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Looking around the Knight Therapeutics website I read the old PR of the licensing deal with them, "Under the terms of the licensing agreement, Knight will be responsible for all commercial activities related to Advaxis current and future products, including axalimogene filolisbac, ADXS-PSA and ADXS-HER2, in Canada. Advaxis is eligible to receive double digit royalty as well as sales milestones."
On their product pipeline chart it looks like they completed PI and PII trials but I can't see what trials were run or are they referring to the Advaxis run trials?.
I think I read the AIM2CERV trial is big used as the confirmatory trial.
Since we're going for conditional approval the PIII would be run to get full approval. Rather like Aratana for AT-014.
Blue, if the combo data is good, it could be a game changer. My understanding was some preliminary data could have been available by last December. I would like to see a teaser of it released before ASCO. I was not aware of the changes to the NEO trial and I assume they are for the best if Amgen is on board. I suspect we may hear more about it at the annual meeting.
From the PR: "In parallel with the MAA review process, the company will continue assessing partnership opportunities for the potential commercialization of axalimogene filolisbac in Europe." Doesn't sound like they're negotiations yet.
I don't think he understands.
If the combo prostate data is good, we might make a good deal with Merck.
Can Chemist pin that post on EU approval?
I appreciate that Big Tony is reining in costs. Less money needed, less dilution (if it goes that way) needed.
Well, of course, he knows so much more than the doctors and researchers at the GOG.
Got it, thanks!
I don't think they'll be getting a waiver. With the GOG supplying the needed information on previous studies and, probably adding the India study, that may be all the need.
"They need to nail down the biomarkers that lead to complete resonse but in the mean time extending life is certainly good news."
I remember a conference call where they mentioned that they were were on identifying some biomarkers to target those who would best respond to the treatment. I think they had identified at least one but did not state which biomarker. That could certainly help efficacy.
I would rather see them announce now that they submitted and, shortly before the meeting, announce a good partnership. That way the EU filing will (hopefully) start to move the PPS north. The partnership would build on that momentum.
$0.15, but it took over a month to have them filled. $0.11 for July @ $7.50
I added some April and July call options. Been chasing them for a while but maybe this time I'll be lucky. Hmm, sounds like a song from "Cabaret"...
It could be a couple of things. Gearing up for anticipated EU approval or making the staff look attractive to a buyer. Fill all the necessary job slots so BP would have an already staffed company. I am surprised at all the hiring lately myself. Still waiting for the CMO, as the BOD was interviewing. Maybe hire a CMO from an interested BP company to start taking control of processes now. Just my own opinions.
Thanks, Mazo! Great information.
If it's any consolation, there are many bios down 3% - 4% today. Here's hoping for good news on Monday. EMA submission, new CMO or CEO, partnership announcement, licensing announcement...hell, I'd even be happy to hear Big Tony switched to GEICO.
The annual meeting is in March. If the company wants to avoid a very ugly meeting, they need to have it filed by then. Noelle said it's on track for this quarter and I'll take her word for it. I don't expect the filing to solve all our problems but I think it will start a turnaround.
I'm hoping they do. The first quarter will be half over and there will be one shot (I believe) in March. Better sooner than later.
What do you think? Filing on Monday?
"Daniel O. Villarreal, Ph.D., Principal Scientist, Advaxis, Inc." I think I saw a job opening for principal scientist a few months ago. That position is apparently filled. He'll be presenting an abstract in Montreal: http://ir.advaxis.com/press-release/conferences/data-highlighting-advaxis-antigen-delivery-platform-accepted-multiple
"...executing high quality global submissions within required timeframes and is the principal point-of-contact with electronic submission vendor for all initial and lifecycle management filings, submitted electronically to the Health Authorities."
In all honesty, I do not know what the problem is. I suspect it's reasonably complicated or just a case of Big T. not liking the offers. There is no way on God's green earth we should be at the price we are now but I'm confident once the EMA is filed we will see a turn around. Everyone of us is probably under-water and I am as frustrated as anyone else but I have to maintain a reasonably positive attitude to keep my sanity.
"And it is saying ADXS got nuthin." I'll take the best ever GOG results for cervical cancer, excellent anal cancer results and a conditionally approved vaccine that we have something. Those who don't believe the stock will do well have options.
Can you please cite instances where BP considers AXAL a dud? Thanks in advance.
Well, I'll put my faith in Dr. Mason. This quote refers to the combo trial Dr. Mason is/was running. Not saying some sort of cardiac toxicity may not one day show up here but, for now, who do you believe, a respected doctor or a poster on the board...
"On Monday, April 20, Nicola J. Mason, BVetMed, Ph.D., DACVIM, Assistant Professor of Medicine, University of Pennsylvania's School of Veterinary Medicine, presented preliminary data from an ongoing Phase 1 clinical study of 10 companion dogs with osteosarcoma (Poster Board #7; Abstract #LB-113). The data suggests that ADXS31-164 in combination with palliative radiation delayed tumor progression and prolonged overall survival in pet dogs with spontaneous osteosarcoma that were not candidates for primary tumor removal (amputation). Repeat doses of ADXS-HER2 were well tolerated with no systemic or cardiac toxicity."
This link may have been posted before. It's a survivor study from the high dose trial.
Good one, TC!
3. In 3-6 months, though filing the EMA this month with a deal could start the ball rolling.
What makes you think that it leaked?
Now, wouldn't that be a nice early Valentine's gift...
Ig, where did you find out the EMA portal is open on the 12th? Thanks!
Noelle has put out her number and it's been widely shared here (not that we couldn't get it from the website) so, it's safe to say she's probably received many calls. I have no doubt that she knows the shareholder sentiment and shares it with management. I have no reason to doubt Big T's sincerity about creating shareholder value. We've not seen concrete results yet but I can bet they are in meetings trying to make deals. I did find it odd that the JP Morgan conference wasn't PR'd or maybe I just missed it. I did pick up some cheap Apr and Jul options.
And, if Advaxis is added to the mix, they may not recur at all!
Found Sara's number and left a VM regarding stock purchases and options vs RSU's.
Blue, do you or anyone have Sara's direct line? I can't find it at the moment. Thanks.
I emailed.
Just sent my email.