I cannot disagree that the most important influence on the PPS will be the hard data when it is released, and the 3 and 4 mg data seems to be the next up to bat, so to speak.
But that data was still blinded, for whatever reason (and there are many possible reasons), and so we cannot realistically expect it until it is unblinded.
I, personally, think it is more likely that ARWR management does not have the blinded numbers this time around, even though they did have the blinded numbers shortly before they released the 1 mg and 2 mg data.
I think Givens gave us the answer a couple of times that they are not drawing those numbers because they do not want any perturbations in the data base. They are afraid that any disturbance of the trial to gather premature data might cause a challenge by the FDA, so they are resisting taking a peak. If they had the data, they might say something, as they did the last time.
Yeah, there is another way to look at it and conclude they do have the data, Then you draw a bunch of conclusions about why they have not released at least the 3 mg data.
Keeping it simple, I have decided that they probably don't know how much KD they got!!! I don't think they control the investigator nor do I think they want to. The purpose is to have someone beyond reproach to do the investigation and run the trial. They want independence and valid data, not early peaks.
I did not predict the profit taking or the effect it would have. However, it looks to me that someone sold about 200K shares, possibly to finish off a sell order. The MMs dropped the price quickly as they absorbed that large sale. As soon as they owned the stock they let the price rise back so they could distribute it for a profit. That selling might have been the end of a larger sale order that was driving the PPS down today. Presumably the selling was done by a short term player that bought in the range from $6.25 to $7.00 and dumped in todays selling. Some others probably sold on the prior two days, and "profit taking" is the "cause" of the last 3 days of down moves. You can see the selling all three days were light so their is no real distribution. On the down days, the shorts will help any way they can, but they are not shorting heavily right now, not at these low prices.
The confluence of events you talk about is very suspicious. There is a group profiting from price drops in a stock that is making good clinical progress, and that group seems to be manufacturing or causing some of those price drops.
You can add to the items you mentioned, some others that I found bothersome. There are odd downgrades with poorly crafted rationales from RBC (PT from $45 to $9 after the first KD in Humans is disclosed on only a single dose of 2 mgs, where the chimp data was published and available and should have not been a surprise) and DB (with a PT of $7 for not good reasons).
There is a large number of class action suits following the 10/8 drop, which might not be a surprise, except there were so many of them and they put out a chorus of self serving Press Releases that tended to sound the alarm over and over for a solid month or two, from a crowd of lawyers that wanted the price to remain down for 90 days so there suits would have damages to complain about. These suits assert unusual claims of fraud for using the word "similar" in comparing the human to the chimp data, plus the highly unusual citation in the complaints of AF's articles, as if that self serving argument were proof of the fraud!
There also is was strange round of false buyout rumors published in Seeking Alpha and other suspicious locations without any substantation. Who started those rumors? Shorts faded the rumors. If you look at the "evidence" it is not illogical to conclude that short sellers ran the buyout rumors to create short selling opportunities. It is all a game of price manipulation to them that do these dirty tricks.
No real substance.
All the while we, on this message board, have discussed the fundamentals that look good, the likelihood of good KD in ARC-520, and the positive elements of the story, none of which are given weight by the group profiting from the price drops.
But we have jet cloud, vrrrummm and jerry to disrupt our discussions.
Thanks for your ideas of support and resistance. My forecasts of the daily movements of price today are proving to have been too optimistic. There was some selling today that I did not expect. It makes little sense to see selling as the clinical trials make progress, but there is no real news or data to report, so it is hard to time and predict daily volatility in an environment without real catalysts.
Also, shorts and price manipulators still operate here with impunity, and they go the opposite of what I would expect. They are an ever present wild card that can bend logic with cash.
It does not matter to them that the company is making progress, or that the clinical trial programs are going well. Without a positive catalyst that generates buying, the PPS defies logic. We don't have such a buying catalyst right now.
Instead, apparently there was some liquidator today that sold a few hundred thousand shares; and that give MMs the chance to lower the price, and give the seller the least amount possible. Maybe they bought that stock and will take it up later so they can sell it for a profit.
In the meantime, good luck predicting what the ones in control of the PPS will do next. I don't think the answer lies in the chart patterns. The chart patterns do not predict what will happen, they only help you see what has happened and give you a framework to evaluate changes.
Cramer was talking about a nanotech stock comparable to a semiconductor stock not a siRNA stock. He made no substantive comment that remotely applies to ARWR. At most, he was referring to the rumors that GILD was going to buy ARWR out and was saying that the rumors are not substantiated and no "marriage" has happened.
Obviously, from his comments, he either does not know what industry in which ARWR competes, or he (or his pals) are shorting this stock. His negative comment did not focus on any substantive issue that would give an investor pause or reason to worry.
We would all be better off giving Cramer's "lightning round" its due. It is pure entertainment.
