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clock Created with Sketch. 08/10/20
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Originally posted by imback
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We don't have any evidence which shows the FDA advised against or didn't agree to single arm trial. In a recent video posted here on HC from 2017, it appears an MSB official stating it was agreed between them and FDA that based on the efficacy of the 2/B trials, it would be unethical/unfeasible to run an RCT. So we need to be careful what assertions we make on what was agreed between FDA and MSB. We also cannot ignore the testimony on public record of an preeminent professor clinician who lives and breathes pediatric aGVHD and stem cell therapy for the last 20 years when she stated she or her colleagues would not do an RCT on children, given the effectiveness of MSCs. This was also stated by other experts in the field during the ODAC meeting. That is one of the reasons why FDA convenes these panels, so as to understand the clinical situation which they have no day to day experience in. We also can't now ignore that 9 panel members who voted that the data supports Ryoncil's effectiveness. In any informed consent documentation, parents would need to be made aware of the effectiveness of the active arm and it would be negligent for any principal investigator to not provide that 9-1 vote information in that informed consent waiver as well as other study data.
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In a criminal trial, the accused is innocent until proven guilty. The burden of proof is on the prosecution, with the assumption that the accused is innocent.
Last edited by
whytee :
08/10/20
(20min delay)