The company is privately funded, but it's clearly
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Posted On: 10/09/2017 3:32:41 PM
Re: GreenMachine84 #11059
The company is privately funded, but it's clearly their intention to bring it on the market once they have approvals and sales established somewhere.
As to your view on the FDA, I too would like to see the FDA properly staffed and doing the job they're intended to do. Sadly our Govt. cuts such agencies, even the IRS to save money when those agencies could generate far more revenue if they were expanded.
I have a completely different concept for drug approvals where the drug developer would essentially do a Phase 1/2 to establish proof of concept. At that point their either could be options, or the FDA could take over the approval process completely. I believe the fact that the FDA was in control would eliminate the thought that the drug developer was hiding something, and clinical trials could be dramatically shortened. If their were options, they'd involve less FDA involvement, but greater cost. The key would be, the more involved the FDA was, the greater the royalty they'd receive from sales of approved products. The key would be, the FDA over time would be fully funded from royalties from the approved products, but of course the Govt. would need to provide seed money to get such a process started.
I believe that getting such FDA involvement in the process would permit all sorts of tiny Biotech's to advance drugs to approval without the almost mandatory partnership with big Pharma, but in the end big Pharma would probably still contractually end up manufacturing, distributing, and selling the product, but the agreements would be far fairer than they are today, and the cost of drug development would be far lower.
The FDA would be able to do all the things they don't allow drug developers to do when they run a trial. If in the middle of a trial they believe the trial drug could be more effective if patients were permitted to use some other drug that either improved the performance of the trial drug, or prevented unacceptable side effects, they could do it. Today, a drug maker would be told to run an additional trial with the additional therapies in the protocol. I.E. the FDA has never cared how much their actions cost the drug developers. I believe that if the FDA were responsible, the costs would come way down as they'd do the logical things they currently prevent the drug developers and clinicians from doing. This of course would apply equally to drugs developed with components coming from cannabis.
Gary
As to your view on the FDA, I too would like to see the FDA properly staffed and doing the job they're intended to do. Sadly our Govt. cuts such agencies, even the IRS to save money when those agencies could generate far more revenue if they were expanded.
I have a completely different concept for drug approvals where the drug developer would essentially do a Phase 1/2 to establish proof of concept. At that point their either could be options, or the FDA could take over the approval process completely. I believe the fact that the FDA was in control would eliminate the thought that the drug developer was hiding something, and clinical trials could be dramatically shortened. If their were options, they'd involve less FDA involvement, but greater cost. The key would be, the more involved the FDA was, the greater the royalty they'd receive from sales of approved products. The key would be, the FDA over time would be fully funded from royalties from the approved products, but of course the Govt. would need to provide seed money to get such a process started.
I believe that getting such FDA involvement in the process would permit all sorts of tiny Biotech's to advance drugs to approval without the almost mandatory partnership with big Pharma, but in the end big Pharma would probably still contractually end up manufacturing, distributing, and selling the product, but the agreements would be far fairer than they are today, and the cost of drug development would be far lower.
The FDA would be able to do all the things they don't allow drug developers to do when they run a trial. If in the middle of a trial they believe the trial drug could be more effective if patients were permitted to use some other drug that either improved the performance of the trial drug, or prevented unacceptable side effects, they could do it. Today, a drug maker would be told to run an additional trial with the additional therapies in the protocol. I.E. the FDA has never cared how much their actions cost the drug developers. I believe that if the FDA were responsible, the costs would come way down as they'd do the logical things they currently prevent the drug developers and clinicians from doing. This of course would apply equally to drugs developed with components coming from cannabis.
Gary
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