I believe the company is presenting trial peeks in their proper perspective. Investors on the other hand seem to always believe that when they get a peek, miraculous information will be released. A recommendation to continue the trial is really about as positive a statement as should be expected from the clinicians.
Certainly, for a very tiny percentage of all Phase III Trials the clinicians say more. In the worst case they say it's futile to continue, the trial's simply not near to meeting it's goals. In the best case they recommend going to the FDA for early review as the data greatly exceeds the requirements.
Frankly in one case the clinicians made it sound like the drug barely missed the target for approval at the second peek. They recommended an additional peek be added with a P-value established somewhere between the second peek P-value, and the final required value. This sounded very positive, but it didn't happen. Far worse than that, in the end the drug failed to meet the required P-value and the drug wasn't approved. I don't know how in the final third of the data a trial slips from almost meeting an interim goal that's much tougher than the final figure, but failing to meet that figure in the end.
What I'm suggesting is not getting caught up in what is, or isn't said. The FDA has a terrible habit of asking for more information after all trial goals have been met or exceeded, it's something we all need to remember. I'm a strong believer they should approve, and require all inclusive Phase IV trials until they're satisfied that the drug's working well and requires no further label modifications.
Phase IV Trials shouldn't generally cause drugs to be removed from the market, however if some problems are noted, they should be dealt with, normally with some modification on how the drug is to be used.
Gary
