Just a quick explanation around the significance of this announcement for our main clinical focus on anticancer/cardioprotection. This clinical program of course would not be eligible for ODD (as ChatGPT points out the market is massive), but it allow us to leverage the orphan designation to increase our interactions with the FDA. We have and will continue to use the ODD process to advance our AML program, but this designation also allows us to have lots of discussions with the FDA around how to best advance the whole anticancer/cardioprotection program. Getting serious input from the the FDA early is pure gold.
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- Ann: US FDA Orphan Drug Designation Awarded to RC220 Bisantrene
Ann: US FDA Orphan Drug Designation Awarded to RC220 Bisantrene, page-34
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