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They could throw a couple of billions at us. I wouldn't mind.
fbg, I believe you are correct.
Well spoken, sir, well spoken. In addition to what you stated, I am excited about the interest in dog owners for the canine vaccine. I hope full approval does not take too long.
I agree it's hard to tell sometimes who's lying and who isn't. I find many of the posters here seem to be pretty much on the level regardless of their opinion of the company and management. I respect all opinions and, like you, I would rather nobody try to say they are the bearers of information that we are not privy to.
OT, I'm looking at the chart today on Yahoo and I see some very healthy spikes of buying but we're stagnated around $1.83 or so. Any ideas why this buying should not spike us up?
I understand the anger and disappointment of many people here but how are Blue's posts different from the company bashers? Blue is optimistic and some bashers say BP knows AXAL is a bust and will never be approved. This is a message board and anybody can post. You have the choice to ignore users if you don't want to read their posts. I'm hoping for a positive outcome from the EU filing and full approval for the canine vaccine. I'm down lots of money here like 90% of investors probably are but I stay because I think, eventually, I'll get a good return on my investment. I'm open to reading posts from all posters and I respect all views. I just happen to be leaning on the positive side. I hope we all get a good payday.
Which failed trials?
Thanks! That was fantastic reading! It also sounds like the word is getting out and hope is rising among dog owners that this condition has a new treatment. All longs need to check out those links.
I am still confounded that, considering how successful the HER2 vaccine was in dogs, that no one has bought it yet.
I think it may be older news but this is (for us) the best part and bears repeating: "Also on Thursday, Nicola Mason, B.Vet.Med, PhD, DACVIM, of the University of Pennsylvania, School of Veterinary Medicine, presented preliminary research based on her clinical work with the osteosarcoma vaccine immunotherapy candidate. This novel HER2/neu-directed cancer immunotherapy (AT-014, ADXS-cHER2) is licensed by Aratana exclusively from Advaxis, Inc. The preliminary results from this study suggest that AT-014 is able to delay or prevent metastatic disease and prolong overall survival in dogs with osteosarcoma that had minimal residual disease following amputation and chemotherapy. Median survival in control dogs was 316 days (n = 13), and at the time of Dr. Mason’s presentation, the median survival in treated dogs had not yet been reached, with 80% of the dogs that received the complete vaccine series remaining alive (n = 15). Dr. Mason is conducting a second study evaluating combination therapy with AT-014 immunotherapy and radiation for dogs with primary osteosarcoma that cannot undergo amputation."
I was looking through the Knight Therapeutics presentation and they have a very good record of submissions to approval: "Significant experience in all aspects of the regulatory process ~30 submissions to Health Canada with a 90% success rate." I'm hoping EU approval would move them to file for the Canadian equivalent.
Thanks for the clarification.
I see 32.96% institutional ownership on NASDAQ. What do you consider low, Sparky?
The OS in the cervical cancer and canine cancer trials was very good. Some CR's, too. I think that bodes well for approval.
I think the primary endpoints of the combo data are safety and tolerability. I suspect most of the data will reflect that. It would be nice to see signs of efficacy/synergy.
Blue, I admire your boundless optimism. At this point, I'm almost afraid to believe we can achieve success like that at the moment. I hope we're all not going to be disappointed if the combo results are not stellar. I do believe they will be good but, how good, I'm just not certain.
In talking with IR in the past, I would ask about the sentiment for the combo data and they were always careful to say "if" the data is good it could be a game-changer. Checkpoint inhibitors, in the past, did not show much activity in prostate cancer so even moderate success may pique Merck's interest for a deal. We'll know soon enough. GLTA!
300K+ in the first 45 minutes.
What is with the volume this AM?
Consider the start of NEO, (hopefully) good prostate combo data and an EU deal. Could happen. If it does, I get my new house!
Thanks!
Nice to see that dogs are being enrolled at sites. Any idea of the length of the study before full approval?
Also, volume has been picking up. Volume precedes price?
It would be nice if the PR was used for priming the announcement of the first dosing in NEO. Timewise, it should be happening soon.
