Old Wegmaster from Yahoo Board
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Patience pays...over and over. Meish mentioned it could be 2 years, ouch. Product being made and sold. Europe? The day FDA gives us their full blessing, bingo. In meantime, we get nothing but good steady news and everything is being managed well. Solid investment support, Trials all positive, Orphan statuses, Great manufacturing facility, just painfully slow.
I voted Yes across the board. I own over 80K shares.
Agreed, so is it the shorts or the dealmakers keeping us down? The short dike will break and the will have to move on. They probably ride waiting periods in in biotech all the time.
Dan has a "bad ass" resume too. When he arrived, I felt a lot better. I was wegmaster on YMB.
I like it. March 15 James said we would have a deal by April 5. Feels due.
Saving lives and making money, why not? I don't see DOC as a patient exploiter.
Balance Sheet looking strong. Decent amount of cash to carry us through some big milestones.
DOC spends, but spends for first class, do it right ways. I think ADXS is all Top Pros.
If I was more liquid, I would buy buy and buy TODAY. Bargain prices ;)
Blunt is top pro, no time for amateur hour. Nothing more important than Clinical Trials!
So why are we getting hit today? New Health Care Proposal?
And why is AUPH up 1.5, almost 30% and I don't see any real news...
Patient and Frustrated....
Mast, others....Could one say that with
"We believe that the use of our proprietary Lm-based antigen delivery technology with SELLAS’ proprietary technology could result in a very compelling WT1-targeted cancer immunotherapy.”
Advaxis could be a delivery system for many immunotherapy drugs and therefore have many deals that kind of take potential competitors to be customers instead? Sorry I am not a biotech wizard.
The precise targeting of cancer cells seems to be critical IP.
One thing is for sure, DOC cannot control everything. He too needs certain stars to line up, superstar or not. Like the FDA. He is the captain of the ship and he is paid to navigate the waters. Problem is it is a long trip across this ocean. I hope in 2017 we get there.
Owning the manufacture facility is huge IMO, for IP protection, quality control, financially, and overall control of your business. Another smart move by DOC.
Interesting, your posts are insightful. On
"ADXS's Lm is, therefore, obviously considered a low-probability approach or many others would be pursuing similar approaches. Few are. That tells me something about likelihood of success. "
Perhaps you meant low popularity vs. low probability. There are no statistics from trials, showing any low probability, even with the low conservative doses. ZIOP is interesting, but their balance sheet is rapidly deteriorating.
I am glad you are on board and it will be interesting to see if ADXS will distinguish itself from the pack which I believe a plus with the bacteria approach. 60% plus owned by institutions shows a lot of reputable believers in LM delivery platform.
Many of us own large amounts...including me...
See you later Shorties, EU, Infectious disease, Cervical trials, on and on, The James list...
2017 OPERATIONAL MILESTONES
Advaxis anticipates the following development milestones in 2017:
Clinical Operations
Axalimogene Filolisbac
Present a detailed data analysis of the completed Phase 2 GOG-0265 trial, which was conducted by the GOG Foundation, Inc. (GOG, now part of NRG Oncology), evaluating patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), at a medical meeting in the first half of 2017. Top-line data released in 2016 showed a 12-month overall survival rate of 38 percent observed in 50 patients in the trial. This is a 52 percent improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors.
Attend an end-of-Phase-2 meeting with respect to PRmCC with the U.S. Food and Drug Administration (FDA) to discuss the results of GOG-0265.
Submit a marketing authorization application to the EMA for approval of axalimogene filolisbac to treat patients with metastatic cervical cancer in the second half of 2017.
Open approximately 150 clinical sites for the global, 450-patient Phase 3 AIM2CERV trial in patients with HRLACC, with a trial enrollment update to be issued at a medical meeting in the first half of 2017. There are 10 active trial sites in the United States as of this week.
Initiate a second global, registrational Phase 3 study in patients with metastatic cervical cancer in the second half of 2017.
Present updated clinical data from the Phase 1/2 combination trial with AstraZeneca’s investigational anti-PD-L1 inhibitor, durvalumab, in patients with recurrent, persistent or metastatic cervical cancer or HPV+ squamous cell cancer of the head and neck (HNSCC) at a medical meeting in the second half of 2017.
