I had looked at them and thought it was too risky and Fibromyalgia seemed to be one of those indications that could result in a high placebo effect. If memory serves wasn't this the 2nd trial and the first one failed to reach significance? In fact if I recall correctly Cypress started the second trial before the results of the first were known much to Forrests disapproval. I wonder if this is enough for approval?
CYPB +104% (!) in AH trading. The gain is so large because most investors (including me) had written off the fibromyalgia program for dead.
Actually it is probably so large because even ardent longs had written off a label for Fibromyalgia syndrome. In discussions of the previous trial all CYPB said was that that endpoint wasn't stat sig - in contrast they said the Fibro pain endpoint just missed stat sig. Now here it is again - and stat sig.
In contrast I suspect that the recent PFE NDA filing for Lyrica was probably only for pain relief. So Milnacipran will come out of the FDA perhaps 12 months later - but with a significantly more comprehensive label if the ph ii plus the first ph iii is supportive enough. Perhaps doubling the market size?
Note that there are unknowns that will remain unknown for a while - e.g. after the first failed ph iii CYPB said they were going to tune the endpoints and they forthrightly said they would not tell us how for competitive reasons.
I like CYPB precisely because they are so forthright and self aware (self awareness being VERY important in order to avoid Feynman's folly) - the pity is that the really forthright spokesman (the CEO Kranzler) stopped talking when they decided they made a conscious decision to keep quiet.
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