great summary. The oncology panel discussion highlighted Ariad Pharma a smaller biotech that was denied then later granted BTD.
They submitted based on P1 dose escalation n = 16 with 75% ORR but were told by FDA too early. Duration of response for R/R NSCLC was relevant.
At a long shot perhaps the nature of CPACS maybe Race can submit BTD earlier. Being realistic P2 data might be required. If we get it at P1 that is perhaps a massive endorsement from the FDA.
So what happened to Ariad Pharma after that?
No less than $5.2b USD deal and it went quickly.
https://www.forbes.com/sites/antoinegara/2017/01/09/ariads-5-2-billion-sale-to-takeda-nets-260-million-windfall-for-hedge-fund/
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