I don’t think anyone else is saying there hasn’t been a few mistakes from RAC however they at least appear to be failing forward.
The two stratum EMD AML trial had high dose chemo as the only option that was able to utilize the 505(B)(2) pathway to accelerate approval. The low dose stratum was an FTO POC trial, at the time I think everyone agreed this was an appropriate use of funds covering both opportunities. Without the potential for breakthrough drug designation status via RC220 and cardio-protection it may very well have still been relevant.
Hopefully enough options are converted t
hat the new investigator led AML trial can go ahead. But at least we have 6 months to decide if the management team are capable before SH need to recommit.
All the best Kron00, hopefully the AGM can answer some of your questions.
General Comments / Chat, page-9540
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