The cost will depend on the path forward which I believe will shorty be released
“What happens after breakthrough therapy designation?Once the breakthrough therapy designation is requested by the drug sponsor, the FDA and sponsor work together to determine the most efficient path forward.”
I would imagine the company has lodged this application as I believe it meets the criteria to do so ,safety being a major criteria, and feedback from the FDA is within 60 days, which could be any day or week now.
Overnight Market report, page-2339
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