The trials are being done in Australia where they have obtained permission under their Federal clinical trial scheme. "Trial initiation followed successful completion of the Clinical Trial Notification (CTN) regulatory process in Australia. "
Even though this is a Phase 1 safety test, one of the objectives will be to determine the knock down effect on AAT in both healthy and patients with AATD, which means they will test efficacy of the drug in Phase 1. "The primary objectives of the study are to determine the safety and tolerability of escalating doses of ARC-AAT, evaluate the pharmacokinetics, and determine the effect on circulating levels of alpha-1 antitrypsin.
Since "Initial data from this study is expected in late 2015," these tests should show if the DPC delivery system performs to achieve KD in a second drug with Humans, thus it should further confirm effectiveness of DPC in delivery to the liver. This is very important, IMO. It also will show if the kind of high KD they got in the pre-clinicals will carry forward into humans.
This is a case where they are trying to KD an defective endogenous gene, which is something different than ARC-520 does, as that drug attacks a virus production of proteins while this drug attacks a defective production of alpha-1 antitrypsin. And it is a finely tuned attack aimed at a particular type of defective gene, so it will prove the concept of specific gene silencing in humans.
This treatment is badly needed and will command large fees and orphan status because " no current treatment options, short of liver transplant" and it is "a rare genetic disorder " which means they likely will gain extended protection and tax benefits under the FDA orphan drug program. They already have shared costs with the Alpha-1 Foundation, so this can be a very profitable drug if it is effective.
There is a lot of information in the PR which should be read slowly and carefully evaluated. IMO, the PPS treats this at zero value!!
This is a single-center, open-label study of ARC-520 in combination with entecavir or tenofovir administered to patients with immune active chronic HBV infection. An iterative trial design is anticipated with potential inclusion of additional cohorts with anticipated enrollment of up to 60 patients. Patients who have signed a Human Research Ethics Committee approved informed consent, and have met all of the protocol eligibility criteria will continue receiving daily oral entecavir (0.5-1.0 mg/day) or daily oral tenofovir (300 mg/day) and a single IV injection of ARC-520. If a serious adverse event (SAE) deemed possibly or probably related to study drug should occur at any point during the study, any further dosing will be put on hold pending a complete review of safety data by the sponsor and the Principal Investigator. Patients will undergo the following evaluations at regular intervals during the study: medical history, physical examinations, vital sign measurements (blood pressure, heart rate, respiratory rate, and temperature), weight, AEs, 12-lead ECGs, concomitant medication, blood sample collection for hematology, coagulation, chemistry, PK and exploratory PD measures, HBV virology. Patients will be monitored for a total of 12 weeks. Clinically significant changes including AEs will be followed until resolution, until the condition stabilizes, until the event is otherwise explained, or until the patient is lost to follow-up.
Light volume selling is nothing but MM and short seller action, looking for stock. Don't sell your stock to thieves.There are few publicly known reasons for ARWR to be sold here. Many positive developments and ARWR to announce the start of US Phase 2B trials any day now.
Multiple dose loading is going to be more and more accepted as the clinical data is released supporting it. It might not be fully accepted yet, as it is largely in the preclinicals and theoretical realm.
However, there is the new preclinical multi dose study that should help when the data is released; and there will be growing confidence as the market sees the additive effect come to fruition in human testing with ARC-520 and ARC-AAT. This is a reality with other drugs and it really is not in doubt conceptually. The post 10/8 letter to shareholders explained it, and everyone understands the issues in a more accurate light now. This is not the pre-10/8 world.
When the 3 and 4 mg doses data is released the first thing that will happen is the PPS will spike up. It would be an easy day trade except no one knows how high it will spike or how many days it will keep going, LOL. The shorts, day traders and profit takers will fade that spike and drop it back an amount, yet to be determined. 50% of the traders will get it wrong BY DEFINITION!
It is extremely unlikely that the initial reaction will be some kind of sell off, and there is not going to be a big bear raid like we saw on 10/8--at least not to start.LOL. If by some miracle it drops following the 3 and 4 mg announcement, it is just going to be another buying opportunity, as those numbers will not stop the trials or prevent FCs or benefits from a s-AG knock down drug.
But, there always will be profit taking , like there is any time a stock runs up; and the PPS is going to become volatile for 5 to 10 days after the new data is released . IMO.
All we investors need to do is buy in front of that release and hold during all the volatility; or if you think you can pull it off, you might try some day trading at that time, since the PPS will likely be moving a bit more than the 20 cents we see now a days.
I don't think you are totally correct about the potential impact of withheld information, but I don't want to dignify those fatally flawed complaints by mincing words with you about how misrepresentation, in general, might be proven. That does not matter here, because their cases are frivolous, at best, and intentional manipulations in aid of the shorts, at worst.
That was my conclusion too, "Only IF ARWR uses whatever they licensed from ALNY. "
The issue, then, is why doesn't ARWR tell us if ARC-520 uses whatever they licensed from ALNY?