Present additional data from the Phase 2 BrUOG trial in high-risk, locally advanced anal cancer, conducted in collaboration with Brown University’s Oncology Research Group, at a medical meeting in the first half of 2017.
Present additional data from the Phase 2 window of opportunity trial in HPV-positive head and neck cancers at a medical meeting in the first half of 2017.
With full enrollment achieved in Stage 1 of the FAWCETT Phase 2 trial in patients with persistent or recurrent metastatic anal cancer, the company plans to present a preliminary trial update at a medical meeting in the second half of 2017.
ADXS-PSA
Complete initial dosing of Part B of the Phase 1/2 trial evaluating ADXS-PSA in combination with KEYTRUDA® (pembrolizumab) in advanced, metastatic castration-resistant prostate cancer (mCRPC) and present preliminary data at a medical meeting in 2017.
Initiate and complete enrollment of the expansion cohort by year-end 2017.
ADXS-HER2
Initiate a study in pediatric osteosarcoma in collaboration with the Children’s Oncology Group in 2017.
Expanding Pipeline
ADXS-NEO Collaboration with Amgen
Submit an Investigational New Drug (IND) application to the FDA in early 2017.
Initiate the first-in-human ADXS-NEO clinical trial.
Accelerate the discovery of personalized cancer immunotherapies derived from neoantigens as part of the TESLA (Tumor neoantigEn SeLection Alliance) with the Parker Institute for Cancer Immunotherapy and the Cancer Research Institute.
ADXS-HOT
Prepare and file an IND with the FDA for ADXS-HOT constructs that target tumor driver genes, so-called hotspot mutations or public mutations, found in various cancer types in the second half of 2017.
We are all in it together. Patience Pays....
Thanks James, lately I have seen a few posts about "competitors". Since you know science better than most, can you remind my why you think we are leg up on others?
Advaxis Lm Technology is under investigation and designed to stimulate a tumor-targeted immune response directed by plasmids
…so that cancer can be recognized …and killed
and the stock price goes up!
http://www.advaxis.com/lm-technology/
I am long term. I get it why a great biotech like ADXS is a short play and a day traders target. During waiting periods for trials and news.....the stock gets preyed on. These gamblers will lose when the facts are in and big pharm has seen enough and can't turn down the great deal, these shorts have left them.
Lost Trader here is borrow copy/ paster from an all star poster James Salmon:
2017 OPERATIONAL MILESTONES
Advaxis anticipates the following development milestones in 2017:
Clinical Operations
Axalimogene Filolisbac
Present a detailed data analysis of the completed Phase 2 GOG-0265 trial, which was conducted by the GOG Foundation, Inc. (GOG, now part of NRG Oncology), evaluating patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), at a medical meeting in the first half of 2017. Top-line data released in 2016 showed a 12-month overall survival rate of 38 percent observed in 50 patients in the trial. This is a 52 percent improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors.
Attend an end-of-Phase-2 meeting with respect to PRmCC with the U.S. Food and Drug Administration (FDA) to discuss the results of GOG-0265.
Submit a marketing authorization application to the EMA for approval of axalimogene filolisbac to treat patients with metastatic cervical cancer in the second half of 2017.
Open approximately 150 clinical sites for the global, 450-patient Phase 3 AIM2CERV trial in patients with HRLACC, with a trial enrollment update to be issued at a medical meeting in the first half of 2017. There are 10 active trial sites in the United States as of this week.
Initiate a second global, registrational Phase 3 study in patients with metastatic cervical cancer in the second half of 2017.
Present updated clinical data from the Phase 1/2 combination trial with AstraZeneca’s investigational anti-PD-L1 inhibitor, durvalumab, in patients with recurrent, persistent or metastatic cervical cancer or HPV+ squamous cell cancer of the head and neck (HNSCC) at a medical meeting in the second half of 2017.
Present additional data from the Phase 2 BrUOG trial in high-risk, locally advanced anal cancer, conducted in collaboration with Brown University’s Oncology Research Group, at a medical meeting in the first half of 2017.
Present additional data from the Phase 2 window of opportunity trial in HPV-positive head and neck cancers at a medical meeting in the first half of 2017.
With full enrollment achieved in Stage 1 of the FAWCETT Phase 2 trial in patients with persistent or recurrent metastatic anal cancer, the company plans to present a preliminary trial update at a medical meeting in the second half of 2017.
