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Pre-clinical data is mandatory for filling an IND.
FDA would require it, but tell me why would you want to start a clinical trial if you don’t show efficacy on murine models? You’d be wasting your time and money.
They presented pre-clinical data for HOT at AACR annual meeting this April.
Short interest down by 1,344,761 shares:
Settlement Date Short Interest Avg Daily Share Volume Days To Cover
6/29/2018 2,750,913 1,051,998 2.614941
6/15/2018 4,095,674 730,736 5.604861
Look, they've been unable to sign a paying partner for AXAL forever not counting those half-ass deals with some 3rd tier companies. Why do you think Ken is able to ink a cash deal for AXAL within two months? Why would anyone pay for it knowing very well ADXS is going to shut down all AXAL-based programs? They can get the entire program for a song and a dance if they wait for a little longer. Do you realize how Dr Yvonne Patterson is pissed? This is beyond criminal what those idiots (DOC, TL, and KB) have done.
As for Stendhal not allowing to discontinue the trials, what are they going to do? Force majeure! C'est la vie.
Sucks big time.
Dew,
you mentioned that MAA did not cost much. Although I can't find the precise numbers, the 10Q statements sounded like the expenses were significant. We are talking about millions and millions of dollars. Do you believe ADXS was disingenuous about their costs re: EMA MAA filings?
From 3/31/2018:
Professional fees increased $1,374,970 to $2,945,699 for the three months ended January 31, 2018 compared to $1,570,729 for the three months ended January 31, 2017. The increase is primarily attributable to an increase in drug manufacturing process validation costs and drug stability studies in support of the MAA.
Laboratory costs increased $780,969 to $2,050,700 for the three months ended January 31, 2018 compared to $1,269,731 for the three months ended January 31, 2017. The increase is primarily attributable to an increase in headcount and laboratory space, as well as support of the MAA.
During July 2017 and January 2018, the Company established two letters of credit with a financial institution as security for the purchase of custom equipment and as security for application fees associated with the Company’s MAA in Europe. The letters of credit are collateralized by cash which is unavailable for withdrawal or for usage for general obligations. No amount is outstanding under either letter of credit as of January 31, 2018.
From 12/21/2017:
[url]Professional Fees
Professional fees increased $6,652,634 to $14,453,151 for the year ended October 31, 2017 compared to $7,800,517 for the year ended October 31, 2016. The increase is primarily attributable to an increase in drug manufacturing process validation costs and drug stability studies in support of the MAA.
Laboratory Costs
Laboratory costs increased $5,859,125 to $8,610,682 for the year ended October 31, 2017 compared to $2,751,557 for the year ended October 31, 2016. The increase is primarily attributable to an increase in headcount and laboratory space, as well as support of the MAA.[/url][tag]insert-text-here[/tag]
Pretty soon we will be saying "pre-pre-split".
6. HFT manipulators
7. MB posters who pretend to own shares
8. Russell index rebalancing
It's all about HFT manipulation. DOC has an aura around his head which is visible to only AI or ET machines and attracts robots to slaughter the equity. I think these machines did not get memo that DOC has moved on from ADXS to DOC. Someone forgot to update links?
This is real, it's happening. Large funds are throwing white towels in...
When the stock prints all time lows daily, it will take a very major news to reverse the trend.
Yes, you must be very smart man/woman to ride down from $30 to the all time lows now. Keep it on!
This is my prediction for the foreseeable future:
Absent any news (deals, cash partnerships), we will trend down towards $1 or even lower within a month. Then, within 30 trading days, we will get a deficiency note from NASDAQ and will have 90 days to comply with their requirements. In the worst case scenario, when the company is unable to secure any deals, we will see a reverse split and then a secondary. A vicious cycle of self-destruction will be accelerated beyond the point of no-return. I really hope and pray that it does not happen, and it starts looking very much likely with every day passing.
Forget about $20, or $10 or even $5 per share predictions, we need to reverse a trend for now. Stop the bleeding. Get something positive done.
Dew,
you obviously were spot on re: EMA importance. The lingering question now is who orchestrated the entire submission process? It was a long shot to get a conditional approval, but I thought Petit would not the chances are low given the incompleteness the data. Why waste dozens and dozens of millions of dollars to prepare and submit that application if they knew the probabilities? If they did not know someone must be responsible for making very costly and damaging decision? Was it DOC's decision alone? Lombardo concentrated the company's resources on the submission, so was it his fault? Was it a mistake by VP of regulatory affairs? Who's fault is that? Inquiring minds want to know.
