I know some here have stated the science doesn't work and BP knows it but I find it hard to believe a faulty science could result in CRs. They don't (usually) happen by miracles. I believe, though I've been accused of being a pumper, that the science DOES work. We are coming to an inflection point. Finances are precarious. Shareholder confidence is practically nil (and here I do lay the blame at the feet of the management and BOD) but I still believe there is a chance to turn this around. A lot of people blame KB for all the woes but, really, it's been a snowball effect. I'm hoping he realizes what is on the line and makes some decent deals. If he can, he can write his ticket to anywhere. God forgive me for being a (cock-eyed) optimist. Apologies to R&H.

I don't think they've ever stated before that they would PR a summary of a presentation. They said it was new info but if it was that material, I'd assume it would be PR'd before the presentation. Who knows what we'll hear.

Volume precedes price (hopefully).

And she is using an Advaxis product so her faith in its effectiveness must still be strong.

I had to look for the part where it was stated that non-amputated dogs were also treated. I had thought it was to be a separate trial. Dr. Mason obviously feels very strongly about the vaccine. I only hope it works as well, or better, in the pediatric application.
https://www.vet.upenn.edu/research/centers-initiatives/mason-immunotherapy-research/therapies-trials/canine-osteosarcoma

I had been called out here recently as being wrong in every post I've written. I had said I read somewhere that a trial would be run with some dogs having osteosarcoma treated without amputation. Here's what I found. "The Mason lab is currently evaluating a vaccine, called ADXS31-164, that aims to stimulate the body’s immune system to recognize and kill bone cancer cells.

The vaccine is made from the bacteria Listeria monocytogenes, which has been genetically modified to express a tumor protein (HER-2/neu) that is found in many cancer cells, including canine osteosarcoma.

The bacteria is highly attenuated, which means it has been weakened so as not to cause disease when administered to the patient.

The vaccine is given by intravenous injection and aims to stimulate an immune response against cells that express the tumor protein (HER2/neu).

In this way, it is hoped that the immune system can be trained to recognize both primary and metastatic cancer cells and eliminate them, helping to delay the onset of metastatic disease and in cases where dogs are treated without amputation, prevent primary tumor progression.

I believe I read (somewhere) that a trial would also be run with animals who had not undergone amputation.

I saw that and was going to post it. That is EXACTLY what we need.

Overall, not a bad week for Advaxis. I had feared, with the partial hold, that the PPS would take a pummeling. I was pleasantly surprised it did not. The PR regarding the presentation seemed to instill some confidence and the PPS rose further. I still think antigen spreading is one of the LM platform's strengths. If the vaccine showed T-cell responses against prostate cancer antigens not included in ADXS-PSA, then I assume this may happen with the other versions of the treatment. Instead of baby-steps, though, I would love to see a giant leap ahead. We are at bargain basement prices. Time for us to move up. Still waiting on the IST to start and, hopefully, some good data readouts. Maybe the RS can be avoided. We should know shortly.

IMHO, the best parts of the PR.

"The data presented support the potential of Advaxis vectors to be among the most efficient and effective at generating CD8+ T cell responses to neoantigens, including some that are not immunogenic by alternative methods of vaccination."

"All nine ADXS-PSA patients who received three or more treatments showed T cell responses against one or more prostate cancer antigens not included in ADXS-PSA, providing evidence of antigen spreading."

https://www.jhsph.edu/news/news-releases/2018/cost-of-clinical-trials-for-new-drug-FDA-approval-are-fraction-of-total-tab.html

I hope it's wrong!

My guess would be they broached the FDA on an AA for AXAL earlier but didn't receive a positive opinion as it was a fairly new treatment (all conjecture on my part). Now, with multiple trials run, the FDA might be more receptive.

"...including potentially the ability to stop the study early based on positive efficacy results and proceeding towards an earlier filing for approval."

Sounds good to me.

https://wallmine.com/people/679/david-sidransky

Is he earning his keep?

