bleeding disorder that is potentially life threatening.
Approval was based on a phase 3 study that was open labeland single arm.
The idea that the FDA will be bending the rules or betraying its madate if it grants approval to MSB is rubbish.
The decision will be based on the totality of the evidence submitted, the seriousness of the condition, the unmet need, and the 11-1 Advisory Committee vote.
2023 The Final Countdown, page-1243
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