I re-read the Ann and can take that my question #2 was answered regarding ODD approval date as it was maintained thru annual submission, so instead of RC110 they have applied for RC220. So unless FDA considers RC220 as an bioequivalenf of RC110 how could they transfer the ODD status to RC220 based on historical data? Hence my other questions regarding toxicology report. Can you point me to the answers for my other Q’s? Thanks
Ann: US FDA Orphan Drug Designation Awarded to RC220 Bisantrene, page-97
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