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Ann: RC220 Peripheral Infusion Safety Confirmed, page-22

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    Yes you can submit the HREC paperwork ahead of receiving the final reports from the toxicology studies. There is usually quite a bit of back and forth with the HERC committees over minor issue (the people on them like to feel like they are adding value) and the time before getting the final toxicology results can be used for this dance.

    While the toxicology studies are required as RC220 is considered a new drug entity, given the history of bisantrene it is really little more than a box ticking exercise.
 
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