Claritas Pharmaceuticals Inc CLAZF

RE:Actual Facts - Not Opinions

[Jmk2454]

Quorra wrote: Facts for why KLY will be a massive success.
 
This is a recap of the news releases and positive milestones by Kalytera to date. This can all be verified by news releases and numerous websites. Very easy to find. 

 Here are the facts.
 
1.     Phase 2 of their lead product development program evaluating cannabidiol for the prevention of acute graft versus host disease has been extremely positive and encouraging. No patients in the first cohort developed grades 3 or 4 acute GVHD while receiving oral CBD treatment, and only one patient developed grade 2 acute GVHD.
 
2.     Phase 2 will likely be completed no later than October/November. To date, no patients in the medium dose cohort have developed acute GVHD of any grad. Once completed, they are planning a seamless and immediate transition into phase 3.
 
3.     Current interest from numerous pharma companies to partner or licence the GVHD drug. The business strategy Kaly is pursuing for their GVHD products is to out-license the commercial rights for these products once they have completed the Phase 2 study in prevention of GVHD. They have engaged Echelon Wealth Partners to determine the value, on a risk-adjusted basis, of its CBD therapeutic products for the prevention and treatment of graft versus host disease, and to assist with the review of potential out-licensing opportunities for the commercial rights to these products.
 
4.     Kaly has invented a novel first-in-class cannabinoid molecule for treatment of acute and chronic pain, designated KAL-1816. The progress of this drug is extremely positive and the commercial opportunity is very large.
 
5.     Numerous patents on both drugs. Proprietary rights my friends.
 
6.     Kaly is acquiring a 51% stake in a state-of-the-art Clean Bi Design CBD extraction business. This will be amongst the largest such operations in the US capable of producing 600 kilograms of CBD isolate per shift, per month. On the property there is an 8000 square-foot factory built to food grade manufacturing standards and certified as food grade by the US department of Agriculture. This transaction will provide near-term path to revenues. Closing is expected to occur on or about October 1, 2019. The forcasted market for CBD is estimated to be 20 billion dollars by 2014. They expect to report initial revenues from CBD isolate sales by Q4 2019. 
 
7.     Kalytera’s new Consumer Products Division is also planning to launch an E-Commerce website that will support online sales of consumer CBD products derived from hemp, including CBD oils and other CBD consumer products. The platform will support Kalytera’s own family of brands, selling CBD wellness products to all legal CBD markets across the U.S.
 
8.     Completion of Food Effect and QTc Study. Preliminary results for the Food Effect and QTc Study are positive and as expected. CBD was well tolerated, there were no safety concerns and the EKG data that is required to evaluate the effects of CBD on cardiac rhythm have been obtained.
 
9.     Kalytera has applied for FDA fast-track designation. Preliminary FDA approval may be given after full phase 2 results later this year. This is very likey to happen due to the amazing results of the drug in testing so far. Kalytera likely won’t need phase 3 to start marketing their drug. Kiadis Pharma in the Netherlands followed the same path for their GVHD cure. 

Excellent post - many have posted these facts but you nailed the probable completion timeline of the second cohort. Patients were still being enrolled into the cohort in July so that cohort cannot be completed before some time in October. 

i am also a longtime holder who is beyond excited and am hopeful there is news soon. There is an excellent group for shareholders on Facebook where there is really no bashing, but there is discussion. I know some of you are already part of that group but for those new here, it is worth checking out.