Agree with almost everything that you have said, other than the fact that this is a pretty big gamble, I would argue that the real gamble is in the asset "flavour" rather than in the specifics of the company or trial design. I think once one is prepared to take on a Phase III CNS risk, in a single asset development business, then this is about as low a risk as it it is possible to be, within that favour profile. Based on the history of all phase III trials involving generic drugs, statistically, we are looking at about an 80% chance of a positive outcome about 68% without a CRL and 80% after an initial CRL. My own view is that the risk of a CRL is lower than this base statistic given just how widely prescribed our API and the size of the effect that was seen in Phase II.
I have been thinking over the past few days about where the possible risks to this scenario might lie and I can really only come up with one "small" concern. Here I trust the experience of out CSO who will have significant experience in dealing with 100s of clinical cases and the Phase III trial uses the approach she uses in the clinic everyday. That concern relates the the change in method for the measurement of Intracranial Pressure between the Phase II and Phase III trial. You will recall that in the Phase II trial we implanted in to the patients skull pressure monitors that took tens of thousands of measuremets. However, in the Phase III trial we are using opening pressure at LP, obviously this is a lot less invasive but also a cruder method and we are taking just two measurements over the 24 weeks. However, given the size of the effect seen in the Phase II trials and the uniformity of the response and the fact this is how they measure ICP in the clinic then I am sufficently reassured .
IXC Price at posting:
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