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Re: None

Thursday, 09/29/2016 5:41:53 PM

Thursday, September 29, 2016 5:41:53 PM

Post# of 203916
HOLY F@#$ READ THIS 2 ORPHAN DESIGNATIONS COMING:


LOOK AT WHAT HAPPENS WHEN YOU GET ORPHAN DESIGNATION STATUS:
AMDA GOT ORPHAN DESIGNATION BACK IN AUGUST:



WE HAVE 2 ORPHAN DESIGNATIONS COMING:
Target Indication Collaborator Status

Multiple Myeloma Sheba
? Entered into a research agreement for in vitro studies
Academic ? Negotiating terms of a research agreement for in vivo studies
Medical Center ? Completed one in vitro study
? Proceeding with further pre-clinical in vitro studies (safety and toxicity, pharmacokinetic, and pharmacodynamic)
? Submitted a clinical trial protocol to the Israeli Institutional Review Board and received its approval to commence a clinical study
? Intend to commence a clinical study in the first quarter of 2016
? Drafted a clinical trial protocol synopsis, which we believe will assist us in preparing an application for orphan status designation

? Entered into a Research Collaboration and License Agreement but have not commenced any studies to date
Psoriasis Sheba
Academic
Medical Center ? Drafted a protocol of a Phase I, double blind, randomized, placebo controlled, multiple escalating dose study to determine the safety, tolerability and pharmacokinetic profile of medical grade cannabis in healthy volunteers

? Entered into a nonbinding memorandum of understanding for the development, manufacture and marketing of a cannabinoid-based topical cream
Psoriasis Emilia Cosmetics Ltd. ? Intend to enter into a binding agreement in the second quarter of 2016
? Intend to initiate development of the topical cream in the second quarter of 2016

? Entered into a research agreement for in vitro studies \
Fibromyalgia Sheba Academic
Medical Center ? Drafted a clinical trial protocol synopsis, which we believe will assist us in preparing an application for orphan status designation


Referenced from these 2 posts regarding orphan designations:
http://investorshub.advfn.com/boards/replies.aspx?msg=124751528
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124751474
OWCP