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Posted On: 07/25/2017 12:37:07 AM
Post# of 15624
I believe that you need to put things in order. It's my understanding that the company is blind to the Phase 1 Safety Trial until the results are in. If I'm correct about that, how can they possibly announce where they intend to sell the product until they know just how safe it is, and what, if any restrictions should be placed on its use.
Beyond some possible new partnership or the initiation of new trials, I believe that the safety results are the first major news we should hear. As for sales, barring some new relationship for somewhere where the cream can be marketed sooner, Mediq has said they were running some efficacy trials that would take 3 to 6 months, then sales in Germany become possible. This to my knowledge has only been expressed to people who've contacted them, no PR has been issued.
Israel could be the one place that sales could occur before Germany. I believe that Emilia is manufacturing the cream in Israel. The question is, would the Israeli Govt. want additional efficacy testing before putting the drug on sale as a drug. Remember, OWCP isn't looking to market the cream as a cosmetic.
If the safety trial shows the drug to truly be very safe, perhaps the efficacy trials can be far less rigorous than the safety trial was. I believe the benefits of the cream should be seen in days to weeks by people who have psoriasis. If say 50 people with psoriasis tried the cream for a month and 35 of them had clearly improved conditions, that's 70% which is at least as effective as drugs with much worse side effects, and probably substantially higher costs. While the FDA certainly wouldn't approve a drug with this small a trial, I'm uncertain that Israel, or other countries won't permit it to be sold with that much information.
Note, I'm not suggesting that full govt. approval would come from such a test, but we know that the cream could be marketed as a cosmetic if they wished, with reasonable testing I would hope they could approach sales as a drug.
Gary
Beyond some possible new partnership or the initiation of new trials, I believe that the safety results are the first major news we should hear. As for sales, barring some new relationship for somewhere where the cream can be marketed sooner, Mediq has said they were running some efficacy trials that would take 3 to 6 months, then sales in Germany become possible. This to my knowledge has only been expressed to people who've contacted them, no PR has been issued.
Israel could be the one place that sales could occur before Germany. I believe that Emilia is manufacturing the cream in Israel. The question is, would the Israeli Govt. want additional efficacy testing before putting the drug on sale as a drug. Remember, OWCP isn't looking to market the cream as a cosmetic.
If the safety trial shows the drug to truly be very safe, perhaps the efficacy trials can be far less rigorous than the safety trial was. I believe the benefits of the cream should be seen in days to weeks by people who have psoriasis. If say 50 people with psoriasis tried the cream for a month and 35 of them had clearly improved conditions, that's 70% which is at least as effective as drugs with much worse side effects, and probably substantially higher costs. While the FDA certainly wouldn't approve a drug with this small a trial, I'm uncertain that Israel, or other countries won't permit it to be sold with that much information.
Note, I'm not suggesting that full govt. approval would come from such a test, but we know that the cream could be marketed as a cosmetic if they wished, with reasonable testing I would hope they could approach sales as a drug.
Gary
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