You also said:
No surprise there, we've been in downtrend for a long time now, and the 1st NEO patient dosing didn't change that. I believe the company has a stigma of a perpetual loser thus the markets are in "show-me" mode.
The entire management has proved once again their shortsightedness (borderline stupidity) by betting on AXAL EU horses, draining dozens and dozens of millions of our hard earned cash into a sewer and now killing that application just 5 months later.
Buying the shares in open market was likely an act of collective desperation. They issued lots of shares to themselves, so why not pour a fraction of what they make to show a "support for the company". Note that Wall Street was not overly impressed by those buys. They need to do much more than take those "go-and-buy" orders from Sidransky or Berlin, whoever ordered that.
JS wrote:
Yes, I did read the PR. Very carefully. Although I hold only a GED in English, I understand you were probably referring to the following statement form the RP:
snip:
If so, let me clarify why Ken has virtually shelved AXAL altogether. Ken stated that EMA app withdrawal has no impact on an ongoing Aim2Cerv trial. That would have been acceptable statement had he not stated before that he planned to shelve Aim2cerv trial soon if there are no takers. He suggested he'd update us on the status of the CT during the next conference call. That was over a month ago. Now, if he knew he'd be able to partner Aim2Cerv within two more months, his obvious move would have been to package entire cervical program (AXAL+Adjuvant) and sell to the highest bidder with an EMA application/rights included. That would be a very logical thing to attempt. Instead, he pulls the application. Why? He could not buy more time with the EMA to allow the negotiations to come to fruition? You know very well that there is no restarting that EMA application from this control point. It all has to be restarted with a resubmission if that ever to occur.
Interpret however you want but Ken just killed entire AXAL platform. How shameful!
He actually exceeded expectations: He pulled AXAL two months ahead of the anticipated update during the next CC. That's an accomplishment.
Disclaimer: Past failures do not guarantee future success.
@wmtgreeter
Can't agree with you more!
All ADXS CEOs and BOD members deserve the fate of Sisyphus.
https://en.wikipedia.org/wiki/Sisyphus
Blackrock is the first one to throw in the towel. Joe Edelman next? Adage will likely either reduce or completely sell out. The next HF report will be terrible.
Is the SI report today after the close? Watch for a spike of short interest.
Again, the fact that ADXS pulled the EU MAA application indicates that the AXAL negotiations are not going well and unlikely to lead to any deal of any significance. If the current negotiations were going well and there was any BP's interest in taking over AXAL, Ken would have tried to include a possible Ph3 AXAL trial to satisfy an EU feedback. At least, he would not have pulled the application that quickly and decisively. AXAL is a dead program now, like it or not. We don not need to wait until the next conference call to hear that news from Ken.
Blackrock cut their position by more than a half. Sold 1,528,484 shares.
https://whalewisdom.com/stock/adxs
BLACKROCK INC. 1,396,933 $2,025,553 0.00 0.00 3645 1,528,484 2.6547% 13G 2018-06-30 2018-07-10
Withdrawing EU application tells us that the ongoing AXAL negotiations are not going well. Likely, no one is interested in signing a deal to continue Aim2Cerv studies. That CT is next to be canned.
Agree that fewer options are now left to avoid a secondary down the road. Will be a red day after a red day after a red day for now... Going sub $1? You bet.
Ken looks like not up to the task. His ROSG performance just spilled over to Advaxis...
What's the good news I missed?
Pathetic, just speechless...
This confirms Tony's tenure was much worse than a bust.
Now what?
Therein lies the problem: The lack of accretive deals. In the past few years, the management was able to sign only one single deal of any significance. Gbrown provided a list of major events for ADXS so that everyone is reminded of how poor the track record looks like. Most "deals" were non-binding as no cash was involved and you know they are dead now. Not a peep about those grandiose partnerships. The most important deal was with Amgen, and even that NEO deal was not perfect. I believe it would have been on much better terms for ADXS had DOC waited for few months and negotiated. Potential was huge, and ADXS got a small fraction of that upside. What's done is done, and there's no crying over spilled milk.
One okay deal in how years, and now we are waiting to strike few deals within a year or so? The markets do not believe it's going to happen. Ken has not been able to pull any surpises, not yet, but we shall see. PSA deal is likely not going to happen this year. HOT? A wild card now. AXAL deal for EU plus ROW? Maybe, but the longer the delay, the lesser chances of inking that deal. Time is not on our side as time is money and we are running out of money relatively quickly.