"As the Independent chairman of the Board of Advaxis, the total compensation of David Sidransky at Advaxis is $2,020,800. There are no executives at Advaxis getting paid more."

"The amount of CMC information needed varies
according to type of trial
– Phase, Size and Duration of clinical trial, Dosage
form, Prior Usage, History, etc."

https://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm301050.pdf

I agree 100%. Time will tell. I hope it works out for all of us.

"What is the need for a second interim analysis for safety? let along efficacy? Moving the goal posts after all these days of touting we have IND. Note the 'among other things' - that they have not bothered to mention; the devil is in the details and as usual it is missing.'

Many trials have interim analysis for safety and efficacy. Some have more than one.

"Manageable safety profile ? how close is it to inflection? When it comes to safety it has to be beyond any doubt, not manageable. Seems that they are already telling us to not to be surprised if safety is a issue once the trial starts. How confident would one feel about efficacy after reading what ADXS had to say about the whole AXAL."

The two previous holds were resolved without the safety of the vaccine being an issue. And the trial has been running for some time now. I suggest you go back and read why the company wants these changes.

"If FDA review was prompted by 'our proposal to modify the AIM2CERC trial analysis plan...', then why did ADXS not have all information ready for FDA's perusal at the onset? why is the company addressing it now at the request of the FDA? In reality, did the FDA throw back the initial submission back at ADXS pointing shortcomings and pitfalls in the whole design (designated as probably inadequate) or is ADXS that we know of, proactive, even in a delayed mode of operation?"

I doubt it's possible to anticipate every question the FDA will ask.

Here's what happens when you do a little DD...

“FDA’s review of the AXAL Investigational New Drug (IND) application was prompted by our proposal to modify the AIM2CERV trial’s analysis plan to include, among other things, allowance for a second formal interim analysis for both safety and efficacy,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “The primary focus of the items raised by the Agency relates to providing additional clarifying details for CMC information previously provided in support of Phase 3 development and which will help support a future Biologics License Application. We have already begun efforts to address the Agency’s requests for information and are working to respond as promptly as we can.” He concluded, “Our AXAL product has demonstrated a manageable safety profile in the over 400 patients we have dosed to date and we look forward to enrolling new patients in our AIM2CERV trial after FDA agrees that the information we submit is responsive to its requests.”

Thanks! Good article.

Other than data releases and updates, I think the first big news (depending on how you look at it) may be full approval for the canine vaccine. The extended field study has been going on for some time. The revenue from it may not amount to much but it would be a full approval. It would be hard to doubt the science if Aratana gets it and the earlier results were excellent. Of course, I would LOVE to see some partnerships.

blue, a lot will depend on the upcoming data for the PSA trial. If ADXS-PSA can boast efficacy combined with KEYTRUDA, I see no reason why Merck would not want to test the waters further. The cost of producing AXAL (based on previous company disclosures) by itself is lower than producing NEO, so that would be a plus. Safety is another plus. We'll know in a few months. We may see full approval for the canine vaccine as the extended field has been ongoing for some time (a year?). If that does happen, I'd like to see OS Therapies try to pursue an accelerated approval trial for the pediatric indication. So, are good things coming? Quite possibly. Is the science sound? I believe so. Is management capable of seeing this through? Well, that could be the billion dollar question. There have been SO many missteps along the way, it's impossible to say. I still have faith the science will win out but I am no longer totally optimistic. This could be the make or break year.

Settlement Date Short Interest Avg Daily Volume Days To Cover
12/31/2018 2,073,019 840,088 2.467621

Hov, while I don't expect a buyout anytime soon, I am intrigued that Ken mentioned term sheets on the call. How far into discussions would a term sheet be generated? I assume there must be a modicum of interest on the part of another company to get to this step. BTW, thank you for your well-reasoned, balanced posts here.

What's up with the price action today?

Volume is nothing to write home about but it looks like some nice buys are going through today.