Good Morning All. So no news this morning. When
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Posted On: 10/03/2018 11:43:10 AM
Good Morning All. So no news this morning. When will we get news? I assume most are looking for answers, and we have nothing. So maybe we should try answering a few questions for a change --- just a thought.
What could UNVC/AGRiMED/SATIVEO be waiting for? Dalton said regulators, and Crockett told someone the FDA and DEA. All could be true, but that does not really help us. The DEA already made their decision, and that leaves the FDA. We know the FDA is currently cracking down on mislabeled cannabis products, and many West Coast companies are in serious trouble right now with the FDA. So could this be the problem? I suspect it certainly could be. The FDA is being overly cautious and taking their time to ensure new products meet the requirements indicated on their labels.
What are the issues? Basically, products are claiming they can cure or improve conditions that research does not corroborate. Thus, more research is needed. Also, when the FDA tests a company's product it must be consistent from one batch to the next (I don't think AGRiMED has a second crop yet). Documentation is needed that proves the product is consistent, and that contaminants are not present in the product. This means rigorous testing and documentation is required if a company wants FDA approval.
Finally, some ask why a company like Merck MilliporeSigma would even look at or be interested in UNVC/AGRiMED/SATIVEO? The answer is actually quite simple. Merck is a German company, and Germany does not allow growers. Thus, Merck needs to look for quality biopharmaceutical companies operating elsewhere.
We could sure use that Farm Bill now.
What could UNVC/AGRiMED/SATIVEO be waiting for? Dalton said regulators, and Crockett told someone the FDA and DEA. All could be true, but that does not really help us. The DEA already made their decision, and that leaves the FDA. We know the FDA is currently cracking down on mislabeled cannabis products, and many West Coast companies are in serious trouble right now with the FDA. So could this be the problem? I suspect it certainly could be. The FDA is being overly cautious and taking their time to ensure new products meet the requirements indicated on their labels.
What are the issues? Basically, products are claiming they can cure or improve conditions that research does not corroborate. Thus, more research is needed. Also, when the FDA tests a company's product it must be consistent from one batch to the next (I don't think AGRiMED has a second crop yet). Documentation is needed that proves the product is consistent, and that contaminants are not present in the product. This means rigorous testing and documentation is required if a company wants FDA approval.
Finally, some ask why a company like Merck MilliporeSigma would even look at or be interested in UNVC/AGRiMED/SATIVEO? The answer is actually quite simple. Merck is a German company, and Germany does not allow growers. Thus, Merck needs to look for quality biopharmaceutical companies operating elsewhere.
We could sure use that Farm Bill now.
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