CV Sciences Inc (CVSI)

[Freedom43]

Great finds as always Sleuth: With sales stagnate I'm focused on drug development.

The UC San Diego Study way Published April 28. I think this was the final pre-clinical piece needed to submit the NDA Application to FDA. I wonder, with your sleuth capabilities, if you have seen anything on a possible submission already such as on ClinicalTrials.gov?

I think CV will meet the criteria for Application/User Fee Waivers
https://www.fda.gov/media/72340/download Here are some excerpts:

IV. TYPES OF WAIVERS AND REDUCTIONS According to section 736(d) of the Act, FDA will grant a waiver of or reduction in one or more user fees assessed under section 736(a) of the Act where it finds that an applicant meets the eligibility criteria under one of the following provisions:
• A waiver or reduction is necessary to protect the public health. YES
• The assessment of the fee would present a significant barrier to innovation because of limited resources available to the person or other circumstances. YES
• The applicant is a small business submitting its first human drug application to the Secretary for review. YES

Under this provision, FDA may grant a public health waiver of or reduction in user fees if the Agency finds that the following two criteria are met:
• The product protects the public health; and
• The applicant shows that a waiver or reduction is necessary to continue an activity that protects the public health.

In evaluating whether a product protects the public health, the Agency asks the following questions:
• Is the drug product a significant improvement (or does it have the potential to be a significant improvement if the drug product is not yet approved) compared to other marketed products - MOST Likely
Is the drug product designated as a priority drug has it been granted fast track status? YES (2018) or has it been determined to be a new molecular entity?
I Believe it is Affirmative answers to these questions usually indicate that a product protects the public health.

• Does the drug product demonstrate an increased effectiveness in the treatment of disease? Most Likely
• Does it eliminate or substantially reduce a treatment-limiting drug reaction? Most Likely
• Does the drug product enhance patient adherence to treatment? Most Likely
• Has the drug product shown potential evidence of safety and effectiveness for a new or underserved subpopulation Most Likely
• Is the drug product intended for the treatment of a serious or life-threatening condition? YES
• Does the drug product address unmet medical needs or demonstrate the potential to do so? YES (Smokeless Tobacco Addiction)

Theoretically we could get approval for Clinical Trials at no up front cost.