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Ranchhand, It can be see through the most recent news article at Cytosorbents.com, or try:
Not lately, but he was friends with Sterling Silliphant, who had a son named Lorin. I was the same age, went to the cross town High School. Well, Lorin wanted to be his own businessman at 18, but he ran out of product and was shot in the doorway of his home by an enraged addict. Why these kids who are born with a silver spoon in their mouths can't think, is beyond me. One of Micky Rooney's x-wives and one of Frank Sinatra's relatives also had a house on my paper route! Talking about Twilight Zone... What a neighborhood! Just sayin... The whole neighborhood could have used our filter to clean up their systems! I know, had to add that last part to give the post some relevance...
I know the frustration fantomphan feels. I made my first purchase at 58yo. I'm now 70 working on 71. when I sell I would also like to enjoy the benefits of such a long holding. There have been apples hung before us during quarterly updates that are forgotten during the course of time. Personally, I would prefer just the dry facts with a best guess time line. Just sayin...
fantomphan, Agreed, however, careful you don't mix this up with "Fast Track" designation. Two separate entities. Fast track, the FDA attempts to make decisions within a limited time frame, not necessarily so with break through. Soon,my friend, either designation is a good thing...
Not so fast... need several more quarters of solid gains plus a response with the pps to those gains to start adding to the value, otherwise, we give it away... Most shareholders would sell today for .15. I would like to see at least .60 to .75 if not a buck and that will take a little track record of profits. Patience...
Fantomphan, Thank you for sharing that! I know a few people who are really extraordinary individuals. I notice a common thread that runs through each of you... The willingness to give a lot of your time and effort without the expectation of anything in return. Bravo, Fantom!
Yes, for the last 20 years, and it has been wonderful. .. BUT... there are many more things I would like to experience, that aren't here, especially the Grand-kids. I can ride a Heritage around Oahu nearly twice on a single tank of fuel, so it's really not that large an island... I would like to spend some time traveling to the National Parks. A couple acres on the Rogue River may be my next stop... Could that be the rock fever? Perhaps Cytosorbents can help fix that!
So... fantomphan, Is it fish tacos this weekend? How'd you do? Or are you out on a multi-day? One of the few things I miss about California are the submarine canyons close to the shoreline. There are specific spots where these deep water, upwelling flows bring nutrient rich cool water close enough for some spearfishing from the beach. California Halibut lay on the edges of these canyons in the sand that is no more than 20-30 feet in depth. Perhaps if Cytosorbents brings the bacon home soon enough, I could buy a home within walking distance of a nice surf break and dive spot... Just musing...
Taken from Cytosorbents Q3 2014...
Consent Solicitation, You have been sent a consent solicitation statement seeking your approval of five proposals needed to up-list. Your vote is required before December 1, 2014.
1.A 25 to 1 reverse split of our Common Stock
2.To reduce authorized common stock from 800,000,000 to 50,000,000 shares
3.To reduce authorized preferred stock from 100,000,000 to 5,000,000 shares
4.To approve the 2014 Long-Term Incentive Plan
5.To change the domicile of the Company from the State of Nevada to the State of Delaware
Wouldn't that be obvious to the trained eye? I seem to remember one of the reasons we had the 1 for 25 split, which btw, I felt was a little excessive, still do, was to move to NASDAQ, where we were told there was much less opportunity for manipulative behavior. I guess this is a complicated subject...
All of you this afternoon have posted thoughts that have merit. Well, one or two we might like to question the merit part, however, I will take the middle of the road on the thoughts bantered about this afternoon regarding progress and times a wasting... Don't forget, we have pretty much by ourselves been developing a single treatment that is applicable to a very large array of afflictions. Believe me when I say there are entities out there that would not like for us to succeed. Yes, if we had unlimited funding, unlimited talent, near unlimited influence, this filter would have been done long ago. We don't. But on the other hand, when a small company keeps focused and keeps their eye on the ring, and then succeeds, then the prize is much more significant. I can't find any reasons that we shouldn't succeed with the product that we have, and I've looked hard. The cacophony of noise usually rises just before a significant event. Shouldn't be long now... Thanks to all of you who have had constructive comments, both positive or negative. Wish Bertha was still with us... Good luck to all you longs into the future.
financing, hit out of the blue, just as the stock was ready to move into 12s. Much too big a move to the downside though. Something else is going on, I read somewhere, can't remember the source, that big Pharma has no use for the filter... if this were a pill it would be at $25 right now...
