If that were the case, then the trials were a classic victim of an unexpectedly high placebo effect.
That would render the data from both trials useless in terms of an FDA submission.
If there was some positive difference between Prehistin and Placebo, that might leave the door open to Cobalis partnering with someone and selling Prehistin without FDA approval - i.e. the scenario Randy suggested as a possibility.
It certainly would raise the question of whether Prehistin works since it couldn't adequately separate from placebo.
It would also raise the question of whether the trials could have been designed better to allow Prehistin, assuming it works, to have the opportunity to clearly separate from placebo.
And it would mean the company would, if they didn't partner as mentioned above, continue as Zebra's Law (#msg-5915520) would suggest and eventually run two more Phase III trials.
Everyone can use their own experience to gauge what two more trials would mean in terms of dilution and pps.
"Lets say that the data presented was inconclusive. There wasnt enough difference between the participants taking placebo and Prehistin. But both reported scores of 1 or 2s"
Mike as has been posted here many times over the last few months that was the case with Dvax. A large number of the patients recruited only had mild allergies vs having severe allergies. Patient in placebo and drug groups, had close to the same scores which caused their trial to fail. At least that is what they reported.
For Cobalis it has to be something more. They have to be able to prove that the data entered by the patients was entered in correctly or somehow corrupted after the data was entered.
If they have written diaries or key entry diaries that do not match up with the data on the database used to calculate the trial results, that would be the ticket.
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