is waiting for the inflection point
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I did not delete my own post. There are other moderators and site admins who can remove posts.
I am as positive that you are a legit new poster just as much as I was positive that poor KGRichards lost his dear sister in law in Saginaw to sepsis a few years ago while waiting an vain for Cytosorb in the US.
Treatment of 24 hours a day is not uncommon now. That study also was not powered to demonstrate statistical significance in 28 day all cause mortality. It was a study on IL6 removal and the result of that was statistically significant.
Registration of some existing warrants that should already factored in to your fully diluted share count valuation of the company. Warrants are like options. Why would they exercise them if there are years left until their expiration and the company is potentially in the red zone toward FDA approval? Panic sell this evening IMHO.
Even though my TRVN position was small, that AdComm bugs me. They should have gotten a positive vote and I think big pharma had a hand in it. I think they should use everything they can to try to advance it. As for the ACRX AdComm some of the "no" vote questions/statements were crazy. What if a pill falls on the ground and a child eats it? For real, is there going to be a child crawling on the ground while an adult is being treated in the ER for pain? Plus complaints about packaging and waste with plastics, when the alternative is a whole IV setup for morphine with probably more waste and risk. Big pharma held TRVN back, but the fact that they couldn't do the same for ACRX says something big. IMHO.
Yes. I had a small position in TRVN also. That AdComm sucked. Small enough position that I will just sit on the shares until PDUFA date.
Adcomm vote 10 to 3 to approve for ARCX this afternoon. PDUFA date Nov. 2 for them I think. If you can get in early Monday it could be a good score. Long term, a great score. IV morphine alternative for ER and post surgery situations. Opioid, so it needs to be tightly controlled in the current US situation. There is a morphine shortage right now, plus it does not have the overhead cost of an IV. Also already EU approved, like Cytosorb, so FDA approval could instantly boost sales overseas.
Did you hear me say ACRX. AdComm win today. Monday should be fun. More cash to put in CTSO.
Just got a chance to read your post. You do realize that Dr Kellum is a long time CTSO researcher and supporter who has spoken at many EU conferences for CTSO. This article has an endotoxin spin which just accounts for I think 15-25 percent of sepsis cases. BTW, old news because Cytosorb XL covers the endotoxin and they have patents to protect the tech.
Sorry. I meant to reply to Lakers post. Might want to look into ACRX also.
These are sounding very much like Pearsby questions, but I will respond. It is all about the faster route to first US approval for Cytosorb. Sepsis can have many different sources and each case can be very different from each other, so you will have a somewhat heterogeneous patient population in the study. A heterogeneous patient population would likely require a larger and longer study to prove statistical significance of the therapy. On the other hand non-emergency cardiac surgery has a much more homogeneous patient population, meaning a smaller faster study could get the job done.
Here are some of my notes on Spectral’s product from a few years ago.
Spectral’s product isn’t specifically a sepsis treatment. It removes a potential sepsis trigger. That is endotoxins that are found on the outer membrane of gram-negative bacteria. These endotoxins can trigger an immune response leading to Sepsis. Once full blown sepsis has set in Spectral’s product can do very little to help the patient. Cytosorb IS a sepsis treatment, but it is also much more. Cytosorb eliminates elevated cytokines associated with severe sepsis, septic shock, trauma, rhabdomyolysis, pancreatitis, lung injury, liver and kidney transplantation, liver failure, influenza, cardiac surgery, post-operative inflammation, toxic shock syndrome, necrotizing fasciitis, CAR T-cell therapy and many others. Additionally, it reduces plasma free hemoglobin associated with cardiac surgery, bilirubin associated with liver dysfunction and myoglobin associated with Rhabdo. Spectral’s technology may have a potential market, but Cytosorb has a far greater potential market.
Additionally note the following from a Brown university article: “The drug is very effective as an anti-endotoxin but it didn’t work if you give it to someone who is already infected and in established septic shock.” The gist is the time window for the removal of endotoxins and when sepsis sets in is quite small and you are unlikely to hit it in a clinical setting
https://news.brown.edu/articles/2013/03/sepsis
From the Cytosorb FAQ:
CytoSorb doesn’t remove endotoxins which only occur in gram- negative bacterial sepsis.
