Ok I'm amending what I said before. It seems the BTT designation is like a souped up fast track and to quote the FDA website it gives all of the fast track designation features plus "Intensive guidance on an efficient drug development program, beginning as early as Phase 1" as well as "Organisational commitment involving senior managers".
The site also says "Ideally, a BTT designation request should be received by FDA no later than the end of Phase 2 meetings if any of the features of the designation are to be obtained ". So it's under consideration now or never. We do know they have rare paediatric disease designation already which must help elevate them in the eyes of the FDA already.
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