Cytosorbents Cor (CTSO)

$CTSO what is happening with employees departures?

D. Boral Capital has updated their rating for CytoSorbents ( $CTSO ) to Buy with a price target of 10.

$CTSO CytoSorbents files appeal with FDA for review of request for DrugSorb-ATR CytoSorbents filed a request for supervisory review - administrative appeal - with the FDA under 21 CFR 10.75, of the De Novo Denial Letter issued on April 25 for CytoSorbents' DrugSorb-ATR Device. DrugSorb-ATR, which previously received Breakthrough Device Designation from the FDA, is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting surgery. CytoSorbents is conducting trials to support FDA marketing approval of DrugSorb-ATR for antithrombotic drug removal during cardiothoracic surgery. The denial letter identified remaining deficiencies that must be addressed before the De Novo Request can be granted and the device authorized for U.S. commercialization. In response, the company engaged with the FDA review team to clarify and discuss the remaining deficiencies and determined that a supervisory review through the administrative appeals process was the best path to resolve the remaining deficiencies. The administrative appeals process allows the Company to engage with upper management of FDA's Center for Devices and Radiological Health in a prescribed procedure that includes a formal hearing, with a final decision typically issued approximately 60 days after the appeal is filed. The company remains confident in receiving a final regulatory decision in 2025.

I found you an Overbought RSI (Relative Strength Index) on the daily chart of Cytosorbents Crp. Is that bullish or bearish? $CTSO #RsiOverbought #NASDAQ

$CTSO: CytoSorbents Reports Strong 1st Quarter 2025 Results https://buff.ly/2GKh8ub

D. Boral Capital has updated their rating for CytoSorbents ( $CTSO ) to Buy with a price target of 10.

$CTSO key is the FDA and Canada approval if this will happen the share price will be in long term by to $10+. During the call yesterday it seemed that Cytosorbens is more less confindent that this will happen.

I found you an Oversold RSI (Relative Strength Index) on the daily chart of Cytosorbents Crp. Is that bullish or bearish? $CTSO #RsiOversold #NASDAQ

$CTSO The link you provided points to an SEC Form 8-K filing for Cytosorbents Corporation (Ticker: CTSO), dated May 13, 2025. Here are the key highlights from the filing: Item 8.01 – Other Events: Cytosorbents Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Premarket Approval (PMA) application for CytoSorb®. The FDA has assigned a target review completion date (PDUFA-like date) of November 10, 2025. What This Means: This is a significant regulatory milestone: acceptance of the PMA indicates the FDA has deemed the application sufficiently complete to begin a substantive review. The target action date (Nov 10, 2025) is when the FDA is expected to complete its review and provide an approval decision, though this is not guaranteed.