I am watching Zevra today. (ZVRA on Nasdaq)
They had a drug Arimoclomol approved by the FDA today. It was their third BLA attempt and had Fast Track, Priority Review, Breakthrough Therapy, and Rare Pediatric Disease designations by the FDA. Price at trading halt is $7.64, still halted as I am writing this post. It is interesting to me as the journey is similar to our current BLA from a big-picture view. Not the same of course, but somewhat similar.
Their approval came one day before the PDFUA date, however they did have and ADCOM meeting on August 2nd whereas we do not have an ADCOM for our BLA.
Just interesting stuff for me, watching these BLA's play out with the FDA. Thought someone else might find it interesting as well.
Have a good weekend everyone,
D#
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I am watching Zevra today. (ZVRA on Nasdaq)They had a drug...
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