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Fly News Breaks for May 24, 2016
SRPT
May 24, 2016 | 07:58 EDT
With the FDA action date for Sarepta's eteplirsen due on May 26, Janney Capital analyst Debjit Chattopadhyay laid out what he sees as the probabilities of the three outcomes that may be seen in the next 72 hours. Chattopadhyay sees a 15% chance that the company receives a "clean" accelerated approval with a broad label for the drug and thinks such an outcome could push the stock above $40 per share. He sees a 35% probability that the PDUFA is delayed or the drug is approved with a restricted or compassionate use label. However, the most likely outcome, by Chattopadhyay's estimate, with a 50% probability in his view, is that the company receives a complete response letter, or CRL. In that case, the stock could trade down to below $3 if a randomized study is needed for an NDA or between $5-$10 per share if the FDA only requires interim 48 week data, said Chattopadhyay, who keeps a Neutral rating and $10 fair value estimate on Sarepta shares.
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