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Accentia Biopharmaceuticals, Inc. Message Board

luvboats2003 133 posts  |  Last Activity: May 20, 2015 10:25 AM Member since: Feb 8, 2006
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  • Reply to

    Can't see Cytosorbet getting EAP approval

    by proudamerican79th May 20, 2015 9:22 AM
    luvboats2003 luvboats2003 May 20, 2015 10:25 AM Flag

    From the FDA EAP guidance:

    Intermediate and Surrogate Endpoints
    As discussed above, EAP Devices must meet the statutory standard of PMA approval of reasonable assurance of safety and effectiveness. FDA may, as a basis for PMA approval, rely on assessments of a device’s effect on an intermediate or surrogate endpoint that is reasonably likely to predict clinical benefit (on the condition that remaining uncertainty about the predictive relationship between a surrogate and clinical benefit is minimized through confirmatory post-approval studies or on the condition that clinical benefit is verified through confirmatory post-approval studies).

    1. There have been over 5500 human treatments with no safety issues. EAP required reasonable assurance of safety: check.
    2. There is little argument that Cytosorb has proven to reduce elevated cytokines. EAP required effect on a surrogate endpoint: check.
    3. The EU sepsis study showed a correlation between CytoSorb™ cytokine reduction in patients with highly elevated levels of IL-6 (≥1,000 pg/mL) or IL-1ra ( 16,000 pg/mL), which are both independent predictors of mortality in sepsis. Statistically significant absolute reduction in 28-day all-cause mortality (0.0% vs 62.5% control, p=0.03, n=14). Trends to benefit in 60-day mortality (16.7% vs 62.5% control, p=0.14, n=14), fewer patients on mechanical ventilation at 28 days (33% vs 88% control, p=0.09), and fewer days in the ICU (23.8 vs 27.5 days control). EAP required surrogate endpoint that is reasonably likely to predict clinical benefit: check.

    Sentiment: Strong Buy

  • Reply to

    New Presentation And Very Different On Website

    by berthabluefish May 18, 2015 11:04 AM
    luvboats2003 luvboats2003 May 18, 2015 11:32 AM Flag

    What is different on the web site?

    Sentiment: Strong Buy

  • Reply to

    Recap of 2015 so far

    by ping_pow_princess May 15, 2015 1:46 AM
    luvboats2003 luvboats2003 May 15, 2015 6:09 PM Flag

    So Fresenius is not a real partner?

    Sentiment: Strong Buy

  • luvboats2003 luvboats2003 May 14, 2015 9:59 AM Flag

    Zacks got it wrong. Here is Dr, Chan's reply to my question:

    Thank you for your email. No, we would not mothball the cardiac surgery trial. We will be on a parallel path for approval in cardiac surgery (intra-operative use) and the EAP path for most likely sepsis (assuming that we can achieve EAP Designation). The question was what would happen if we were not able to achieve EAP Designation. My answer to that question is that we would still pursue the cardiac application and work to expand the label for sepsis with additional clinical data (either US or ex-US) later.

    Sentiment: Strong Buy

  • luvboats2003 luvboats2003 May 13, 2015 4:59 PM Flag

    I just sent the company a message questioning this. I'll let you know if they respond to it.

    Sentiment: Strong Buy

  • luvboats2003 luvboats2003 May 13, 2015 4:21 PM Flag

    The shareholder letter mentions looking into EAP in parallel with the cardiac study but did not state that the cardiac study might be dropped: "We believe this new program could benefit CytoSorbents as CytoSorb® currently targets the treatment of many life-threatening conditions such as sepsis, acute respiratory distress syndrome, severe acute pancreatitis, trauma, and many others that do not have effective treatments. As we move forward with our REFRESH cardiac surgery trial in the U.S., we plan to aggressively pursue this EAP opportunity for critical care applications in parallel, and foster open collaboration with the FDA."

    Sentiment: Strong Buy

  • luvboats2003 luvboats2003 May 12, 2015 1:13 PM Flag

    It is not declining because of weak sell-through, it is declining because the direct sales force had to be completely restructured. If you disband you sales force sales will suffer until it is rebuilt. As for the distributors and partners, in most cases the are still working on regulatory approval to sell in their respective countries. That is no weak sell-through, that is red tape before sales can even be attempted.

    Sentiment: Strong Buy

  • luvboats2003 luvboats2003 May 12, 2015 12:01 PM Flag

    The drug route and failed over and over again. Filtering a broad range of pro-inflammatory cytokines will succeed where the many other drugs have failed.

    Sentiment: Strong Buy

  • luvboats2003 luvboats2003 May 12, 2015 11:41 AM Flag

    It is my post, not jmsabula's. I am in because I think in 3-5 years Cytosorbents will be a multi-billion dollar company. I list some of the near term catalyst that will start the company moving that direction. Imagine if there was not the issue with the German sales team and the sales increased 30% in Q4 and then another 30% in Q1. The share price most certainly be higher now, but we would still be looking at the same near term catalysts and overall commercialization strategy. This roller coaster ride has not been fun to watch, but I think ultimately it will have zero impact on where this company is 3-5 years from now. They are still in the infancy of commercialization and there will be many successes and more missteps as they continue to grow.

