No. For BTD FDA does not require the same level clinical proof of efficacy than for marketing approval - I would say 'reasonable' expectation for improvement is enough, especially when there is no approved therapy for the indication. Brilacidin P2 trial does meet that 'standard'. In my opinion even fuzzy results with weekly cisplatin do not warrant rejection of BTD application.
But, FDA is free to disagree. They are also free to ask clarification for any part of application they please. And sometimes they really do please a lot - well beyond being an impartial gatekeeper.
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