I say a risky short (depending on your time horizon obviously). My guess is if one believes history repeats itself (to some degree) we see a lot of volatility till FDA decision. One could look at what happened after the Actimmune Phase and the NEJM article.
They did hit .001 in one trial but the miss in the other was so big that it raises lots of questions.
I think this buys them time to advance 191 and Dan Welch made a point of mentioning other compounds. The big question is what do partners think. Would one risk a deal now at a possible discount to approval deal price with the risk of no approval and what would ITMN take. Keep in mind there are two shots FDA and EMEA (which may actually be better since Orphan drug is longer there).
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