The key to the myeloma research is to have an IRB
Post# of 15624
(Total Views: 301)
Posted On: 04/25/2017 5:54:21 PM
The key to the myeloma research is to have an IRB trial in Israel coupled with an FDA submission for the same trials.
The FDA can't(or won't) approve a plant cannabis trial in the US, but it can't deny one that takes place in Israel. (Fact, it's already done)
IMO, OWC is gaming the US system. Look how they are doing it with the cream. Get accepted for FDA safety trial. Since no trial can be legally done in the US with plant based cannabis, it's being done in Israel. The results are then forwarded to the FDA which the FDA must under treaty accept. And let's not forget the political aspect of it either. Israel is a protected state of the US.
Then comes Phase II and III. Must be accepted by the FDA's own rules.
So OWC files for an IRB in Israel for Phase I of the myeloma treatment. Does the same in the US since the treaty says it can be so. Bingo, we are off and running for future Phase trials that are submissible and acceptable by the FDA because of the politics. Will be accepted at a 80% yes, 20% no. But the trials are done in Israel since it is legal there and not the US. Brilliant
The management of OWC is not to be messed with and they are not playing games although it may seem like it. They know the system and have brought top notch folks on board to play the game, only they are not playing. This is why it is taking time to see results.
"This is White Rook to Queen's Bishop, Over?"
Tell ya what all. OWC is playing for keeps. This is high politics and finance rolled into one. Heck, what will the name of the movie be in 15 years.
Try this, Heaven Helped Us
The story of how an obscure Israeli startup pharma company, through it's relentless research, helped mankind find a better way through the God given cure know as cannabis. A David vs Goliath action film in the financial columns of Wall Street to the Halls of Congress. The gripping true story of the fight or survival of mankind
Okay, got carried away. It was boring with the price, so ya'll get this. True though IMHO.
The FDA can't(or won't) approve a plant cannabis trial in the US, but it can't deny one that takes place in Israel. (Fact, it's already done)
IMO, OWC is gaming the US system. Look how they are doing it with the cream. Get accepted for FDA safety trial. Since no trial can be legally done in the US with plant based cannabis, it's being done in Israel. The results are then forwarded to the FDA which the FDA must under treaty accept. And let's not forget the political aspect of it either. Israel is a protected state of the US.
Then comes Phase II and III. Must be accepted by the FDA's own rules.
So OWC files for an IRB in Israel for Phase I of the myeloma treatment. Does the same in the US since the treaty says it can be so. Bingo, we are off and running for future Phase trials that are submissible and acceptable by the FDA because of the politics. Will be accepted at a 80% yes, 20% no. But the trials are done in Israel since it is legal there and not the US. Brilliant
The management of OWC is not to be messed with and they are not playing games although it may seem like it. They know the system and have brought top notch folks on board to play the game, only they are not playing. This is why it is taking time to see results.
"This is White Rook to Queen's Bishop, Over?"
Tell ya what all. OWC is playing for keeps. This is high politics and finance rolled into one. Heck, what will the name of the movie be in 15 years.
Try this, Heaven Helped Us
The story of how an obscure Israeli startup pharma company, through it's relentless research, helped mankind find a better way through the God given cure know as cannabis. A David vs Goliath action film in the financial columns of Wall Street to the Halls of Congress. The gripping true story of the fight or survival of mankind
Okay, got carried away. It was boring with the price, so ya'll get this. True though IMHO.
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