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NP stated something about paying a penalty if CYDY wished to see the unblinded interim data. He gave an example like instead of p=0.05 there may be a penalty that results in p=0.045. - mtrong34

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If the DSMC retains the data and recommends ending the trial for superior efficacy and turns over their report to the FDA , then the FDA will likely accept a higher p value then if Amarex gets the data and submits it. If the DMSC says we have good results but doesn't recommend filing and we take over the data the FDA will want a higher level of efficacy for approval because the data is no longer considered clean.

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What cmon CDiddy get serious how can you make those statements . - reallypeople?

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Why wouldn't moderate or severe be approved by the end of the year. Longhaulers most likely would do to needing a phase 3 with the phase 2 patient population anticipated. I think the longhaulers phase 2 should be overpowered with a much larger patient population to increase the likelihood of approval on phase 2.

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“Anyways looks like cancer is plugging along, 5 patients results being submitted soon for BTD? I don’t think the FDA Is going to give us BTD.”

Did he really say only 5 patients?

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That is the minimum number of patients the FDA will consider for a BTD, I'm sure we'll submit the number of patients that we have longer results for.