If the safety trial has been expanded, as we've be
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Posted On: 09/10/2017 12:40:03 AM
If the safety trial has been expanded, as we've been told, with patients with a variety of skin diseases, the trial can certainly be expected to take longer, but it could yield data that's far more meaningful. In fact, it might be this data that's all that's preventing Mediq from marketing the cream with limited proof that it works.
If the addition of the patients with skin diseases didn't begin until the original Phase 1 trial was due to complete, I would have to guess that we're talking about at least October to complete the modified trial.
It's my belief that the company could have updated the clinical trials database to show the changes in the trial, as well as when it's targeted to complete, but clearly they haven't done any update, at least not yet. I believe the evaluation period will still be 60 days, so even if after a week it was clear that a patients psoriasis, or some other skin disease was clearly improved, they'll still wait until the patient reaches 60 days before reporting what's happening, and I don't believe the trial is unblinded until the last patient to enter the trial has completed day 60.
Of course I could be very wrong, even if I'm right about additional patients, perhaps the observation time is less. The point is, we really know nothing, and the company has intentionally kept it that way. They can say the trial wasn't being done in the U.S. so they didn't update the site, but I know of other foreign trials where the database was routinely updated. It was their choice, not something dictated by the FDA or SEC.
Gary
If the addition of the patients with skin diseases didn't begin until the original Phase 1 trial was due to complete, I would have to guess that we're talking about at least October to complete the modified trial.
It's my belief that the company could have updated the clinical trials database to show the changes in the trial, as well as when it's targeted to complete, but clearly they haven't done any update, at least not yet. I believe the evaluation period will still be 60 days, so even if after a week it was clear that a patients psoriasis, or some other skin disease was clearly improved, they'll still wait until the patient reaches 60 days before reporting what's happening, and I don't believe the trial is unblinded until the last patient to enter the trial has completed day 60.
Of course I could be very wrong, even if I'm right about additional patients, perhaps the observation time is less. The point is, we really know nothing, and the company has intentionally kept it that way. They can say the trial wasn't being done in the U.S. so they didn't update the site, but I know of other foreign trials where the database was routinely updated. It was their choice, not something dictated by the FDA or SEC.
Gary
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