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Re: None

Monday, 05/29/2017 3:51:48 PM

Monday, May 29, 2017 3:51:48 PM

Post# of 203909
I really can't tell anyone how many psoriasis creams or sublingual tablets are available that are in any way cannabis based. If their is competition, I'm fine with it as I believe that we have people who're leaders in the industry who've developed our products.

With cannabis becoming legal all over the world, and hopefully eventually here in the U.S. the key is demonstrating product safety, and effectiveness, but not necessarily at the level required for drug approval.

Sadly, IMHO, the price of proving a product worthy of being considered an approved drug is often just far to high to justify. Big Pharma will tell you they spend over a billion dollars for each approved drug, when they factor in the cost of all their failures. While I suspect this might also include the cost of their executive jets and other perks, even tiny biotech's spend hundreds of millions.

To me, once proven safe, a psoriasis cream that's tried on a few dozen people where the majority testify that they've seen dramatic improvement should be sufficient to market the cream with testimonials of it's effectiveness. On the other hand, FDA Trials for the product would probably involve hundreds, or even thousands of people. The FDA trials would last for months, perhaps even year's. Each of the people in the trial would have to not only be observed by professionals, but would have to routinely have their blood drawn, etc to check their general health. Perhaps the worst part of the scenario is perhaps on third of all involved patients would be using a placebo cream, so they would probably see no benefit, but would have to be subjected to the full terms of the trials.

I frankly wonder if FDA efficacy trials for the cream are worthwhile if the cream can be marketed everywhere that medical marijuana is permitted by law.

Sadly, I believe their are all sorts of other products, many that aren't cannabis based at all, who's use is only supported by anecdotal claims of efficacy, because the FDA and other similar agencies, only insist on extremely rigorous testing, or no approval at all.

Virtually millions of products that are largely made from natural things accepted as safe are marketed with anecdotal evidence of efficacy, but without the acceptance of the medical community, because they've not had FDA efficacy tests and approvals.

The real problem IMHO is that Doctor's will rarely use, or suggest the use of these products, along with conventional medicine, to benefit their patients. The products may often have benefits that supplement the meds being prescribed, but few Doctors, and no insurance will prescribe them.

As a patient, the prescription medication you used might have a retail price of thousands of dollars a month, but cost less than one hundred. Meanwhile, if you did take all the supplements that could benefit your condition, you might spend thousands, certainly hundreds, as no insurance covers these costs.

It's my belief that to get accepted for the treatment of multiple myeloma, OWCP needs to undergo the full FDA testing. However, to gain acceptance for psoriasis, acne, eczema, etc, the patient can try the product and make their own judgement. Anecdotal testimony ought to sell these products. Perhaps in time Insurance may see that paying for the cream could be of benefit to them, because they could be paying less than for conventional medicines, which may prove to be less effective than our cream. Time will tell.

I know people who have MM, while they may generally know how they feel, they really can't know how well they're fighting the disease without the lab tests which routinely need to be done. That's not needed for people with psoriasis, acne, etc. They can look at their skin and see that their condition is better, worse, or unchanged. Photographs of their skin would be sufficient to make such judgement.

It's up to OWCP as to how much clinical testing they intend to support, but I for one would be fine with marketing the cream and gathering anecdotal evidence of how effective it is. I find it hard to justify the expense of hundreds of millions for each skin disease that the cream could benefit to get it labeled a drug. I would fully support an FDA initiative to dramatically lower the cost of approval, perhaps to the point that it can be gained with just the submission of a lot of anecdotal evidence.

Gary