My guess is that the FDA didn't like the permutation testing methodology used. (If you look at the original positive Ph II trial ann they mention this). They probably just looked at the graphs in the original report and said "not good enough". Which I think, given there are effects clearly greater than the error bars, is a bit harsh.
While I'm comfortable with permutation testing I'm not surprised that the more conservative FDA isn't.
So my perspective:
We all knew BT was (statistically) a long shot and that the FDA demands very strong clinical data. The rejection of BT does not mean the data is no good. What we may be seeing is a variant on the FDA requirement with BT for large trial numbers. One of the points of permutation testing is that it's a different (Bayesian) way of looking at the data and working out likelihoods. It's quite possible that the FDA looked at the data and said "naaah the raw error bars are too big, you need more trial patients". It's also possible that the FDA looked at each data set individually (for each measureable) and didn't allow the combination of measureables (which is what the permutation testing does).
It remains to be seen (presumably at the next meeting with FDA) what the way forward is. The best case for now is going to a Ph III trial which will take at least 6 months to set up and at least a year to do which means nothing to market before 2017.
And no news for another 6 months. So the big thing now is for NEU to keep to their timelines.
I think the SP is an overreaction- I felt that 15-18c was more than fair just for Ph II. But hey you can't fight the market.
NEU Price at posting:
10.0¢ Sentiment: Hold Disclosure: Held
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