On December 30, 2013, we entered into a personal employment agreement with our controlling shareholder, Mr. Allen Baharaff who serves as our president, chief executive officer and as a member of our Board, as amended on March 15, 2016 and July 20, 2017, which provides that Mr. Baharaff’s terms of office and employment are for an undefined term, subject to re-approval under the Companies Law and termination in accordance with the terms of the employment agreement.

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Found an old DE patent from 30s (sorry! don’t have the exact reference at hand right now but it can be found with a Reaxys reaction search) describing a rather straightforward synthesis of NDMA and NDEA from the corresponding tertiary amines with nitrous acid, just conc. HCl and NaNO2 and said amine needed. Not quite sure how one alkyl group is cleaved, but if that’s legit, then any Et3N residues may potentially form NDEA during azide quench with nitrous acid. Also maybe a thing to be on the lookout for if one is planning to use nitrous acid in an API process…

        An applicant seeking approval to market and distribute a new drug product in the U.S. must typically undertake the following:

Cannabis Science Inc. (OTCBB:CBIS) is at the forefront of medical marijuana research and development. The Company works with world authorities on phytocannabinoid science targeting critical illnesses, and adheres to scientific methodologies to develop, produce, and commercialize phytocannabinoid-based pharmaceutical products. In sum, we are dedicated to the creation of cannabis-based medicines, both with and without psychoactive properties, to treat disease and the symptoms of disease, as well as for general health maintenance.

Jeffery, T. K. & Morrell, N. W. Molecular and cellular basis of pulmonary vascular remodeling in pulmonary hypertension. Prog. Cardiovasc. Dis. 45, 173–202 (2002).

During the development of a new drug, sponsors are given opportunities to meet with the FDA at certain points. These points are typically prior to the submission of an IND, at the end of Phase 2 and before an NDA is submitted. Meetings at other times may also be requested. These meetings can provide an opportunity for the sponsor to share information about the data gathered to date and for the FDA to provide advice on the next phase of development. Sponsors typically use the meeting at the end of Phase 2 to discuss their Phase 2 clinical results and present their plans for the pivotal Phase 3 clinical trial that they believe will support the approval of the NDA. If a Phase 2 clinical trial is the subject of discussion at the end of Phase 2 meeting with the FDA, a sponsor may be able to request a Special Protocol Assessment, or the SPA, the purpose of which is to reach agreement with the FDA on the Phase 3 clinical trial protocol design and size that will form the primary basis for the demonstration of effectiveness in a marketing application.

Liz is definitely a good speaker and I hope she will get the funding she needs. However, I don’t like too much idea of creating a clinic offshore without the proper trials.

Loscalzo, J. Nitric oxide insufficiency, platelet activation, and arterial thrombosis. Circ Res. 88, 756–762 (2001).

Once an approval is granted, the FDA, European authorities and other regulatory authorities may withdraw the approval if compliance with regulatory requirements is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further regulatory authority review and approval. Some of these modifications, especially adding indications, would likely require additional clinical studies. In addition, the FDA may require testing and surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs.

Now I point all of this out in empathy with most of you who aren’t in this profession and have limited options regarding your medical care. It’s a fact that most doctors will be unwilling to treat aging as some sort of illness. Not now. Not ever. So no matter what discoveries we make, if it involves meds , it’s going to be difficult.