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Posted On: 12/14/2022 8:30:32 AM
Post# of 148870
Ohm can weigh in but two quick points:
1) The presentation made clear the duration is not forever…it seems to last at least 3 months which if shown in human trials would set the low end for drug interval.
2) There is certainly precedent for FDA approval of drugs which could not be quickly reversed. The novel oral anticoagulants would be an example. While there are reversal agents now for dabigatran, rivaroxaban and apixaban, when they first came to market they did not exist. Benefit outweighed risk and that argument would be very compelling in the case of an HIV preventive.
1) The presentation made clear the duration is not forever…it seems to last at least 3 months which if shown in human trials would set the low end for drug interval.
2) There is certainly precedent for FDA approval of drugs which could not be quickly reversed. The novel oral anticoagulants would be an example. While there are reversal agents now for dabigatran, rivaroxaban and apixaban, when they first came to market they did not exist. Benefit outweighed risk and that argument would be very compelling in the case of an HIV preventive.
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