Just crossed 700K volume. Not bad.
Blue, I've always admired your optimism and upbeat attitude. Lately, following the last offering, let's just say my optimism has been lagging. I still believe in the science. That is irrefutable to me but my cautious optimism is, well, more cautious. I hope we're not disappointed by the combo data. I had hoped we would see a pretty good price increase before ASCO but it's possible the company is really being tight-lipped about the data. I'm certainly willing to give Ken a chance to turn things around. I still feel we are way, way undervalued especially compared to some other bios who are less advanced in trials than we are. I guess we will know very soon. I'm hoping for a good outcome.
Was it this? "And finally, in our prostate cancer franchise, we anticipated a preliminary data readout of both Part B monotherapy and checkpoint combination data for ADXS-PSA. The immunotherapy landscape continues to evolve with promising technology advancements such as checkpoint inhibitors and most recently CAR-T therapy.
However, there are still significant unmet needs which we feel that the Lm Technology can address, specifically Lm Technology has the potential to enhance the treatments in combination as having generally well tolerated safety profile and does not generate neutralizing antibodies."
Blue, with good to very good combo prostate data (due soon), what wold be your expectations?
This is the lowest I've seen in a long, long time.
From Ken's bio on the CEO PR I liked this part the most, "From 2001 until 2004 he served as Vice President, Licensing and New Business Development in the pharmaceuticals group, and from 2004 until 2007 served as Worldwide Vice President, Franchise Development, Ortho-Clinical Diagnostics. He has been responsible for numerous licensing and/or research collaboration deals in oncology, metabolic disease, cardiovascular disease, CNS and women’s health, including the ex-U.S. license to Millennium Pharmaceutical’s VELCADE, a first-in-class, oncology therapeutic with peak reported sales outside the U.S. of approximately $1.8 billion."
I certainly want him to succeed here.
Just crossed 200K in volume. Haven't seen that this early in the day for a while.
Thanks!
Was this recent?
For the naysayers who have brought up NEO's delay, they are in fact correct. The trial has been delayed. There were changes made for the better, per IR, with which Amgen agreed. Obviously, if Amgen is providing funding, their agreement would be crucial. The hiring of a bioinformatics scientist would clearly indicate the trial is moving forward.
"Contribute to the development of novel approaches for the identification of neoantigens and tumor escape mechanisms." I'm hoping this motivates the best minds to rise to the challenge and apply for the position.
Combo prostate data on the way soon, also. I think a lot is riding on this as CI's have shown little effectiveness for this type of cancer. If the data shows at least some synergy, we could well be on our way out of single digits. No, I don't mean overnight but I believe it would start an upward trajectory. No one investing in this company wants it to fail unless they want to commit financial suicide. Those of us who have been here for a long time are hoping Ken is able to negotiate a deal with cash upfront and NOT with dilution. I think we're approaching some major events and we'll know soon enough if they are positive or negative. I'm still leaning more to positive. I completely understand the frustration, bitterness and outright hate some have for the stock. I'm hoping this year that finally turns into satisfaction and relief for all of us who have waited this long as well as for cancer patients who may well nigh have a new SOC.
Most likely a combination of issues: biotech in general, uncertainty about a new CEO, trial delays and prioritization of constructs, etc...
Gosh darn, James! You beat me to it!
Here's a flyer to the trial at UC Davis in case anyone of you know someone with a dog that could benefit from it:
http://www.vetmed.ucdavis.edu/clinicaltrials/local_resources/pdfs/flyers/willcox-osteosaroma.pdf
Also, Colorado:
https://www.csuanimalcancercenter.org/Evaluation-of-recombinant-attenuated-Listeria-monocytogenes-expressing-chimeric-human-HER2/neu-protein-in-dogs-with-osteosarcoma
I see no evidence that the NEO trial is delayed now. The clinicaltrials.gov shows recruiting. Would you like some help in navigating the site so you can check for yourself?
Not sure who is selling it right now but found some trials.
https://ebusiness.avma.org/aahsd/study_search_results.aspx