HBV is producing “decoy” sAG at the rate of 100:1. The virus is producing these “decoys” for a reason
HBV Particle Types: The hepatitis B virion, also known as the Dane particle, is the one infectious particle found within the body of an infected patient. This virion has a diameter of 42nm and its outer envelope contains a high quantity of hepatitis b surface proteins. The envelope surrounds the inner nucleocapsid which is made up of 180 hepatitis B core proteins arranged in an icosahedral arrangement. The nucleocapsid also contains at least one hepatitis b ploymerase protein (P) along with the HBV genome
In infected people, virions actually compose a small minority of HBV-derived particles. Large numbers of smaller subviral particles are also present, that uusually outnumber the virions by a ratio of 100:1. These two other subviral particles, the hepatitis B filament and the hepatitis B sphere, are often referred to as a group named surface antigen (HBsAg) particles. They are both 22nm in diameter and are totally composed of hepatitis B surface proteins. The sphere contains both middle and small hepatitis surface proteins whereas the filament also includes large hepatitis B surface protein. The absence of the hepatitis B core, polymerase, and genome causes these particles to have a non-infectious nature. High levels of these non-infectious particles can be found during the acute phase of the infection. Since the non-infectious particles present the same sites as the virion, they induce a significant immune response and are thought to be non-advantagous for the virus. However, it is also believed that the presence of high levels of non-infectious particles may allow the infectious viral particles to travel undetected by antibodies through the blood stream (Garces, HBVP).
they did a nonhuman primate study.
Nov 10, 2014 AASLD – The Liver Meeting, Plenary Session Speaker: Christine Wooddell, Ph.D., Group Leader Location: Boston
Long-term reduction of AAT in nonhuman primates following repeat dosing with ARC-AAT 6 mg/kg AAT-UNA 3 mg/kg ARC-EX1 N=2 Efficacy: ~90% reduction of serum AAT after first injection of ARC-AAT Long duration of effect: ~80% reduction at 6 weeks Sustained reduction of AAT with q6w dosing Safety: no changes in clinical chemistry (ALT, AST, BUN, Creatinine)
Exactly what I was thinking these are conservative numbers.
this is why I am hoping they will not get bought out. I plan to sell shares all the way to $1500.
I was reviewing some of the recorded CC from the website today. I found it interesting that as they test the 3mg and 4mg dosses they seem to expect to see the depth and the duration increase will the larger doses.
I fully expected the depth to increase but the duration was not something I expected. It will be interesting to see if the duration increases and if so to what degree. It could be 85 days will not be long enough to see the numbers start to return to baseline.
Many people on this board have a better understanding of the science then I do so if I am incorrect here I hope they will correct me.
When I was 15 years old I got the chicken pox. After a several days the outbreak cleared up. Now today I still have the chicken pox but my immune system has the virus under control. I am not contagions and as long as my immune system is not compromised I will be fine. So I have been functionally cured of the chicken pox.
This same thing happens to many HBV patients they will always have the virus but their immune system has the virus under control (They got to functional cure on their own). The market For ARC-520 is those people that do not get to functional cure on their own and have chronic hepatitis.
The risk of becoming chronically infected depends on the age at the time of infection. More than 90 percent of newborns, 50 percent of children, 5 percent of adults infected with HBV develop chronic hepatitis. Those who are unable to produce an effective immune response allow the virus to replicate for long periods in their livers, causing chronic hepatitis HBV infection.
I believe the 2B people that have the virus and are not chronically infected. the immune system has the virus under control. If they are not chronically infected already have what ARWR is trying to achieve.
The "shorts" on this board are all day traders and can not even convince jerry to sell. The old argument that you should sell because the stock is going down doesn't work on the way back up.
I hope that any buyout would be turned down. !0B would be nice for current shareholders but as you point out above the last time they spent that kind of money it add over 10 times that in market cap. I would much rather sell this for $1700 a share VS $170 a share. Does that sound greedy?
At one of the resent meetings someone asked: if you keep knocking down the s-AG theoretically you could get to s-AG undetectable levels. How will you know that you have achieved FC?
The company said they did not think that ARC-520 could get to s-AG clearance on its own. Once they have some patients that test s-AG clear they will stop dosing half of those patients to see if they continue to test S-AG clear. They said they will keep dosing the other half. They defined FC #$%$-AG clearance with no additional treatment. The immune system will keep the virus in check unless it is compromise. For example A patient would need to take Immunosuppressant drugs.
Yes, lots of things have to happen before we get to Accelerated approval. I was just pointing out that the company is preparing for it.
Once they receive approval to begin the phase 2b trials. They have to get 240 patients screened and dosed. I believe this will go relatively quickly they have started the ground work and it would be an easy decision from a participant point of view.
They should be able to dose the 4mg before the 4mg 2A is complete. The phase 1 data is complete and 2a did not specifically mention safety as part of the study design. (of course safety is always a focus )
I think the multi dose trials will go well:
I see the odds of them getting to 1 log at better than 90%. It is all about the duration.
I see the odds of the safety continuing to be stellar at 80%. The company said that DPC clears the system quickly.
I see the odds of ARC-250 will result in FC is better than 50%.
People may think I am overly optimistic we will see.
In some of the recent events they have gave us some clues about accelerated approval.
The first clue was the fact that they are already making deals to achieve full commercial production capabilities. They mentioned things will move fairly quickly once they have cured some patients.
The second clue is the company mentioned they may build a sales force in the US and possibly Europe. They indicated that they would partner with other companies for sales to the rest of the world.
If you read between the lines it appears they are planning to get approval in the Eastern part of the world first and use the proceeds to build a sales force in the west. It appears the company is preparing for things to move very quickly. 2015 should be an interesting year for the company and its investors.
Exactly who is buying and who is selling and what is the significance of $6.39
that is 3m shares bought and sold at $6.39 if you add in the after hours volume.
Lots of big buys in the final seconds of trading several 100k blocks along with the 1m share block. I posted the last 100 trades from nasdaq but it was deleted.
paranoia would imply fear. I am more intrigued that someone would telegraph a move like that. if you had unlimited cash it would not make a difference obviously that is not the case.
like I said it could be just a coincidence.
n16m15 posted at 1pm Eastern time. ARWR was trading between $6.34 and $6.35 within minutes all the bids from $6.34-6.32 were taken out and an ask of 50,000 shares showed up at $6.32. The stock was under pressure for the next 30min or so. Coincidence? Or was this guy telegraphing a short attack? hmmm.
As we approach the end of the year I would to thank all who participate on this board. I truly believe this is one of the best boards on yahoo. I have learned a lot from many of you (of course as always trust but verify). It appears we are going to have a quiet period for at least a few weeks. We have discussed just about every aspect of this stock/company: Management, obvious manipulation, ARC-520, DPC delivery system, and Dose response curves...........the list goes on and on. I would like to hear what people think the message board chatter will be next year at this time. My guess is the message board will be talking about: Arc-520.phase 3 trials, projected sale, DPC delivery system and Arc-AAT. Of course none of that is a stretch so I will also predict that the next drug will be outside of the liver. Lastly I will project a higher than 50% functional cure rate. It will be interesting to see how close the guesses are next year.