The only way this plan can possibly work is to require more intensive P4 testing.
i think that is what he is proposing. i am only agreeing with his proposal and hoping he means it. “Let’s prove efficacy after they’ve been legalized.”
“We should reform FDA so there is approving drugs after their sponsors have demonstrated safety -- and let people start using them, at their own risk, but not much risk of safety,” O’Neill said in a speech at an August 2014 conference called Rejuvenation Biotechnology. “Let’s prove efficacy after they’ve been legalized.”
Here he is saying that companies like Ariana can be extremely important.
“In order to regulate in this space, FDA had to argue that an algorithm, a series of numbers that match up to things, is a medical device,” he said. “I found that really astonishing -- astonishing that someone could say it with a straight face, and astonishing that someone could claim the ability to shut down companies that were never touching a patient but only accurately matching algorithms.”
Hi Xena I think it is like the new Japanese FDA rule. If p2 shows the drug is safe and reasonable efficacy it would be able to market and p3 will continue while the drug is on the market.
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