Hope you're doing alright Scott.
Around minute 29:15 mark in the Feb ********* video Stamler talks about getting mechanisms in place to get efficient interactions with FDA. I Hope he is referring to applying for Breakthrough Therapy Designation. I'm not sure if they would wait to full analysis is complete to apply for BTD, or they'd do it straight from the late Jan topline results, if it's the latter then perhaps a decision could be known soon. You'd think 434 would have a good chance at achieving BTD.
Here's a good read up on BTD https://www.parexel.com/insights/new-medicines-novel-insights/advancing-rare-disease-drug-development/effective-regulatory-strategies/timing-and-data-are-critical-winning-breakthrough-therapy-designation-rare-disease-drugs
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Open | High | Low | Value | Volume |
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37 | 16255465 | 1.0¢ |
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15 | 24953518 | 0.006 |
Price($) | Vol. | No. |
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0.012 | 20418298 | 32 |
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