Cobalis Corp. (fka CLSC)

[gfp927z]

Randy, From the graph of the first PreHistin Phase 3 results, I did some rough calculations. Of the trial's four arms, the two arms that correspond to the arms being used in the twin trials (6 weeks placebo, and 6 weeks drug) showed the best efficacy separation -

I come up with an approx 33% increase in allergy symptom scores in the placebo arm (going from roughly 7.2 to 9.6) vrs an approx 21% increase in the symptom scores in the drug arm (going from roughly 6.8 to 8.2). If we adjust for the differences in the baseline levels for each arm (an adjustment of 0.4), we can make a direct 6 week comparison of symptom scores of 9.2 (placebo) to 8.2 (drug), (the higher the number = more allergy symptoms).

In the November presentation, the CEO indicated that the FDA requires only a 10% separation between placebo and drug in allergy trials. Not being an expert in bio statistics, I was wondering which comparison would be appropriate, the ~36% reduction in the increase in symptoms between placebo and drug arms (representing the difference between the 33% increase in symptoms for placebo vrs the 21% increase in symptoms for drug), or on the other hand would it be the ~11% difference between the actual symptom scores (9.2 for placebo vrs 8.2 for drug)? Either way, the 10% criteria is met, but by the one calculation it is easily met, and by the other it is barely met.

Any ideas? Thanks.