Hi @ahjay. Not sure if phase IIb will suffice for NDA (new drug application). Fast tracking mainly means "VIP" access to FDA (easier and more frequent meetings) and generally after phase II that may lead to discussion by FDA for resdisign of what would be a "standard" phase III. Sometimes they consider the drug and may decide phase II (b) can be expanded to fulfil phase iii.
Ann: US FDA & IRB approves start of ph2b head & neck cancer trial, page-9
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