In addition to some of the previous key points highlighted, I would assume the
"...and acknowledged that Acute Myeloid Leukemia (AML) continues to have significant unmet clinical needs which require new treatment solutions"
is very significant!! My (limited) understanding this would make the (eventual) pathway to commercialisation significantly faster and potentially easier.
Some-one with expertise in this area may wish to correct or confirm this.
Ann: Positive Pre-IND Guidance from FDA on Zantrene, page-30
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