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Re: longmike2 post# 1975

Sunday, 06/03/2007 1:23:57 PM

Sunday, June 03, 2007 1:23:57 PM

Post# of 6451
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.

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