More thoughts on the investigator sponsor AML trial. Should Race redeploy funds to MOPs?
I think it’s been mentioned @johndprent Race may await safety data on the P1 prior to any AML trial. Also does it make sense to run a $4m AML trial if really there isn’t going to be a commercial result before CPACS. If an aml trial runs in parallel to CPACS or starts after CPaCS? Emory can’t possible take a year to submit a request and not be accepted / rejected already?
At a stretch a PRV may be granted for RPDD but to obtain this likely need adult trial then paediatric expansion. Also, the PrV sunset period is continually counting down even if extensions applies there is a risk this doesn’t occur under trump.
It’s a cost / resource that’s hard to justify at this stage if there is a better use for funds within the CPACS opportunity. Thoughts?
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