Dr. Ninja, Excellent Quarter, and a decent base line to extrapolate future earnings growth. Considering overall market size, (1.7B), it's reasonable to expect a 20% quarter over quarter increase. Perhaps slightly higher than that next quarter, a reflection of our pricing policy, and as long as our competition does not adjust their prices to our entry into the market, I expect we will pick up the slack price wise as time moves forward. Plenty of elbow room for all in this space. Should we average a 20% gain, quarter over quarter, we will end the fiscal year closer to 40m in revenue.
My understanding is there is really no set rule as far as what institutionally based trading follows. They can buy and sell as freely as anyone else. That being said, it is often bantered about that the vast majority of trades by institutions are at or above the $5.00 level. I would think it would be easier to abide by the fiduciary requirements for their clients accounts at $5 and above as there is less risk involved.
Great article. Thank, Techxen...
Goodsport, A few years ago I researched ways to exclude my shares from the shorting pool. I came up with only one method. This applied to Schwab, don't know about any others. With Schwab, the only way to lock up shares is to take delivery of actual certificates of stock in your name. The vast majority of stock in investment accounts are held in the brokers name for the account of the holder who purchased the stock. That affords the fluidity needed to trade quickly. If you don't need that quickness, then you can receive your individual certificates, but it may take several weeks to verify that they are genuine when you decide to sell. This may have changed since my research, however at the time, my measly number of shares wouldn't make a dent against the numbers outstanding, so that was not worth the inconvenience.
Thanks Techxen, but you give me too much credit. During the course of my personal research, if I have a question I can't find the answer to or, if I run across a fact that would benefit the members here, I will pass the information on. I will be double checking the restrictions on De Novo 510k submissions vs 510k's and pass what I find if I need to make any corrections to my post. Thaks for your posts. Excellent quality!
Hemo, These are the questions that the current meetings with Dr. Makis and the FDA are discussing. I believe we could file a De Novo 510k application, (for a class 2 device), that would be pretty straight forward as far as ticagrelor goes, however, as I read the limitations of this route, we would not have the convenience of off label prescription. We would need to file a 510k for other uses. Grey areas: I passed over automatic designation of a device catagorized class 3, which might allow off label use. I didn't look for that solution, nor the other quoted sections that could come into play.
Section 513(f)(2) was modified by section 607 of FDASIA, which created an alternative mechanism for submitting a De Novo request that does not require that a device be reviewed first under a 510(k) and found NSE prior to submission of a De Novo request. If a person believes their device is appropriate for classification into Class I or Class II and determines, based on currently available information, there is no legally marketed predicate device, they may submit a De Novo request without a preceding 510(k) and NSE (hereafter “Direct De Novo”).
Whatever the decision, we should hear soon on the route decided between Cytosorbents and the FDA.
If you haven't had the opportunity to watch the webinar; KOL Call on The Use of CytoSorb® for Antithrombotic Drug Removal, it is about 1:30 long, and it give a thorough presentation on what is going on in this space currently. Dr. Makis is the moderator, and he again gives an impressive showing for himself, his knowledge and his ability to keep the focus on the important subject matter. The presenters are also equally impressive. Watch with a nice Cab during the evening, the replay allows you to stop and replay points that you are interested in or points to replay for clarification. Webinar is front and center at Cytosorbents.com Careful with that chainsaw!
Fantom, Hoping your weekend is not too busy cleaning up after the storm... If I heard correctly, we were informed Dr. “Makis” Deliargyris is our representative in the meetings going on at FDA. If so, I expect we will be notified fairly soon regarding the path we will take to FDA approval. Days, maybe weeks, not months.
Thanks for the clarification Vinovista... The original grant was expanded recently from the US Army...
