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Tex, this language from what you posted seems to indicate that BTD must be applied for prior to Phase 3: "Ideally, FDA should receive a
breakthrough therapy designation request before initiation of the clinical trial(s) intended to serve as the primary basis for demonstration of efficacy if most of the benefits of designation are to be obtained."
Cervical? I thought BTD was reserved for indications in Phase 2 or earlier?
I wonder if ADXS will get BTD for the throat cancer and/or prostate indication. The initial results are crazy good, 100%. Hovacre?
Bourbon, the only cure is time and patience. Although a big fat EU deal for AXAL and EMA approval would help.
No, it's not. The market is inefficient, especially when it is manipulated. There is no connection between the actual value and the share price. Management creates actual value, not share price.
Because, FB, you are still confusing actual value with share price. The company is worth way more than $300 million right now, and you know it.
What's the difference? In the "two years ago" market the company could very well be worth $2 billion right now, regardless of the share price. It's worth at least $1 billion even in today's market.
We agree, FBG. Although, to be fair, authorizing additional shares to cover future management options does not actually grant options. However, the size of the available pool should be voted on as needed.
I am certain that the votes against the Management Compensation shareholder proposal was a reaction to the provision of automatic renewal of an increase in authorized shares without future votes. Whoever came up with that idea failed Corporate Governance 101.
Please explain the negative value of having a Phase 3 trial underway with SPA and fast track (fully paid or by a BP partner), an impending application for EMA approval, a $550 million deal with Amgen for a pre-clinical construct, etc.
They have delivered lots of "value" in the last two years. One Phase 3 underway with SPA and fast track, all paid for by a partner; another Phase 3 starting soon; raised $120 million+; signed a huge $550 million deal with Amgen on a pre-clinical technology; about to apply for EMA approval that is also fast tracked; etc., etc. The fact that the value is not reflected in the share price is not their fault. Unless you disagree with the "value" of the accomplishments listed above, you must conclude that the share price is irrational.
It again impresses me how well Dan understands and explains the technology, for a layperson. Very articulate.
Bring it on, Tex. I'd say you may be right on NEO getting the red carpet rolled out for it. Also, people tend to forget our combo therapies, maybe because we never hear anything about them. But I assume they are all doing well in trials. We could hear of some special FDA treatment for one or more of them. I'm guessing that because they are combo treatments the FDA may find there is less risk to patients of conditional approval of the combos, particularly given the vaccines' excellent safety profile. If the addition of ADXS shows even marginal improvement over the checkpoint inhibitor alone, what's the harm? It's not like patients will be putting all of their eggs in one basket, i.e., ADXS's basket.
Partially agree, Meisha. You are probably correct that the cost of them trappingg the pps in the range is relatively light, considering the low recent volume. Plus, they are probably making money on their swing trading. I tend to disagree with you that we need Phase 3 approval (or imminent approval) for a sustainable move up. But we've already had that conversation. It will not take an unrealistic amount of steady tutes accumulation to throw a monkey wrench into the algos' program. Which could very well come with an EU AXAL deal and potential (or actual) EMA approval. If nothing else, longs will increase their bets and shorts will decrease theirs as the EMA process plays itself out. IMO. And if we actually get EMA approval that will be major validation of the entire platform. I'm also looking (hoping) for BTD/fast track and possibly even accelerated approval on a combo indication before Phase 3 AIM2CERV completion/decision. Although I believe that could get accelerated approval on interim data also.
I keep forgetting that 50% of the GOG Phase 2 patients had previously been treated with the SOC (Avastin). Add this factor to the discussion earlier today regarding AXAL's chances of showing better results than Avastin in Phase 3, with a more direct comparison to Avastin.
A possible "partial" explanation for the algos keeping the pps trapped between 7.50 and 10 is that the January options show a fairly large short strangle position of 6k contracts, with 6k puts at 7.50 and 6k calls at 10. That means someone wants to keep the stock between 7.50 and 10 and simply pocket the premiums they received on 12k contracts, representing 1.2 million shares. Probably not enough in itself to motivate such extreme manipulation, but there certainly could be at least one algo working toward that end.
"It's nice to see the buys by the other institutions, though!" Such as? Are the quarterly reports out today?
Meaningless rebalancing by Fidelity.
Terry: why do you refrain from commenting on the efficacy results of the dose escalation study? And, since you did refrain, why do you say that "this looks like it could be a very big deal with a step up in potency and a step down in toxicity." I'm not challenging you--you clearly know more about clinical science that I do. It is a sincere question. Despite not being powered mainly for efficacy results, wouldn't we expect pretty good results nonetheless? Or did the design of the study inhibit such results?
Bourbon, a good amount of shorts will inevitably cover upon the risk of EMA approval, which would be a disaster for them. And I'm still convinced a deal for EU is coming soon, possibly in conjunction with the EMA application. I wonder, would the BP partner be listed as co-applicant? That would help, based on prestige/credibility and possibly "connections" that a BP might have. Also, someone like Astra obviously has experience with the EMA and could at least offer guidance.
