Voyageur Pharmaceuticals Ltd V.VM

Fantastic news for VM today

[whitenorth72]

For those of you still paying attention to this wild ride. Our friends in Texas have overturned the ruling on Barium as a drug. So yes as it stands Barium is reclassified as a DEVICE again.
Why is that so important? Our company will save millions on application processing.
That should re-pump our tires from last year's set backs.
So let's get this party started.

https://justthenews.com/sites/default/files/2024-02/Quorum%20Clause%20opinion.pdf     https://justthenews.com/government/courts-law/win-paxton-court-declares-17-trillion-federal-omnibus-was-passed

[VpharmCEO]

This post has been removed in accordance with Community Policy

[biggdogg]

Looks like a window of oppurtunity has emmerged. This is a game changer, as they can get their first product to market in the US very soon. Any legal experts out their that can comment on this significant ruling in Texas?

[postie1]

Got  questions. Was it the FDA or Congress that ruled it a drug? Does that ruling affect FDA rulings?

[lscfa]

Your links don't work

[postie1]

There are 2 links. 1 at a time

[lscfa]

2021 ruling https://www.thefdalawblog.com/2021/04/big-win-for-hpm-client-court-of-appeals-tells-fda-to-regulate-barium-sulfate-as-a-drug/

[lscfa]

Bloody technology. If I highlight your link and select open link in chrome ipad I get nothing but if I copy the link and paste into the browser it works. 

[lscfa]

Your 2 links make no sense without this one... https://www.ropesgray.com/en/insights/alerts/2023/01/new-fda-reform-legislation-congress-gifts-a-fdora-for-the-holidays Classification of Certain Products as Drugs. FDORA clarifies that any contrast agent, radioactive drug, or over-the-counter monograph drug is to be classified as a drug and not a device. This provision was enacted in

[biggdogg]

Considering this is a $1.7 Trillion Bill, I would suspect that it will just get re voted and passed toot sweat. If I am Voyaguer, keep going down the drug pathway, do not make any U Turns.

[WarrantOfficer]

Thank you Iscfa. I started yawning about 5 pages into the 120 page memorandum opinion & order concluding the 1.7 trillion federal omnibus was passed unconstitutionally. I found zero correlation btwn barium sulphate drug or device, but I have always known I am not the smartest cheese on the block, so perhaps I missed something. I do not recall Voyageur bringing this news forward to