I stand by the common-sense answer I gave in the previous post: that the lack of preclinical data for treating fibromyalgia with Milnacipran will place a higher than usual burden on the clinical data.
In that case I will choose to disagree with you - it would be largely nonsensical for the FDA to sign an SPA that would have them approving two 0.045's but disapprove an 0.06 and an 0.01.
Is it a guarantee? Clearly not since this is *somewhat* subjective and certainly there are times when the FDA is nonsensical. But probably a worthwhile play for Cypress/Forrest especially if they have another in the pipe anyway to expand the indication.
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