ADXS-PSA
Complete initial dosing of Part B of the Phase 1/2 trial evaluating ADXS-PSA in combination with KEYTRUDA® (pembrolizumab) in advanced, metastatic castration-resistant prostate cancer (mCRPC) and present preliminary data at a medical meeting in 2017.
Initiate and complete enrollment of the expansion cohort by year-end 2017.
ADXS-HER2
Initiate a study in pediatric osteosarcoma in collaboration with the Children’s Oncology Group in 2017.
Expanding Pipeline
ADXS-NEO Collaboration with Amgen
Submit an Investigational New Drug (IND) application to the FDA in early 2017.
Initiate the first-in-human ADXS-NEO clinical trial.
Accelerate the discovery of personalized cancer immunotherapies derived from neoantigens as part of the TESLA (Tumor neoantigEn SeLection Alliance) with the Parker Institute for Cancer Immunotherapy and the Cancer Research Institute.
ADXS-HOT
Prepare and file an IND with the FDA for ADXS-HOT constructs that target tumor driver genes, so-called hotspot mutations or public mutations, found in various cancer types in the second half of 2017.
CREX is going to pop. This management team is top notch. It is a sleeper, the day will come.
Thank you Meish, FBG, did I hear a soft approval of DOC compensation? ;) We should all be feeling great about ADXS, great company and well run. I have peace of mind ship is coming in.
FBG/ Meish is very reasonable. Homework. How much is Dan's pay and share compensation plan truly? Who is our number cruncher?
An interesting article which I came across
CEO equity ownership for Biotech and internet companies is approximately 3.3% at median;
Base salaries for CEOs in Pre-iPO Biotech, internet, and general industry companies are, at median, $410k, $400k, and $500k, respectively; for CFOs, base salaries are $275k, $275k, and $330k, respectively
y 82% of Biotech companies and 52% of both internet and general industry companies have an annual target bonus for the CEO; of these companies, the median target bonus as a percent of base salary is 50%, 50%, and 100%, respectively
y total Cash Compensation for CEOs in Pre-iPO Biotech, internet, and general industry companies is approximately, at median, $600k, $600k,
and $1.24M, respectively; for CFOs, total cash compensation is approximately, at median, $375k, $400k, and $590k, respectively
y typical CEO equity ownership for Biotech and internet companies is approximately 3.3% at median; CEO ownership in general industry companies is slightly lower, at approximately 2.8% at median
y Median total potential dilution (overhang) at the time of the iPO for all of the companies researched is approximately 15%, with many companies having overhang levels of 25% or greater; overhang levels for Biotech & internet companies are higher than general industry
http://www.capartners.com/uploads/news/id217/capartners.com-capflash-issue67.pdf
Mieish, Thanks for your take. This is a big boy's game, like it or not. Dan has an awesome resume and it is for real. He may become beyond rich. Skin in the game and no selling! I hope we can all complain about having too much money with Dan when he leads us to our success through bio patience and diligence.
I remember how bad things were financially when Dan joined the company and how impressed I was that he came on board at all. I am on a second round with ADXS and this time I am all in.
Great Post, I am formerly webmaster from Yahooboard, an old timer, 8 cents. I got out once at 20 and now average in just above 9, mucho shares. Dan has had difficult decisions, like reverse splits and once we got above 5, guess what, we got big institution interest. We do have a top mgt team in terms of credentials. I trust that... If that pay is the norm, than that is what is. Capitalism at its best.
James, you really keep track and on track. Question: Let's say Mgt is as busy and expedient as pragmatically possible and meets top credential standards, is there compensation compensurate with industry standards? I am not an expert in evaluating just compensation for this situation, in all humility.
I like that they have stock and "skin in the game", but understand some of concerns that they could win without shareholders enjoying their same ride.
Ignatius, so you have no concern and think authorization does not mean is not implementation.
Compensation "potential" is fair in terms of industry "standards"?
FBG, Why don't you start a petition and send a group letter to the folks who own 61% of ADXS
btw I saw Dan got a cool $1 mill bonus for Adage deal, 5% of deal went to mgt...