The focus is on Plasma, from Cytosorbents, Products, HemoDefend:
In June 2016, the U.S. Army Medical Research Acquisition Activity (USAMRAA) awarded CytoSorbents a $150,000 Phase I Small Business Technology Transfer contract to develop blood purification technologies to enable universal plasma. Plasma is a core whole blood component that contains many essential proteins such as albumin and coagulation factors. It is often used to expand blood volume and restore the ability of blood to clot in many serious illnesses such as trauma and massive hemorrhage, shock, liver disease, severe burn injury, sepsis, and other conditions. It is also used in plasma exchange procedures to treat autoimmune diseases. More than 10,000 units of fresh frozen plasma are administered each day, or more than 3.6 million units per year, in the United States alone. With the exception of Type AB plasma, plasma typically requires blood-type matching with the patient to prevent incompatibilities and reduce the risk of major transfusion reactions. Because Type AB plasma lacks blood type-specific antibodies, it is called ‘universal plasma’ and can be readily administered to patients in emergency situations, making logistics fairly straightforward for both military and civilian applications. However, there are not enough Type AB plasma donors to supply current demand. Under this Phase I STTR program, HemoDefend™ is being modified to remove these blood-type specific antibodies from all blood-type plasmas to demonstrate the proof-of-concept production of a true ‘universal plasma’. In doing so, it may enable the relief of a major bottleneck in the availability of plasma to help address these major unmet medical needs.
Hey, Fantomphan... Although you have been taking grief from fellow posters for your openness, thanks for telling it like it is in your own words. You vocalize frustrations that I'm sure others also feel who have been here and believe in the product for a long time. Your question is a good one, worthy of discussion. The more the merrier to help us focus on what is around the corner. Personally, with the recent breakthrough designation for the removal of Ticagrelor and the current on going talks with the FDA and our new CMO, I think we will be hearing very soon some positive results of those meetings that will have a profound effect on the fortune and direction going into our future.
Sidebar: Regarding our new CMO. In my opinion, this appointment, of
Dr. Efthymios “Makis” Deliargyris, will be looked back upon as an inflection point for the company. Everyone reading this, I ask you to take a moment and review Dr. Makis's bio, in the Executive Management section of "About" at Cytosorbents.com. We have heard him speak now several times, and each time I listen, I hear a confident, highly intelligent leader who has an excellent grasp of what we have to offer. He is exactly what we have been needing to help direct and present the face of Cytosorbents.
Hemodefend... This is big. There have been attempts to create in the laboratory artificial blood/plasma, having universal attributes. So far, this has failed to become commercially viable. Hemodefend could be the golden key to unlock that door to a universal blood supply. I expect it won't be too long before we hear from Dr. Chan regarding developments of Hemodefend, considering the financial infusion specifically for this program. Someone sees something worthwhile to fill a huge need in this lifesaving space.
Yes, the momentum may be waning, but only temporarily... I see a Darwinian effect in store for the shorts that fail to be nimble with CTSO.
Techxen, First, let me predicate my thoughts with the admission that your knowledge and processes are much more fluid than mine at 70yo. That said, we have a novel device that transits perhaps all three FDA classes, definitely the class 2 and 3 designations. The easiest path, from an acceptance standpoint, of off label prescription, would be the PMA which includes the class 3 uses, which comprises most of the indications that Dr Chan lists during his presentations. The problem for Cytosorbents is the crossover from class 1 or 2 into class 3 use by off label prescription, in the eyes of the FDA. This is not a problem for Dr. Chan nor the prescribing physician, but it could be a big problem for the FDA. They very well may require a PMA due to the severity of the indications of class 3. Strictly by the letter of the law, Dr. Chan could file for the De Novo submission under 510k, however the FDA knows how vast the grey area extends with the filter, and therefore may insist on the stricter requirements of a PMA.
The following is the Title 21 rules that I believe are in play for us.
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES
Subpart F--Therapeutic Devices
Sec. 876.5870 Sorbent hemoperfusion system.
