CytoSorbents Corporation (CTSO)

[Murph1953]

Hemopure,
Do you have an objective, historically based estimate of when the FDA might decide on Ticagrelor indication?

I can no longer believe anything from the mass murderers at FDA/NIH, but do assume that Big Pharma's type A's (with CHD/BMI 99/ejection factor<10) might want this to market ASAP.

2025? 2034? 2055?

"FDA will work with CytoSorbents to expedite the development, assessment, and regulatory review of CytoSorb for the removal of ticagrelor, while maintaining statutory standards of regulatory approval (e.g., 510(k), de novo 510(k) or premarket approval (PMA)) consistent with the Agency’s mission to protect and promote public health."

https://cytosorbents.com/development-update-u-s-fda-grants-breakthrough-designation-to-cytosorb-for-removal-of-ticagrelor-during-cardiopulmonary-bypass-in-emergent-and-urgent-cardiothoracic-surgery/

thanks in advance