the liberalization of the FDA has been a rare bright spot of leadership throughout this crisis. if someone in critical condition wants access to experimental drugs, they should be allowed. their body, their prerogative.
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Tbh this is standard FDA practice, not ‘liberalization’; compassionate use has been around since the 1960s, and remdesivir is a Ph3, so it has already passed safety and is now being evaluated for efficacy. It’s also orphan designated, so incentives are aligned to accelerate use.
but we also have ‘right to try,’ now. it will be interesting to see how that factors in.
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Unfortunately it may add noise to data + slow down our ability to find a treatment, diverting resources that could be spent on more promising avenues. I’ve been in the tough conversations re: compassionate use. It diverts resources on everything from manufacturing to liability.
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e.g. Ascletis Pharma has four different formulations in process for covid. If they received data that one didn’t work, but with “Right to Try” were asked to keep producing, distributing, and monitoring, that’s resources taken away from studying the other three prospects.
End of conversation
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