Voyageur Pharmaceuticals Ltd V.VM

FDA Drug Submission

[Budd22]

This is from Nov 2022. Proof they knew that they would have to proceed with a drug submission not a device. Hopefully FDA application will be submitted soon. 

"Brent Willis, CEO, stated: “The completion of production testing for SmoothX and the scaleup to commercial quantities to launch sales in Canada is an important milestone for the Company. It also marks a key point in our journey to create a fully integrated Canadian supply chain for barium contrast media. It also supports Canada’s national strategy of de-coupling from China for the supply of critical minerals and critical pharmaceutical production. Basing our production testing on FDA protocols will advance our preparation for a generic drug submission to the FDA for the approval of SmoothX for gastrointestinal imaging. We have been engaged with the FDA on the path to approval for SmoothX since earlier this year and are now formally in contact with the FDA’s Office of Generic Drugs regarding the specific requirements of approval for SmoothX.” In preparation for a generic drug submission to the US FDA, Voyageur has produced the recent batch in a manner that adheres to the company’s FDA and Health Canada compliant quality management system, which was implemented to ensure that a consistent and high-quality product is delivered to Voyageur's customer base. "

[biggdogg]

Drugs bring more value to the company versus devices, I think FDA reverting it to a drug is much better long term for Voy. I hope they can create new ones as well. Drug pipelines are far more valuable than Device pipelines.