(a) Identification. A sorbent hemoperfusion system is a prescription device that consists of an extracorporeal blood system similar to that identified in the hemodialysis system and accessories (876.5820) and a container filled with adsorbent material that removes a wide range of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are usually activated-carbon or resins which may be coated or immobilized to prevent fine particles entering the patient's blood. The generic type of device may include lines and filters specifically designed to connect the device to the extracorporeal blood system. The device is used in the treatment of poisoning, drug overdose, hepatic coma, or metabolic disturbances.
(b) Classification. (1) Class II (special controls) when the device is intended for the treatment of poisoning and drug overdose. The special controls for this device are:
(i) The device must be demonstrated to be biocompatible;
(ii) Performance data must demonstrate the mechanical integrity of the device (e.g., tensile, flexural, and structural strength), including testing for the possibility of leaks, ruptures, release of particles, and/or disconnections under anticipated conditions of use;
(iii) Performance data must demonstrate device sterility and shelf life;
(iv) Bench performance testing must demonstrate device functionality in terms of substances, toxins, and drugs removed by the device, and the extent that these are removed when the device is used according to its labeling, and to validate the device's safeguards;
(v) A summary of clinical experience with the device that discusses and analyzes device safety and performance, including a list of adverse events observed during the testing, must be provided;
(vi) Labeling must include the following:
(A) A detailed summary of the device-related and procedure-related complications pertinent to the use of the device;
(B) A summary of the performance data provided for the device, including a list of the drugs and/or poisons the device has been demonstrated to remove, and the extent for removal/depletion; and
(vii) For those devices that incorporate electrical components, appropriate analysis and testing must be conducted to verify electrical safety and electromagnetic compatibility of the device.
(2) Class III (premarket approval) when the device is intended for the treatment of hepatic coma and metabolic disturbances.
(c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA by April 17, 2014, for any sorbent hemoperfusion system indicated for treatment of hepatic coma or metabolic disturbances that was in commercial distribution before May 28, 1976, or that has, by April 17, 2014, been found to be substantially equivalent to any sorbent hemoperfusion device indicated for treatment of hepatic coma or metabolic disturbances that was in commercial distribution before May 28, 1976. Any other sorbent hemoperfusion system device indicated for treatment of hepatic coma or metabolic disturbances shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
[79 FR 3094, Jan. 17, 2014]
Orangecat, I had a Randy Rarick, Bear, woody stolen from a rack. We immediately scanned the local board shops and found it. They bought it for $75 from a dirt bag with a sob story. I have photos of all the serial # of my boards. Shop owner without question returned the board. Don't waste more than a couple hours looking. Homeowners should cover that. Happy 50th!
Good luck, Mike, and to all of us, I see we are down after hours with a record breaking report again. That's ok, the water behind the dam keeps rising...
Hemo, I am fairly certain Mike is a short. A kid that plays, naa... all BS, he has nothing good to say about the filter or the team that has singlehandedly developed a concept modality into an approved medical device. Tomorrow should stir the pot a bit. Numbers will be good, I'm more interested in the depth of information that will be shared.
Congratulations, Orangecat! 50 is a big one. Enjoy it!
Thanks, Good Sport... Your response should keep me busy for a while, or, since I'm not an attorney or CPA, maybe I will trust in the system like everyone else and go surfing... The lock-up appears to restrict only the general officers of Cytosorbents and perhaps the BoD. I think the answer to my question can be summarized by saying the market makers can write their own ticket, we are at their mercy, subject to the skill and fortunes of the corporation...
Mike, that's BS, the company is NOT selling additional shares on the uptic. They just filled their coffers a few days ago to the tune of about 50 million dollars. They are good to go now. Hopefully, they spend the money responsibly... On another note...
Perhaps someone can explain to me why the underwriters were able to sell 5 million shares in two days, all ranging between 10.00 and 10.90 per share, and within days we are in the 9.50 range. I assume the ticker that we watched that looked like GE on steroids was in fact the underwriters selling the 5 million shares into the general market. If true, and there is that much of a market out there, how is it are we now in the mid 9s? What is the dynamic that I'm missing here? Thanks...
