is waiting for the inflection point
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From Purdue Pharma, the company that largely responsible for the opioid crisis. Not sure how I feel about that, but they sure know how to market and sell a product.
Mostly info presented before. Remove trial over 50% enrolled. Hemodefend should start enrolling this year and will likely be completed before REFRESH 2.
Maybe Cytosorb would get more recognition with a catchier name like Viper Rescue!
The FDA Breakthrough device program guidance says that the program replaces the EAP program. Cytosorb did not get EAP because the FDA did not want to accept surrogate endpoints for a sepsis trial. After the denial, Dr. Chan stated that any US sepsis trial would be granted fast track status so there is no benefit to the EAP program without the surrogate endpoints.
It sounds like they are trying to filter out the TNF proteins. It looks like their molecular mass ranges from 17-30 kDa. Right in the middle of the Cytosorb range of 5-60 kDa. Perhaps we have stumbled on the other method that Cytosorb helps in fighting cancer, alluded to by Dr. June?
Just a 2 hour drive for me.
Interesting that they were able to use a standard Cytosorb cartridge in a 12 lb baby given the low volume of blood in such a young child. I am guessing the red blood cell suspension instead of saline made it possible. I have wondered for years why they have not introduced a lower volume cartridge for pediatric use already. I imagine it would simply be a matter of packaging the same beads in a smaller volume cartridge.
Ops. Looks like someone posted under the wrong alias...
Dude. You are in your late 70s. Chances of you even having a living FIL are extremely unlikely.
Most trial stage companies do not want the overhead of managing compassionate use treatments. These are treatments that companies do not usually even charge for.
Wait a minute, when you joined this group didn't you stated that you were pretty much a newbie? Now in a few weeks you consider yourself one of "we in the biz". LOL.
How exactly would you know what I did or did not delete unless one of your many other aliases is a moderator.
Whatever Paul...
Triple Witching day Friday. I wonder if we will see a nice pop?
Cytosorb XL adds endotoxin removal, which is something that can trigger sepsis in cases of gram negative bacterial infections. I think this is the trigger in only about 20% of sepsis cases .The cytokine release issue in sepsis is a positive feedback loop which feeds itself. Cytosorb targets those cytokine to stop the loop. Endotoxins from gram negative bacteria are one of the ignition sources of the cytokine storm, so removing them with the cytokines is a win win situation. Also look for Brown University article on the topic. Nice to remove endotoxins, but it is usually too late to help the patient, because the cytokine storm has already started and is feeding itself.
There device only removes endotoxins which can be one of the many triggers of sepsis.
Come on guys, we are slacking. 4 whole hours and nobody stepped up to do Laker's DD for him?
When speaking of the FDA not accepting a surrogate end point for a Sepsis approval of Cytosorb through EAP Dr. Chan stated "Finally, in terms of other advantages of the EAP program, sepsis is already considered a
disease that would receive expedited review, so we should benefit from a kind of “fast-
track” when we get there."
Great results other than the 3 out of 44 patients who died from CRS. If only there was a more effective treatment for CRS.
I am probably in the other 2 with you. It has been a beat down recently. But like CTSO they have huge prospects. Sitting long and strong on all of them and adding here and there.
There are huge uncertainties investing in any small biotech. If you are a trader that was hoping for a big pop on FDA approval the price action was a huge bummer. I am long and have some 2019 calls also, but I too thought there would be a pop on approval and picked up some Nov. calls. I suspect there is about a 98% chance they worthless. That sucks, but I still feel good about my long term investment.
There has been obvious coordinated manipulation by shorts since FDA approval. If full blown max potential sales were a 100% certainty it would be trading far higher and this would not be a investment with tremendous upside from here. If you have done your DD and don't think the company can successfully transition to commercialization, with or without a partner, cut your losses. I happen to beleive the capital raise is partially in an effort to give them an upper hand in partnership negotiations or even a BO. I think overseas partnership is a certainty and that partner will hit the ground running with an established sales force and distribution channels so sales there will likely ramp up faster than in the US. They now have the world wide gold standard approval, the FDA. They should also have the near term large sale to the US DOD. How could that sale not be great for marketing world wide.
Yes I am. A biotech transitioning from development stage to commercialization should still be largely valued on potential not just actual sales.
