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Going Concern
9 Months Ended
Jul. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Going Concern

Note 3 – Going Concern

 

As shown in the accompanying consolidated financial statements, the Company has incurred significant recurring losses and negative cash flows from operations due to various factors such as: (i) uncertainty surrounding the PMTA process with FDA, (ii) lack of enforcement on illegally marketed competition, and (iii) the MDO that was issued to Bidi Vapor on its flavored ENDS products. These factors raise substantial doubt about the Company’s ability to continue as a going concern. However, the MDO has now been set aside and remanded by the 11th Circuit.

 

It is possible that FDA could appeal the 11th Circuit’s decision. Such a process could take months before a final decision is made, at which point Bidi could evaluate its legal options in the event of an adverse decision. The Company anticipates being able to continue marketing and selling the BIDI® Sticks, subject to FDA’s enforcement discretion, for at least the duration of such an appeal.

 

Alternatively, FDA could decide not to appeal the 11th Circuit’s decision and move forward with a review of Bidi’s PMTA on remand, as directed by the Court. A complete scientific review of the PMTA would require FDA to review all of this information before making an APPH determination; based on FDA’s history, this scientific review process could take 1-2 years to complete, or longer. An extended impact, or a negative ruling on an FDA appeal of the decision, or the FDA ultimately not authorizing Bidi’s non-tobacco flavored applications upon re-evaluation could have a material and adverse effect on the Company’s sales, earnings, and liquidity.

 

These consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded assets, or the amounts and classification of liabilities that might be necessary in the event that the Company cannot continue as a going concern.