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Tuesday, November 06, 2018 7:28:00 AM
But the regulatory pathway for CBD-based drugs is evolving. Comparing it to other pathways will likely be misleading. For example, there should be no safety issues associated with CBD, so the trials should mostly come down to efficacy and statistical significance.
If there is a significant unmet need, the FDA can expedite the approval process. The European agency tends to be more open to novel drugs, so it's possible Nexien pursues European approval first, particularly given Dr. Schloser's standing in the European medical community.
Also, keep in mind that Nexien intends to raise capital at the project level to fund development. This is to mitigate risk and allow for the drugs to be more easily sold to other companies. They seem acutely aware of the cost and risk of commercializing drugs and would rather focus on R&D and perhaps get a royalty on eventual sales. Alain understands corporate finance and to this point, has done everything he can to minimize dilution.
I'm hoping we get an update on XactDose soon. That could propel the stock even higher given the near-term revenue potential.
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