Looking back at TL and his failure to accomplish anything of a significance, I found that he was a "a Ph.D. candidate at Cornell Medical School in cardiovascular physiology" at some point [url][/url][tag]http://biomedtransitionpartners.com/team/index.html[/tag]. So he was close to be one of the PhDs, but for some or other reasons, he did not. He also was "close" to save ADXS at some point, and then it all collapsed.
Another interesting thing is his son, Anthony Lombardo, was an intern at Advaxis in 2014 (June-July), long before TL joined the company. Was it through their friend Sidransky?
Investor Relations Intern
Company NameAdvaxis, Inc.
Dates EmployedJun 2014 – Jul 2014 Employment Duration2 mos
LocationPrinceton, NJ
Conducted market analysis presentations of biotech industry to executive team. Researched potential investors and prepared cancer research grant applications
https://www.linkedin.com/in/lombardoanthony/
That would be really bad if the hold is to last two more months.
Just a question for you. If the FDA uses a 30-day response rule how very significant fraction of the holds are resolved in less than a month? Do these companies have a direct communication line with the FDA bureaucrats?
Day 122 of the HOLD. This starts Month 4 one of the lengthiests I've ever seen. For those who deny any significance of this hold, I can't help you but the hold sheds a really bad optics on us and the resolution of the issues should have been prioritized by the management. Regardless of the statements made here by some of the "positivists" that it's on AZ and their toxic drug (which could be true), ADXS needs to be officially cleared by the FDA to show that their LM platform is safe.
@wmtgreeter
Great read: b2k’s guide to oncology:
https://www.investorvillage.com/groups.asp?mb=19611&mn=2777&pt=msg&mid=18447210
Credentials are just credentials, nothing more at this stage of the game. The new management style is yet to bear any fruits. What matters now is the execution. If Ken executes, then he earns the trust. Until then, we are in prove me mode.
I know you don’t. You made it clear and it’s okay.
What I’m saying is that the investment community doesn’t treat Ken as a tabula rasa. He has a resume and his legacy is associated with RG. Regardless of what transpired there and whether it was his fault or not Ken was responsible was ultimate success or failure. It’s his legacy and this is how the funds evaluate him. He doesn’t get a clean slate to start a new life at Advaxis. Like you, I also gave him the benefit of the doubt but I also mentally set a time frame to see how he performs. We shall see, right?
Of course, not overnight. Ken has been at the helm for 2.5 months now and although the jury is still out on him we can summarize a little. He hasn’t delivered a winning blow to the shorts. He hasn’t done much if anything to convince buyers. As I said previously, I’d give him 1.5 more months before assigning him a final grade. So far, his legacy from Rosetta Genomics is what matters to the Wall Street in evaluating the future of Advaxis. Until proven otherwise, Ken is a continuation of Rosetta Genomics tenure. And it hurts us, the shareholders.
NEO will make cold Advaxis HOT again!
Need to identify some mutations on the management level first and start dosing them with the current reality.
Congrats to all who survived the first year without DOC!
It’s been a year since his ass was kicked out and another inept iCEO was hired.
I would be one to sell once it reaches my break even price level. But it all depends: first, I will need to see and be convinced that the fundamentals changed and it's a buy. I might even buy to reduce my average price. If not convinced, I'd sell all and walk away with a huge sigh of relief.
Question is how does this stock turn around to get over $10? It'd be a miracle. It's as much possible as a J&E coming back from virtual ashes.
We were told by a group of optimist posters that the last drop from 1.90 to 1.45 area was facilitated by shorts who perfectly timed their attack with the Russell index rebalance. Is there another Russell index rebalance soon to let the share price rise back to 1.80-1.90 area? I somehow am convinced that our best posters know that information to repeat a washing machine cycle. But keep in mind that once that cycle ends, we will be hung dry before ironing. It's an extended life cycle for ADXS longs.
That's just +537% from these super attractive, back-up-the-eighteenwheeler-and-load-up prices. Very much doable.
iii) if the share price continues to climb at 2% rate daily, we'd need 150 up trading days to hit that $30 threshold.
This public message brought to you by @wmtgreeter: opening doors to the paradise for one ADXS investor at a time since ... forever.
TGIF tidbits:
i) the share price needs to up by +1,900% to get to the all time highs;
ii) the share price needs to climb +5% daily for 61 days to get just over $30 per share. No pullbacks though.
Sounds doable, Ken?
Day 119 of the HOLD.