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Navigating the Maze: Avenue Therapeutics Grapples with Regulatory Hurdles for IV Tramadol

Navigating the Maze: Avenue Therapeutics Grapples with Regulatory Hurdles for IV Tramadol

Avenue Therapeutics (ATXI) has disclosed a new risk, in the Regulation category.

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Avenue Therapeutics faces substantial regulatory challenges due to its development of IV Tramadol, a controlled substance. The intricate web of state, federal, and foreign laws, notably the CSA and DEA regulations, necessitates stringent compliance for manufacture, distribution, and sale. State-level discrepancies in scheduling and regulation could delay or limit market access, even after federal approval. Non-compliance risks include severe penalties, jeopardizing Avenue Therapeutics’ operational and financial prospects.

Overall, Wall Street has a Moderate Buy consensus rating on ATXI stock based on 1 Buy.

To learn more about Avenue Therapeutics’ risk factors, click here.

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