I believe the company wants to be identified as a
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Posted On: 07/14/2017 2:40:46 PM
I believe the company wants to be identified as a Biotech, and as such is saying our products are more thoroughly tested and proven than most of what can be purchased over the counter or in cannabis based stores.
Full FDA approval for a product would mean it could be available in any State, and probably accepted as approved in nearly all the rest of the world. I believe that may be the approach to MM, but it will take many years, and cost a lot of money. In order to achieve that, I believe they need to get the cream and sublingual tablet on the market with far less rigorous testing.
As I understand FDA and other testing, in all except those tests which can be used for approval, the FDA or other agency permits companies to propose tests they wish to run and judge them primarily to be safe, beyond that, most of the trial design is up to the sponsor and the IRB. In short, these agencies will let sponsors spend their money as they choose until such time as they want to establish a trial which may result in their approving the drug, then specific requirements which must be met are established. In some cases, our FDA have still asked for more after drugs met the pre-established conditions, so nothing is absolutely in concrete.
If you accept the above, it's very possible for the company to establish some very small Phase 2 Trials essentially to get some limited documentation of how their drugs work. The trials don't need to be blinded, nor do they need to have two arms, one of which is getting a placebo for comparison. In short, if 20 patients were tested with a product, each would represent 5% of the total, if 17 of them clearly saw improvement, they could say the drug was 85% effective. Certainly this is far to small a trial for the FDA to consider approval, and the FDA would no doubt want two groups, one receiving a placebo, and it would have to be double blinded, but the point is, the company could learn much, and not spend that much time and money running Phase 2 Trials which they define.
I believe the company has good reason to believe the cannabis cream will have benefits with acne, eczema, etc. but they may not have any real proof of that fact. With psoriasis we know they did substantial preclinical studies. Having proven safety in Phase 1, nothing should prevent them from defining their own Phase 2's to demonstrate what conditions the cream is effective for.
If as Mediq proposed, 3 to 6 months from now such trials could be run, the results could be the backbone to a PR campaign in announcing the availability of the cream in Germany, and perhaps many other European countries. I would hope that after the Safety Trials, the IRB's establishing these trials would reduce the requirement for blood draws, etc. I would hope that weekly observations by a clinician for a period of one to two months would be sufficient to judge the benefits of the cream in a number of skin conditions.
Of course this is my hope, the IRB may insist on something far more rigorous, daily observations with blood draws each time. The company may propose a modest trial that has a low cost, but the IRB may complicate the trial, and add to the expense, in order to assure in their minds the trial is being properly run.
This is my understanding of how it can work, I'm no expert, just basing it on what I've seen in the past.
Gary
Full FDA approval for a product would mean it could be available in any State, and probably accepted as approved in nearly all the rest of the world. I believe that may be the approach to MM, but it will take many years, and cost a lot of money. In order to achieve that, I believe they need to get the cream and sublingual tablet on the market with far less rigorous testing.
As I understand FDA and other testing, in all except those tests which can be used for approval, the FDA or other agency permits companies to propose tests they wish to run and judge them primarily to be safe, beyond that, most of the trial design is up to the sponsor and the IRB. In short, these agencies will let sponsors spend their money as they choose until such time as they want to establish a trial which may result in their approving the drug, then specific requirements which must be met are established. In some cases, our FDA have still asked for more after drugs met the pre-established conditions, so nothing is absolutely in concrete.
If you accept the above, it's very possible for the company to establish some very small Phase 2 Trials essentially to get some limited documentation of how their drugs work. The trials don't need to be blinded, nor do they need to have two arms, one of which is getting a placebo for comparison. In short, if 20 patients were tested with a product, each would represent 5% of the total, if 17 of them clearly saw improvement, they could say the drug was 85% effective. Certainly this is far to small a trial for the FDA to consider approval, and the FDA would no doubt want two groups, one receiving a placebo, and it would have to be double blinded, but the point is, the company could learn much, and not spend that much time and money running Phase 2 Trials which they define.
I believe the company has good reason to believe the cannabis cream will have benefits with acne, eczema, etc. but they may not have any real proof of that fact. With psoriasis we know they did substantial preclinical studies. Having proven safety in Phase 1, nothing should prevent them from defining their own Phase 2's to demonstrate what conditions the cream is effective for.
If as Mediq proposed, 3 to 6 months from now such trials could be run, the results could be the backbone to a PR campaign in announcing the availability of the cream in Germany, and perhaps many other European countries. I would hope that after the Safety Trials, the IRB's establishing these trials would reduce the requirement for blood draws, etc. I would hope that weekly observations by a clinician for a period of one to two months would be sufficient to judge the benefits of the cream in a number of skin conditions.
Of course this is my hope, the IRB may insist on something far more rigorous, daily observations with blood draws each time. The company may propose a modest trial that has a low cost, but the IRB may complicate the trial, and add to the expense, in order to assure in their minds the trial is being properly run.
This is my understanding of how it can work, I'm no expert, just basing it on what I've seen in the past.
Gary
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