-In contrast to endotoxin-adsorption- devices, CytoSorb can also be used during gram-positive bacterial sepsis and other systemic infections (viruses, fungi, parasites)
-As well as cytokines, enterotoxins, such as diphtheria-toxin, alpha- hemolysin, Clostidium perfringens toxin or Shigatoxin can also be removed effectively from the circulation by CytoSorb.
-Moreover CytoSorb can be used for all non-infectious causes of a Systemic Hyper Inflammatory Syndrome (e.g. polytrauma, burns, inhalation trauma, pancreatitis).
My notes here are from a few years ago. We now have Cytosorb-XL in the pipeline which will remove both cytokines and endotoxins.
Feel free your share with you Kidney doc friend. I would like to hear his response to the points I cite above.
Wow. He recommended Spectral over CTSO? Don't listen to another word that man says. IMHO.
Don't worry about it. If your FIL is a "kidney Doc", he will probably give the newlyweds a downpayment on the first house if not buy it for you outright. 50 to 300 is realistic for what CTSO has, just not in your timeframe, if there is any truth to your story, which I doubt .
Don't forget to take some profit. It is being helped up by traders pumping. They are trying make people think approval could happen in Q4. They still need an NDA and then you can look forward to your Adcom and PDUFA dates.
That is where my profit will go also.
I'm pretty sure they are seeking approval for a post surgery, in hospital, IV drug. Unless you are Michael Jackson's ghost, with you own personal doctor, you are not going to find the product on the street for use in your home or cardboard box residence.
It really does kinda sound like a scenario he might spin up. You would think an 80 year old would find a more fulfilling way to spend his twilight years.
Where do you see that?
So if the question is: "will hospitals adopt Cytosorb?". 200 treatments/month at a single hospital is evidence that the answer to the question is a resounding YES.
Cantor call. Chan said the 2016 million dollar sale hospital just had 600k sales in one quarter!
Sweet. Picked up some call options myself and may pick up some more tomorrow.
The whole sector has been turbulent. GERN crushed on bad news. SYN open on Friday around 2.5 peeks at around 7.50 mid-day then drops back to near the open. CRMD up 65% in the last 1.5 trading days.
I think it was at about 0.37 then, so you are sitting pretty. I owed my 9 year old boy 5 bucks for washing my truck when it was trading at 0.5. I decided to give a little lesson on stocks and talked him into 10 shares of CRMD instead. Now he has an unrealistic view of what investing is like. A double in a few weeks. LOL.
I am still wondering if this gap will fill next week or if this new level will hold. I think a lot of profits from SYN drove this spike yesterday. Sounds like a lot of folks hurt in GERN moved over here also. There is some serious pumping going on various sites, so the traders are here for sure.
Take a look at the chart for SYN. My theory is that traders took their profit on SYN today and loaded up on CRMD, driving the price up today. CRMD has been discussed by many of the same traders in SYN. I guess if the gap fills next week we will know that this theory is probably true. To me it is not worth the risk of cashing out on the chance there is some real news next week.
Sure is pretty!
There is no such thing as a sure thing with the FDA. I have 45K shares of CRMD. I feel 100% confident in the technology but the botched job by the CRO and CRMD taking over the data collection does add something the FDA can question about the trial. For this reason I am looking for the price to rise enough to cash out and give my remaining shares a zero cost basis. As for TRVN, I think they have a high chance of approval, but I have less faith in adoption of their product by the medical community. They will probably be a short term play for me.
Yes, it was at around 12.35 for a while before it quickly went into the upper 14's.
Here we go again.
LOL bought 20 TRVN Oct. $2.50 options on Monday. I have actually been following that company for over 2 years.
They probably removed it. It was accidently released early.
I contacted the videographer. It was commissioned by Cytosorbents and will officially be released soon. Sounds like more videos are planned. It was nice to see the device in action.
I am liking all that green today!
India health news. If this plays out perhaps it could help with Cytosorb adoption through Biocon. Cytosorb could help save the government in health care costs.
https://www.cnn.com/2018/09/24/asia/modi-healthcare-election-intl/index.html
He truly is an IMN, information mining ninja!
Strangely, the same thing happened to two other biotechs I am in.
This company went out of business over 9 years ago.
No doubt, but our other stock is a long term play and these others have a near term catalysts. Run up 100% nearing, news and cash out 50% to play with free shares.