I believe the full patent will be a matter of filing substantial additional documentation, but it will be done.
To me the big question with the psoriasis cream is based on what Mediq has indicated in terms of bringing it to the German market. They clearly told people that after some trials, it would be on the market in roughly 3 to 6 months, that was a few months ago.
I believe the trials they were referring to are the expanded Phase1 Trials being done in Israel, but in some ways it sounded like trial would be run in Germany. Regardless of where they're run, I cannot see a Govt. approval in such a short period of time, but I can see trials where looking at some pictures, it will be easy to see that patients are seeing improvement in their condition.
It's my belief that Mediq can market the cream in Germany without Govt. approval, but it won't get the same treatment as a fully approved drug. The language used by both companies makes me wonder if that is what really is intended.
If the results of the testing done to date are as positive as I believe they will be, I think it would be a shame not to market it if the alternative is years of additional clinical trials to gain drug approvals. On the other hand, if the Israeli authorities clearly see the benefits and can see approval with just a little further expansion of the trial, I could certainly see delaying to gain Israeli acceptance.
I have no doubt that where cannabis is legal, OWCP could sell the cream, and perhaps even the sublingual tablet, as it exists today without further testing. The question is, just how much clinical proof do they want, and if the answer is full drug approval, I suspect we're talking about at least two years or more, before sales will be initiated. If FDA is involved it could take much longer.
As for the database not being updated, I've seen other trials done in clinics all over the world where the clinical trials database was updated, it may purely been optional, but the company made a choice not to do it, they could have chosen otherwise.
Gary
To me the big question with the psoriasis cream is based on what Mediq has indicated in terms of bringing it to the German market. They clearly told people that after some trials, it would be on the market in roughly 3 to 6 months, that was a few months ago.
I believe the trials they were referring to are the expanded Phase1 Trials being done in Israel, but in some ways it sounded like trial would be run in Germany. Regardless of where they're run, I cannot see a Govt. approval in such a short period of time, but I can see trials where looking at some pictures, it will be easy to see that patients are seeing improvement in their condition.
It's my belief that Mediq can market the cream in Germany without Govt. approval, but it won't get the same treatment as a fully approved drug. The language used by both companies makes me wonder if that is what really is intended.
If the results of the testing done to date are as positive as I believe they will be, I think it would be a shame not to market it if the alternative is years of additional clinical trials to gain drug approvals. On the other hand, if the Israeli authorities clearly see the benefits and can see approval with just a little further expansion of the trial, I could certainly see delaying to gain Israeli acceptance.
I have no doubt that where cannabis is legal, OWCP could sell the cream, and perhaps even the sublingual tablet, as it exists today without further testing. The question is, just how much clinical proof do they want, and if the answer is full drug approval, I suspect we're talking about at least two years or more, before sales will be initiated. If FDA is involved it could take much longer.
As for the database not being updated, I've seen other trials done in clinics all over the world where the clinical trials database was updated, it may purely been optional, but the company made a choice not to do it, they could have chosen otherwise.
Gary
