Having all our tier 1 programs pass phase II is not something we should be taking for granted, with the Teva/Xenon phase II failure clearly demonstrating that it is not a 'given'.
The interim analysis on our aGVHD and CHF programs in the phase III trials were potential pitfalls that were again passed.
FDA clinical trials set exceptionally high hurdles, with a 95%+ confidence level required to achieve a statistically meaningful result in a phase III trial.
Our MSC 100-IV (aGVHD) which has a phase III read-out (final stage) at the end of 2017 achieved overall response of 82% vs 39% at day 28, with a p-value=<0.0001. This is also the primary end-point for the phase 3 trial.
If I am not mistaken, that translates to a statistical meaningful result (99.99% confidence).
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