Minority shareholder protection—overview https://www.lexisnexis.com/uk/lexispsl/disputeresolution/document/393747/58XG-2F51-F18B-7005-00000-00/Minority%20shareholder%20protection—overview
A minority shareholder in a company does not have much power to influence its management and, therefore, sometimes their interests are disregarded. Should they need to protect their position, a minority shareholder can do so in a number of ways, eg, they may bring an unfair prejudice claim, pursue a derivative action or seek a winding-up petition. For a quick guide, see Practice Note: Protection of minority shareholders.
Top Institutional Holders
Holder Shares Date Reported % Out Value
Adage Capital Partners GP L.L.C. 5,939,366 Sep 29, 2016 14.80% 63,491,822
FMR, LLC 4,102,885 Dec 30, 2016 10.23% 29,376,656
Broadfin Capital, LLC 1,519,259 Dec 30, 2016 3.79% 10,877,894
Vanguard Group, Inc. (The) 1,472,352 Sep 29, 2016 3.67% 15,739,442
BlackRock Fund Advisors 1,152,657 Dec 30, 2016 2.87% 8,253,024
BlackRock Institutional Trust Company, N.A. 944,052 Dec 30, 2016 2.35% 6,759,412
Sectoral Asset Management, Inc. 690,074 Dec 30, 2016 1.72% 4,940,929
Marshall Wace LLP 678,683 Dec 30, 2016 1.69% 4,859,370
State Street Corporation 621,505 Dec 30, 2016 1.55% 4,449,975
Sarissa Capital Management, LP 500,000 Dec 30, 2016 1.25% 3,580,000
Top Mutual Fund Holders
Holder Shares Date Reported % Out Value
Fidelity Select Portfolios - Health Care 1,800,000 Sep 29, 2016 4.49% 19,242,000
Vanguard Total Stock Market Index Fund 657,204 Jun 29, 2016 1.64% 5,316,780
Fidelity Advisor Health Care Fund 640,000 Sep 29, 2016 1.60% 6,841,600
Fidelity Select Portfolios - Biotechnology 602,152 Sep 29, 2016 1.50% 6,437,004
iShares Russell 2000 ETF 594,743 Sep 29, 2016 1.48% 6,357,802
Vanguard Extended Market Index Fund 318,203 Jun 29, 2016 0.79% 2,574,262
iShares Russell 2000 Growth ETF 274,871 Sep 29, 2016 0.69% 2,938,370
Fidelity Stock Selector All Cap Fund 227,757 Sep 29, 2016 0.57% 2,434,722
Fidelity Series Opportunistic Insights Fund 215,588 Sep 29, 2016 0.54% 2,304,635
Variable Insurance Products Fund IV-Health Care Port 200,000 Sep 29, 2016 0.50% 2,138,000
Ditto, outrageous mgt compensation, Vote No
I too will wait till we are closer to April to vote. I own a large amount of shares. While I tire of the Dan bashing, I could not agree more ?????? that management should not prematurely get their rewards.
I will vote no's as it stands, but that is all I can do. Otherwise, whining on the message board over and over does nothing, but provide therapy for anxiety.
Clincal Trials.gov seems pretty good-see below sample, front page for Advaxis, not pronouncing our Phase 3s
https://clinicaltrials.gov/ct2/results?term=advaxis&Search=Search
Shows detail on locations, recruiting, lots of detail, however I don't understand why ADXS website shows Phase 3 for axalimogene filolisbac (AXAL) but is buried on clinicaltrials.gov. site.
Study of ADXS11-001 in Subjects With High Risk Locally Advanced Cervical Cancer (AIM2CERV)
This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Advaxis, Inc.
Sponsor:
Advaxis, Inc.
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
Advaxis, Inc.
ClinicalTrials.gov Identifier:
NCT02853604
First received: July 28, 2016
Last updated: January 18, 2017
Last verified: January 2017
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
High-risk locally advanced carcinoma of the cervix (HRLACC) following concurrent chemotherapy and radiation therapy. This is a group of patients with a significant unmet need. The estimated probability of disease recurrence or death within 4 years of diagnosis is 50% and the prognosis is very grave for those who experience a recurrence.
The purpose of the study is to compare the disease free survival (DFS) of ADXS11-001 to placebo administered following CCRT with curative intent in subjects with HRLACC.
