Baudax Bio Inc (BXRXQ)

[SuperDrive]

"Risk Assessment

Baudax is expecting ANJESO to receive a 3-year Regulatory Exclusivity as it enjoys multiple patents covering its formulation, product by process additional formulation patents and 3 additional patents regarding the reduction of flake-like aggregates.

The Company is targeting a potential $6 billion market for IV pain management and intends to start with over 300 fast start accounts that have been vetted by their field team and prioritized in anticipation of the launch. Baudax has set its sights on more than 1450 hospital accounts and 550 ASC’s with an initial focus on 800-1000 accounts on launch. In addition, the Company intends to apply for a C-Code and J-Code in March 2020 and April 2020 respectively.

A good sales team is prerequisite for the success of any new drug in the market and the Baudax is no exception. The Company has plans to set a marketing team in place with John Harlow, the Company’s Chief Commercial Officer revealing that Baudax will bring in 50 sales representatives, 5 regional business directors and five account managers on board in the event of IV meloxicam being approved by the FDA. Efforts are on to make the product available in the market in seven to eight weeks.

The Company is helmed by a management team with extensive experience in commercial launch, product development and regulatory framework. This will hold the Company in good stead, as demonstrated by its handling of two rejections from the FDA for ANJESO.

Baudax had cash and cash equivalents worth $17.7 million as of December 31, 2019 and no debt. The Company believes that it would be enough to fund its clinical development and commercial launch activities associated with ANJESO.

Opioid Addiction is a growing epidemic which has reached an endemic proportion in the U.S. Prescription drug overdose is one of the leading causes of preventable deaths in the U.S, prompting the government to declare a public health emergency in 2017. There is stringent regulatory control and negative perception towards opioid based drugs, which makes it an extremely challenging environment for drug development and commercialization for any company."

https://www.aviseanalytics.com/baudax-bio-scores-a-big-win-with-the-fda-approval-of-anjeso/