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Could this 1,000,000 share offering be advance preparation of CEO & CMO?
Tony did give a deadline of 1H 2018
Thanks gccarlin99, keep us posted.
Will insurance cover drugs that are not FDA approved?
If I was the big health insurance carrier, I would say the answer is HELL NO!
But if that answer could somehow turn out to be maybe or a yes, that could be a game changer for all small cap biotechs
Monday could be interesting for ADXS
ADXS 3 poster presentations this weekend (3/25/18)
http://ir.advaxis.com/press-release/conferences/data-highlighting-advaxis-antigen-delivery-platform-accepted-multiple?utm_content=buffer03859&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer
Checkpoint Inhibitors guidelines (restrictions) developed by ASCO & NCCN:
"Patients who receive immune checkpoint inhibitors, however, may experience a unique set of side effects. These side effects can involve multiple organs of the body, and although they are typically mild, sometimes severe, irreversible, or even life-threatening reactions can occur."
Key guideline recommendations:
In general, checkpoint inhibitors can be continued with close monitoring for mild (grade 1) toxicities, with the exception of neurologic and some hematologic toxicities.
For moderate (grade 2) toxicities, checkpoint inhibitors should be held until symptoms and/or lab values revert to grade 1 levels or lower. Corticosteroids may be offered.
For severe (grade 3) toxicity, patients should receive high-dose corticosteroids for at least 6 weeks. Extreme caution when restarting immunotherapy after a grade 3 toxicity is recommended, if it is restarted at all.
In general, very severe (grade 4) toxicity necessitates stopping checkpoint inhibitor therapy permanently.
Consult the guidelines directly for more specific recommendations depending on which organ is affected.
http://www.pharmacytimes.com/news/understanding-managing-immunotherapy-side-effects?utm_content=buffer420ee&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer
lol bourbon, thanks for the posts... and the suspense....
Thanks Bourbon.. can you please also provide your observation of if ADXS Management seemed to care at all about the current $2 from down from $30?
Reiterating Dew's reiteration of additional shares proxy having no immediate impact on the share price.
So that was it huh, nothing but a dull day for ADXS...
IMO, voting no across the proxy is a way of ADXS Shareholders telling ADXS Management that they Suck!!!!
Nothing else matters right now!
"anybody buying before meeting? History shows typically goes down after, but aren't we due?"
IMO, events don't matter at this price level, buying at $2, $3, or even $5 is pretty much the same for someone following or averaging down since the $30s....
"When is the shareholder meeting?"
Tomorrow (3/21/18).... guess what else is tomorrow?
A forecast of 7 to 14 inches of snow in New York City, where the annual meeting is....
"I voted no across the board."
If only there was a way to vote out the crappy management....
Here it is, 56% 12 month, but 77% survival actually for ADXS!
"In the GOG/NRG-0265 Phase 2 trial (NCT01266460), patients with persistent or recurrent metastatic carcinoma of the cervix treated with axal were 77 percent more likely to survive if they had low serum levels of a cluster of four proteins at the study’s start.
The findings will be presented at the European Society of Gynecologic Oncology (ESGO) 2017 Congress Nov. 4-7 in Vienna, Austria.
Results from this trial showed a strong correlation between levels of four specific proteins and overall survival. The patients were stratified according to the levels of the four proteins in each patient. The first group of 25 patients had relatively low levels of all four proteins, and had an overall survival of 56%. The second group of 20 patients had relatively high levels of all four proteins, and had an overall survival of 15%. The 12-month overall survival of all patients in this trial was 38%."
SOURCE
https://immuno-oncologynews.com/2017/06/29/blood-protein-levels-may-identify-cervical-cancer-patients-likely-benefit-advaxis-drug-candidate/amp/
" It appeared as though there was reasonable activity for pembro in both PD-L1-positive and -negative patients. "
Listed below is copy and paste of the article:
"None of the 9 PD-L1–negative patients responded to treatment."
Source:
http://www.onclive.com/web-exclusives/fda-grants-pembrolizumab-priority-review-in-cervical-cancer
But the forecast is obvious based on the fact that most of MERK's trail had PD-L1 positive patients (71 out of 82)...
And ADXS itself announced that based on specific biomarkers, the GOG results can be translated to like 70% 12-Month Survival (going by memory)
So here we go with ADXS vs MERK
If Merk got to pick PD-L1 positive patients and got 40% 12 Month survival
Then ADXS with specific bio markers (not released public yet) would result is 70% or more 12 MONTH survival
My top complaint for MERK trail is that it is biased with 71 out of 82 patients as PD-L1 positive...
MERK's keytruda only reacts to PD-L1 positive patients...
This makes the 12 Month 40% survival statistic as BIASED IMO
ADXS vs MERK
ADXS:
38% 12-Month Survival with ADXS screwed with FDA hold in phase 2 also (stopped recruiting additional patients)
Tumor Best Response
Overall (N = 50)
CR 1 (2)
SD 15 (30)
PD 22 (44)
NE 10 (20)
Summary:
ADXS 1 COMPLETE RESPONSE AND 15 STABLE DISEASE
----------------------------------------
MERK DATA
82 patients in the advanced cervical squamous cell cancer cohort, with 3 complete responses and 7 partial responses.1 All 10 responses were ongoing at the data cutoff. Seventeen patients had stable disease and 44 had progressive disease.