I can't help feeling saddened by the passing of an influential American, Herman Cain, from the Covid-19 virus. One would think that everything that could be done for him was done, however, I would like to know if he was treated early on with our life saving filter, and if not, why not. We are now approved for covid-19. There are no excuses to allow these lives to slip away like this! We also need to get our manufacturing capacity up immediately. I expect to hear this subject addressed during the next conference call.
Techxen, I've been in a real funk this past week, Hurricane Douglas making a last minute jog to the north around Oahu yesterday and your words of encouragement brightened the day for an old flea bitten veteran. Thanks!
Orangecat, This is true if CTSO is in any way predictable, however, its not. For instance, last Monday, 20th, I was flat certain we would enjoy smashing through 12 bucks. What happened? Share offering, 4 million which turned into 5 million shares, and for some reason we couldn't let the stock price run a little bit. Sure felt like it was going to break out a bit till the offering hit. Result? Down 2 bucks in one day! You would think that a week one way or the other would not make that much of a difference to an offering. Sure threw a bucket of cold water on the sweet little run though!I think they could have priced the shares at 11 or so several days down the road, but what do I know, I've been here over 10 years, faithfully taking little gut punches along the way...
Welcome back, Ping!
Alright Mr. Mike! If that is true, then all the whining about buying your kid a piano is just that... May I suggest that you sell out of your position, go buy your piano, you don't need a bleeping Steinway, Baldwin makes wonderful baby grands, Yamaha is a leader in the field of integrated electronics in their pianos... and invest in your kids lessons. I'm sure he'll play at Carnegie Hall whether he practices 15 minutes a day or not!
Jdizzy, I might question stocking if we actually had a backlog. Dr. Chan has also in the past sent cases of filters to facilities who are running trials and it would surprise me if comping filters was not a part of the sales process.
Not sure how many angioplasties, valve replacements, MRI's for torn hamstrings, aductors, tummy tucks, nose jobs, knee replacements...All these are not life or death situations, and can wait if the patient has any brains. You could always go to a private radiology lab to have the pictures done, they don't shoot covids, but most full service medical centers will be taking pictures of potential covid cases to verify the glass granulation seen in the lobes. I would not follow that patient into the MRI no matter how much the staff washes down the walls and equipment. I might be wrong, but I believe the cause of the delay of the Refresh 2 trial was a screw up by the MD who was released from CTSO's employ. Problem may have come to light within a day or two of the Quarterly report. I don't remember... BARDA's decision to concentrate on vaccines was announced after we saw signs of their commitment to our therapy. I do agree, we could use a lot more transparency, however on the other hand, we don't want to give too much away to others who are trying to emulate us, and beat us to the goal line. I believe we are in a good spot right now, I hope nobody has misled us, as that would be the worst case and probably cause me to cut and run after 10 years of holding.
I have read multiple stories where elective surgical procedures have been put on hold due to this Corona virus. The financial well being of several hospitals has been put into question with this pandemic. I would like to know how the sales are booked, is it upon receipt at the end using facility, and what is the lag between arrival and when the actual payment for those filters is received by Cytosorbents. Is the 9.8 paid receipts or sold but not received yet? How many filters have been shipped out to end users free of charge in order to "prime the pump" so to speak in the facilities here in US? Lets not allow our underwear to ball up until we have clarifying facts. Potential sales would be about 22 million gross if every unit sold for $1000. There is a large disparity there that I would like to have explained. I would hope the pricing would be no less than $10 ps.
Let me split the difference... 70 and 23... Lol... Orangecat, yes, can see the Ilikai from here, walk to Charthouse, favorite watering hole! Getting crowded in the line up. Maybe time to get off this rock.
Orangecat, 50 was a wonderful year for me! I hope it is the same for you! That was the year I put my "Bucket List" into action, only regret... Banks lowering CD rates from 5% to.75%. Forced me back into the markets and took up more time than I cared to spend. Next Q could set the tone going into our future, marking inflection point, profitability... Congrats on your 23rd...
Canada is waiting on the approval from FDA, they will follow soon after. This info from friend who is Canadian and also holds a good number of CTSO shares.