    I understand that if you were in this in hope of a quick trade you could either feel stuck or have taken a loss. However, the big picture has not changed and they are building a sound foundation that will eventually translate into significant shareholder value.

    Sentiment: Strong Buy

  • luvboats2003 luvboats2003 May 12, 2015 11:03 AM Flag

    I got it posted.

    Sentiment: Strong Buy

  • luvboats2003 luvboats2003 May 12, 2015 10:54 AM Flag

    Maybe Yahoo doesn't let you respond to your own post? After
    jmsabula posted the first half of my message I had no problem posting the rest.

    Sentiment: Strong Buy

  • luvboats2003 luvboats2003 May 12, 2015 10:49 AM Flag

    (rest of list)
    7. Announcement of a pediatric version of Cytosorb. There is a blank placeholder page titled “Pediatric Clinic” on Cytosorb Registry web site.
    8. Updates on other pipeline products: Hemodefend, ContrastSorb, DrugSorb and BetaSorb
    9. Results UNV Penn study on cachexia and Cytosorb for cancer
    10. Announcement of additional partnerships and distributors
    11. Results of the 20 patient 3-5 month long FDA feasibility cardiac study for Cytosorb. We Got clarification that the clinical part of this study would be quick. “One and Done”
    12. Updates or results from the US Air Force study on the use of Cytosorb for treatment of Rhabdomyolysis
    13. Update or results from the SBIR contracted study with the US army for Cytosorb treatment after trauma and burn injury
    14. Update or results from the DARPA contracted study for the DLT program to treat sepsis
    15. Possible development with the use of Cytosorb treatment as a rescue therapy for CAR T-Cell therapy
    16. The biggest possible catalyst in my opinion is the chance to enter the new FDA EAP program for approval of Cytosorb as a treatment for Sepsis/ARDS/SIRS. Announcement of a Pre-Sub letter requesting EAP designation could be a big boost to CTSO and an acceptance response within 30 days of the letter could be another boost.

    Sentiment: Strong Buy

  • luvboats2003 luvboats2003 May 12, 2015 10:42 AM Flag

    Try the second half of the list. I could not get it to post.

    Sentiment: Strong Buy

  • Reply to

    Expectations and Potential Catalyst

    by luvboats2003 May 12, 2015 9:35 AM
    luvboats2003 luvboats2003 May 12, 2015 9:42 AM Flag

    Yahoo doesn't appear to want to let me post the rest of my list...

    Sentiment: Strong Buy

  • Reply to

    Earnings out

    by vitruvian_boy May 11, 2015 8:11 AM
    luvboats2003 luvboats2003 May 11, 2015 9:44 AM Flag

    Not likely a mistake as they also shared the link on their Facebook page this morning. That event is not likely an automated one.

    Sentiment: Strong Buy

  • Reply to

    Cytosorbents Corporation Message to the world

    by dhcabinetry May 9, 2015 3:16 PM
    luvboats2003 luvboats2003 May 11, 2015 7:35 AM Flag

    On the surfing topic, if you ever find yourself in Cocoa Beach hit me up. I am always up to meet a fellow investor in person for a chat.

    Sentiment: Strong Buy

  • luvboats2003 by luvboats2003 May 10, 2015 8:16 PM Flag

    Did anyone else the the Cytosorb Registry promotiinal email this morning? It says over 30 clinics have signed up already. It sounds like they are off to a good start. Hopefully the timing is a lead off to more good news tomorrow afternoon. If this has already been posted I apologize. I have been fishing all day with my boys.

    Sentiment: Strong Buy

  • Reply to

    Cytosorbents Corporation Message to the world

    by dhcabinetry May 9, 2015 3:16 PM
    luvboats2003 luvboats2003 May 9, 2015 9:52 PM Flag

    I share your optimism, plus a BSEE, not from UConn though. The bashers post stuff that is nothing but noise, so a bit of positive noise is OK with me. Been in CTSO since 2008, so i have been through months long spans of nothing material be posted to this board. What they have will transform acute care medicine and EAP will now make that a reality much sooner than we could have hoped for. Just read the details of what EAP is. It is almost as if the program was tailer made for a company in Cytosorbents position right now. A device with a perfect a safety record, backed by over 5500 human treatments, an application to fit a major unmet medical need, the EU sepsis study and many case studies to support that the efficacy of the device exists, plus an already FDA compliant registry to support the post EAP approval study requirements. I wish I could triple down, but I have doubled down a few times over the years and I am already all in.

    Sentiment: Strong Buy

  • Reply to

    Cytosorbents Corporation Message to the world

    by dhcabinetry May 9, 2015 3:16 PM
    luvboats2003 luvboats2003 May 9, 2015 7:12 PM Flag

    Cardiac partner could cone in to play soon, but an EAP submission letter to FDA could also be in play.

    Sentiment: Strong Buy

  • luvboats2003 luvboats2003 May 8, 2015 10:40 AM Flag

    Lets not forget that Cytosorbents already has a presence at UNV Penn with their cancer cachexia animal study

    Sentiment: Strong Buy

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