I've just returned from 5 days at one of my favori
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Posted On: 06/19/2018 1:19:31 PM
I've just returned from 5 days at one of my favorite places, Avalon, it's still a great place, but some of my favorite places there have been removed in managements determination to upscale the town. I feel for the business people there who've been forced out of business by demands that they spend millions to upgrade their establishment, or move out.
I see nothing major has happened in my absence, I'm not surprised, but I certainly expect it to happen when the time is right for the company.
We need to acknowledge that the company has managed to create many drugs and patents on a shoestring, and they're bringing them to trial in the same way. It's not unusual to run trials in hospitals that do research, and they've got some excellent agreements, but if you want trials to run quickly, you need to open many sites. The company may in the future run larger trial in numerous international sites, but not until they have more funds to support such trials.
To me, the immediate question is, does the company permit others they contract with to sell products they've developed after they're shown to be safe in a Phase 1 trial, or wait until efficacy has at least been demonstrated in Phase 2. It's very possible to run a Phase 1/2 with patients with the disease the drugs are intended for, but at this time the psoriasis trial was Phase 1 with healthy patients, so clearly they need a Phase 2 with people with psoriasis. Perhaps in the future they'll tell us more about other trials they're running, and we may learn that efficacy may be seen even in Phase 1 as dose escalation determines the most effective dosing protocols which would be used in Phase 2.
Being off for nearly a week has convinced me to back off some in the time I'm spending monitoring what's happening, I'll still be around, but don't intend to be quite as active.
Gary
I see nothing major has happened in my absence, I'm not surprised, but I certainly expect it to happen when the time is right for the company.
We need to acknowledge that the company has managed to create many drugs and patents on a shoestring, and they're bringing them to trial in the same way. It's not unusual to run trials in hospitals that do research, and they've got some excellent agreements, but if you want trials to run quickly, you need to open many sites. The company may in the future run larger trial in numerous international sites, but not until they have more funds to support such trials.
To me, the immediate question is, does the company permit others they contract with to sell products they've developed after they're shown to be safe in a Phase 1 trial, or wait until efficacy has at least been demonstrated in Phase 2. It's very possible to run a Phase 1/2 with patients with the disease the drugs are intended for, but at this time the psoriasis trial was Phase 1 with healthy patients, so clearly they need a Phase 2 with people with psoriasis. Perhaps in the future they'll tell us more about other trials they're running, and we may learn that efficacy may be seen even in Phase 1 as dose escalation determines the most effective dosing protocols which would be used in Phase 2.
Being off for nearly a week has convinced me to back off some in the time I'm spending monitoring what's happening, I'll still be around, but don't intend to be quite as active.
Gary
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