My answer is they are evasive and obfuscating on purpose, and the only reason that I can think of for that is that they do not know if they use ALNY licensed technology, and/or they are not willing to conceded that they do use it. Possibly there are cross license issues as well that they are reserving, such as that any argument they use ALNY technology in ARC-520 will be met with a counter argument that ALNY uses ARWR licensed technology in some of their drug candidates. We simply are not going to get any answers to this question unless the products hit the market and claims are made.
I think both Mud and Jagan are over dramatizing the importance of the 3/4 mg data.
It is true that large KD near 1 log, from a single dose of ARC-520, is an announced goal of ARWR management (see "Open Letter to Shareholders") for the stated reason that such KD works with interfereon in some 6% to 10% of the cases to achieve FCs.
However, the 3 and 4 mg dose KD will come in as a number, and the number will be interpreted on a degree of success scale, not a do or die scale.
The DPC testing to date suggests that above 6 mgs there is some saturation in the ability of the DPC platform to achieve endoscopic release inside the cytoplasm, which is to say they might not have a good basis to escalate above 6 mgs if endoscopic release is the issue.
However, they clearly can go to higher first doses if there is no saturation or toxicity, and the goal is to gain large initial KD.
But large initial KD is not the only goal, or the do or die goal. They have plainly shown with the chimp and the humans in Phase 2A that higher s-AG KD can be obtained by loading doses. Thus, it is the opposite of what Mud and Jagan are saying that is the truth.
The 3 and 4 Mg data will be important, and it will contribute much to an understanding of the pharmacokinetics of ARC-520, but that is just information that is going to be used on the way to finding out if it is capable of providing FCs or other therapeutic benefits in combinations.
For someone that wants to get the PPS to $100 by no later than Jan 2016 because he has options that expire, it will be important to gain large single dose KD as that will shorten the hunt for the best doses, but it certainly is not do or die for any shareholder that is looking at this problem in realistic terms and with their head screwed on right.
The fact that the closed the Phase 2A trials again confirms that they have no present intention to escalate to a 5 mg dose, which out to tell you that things are looking good if you assume they already know!
Is their a definitive statement from ARWR whether or not sale of ARC-520 would require royalty payments to anyone other than Roche?
I did not find anything other than evasive statements in the SEC filings.
It is clear ARWR has a license from ALNY and one from Roche to use ALNY IP, and that payments "might" be owing if ARC-520 makes use of that license, but I can't find anything offering ARWRs position on whether ARC-520 uses the ALNY license.
It is my impression (from the silence) that ARWR does not want to say because the issue is not clear, and they reserve the right to argue about it.
IfIf, I am wrong, and it is clear cut, the they should say one way or the other,IMO, as owing royalties to ALNY on ARC-520 is not a small matter.
I believe it is clear that they would owe an undisclosed royalty to Roche if ARC-520 makes it to market.
Further to this very complex subject, there is a Roche license with Alny which is attached to the 2011 ARWR 10K that you can read, under which Roche obtain a license to use ALNY's technology and know how and that which ALNY had obtained licenses to from third parties. The document is very complicated and I have not studied it with full care, but it seems to obligate ARWR to make certain undisclosed royalty payments if and only if ARWR uses ALNYs patents or know how. Thus, ARWR is free to use ALNYs know how, but it is not required to do so.
There is nothing that I have found that establishes that ARC-520 constitutes a use of ALNY's patents or Know how and it is highly doubtful, IMO, that ARWR thinks they own ALNY any royaltiy for ARC-520 under those licenses. Yet, the lawyers cannot clearly declare that no royalty would be owned, or have not chosen to do so.
It would take someone fully versed in the technology of siRNI, who is a patent expert, to figure this out!!
And even then, the patent experts for the two sides would possibly disagree.
I doubt anyone wants to get into a patent fight, ergo, I am currently thinking that no royalty will be paid to ALNY if ARC-520 is a commercial success. But you cannot tell from either the press releases or the license agreements. You need to read the underlying patents and figure out if ARC-520 uses the teachings of any ALNY patents.
Is there a patent lawyer in the house?
I don't know if there are any disputes or possible disputes with ALNY over whether ARC-520 does or does not use ALNY license rights, but if there are the stakes may be high as the SEC 10K also contains this warning:
"Our Subsidiaries are party to technology license agreements with third parties that require us to satisfy obligations to keep them effective and, if these agreements are terminated, our technology and our business would be seriously and adversely affected.
Through our Subsidiaries, we are party to license agreements with Alnylam Pharmaceuticals, Inc., City of Hope, and other entities to incorporate their proprietary technologies into our drug products under development. These license agreements require us to pay royalties and satisfy other conditions, including conditions in some cases related to the commercialization of the licensed technology. We may not be able to successfully incorporate these technologies into marketable products or, if we do, sales may not be sufficient to recover the amounts that we are obligated to pay to the licensors. If we fail to satisfy our obligations under these agreements, the terms of the licenses may be materially modified, such as by rendering currently exclusive licenses non-exclusive, or it may give our licensors the right to terminate their respective agreement with us, which would limit our ability to implement our current business plan and harm our business and financial condition."