Condition Intervention Phase
High Risk Cervical Cancer
Advanced Cervical Cancer
Drug: ADXS11-001
Drug: Placebo
Phase 3
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer: AIM2CERV
Resource links provided by NLM:
MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources
Further study details as provided by Advaxis, Inc.:
Primary Outcome Measures:
Disease free survival (DFS) [ Time Frame: 5 Years ]
To compare the disease free survival (DFS) of ADXS11-001 to placebo administered in the adjuvant setting following concurrent chemotherapy and radiotherapy (CCRT) administered with curative intent to subjects with high-risk locally advanced squamous, adenosquamous, or adenocarcinoma of the cervix (HRLACC).
Secondary Outcome Measures:
Safety & tolerability Overall survival (OS) [ Time Frame: 5 Years ]
To determine and compare the frequency and severity of adverse events (AEs) as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for the regimens administered on this study.
Estimated Enrollment: 450
Study Start Date: September 2016
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Reference Treatment Group (Arm A)
Placebo Arm A
Drug: Placebo
Experimental: Experimental Treatment Group (Arm B)
ADXS11-001
1:2 Arm A to Arm B
Drug: ADXS11-001
Detailed Description:
This is a double-blind, placebo-controlled randomized study of ADXS11 001 administered in the adjuvant setting after completion of cisplatin-based CCRT in subjects with locally advanced cervical cancer at higher risk for recurrence (HRLACC), or death. All eligible subjects will have received CCRT administered with curative intent according to institutional/national guidelines as well as meeting the minimum standards defined in the protocol. Subjects must initiate the Screening period within 10 weeks after the completion of CCRT. Baseline radiographic assessments and clinical laboratory assessments must be completed no longer than 28 days prior to and 3 days prior to the first study treatment infusion, respectively. Eligible subjects will be randomized 1:2 to receive either placebo or ADXS11-001. Subjects will receive 1 infusion of study treatment administered every 3 weeks for 3 doses for the first 3 months. Thereafter, subjects will receive study treatment every 8 weeks for a total of 5 doses or until disease recurrence. Subjects will receive a 7-day course of an oral antibiotic or placebo starting 72 hours following the completion of study treatment administration.
An interim analysis will be performed when there is at least one-half the number of DFS events required for full maturity of the study.
Eligibility
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Subjects must have a biopsy confirmed diagnosis of squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix. Histologic confirmation of the original primary tumor is required.
Subjects must have received definitive therapy with curative intent, which consist of at least 4 weeks of treatment with cisplatin and a minimum of 40Gy external beam radiation therapy (EBRT).
Have performance status of 0 or 1 on the GOG performance scale
Demonstrate adequate organ function
Exclusion Criteria:
Has not achieved disease-free status after completion of CCRT administered with curative intent.
Has FIGO Stage IVB
Has histologies other than squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix.
Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)).
Has a contraindication (sensitivity or allergy) to trimethoprim/sulfamethoxazole and ampicillin.
Has undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy. NOTE: Women who have had a partial/subtotal hysterectomy are eligible to participate in the study
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02853604
Contacts
Contact: ADVAXIS HOTLINE 844-783-1529
Off of ADXS Website
http://www.advaxis.com/areas-of-focus/clinical-therapies/
Welcome all Ariad Investors! Enjoy the Ride! Stick with the EasyMoney. ;)
I wonder if it is part of shorts gradually fading....
If that is legal, scary, I pray Dan is not snoozing. Perhaps he needs an email from an advocate, Bourbon.
Who is Abigail Johnson ?
Volume so low....are shorts on the run? I believe in DOC, he can't control everything.
I don't have a subscription to that level of info. I know someone on this board does.
btw...We do have 100 mill in bank cash, so the shelf seems not needed for a long time.
ADXS is into so many areas and has so much going right....Our day will come.
Question on Shorts Any opinions on who the F they are? Funds or Individual players? Would any of our own major shareholders play it both ways as they wait for payday they actually may have on their insider calendar?
Not many choices. You either cheer DOC on or submit constructive suggestions you think DOC should do. Being disgruntled, just doesn't help. Let's focus on anything positive and keep the short's fodder unavailable As much as I understand, it is like shooting yourself in the foot. Email Dan directly and perhaps share response. Otherwise, we better cheer on the team!
Different scenario now, things are way much different in a positive way. We are ready to manufacture we are in Clinical 3, Amgen deal, we have institutions and funds owning 60% plus. Too many big stakeholders that will not lose.