I'm pretty much in agreement with this, except I find a risk adjustment of a 33% chance of success in P3 with 2*900 participants to be overly conservative, given that P2b involved 300 individuals. The math of increasing the sample size from 300 to 900, considering the statistically positive P ratio of P2b, indicates a very high probability of success. This would be different if, let's say, P2b had a sample of 30 rather than 300. Of course, there's more to gaining approval than just statistical efficacy.
We can revisit this if/when OPT gets close to 70 cents.
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Ann: Security Class Reinstatement to Quotation- OPTOB, page-27
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