Light Bulb moment...Dr J "What we saw in CD10, rem
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Posted On: 08/05/2020 5:12:19 PM
Light Bulb moment...Dr J "What we saw in CD10, remarkably, was a very clinically significant reduction in SAE....I've been the principal investigator on 300 studies and I've never seen a study where the active drug arm reduced the SAE compared to placebo- we never see that, and that really is for patients with COVID, the important metric period."
Ok, so I didn't fully grasp the significance of that SAE reduction in the safety release on CD 10 last week. Clearly, we need to know exactly what the SAE's were on both arms, and we'll just have to see if the "statistical significance" Nader is claiming to have found is enough to sway the FDA. That goes back to knowing it works vs having enough patient data to get the FDA to approve out of a P2 trial that was cut short. We're kind of banking the severity of the pandemic there.
Topline results next week? We shall see. Going back to a previous post, the results better be good if we're releasing them because we can't afford to tank the share price before the NASDAQ meeting.
Ok, so I didn't fully grasp the significance of that SAE reduction in the safety release on CD 10 last week. Clearly, we need to know exactly what the SAE's were on both arms, and we'll just have to see if the "statistical significance" Nader is claiming to have found is enough to sway the FDA. That goes back to knowing it works vs having enough patient data to get the FDA to approve out of a P2 trial that was cut short. We're kind of banking the severity of the pandemic there.
Topline results next week? We shall see. Going back to a previous post, the results better be good if we're releasing them because we can't afford to tank the share price before the NASDAQ meeting.
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