Replies to post #181374 on OWC Pharmaceutical Research Corp (OWCP)

[skitahoe]

While the answer to your question is yes, if you look at what the company is attempting to do, it's clearly a no, not if they stick to their goal of treating cannabis in various forms as worthy of drug approvals.

I don't know if creams on the market in legal cannabis stores violate the patent OWCP has achieved, or if it's formulation is different enough that they don't violate it. The point is, what's found in legal cannabis stores hasn't been clinically tested for safety and efficacy, that's the approach the company is taking.

I believe if successful in achieving FDA approval products should be able to be sold by prescription in all states, not just in states with approved cannabis stores. If I'm correct about this, you'll go into any pharmacy to purchase them by prescription, and insurance should cover the greater part of your cost, depending on drug coverage.

I believe it's possible that after Phase 2 trials have demonstrated efficacy one of two things may happen. One would certainly be a partnership with one or more BP's who'd carry on the approval process so the product would have approved drug status worldwide. If such partnerships didn't materialize, they may choose to market the product where it's legal to do so to support the costs of a Phase 3 Trial.

If you go into a legal cannabis store, you have to be impressed with the wide variety of products available for sale there. If we had a tested cream, it would simply occupy some shelve space with many other products. Sales might be good, as results were publicized, but the competition would still be substantial, especially if our product is priced above the competition.

On the other hand with drug approval our cream would be the only one of it's type in the pharmacy, and should be covered at least in part by insurance. The time and money spent to achieve such status should make it very worthwhile.

Essentially the same thing can be said for all the other products OWCP is developing. The key is patent rights, once that's established, with clinical trials proving the products benefits the sales in drug stores, rather than cannabis shops, should be huge.

I should note that it's very possible to have the same product available over the counter without prescription, as well as by prescription. While the retail price of the prescription product may be higher, with insurance applied, the cost to the user is dramatically lower. I know your Dr. may say, it's available OTC, but if you ask for a prescription they'll generally provide one, and your price goes down dramatically.

From what I've seen, many cannabis companies our floundering because there is so much competition. I believe that OWCP differentiates itself from most of the others by developing drugs intended for approval that utilize cannabis rather than all sorts of products with cannabis in it.

Gary

[Farmer7]

Included in the patent PR written in December, OWCP talks about procuring the necessary permits for performing the efficacy study. These permits for the study are state IRB, institute IRB, liscense to purchase the cannibis for the study, liscense and contracts to hold cannabis for the manufacturing of the ointment etc. As you can see there is a lot to this. Long story short, their intentions with the patent in hand and an upcoming efficacy study is to move this into manufacturing. This would align with their “ differentiated in the market” approach they’ve taken. Hope this helps with your understanding of their approach with the cream. I can’t answer timelines for you, as I’m not sure how long it takes to procure these permits.

[PhenixBleu]

Yes, and that's exactly what OWC is planning for the tablet. Below is a relevant news release from October 2019. The iBox has Clinical Trial links.

OWC Pharmaceutical Research Corp. to Report Top Line Results (TLR) for a Safety Study on Its Cannabis-based Tablets

PR Newswire

RAMAT GAN, Israel, Oct. 7, 2019

RAMAT GAN, Israel, Oct. 7, 2019 /PRNewswire/ -- OWC Pharmaceutical Research Corp. (OTCQB: OWCP), a developer of cannabinoid-based therapies targeting a variety of different medical conditions and disorders, announced today that, on September 25, 2019, One World Cannabis Ltd., a company organized and existing under the laws of Israel and a wholly-owned subsidiary of OWC received Top Line Results (TLR) of its single-dose, randomized, crossover study to compare the safety, tolerability and pharmacokinetics (PK) of OWC's Medical Grade Cannabis - Orally Disintegrating Tablets (MGC-ODT) vs. buccal Sativex®, in healthy adult volunteers. The study was conducted at the Sourasky Medical Center in Tel Aviv. In this study, participants were administered randomly, either Sativex (5.4 mg THC, 5.0 mg CBD) or OWC-ODT (4.2 mg THC, 5 mg CBD), and then crossed over, with a minimum interval of two weeks. Plasma was collected in the 24 hours following drug administration, at pre-determined time points, and side effects were monitored. The concentrations of THC, CBD and 11-OH-THC were quantified, and their plasma PK determined.

The TLR show that both MGC-ODT and Sativex® administration had comparable mean times of peak concentration, half-life and elimination rates for each of the three analytes (THC, THC metabolite 11-hydroxy-THC and CBD). The results indicated dose-related comparability of both products in rate of absorption and bioavailability. The incidence of treatment related adverse events (AEs) were similar between the treatments.

The most common treatment related AEs were hunger (reported in 25% of subjects treated with MGC-ODT), thirst (reported in 18.75% and 6.25% of subjects treated with MGC-ODT and Sativex®, respectively), dizziness (reported in 18.75% and 18.75% of subjects treated with MGC-ODT and Sativex®, respectively), dysgeusia (reported in 12.5% and 25% of subjects treated with MGC-ODT and Sativex®, respectively). Administration of MGC-ODT was judged to be well tolerated and no unexpected safety signals were observed.

Top Line Results Conclusions: OWC- Orally Disintegrating Tablet is safe to use and appears to have similar PK and bioavailability as Sativex®. Therefore, OWC intends to apply to the Israel Ministry of Health to obtain necessary approvals to market its Medical Grade Cannabis - Orally Disintegrating Tablets in Israel.

Can sublingual pills sales and dermal cream sales commence prior to a patent for the pill

[stockfan100]

Company can certainly now sell the cream as "patented" which puts it above every mom-n-pop or unproven cream out there. However, the real money for the company and the market cap for the investors will come from if/when the cream is also FDA approved.
The reason is that not many who need the skin disease cream can afford a ($60-$150) price tag, on a regular basis, that most "medically unproven" creams on the market are asking now.
But, millions will be able to purchase company's cream through their insurance at a fraction of the price if OWCP cream is also FDA approved!

[MjMilo]

There is already a company based in Canada with 13 patents throughout N. America about to commence sales for many different sublingual tablets all with measured doses...OW has only applied to sell in Israel..if and when they get it.