I suggest reading the SA article: Hopes Are High For AcelRx After Dsuvia Approval - Will Price Follow? I think it has a more educated and well thought through price estimate.
Wow. Not sure where to begin with this post. You think the company will hit 50% of max potential sales in its first year on the market? Not going to happen. You think a company's market cap is based simply on its current year gross sales divided by number of outstanding shares, not taking into account profit margin, PE ratio, etc? I say again, Wow!
Zacks pretty much called this one.
The whole market has taken a dump and biotech got hit harder than other sectors. With CTSO, I just don't know. I park trading funds there because it is just a matter of when not if they succeed. I have gone back and forth on ACRX, but I am leaning toward approval at this point. However, look at TXMD, FDA approval then dropped. Had a 1.1B MC at approval, so they need to prove they can become profitable or sell out to move up. ACRX MC 235M with a potential of over 1B MC near term if approved. But then again this market is crazy right now. Nice discounts on things like CTSO.
You find out about CRMD on CTSO? I had 45k shares averaged in at 0.44. Sold 30k between 1.5 and 2. Depending on how ACRX does in the next week, I may be loading back up on CRMD and more CTSO.
I listened to all the presentations. The last one on the off label use for drug overdoses I thought it odd that he said that he is just now stocking an adsorber in the hospital where before they would order them on demand and it would take 8=12 hours to get them.
Yes. Not buying into his new character, so I refuse to respond to it.
Please look at my recent post. Sorry for the typo in your name.
Swingman, please look at my previous post on this study. The post I am responding to here.
Well, I read DR. Raerford Bown's interview/letter on Wednesday and it it resulted in me selling 3k shares and picking up 30 Nov $5 calls. After additional DD and the recent price drop, I am going to be a buyer of both.
The finances do not make sense for this to become a street abused drug. As a substitute for IV morphine and used as a military battlefield friendly pain killer, it is going to be priced accordingly. That is not cheap! Addicts do not go for an expensive fix and the therapeutic dose will not produce the euphoria that an addict is looking for. I think Dr. Brown may have ulterior motives in his opposition and the fact that the FDA did not reschedule the AdCom meeting makes me think that they may have been aware of this. As for Sen. Markey, what does he have to lose with an uninformed stance against a new opioid delivery system for an opioid that has already been used for decades in IV form. Not much. Sure there is an illicit opioid crisis in the US, so the equally uninformed population will think this guy is making a real stance against the continuation of this crisis. The risk just is not there and the AdCom got it right with the approval vote. If this product is not approved, blame big pharma influence and uninformed politicians grandstanding.
AcelRx’s chief medical officer, Pamela Palmer, told BuzzFeed News that although sufentanil is a more potent opioid than fentanyl, the 30 microgram dose of the tablet delivers less of an opioid effect than the bigger doses in other painkillers do. The benefit of the tablet, packaged individually instead of in a bottle of pills, is that it delivers pain relief quickly, without an injection.
“I don’t think other people would want it — it won’t deliver the effect that illicit drug users want in such a very low dose,” Palmer said. Because of the low dosage, the company found that the drug worked without dangerous side effects even on elderly cancer patients who had never taken opioids before, she noted.
What’s more, Palmer said, “the Defense Department asked us for this drug.”
I held on to my TRVN also. Although I don't have much. I did cut my ACRX in half. CRMD is getting a beatdown, but you can't expect a 5 bagger to not back down somewhat.
OT: Ealier I mentioned ACRX. After reading up on Dr. Raeford E. Brown Jr, I do not have the best feeling about chances for ACRX. He was not at AdCom, but I fear he may still have strong influence on their potential FDA approval.
Oh, OK, just the mention of the study but it is not actually published online anywhere.
Where can this be found?
There is really not enough details in this abstract to draw a conclusion. It says that the adsorber did not significantly decrease plasma free hemoglobin resulting for hemolysis. However, we know Cytosorb adsorption rates are concentration dependent and we don't know if the patient population had hemoglobin levels high enough to even need significant reduction. We also don't know the circuit setup with Cytosorb. Note that REFRESH 2 is using a dual adsorber setup. The abstract also does say that statistically significant differences in the median levels of haptoglobin and lactate dehydrogenase.
In REFRESH 2 hemoglobin reduction is also a secondary endpoint. Primary is reduction in incidents of AKI.
Well, that is not good.