RE:RE:88!! Fair question DV. Allow me to speculate as I have no particular inside track, only deductive reasoning.
The suggestion has been made by some that the Trial could be stopped early for a number or reasons including :
- ethically, it could stopped because in a open Label Trial the Doc's has discovered that PMX does indeed save lives - so morally & ethically how can you treat the control group with a sham filter? It's why Euphas 1 was stopped as a Trial almost a decade or more ago
- the FDA has seen enough. Particularly if they take into consideration other studies and Meta Analyses involving PMX. Principal amount those might be Euphas 2 and EDEN.
- statistically ( at 90 or 100 or 110,etc.) the Tigris Trial has " confirmed" an Absolute mortality benefit of at least 10% ( the opening goal). How? by exceeding expectations on the first 90 ( or 100, etc)
see also Kellum's paper.
However the show might still go on because for example, the FDA has already granted Spectral many unexpected concessions ( eg Fast Track stays, Bayesian, Open Label, extra locations, Etc) so why should they grant more by calling it early? Or, the thought process may be that by going to 150 the final stats/numbers will be such that they end up being much better than 10% overall ( assuming a continuation of results to date that are exceeding expectations) meaning a higher price for PMX could be supported by going to 150.Finally there may be no benefit in terms of speed to market given other regulatory hurdles yet to be completed ( eg approving Baxter's Prism pumps for HP)
Keep in mind as well, that Baxter may decide to " pull the trigger" based on statistical probabilities alone and the need to create sizzle, and continue the Trial to 150 on their own ( hence the need for the additional sites)
Under that scenario Spectral shareholders may not even care if the Trial ultimately goes to 150 or not.
But just all spectralation at this point. Point is it might be prudent to be prepared for any number of eventualities.
AIMHO DYODD
MM