Not to mention that there is an indication that optimal dosing will result in much better results than 38% 12-month OS. More like 50%+.
Superficially ADXS did better than Avastin but it was not a direct comparison of the two, so some variables were not accounted for. Most notably, trial size and patient differences. Although the latter could actually favor ADXS since ADXS's GOG patients had extremely advanced disease. Also, only part of the trial was at optimal dose and the trial ended prematurely.
Understood, Easy. FDA approval of the canine will probably not provide huge revenue but it will result in a milestone payment and also provide some proof of concept. And, as you note, it may lead to a quick start to the development of the pediatric osteosarcoma indication.
Obviously, you can also further lower your odds if you just pick the right companies. lol
I don't understand this view that Aratana will not get approval because ADXS's goal was always to piggyback on that for a pediatric indication. The companies have flat out predicted approval this year. Apparently they know the results are sufficient, and it's only a matter of red tape at this point. If not, they would never predict it so matter-of-factly.
I think your timeline is off, with a caveat. If you mean it might take 2-3 years for the "big" payday, you may be right. But there certainly could be major appreciation long before then, based on a number of developments, including EMA approval, major pharma deals, and even an early buyout (even a bid would do it), or a change of strategy by the short cartel.
Meisha, I think you are neglecting the possibility that ADXS could receive accelerated approval based on interim Phase 3 results. Particularly if they receive conditional EMA approval.
Except that early EMA approval could occur.
This is the most manipulated stock I have ever personally witnessed. It seems to be not just algorithms at work but also collusion by multiple parties working together.
Sandman, all clinical biotech companies keep info fairly close to the vest. And they are all characterized as presenting alot of "ifs ands or buts." Nature of the sector. Good luck with your swing trading, see you when you buy back in.
Fair points, Fraud. It would be nice to have some PR on the positive trial outcomes. And I agree that they should give some report regarding the status of the Asian market trials/deals, which seem to have vanished into thin air.
Catt, I would like to know what's going on behind the scenes as well. But obviously ADXS can only provide limited information with regard to deals, etc. If you mean info such as combo trial progress, etc., then I agree.
Fraudfighter, be specific. What exactly do you suggest management do that will increase the pps? I assume you are going to say "sign an EU AXAL deal." But it is obvious that such is the plan already. It's virtually predicted in the corporate presentation. Aside from that, everything is already set up. Phase 3 underway with SPA. Multiple combo trials that we all believe are going well, but which will proceed at their own pace. Fast track EMA application process about to commence. A good amount of working capital in the bank. Amgen NEO trial to commence soon, with a big deal and milestones already in place. I'm still missing the point of what they are supposedly doing wrong. I'm open to suggestions. But I'm not holding my breath for an answer that makes sense because I don't believe there is one.
No question, bking. ADXS is ridiculously manipulated. It is by far the biggest reason for the current stock price, the other being the relative lack of money going into pre-market biotechs in general. The short manipulation is, however, also a potential powder keg. Any number events could cause a reversal and a squeeze to various degrees, from the tutes recalling their borrowed shares, to large pharma deals for AXAL or a combo, to conitional EMA approval, to a "big name" taking an equity investment, to buyout rumors or overtures, etc. People here have been trained that because it hasn't happened yet that it cannot happen. Which is incorrect. Essentially, people's emotions have them looking at everything through extremely pessimistic glasses. It is the mirror image of the irrational exuberance that investors exhibited during the huge run up in 2015. Both views are not accurate measures of reality.
What algorithms? There is no manipulation. And the mafia doesn't exist either. Conspiracy theories. Btw, that late takedown today was on virtually no volume.
The CEO has taken excessive shareholder assets for himself? See Meisha's analysis a while ago which clearly establishes that Dan's stock/option compensation from the outset is well within industry norms. Personally, I hope he signs a huge AXAL deal soon and gets a big fat option grant at the end of the year.
Yes, I believe DOC would not do a placement immediately after a mega AXAL deal, even if offered to him. Depends on how much AXAL brings in, obviously. I suspect he gets offers from tutes all the time. I'll even bet that short tutes inquire, because it's the only way for them to get a big chunk of shares.
Bingo, Meisha.
Doubtful. When DOC did the private placement after the Amgen deal it was likely designed to: (a) take advantage of a favorable price on the heels of Amgen; and (b) provide additional cash in order to negotiate an AXAL deal from a position of strength (i.e., we do not need your money, Mr. BP). I can virtually guarantee you that if we sign a big AXAL deal DOC is not going to dilute immediately on top of that deal. Particularly with an EMA decision looming. In addition, we should have milestone payments coming soon from Amgen on NEO activities, plus any milestones from an AXAL deal.
There is something about alot of people who frequent message boards that makes them lack patience and to become overly emotional. I think it is because they are watching too closely, and every single day they watch and sweat the price. It's like when you watched the clock in school as a kid; time just seems to move more slowly.