WE hold a patent....we are working towards the gra
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Posted On: 02/26/2019 10:42:49 AM
Re: Hitbodedut10 #14326
WE hold a patent....we are working towards the granting of said patent...so right now we have IP that outlines exactly how our pill is to be made...that holds true for any company that is developing a pill..
As I pointed out last week, GW pharma had their EPIDOLEX epilepsy patent challenged in court by Insys....There was the main part of GW's patent which was then broken down into 13 sub patents.
Insys spent more than 2 million dollars to challenge GW...and they were successful in having the first 2 of 13 patents struck down...
Even though GW's EPIDOLEX was granted FDA approval...they survived the challenge on the 11 other patents but lost on the first 2...
It is speculated that Insys spent this money because they want to develop a similar product to GW's EPIDOLEX...the big difference being Insys will use naturally derived cannabis extracts...
EPIDOLEX is synthetic and one study has shown that over time synthetic cannabis loses its potency over time while naturally derived cannabis maintains its' potency.
You can begin to understand why the company is now entering into phase 2 on a few of it's products as phase 1 is always about the safety of a product to make sure it has no toxic effects on a patient...
Phase 2 is all about efficacy where they study how the drug works and does it perform as they expect in terms of blood levels for example,
The PK study is a blood study which will draw more than 240 vials of blood over a set period of time and analyze the constituents of the drug into the blood..
This is how efficacy can be studied...and just one of the ways of proving efficacy...
As I pointed out last week, GW pharma had their EPIDOLEX epilepsy patent challenged in court by Insys....There was the main part of GW's patent which was then broken down into 13 sub patents.
Insys spent more than 2 million dollars to challenge GW...and they were successful in having the first 2 of 13 patents struck down...
Even though GW's EPIDOLEX was granted FDA approval...they survived the challenge on the 11 other patents but lost on the first 2...
It is speculated that Insys spent this money because they want to develop a similar product to GW's EPIDOLEX...the big difference being Insys will use naturally derived cannabis extracts...
EPIDOLEX is synthetic and one study has shown that over time synthetic cannabis loses its potency over time while naturally derived cannabis maintains its' potency.
You can begin to understand why the company is now entering into phase 2 on a few of it's products as phase 1 is always about the safety of a product to make sure it has no toxic effects on a patient...
Phase 2 is all about efficacy where they study how the drug works and does it perform as they expect in terms of blood levels for example,
The PK study is a blood study which will draw more than 240 vials of blood over a set period of time and analyze the constituents of the drug into the blood..
This is how efficacy can be studied...and just one of the ways of proving efficacy...
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