71 patients with PD-L1–positive tumors, with 3 complete responses and 7 partial responses. Fourteen patients had stable disease and 37 experienced progression. None of the 9 PD-L1–negative patients responded to treatment.
Median overall survival (OS) in all patients was 11 months (95% CI, 4-15), with a 6-month OS of 67% and a 12-month OS of 40%.
Summary:
Notice how 71 of the 82 patients are PD-L1 positive (MERK's keytruda only reacts to PD-L1 positive)
3 complete responses (compared to ADXS 1 CR but ADXS trail had fewer patients)
7 partial responses (compared to ADXS 10 patients with Stable Disease plus ADXS had fewer patients in trail)
SOURCES:
ADXS
https://www.advaxis.com/wp-content/uploads/2017/03/Advaxis_SGO2017.pdf
MERK
http://www.onclive.com/web-exclusives/fda-grants-pembrolizumab-priority-review-in-cervical-cancer
Thanks for your early explanations hovacre, thru those I actually better understood the article and decided to post on this board.
More tumor mutations equals higher success rate with cancer immunotherapy drugs
Analyzing 27 different cancer types for which both pieces of information were available, the researchers found a strong correlation: the higher a cancer types mutational burden tends to be, the more likely it is to respond to checkpoint inhibitors. More than half of the differences in how well cancers responded to immune checkpoint inhibitors could be explained by the mutational burden of that cancer.
The idea that a tumor type with more mutations might be easier to treat than one with fewer sounds a little counterintuitive. It's one of those things that doesn't sound right when you hear it, says Hopkins. But with immunotherapy, the more mutations you have, the more chances the immune system has to recognize the tumor.
https://www.eurekalert.org/pub_releases/2017-12/jhm-mtm122017.php?utm_content=buffer7cf03&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer
Friday (3/23): FDA Pediatric Ad Com meeting. Agenda: Safety reviews (routine agency oversight) for certain drugs and devices.
BioCentury's Future Leaders Conference, NYC.
Ovid Therapeutics (NASDAQ:OVID);
GlycoMimetics (NASDAQ:GLYC);
Vericel (NASDAQ:VCEL);
Advaxis (NASDAQ:ADXS);
Protalix BioTherapeutics (NYSEMKT:PLX).
SOURCE:
https://seekingalpha.com/news/3338094-key-events-next-week-healthcare-continued-1?app
"Why April 16?"
three being late-breaking research abstracts, LB-148, 149, and 150:
http://www.abstractsonline.com/pp8/#!/4562/presentations/listeria%20advaxis/1
There is also a 4th abstract under vaccine section, #5639.
"You think they wanted to see how Aduro’s trial went before starting their own NEO trial?"
Not a reason to delay for this long IMO... besides Aduro ain't telling sh*t to ADXS....
Aduro has been failing miserably in LM trails, but one thing I give them credit for is that they kept moving forward with no delays....
"Anyone think we could get to $10-$15 by mid year"
It took ADXS about 2 months to go from $2 to $30....
ADXS just needs the right momentum to get going and Management needs to grow up....
Every single milestone of 2H 2017 delayed, as Dew pointed out... ADXS-NEO delayed by a full year... THIS IS UNACCEPTABLE
"Monday April 16th looks like a big day."
Wednesday March 21st should be a bigger day....
If someone wants to make money, buy a dozen or so pitch forks and sell them outside the conference where ADXS Management will show its face to its investors....
"Looking forward 2018, lot of things going on with advaxis.hold for long term."
I guess one reason ADXS is probably this low is because every single milestone of 2H 2017 was missed....
NY1972, I'm sure you're posting important stuff, and thank you for that....
But, is it possible to post in simple English for medical illiterate folks like me?
"In the phase-1 NEO trial, the doses to be tested (in ascending order) are 1.0, 2.0, and 4.0x10^9."
So they may end up saying maximum tolerable dose is 4x10^9.... but will actually proceed with a standard dose of 1X10^9 or maybe 2x10^9?
I suspect It's going to be 10^9... that's the ADXS dose for all trails....
What's MTD?
Another excellent clarification. Thanks hovacre!
Short answer is "The Middle Man".
I think the ADXS sold these warrants for $0.01 to Financial Tutes, who then sold them to the market.
I could be wrong, but that's how I understand it.
Is there such voting possible where we, as shareholders, would vote wether to keep or KICKOUT ADXS Management?
If so, I would vote out for every single one of em....
Great post, now I understand. Thanks hovacre!
Can someone please translate the following in English?
"LB-150 / 17 - Neoantigens that fail to elicit measurable T cell responses following peptide immunization can control tumor growth when delivered using a Listeria-based immunotherapy platform"
http://www.abstractsonline.com/pp8/#!/4562/presentation/10472
This is a "burden" to understand...
So instead of burdening my brain neurons to mutate to understand this, I will conclude that ADXS-NEO's tumor recognition is superior compared to whatever that other thing is and stuff...
"Neon has to pick 20 out of dozen neoantigens and using novel adjuvant. "
I'm not biotech lingo savvy but that statement is mathematically confusing.... how can you pick 20 out of a dozen (12)?
Wasn't AMGN supposed to run ADXS-NEO trails and ADXS was only responsible for IND?
What about the modified IND submission news?