I, of course, want you to be correct but they've missed or changed expectations before.

I hope it's a combo trial.

I would suspect it will depend on how good or not the updated NEO data is

Clearly, they have had CR's.

AXAL Phase 2 Study in India: Prolonged Survival and Tumor Response in Randomized, Multicenter Phase 2 Study in Recurrent/ Refractory CC Illustrated the Promise of LmTechnology1?34.9% 12-month survival rate (38/109), 24.8% (27/109) 18-month survival rate, 3 confirmed CRs observed (RECIST 1.1)

Corporate Presentation.

Wasn't there a May CP to be posted?

Iovance gets Breakthrough Therapy Designation for LN-145 for treatment of advanced cervical cancer. Did we ever apply for it after the "best ever" results from the GOG trial?

It's in Aratana's paws.

Looking at the fintel page made me sick.

I have seen other companies give enrollment updates on blinded trials. Of course, they don't see the data but they know how many patients are in the trial. I always assumed we would get the FDA decision on the interim analysis at the same time as the hold would be lifted. I was surprised not to hear anything on it. Wasn't the hold the result of asking for the changes? I think most of us thought so.

Yes, Iovance's results ARE impressive. At the time, Advaxis' results were impressive. If they used the same exclusions that Iovance used, they may have seen even better. It will also come down to cost issues, side effects, quality of life, etc. You are correct in that the delays, stops and starts and a lack of focus have pushed Advaxis out of the forefront when they had a clear advantage. If they DO get an earlier interim analysis then they MIGHT be able to go for an accelerated approval if the results are very good. They are in a PIII so I don't think we're still at square one but it sure feels like it. I'm not disputing anything you say, I'm just hoping that we can get to the finish line first.

It would appear that Iovance made some adjustments to the PII trial: "The response rate in cervical cancer jumped to 44% from 27% in an earlier test. The results included one complete response, nine partial responses and two unconfirmed partial responses.

"This substantially exceeds the prior response rates reported for 15 patients in October 2018 and reflects a shift to patients with fewer prior lines of treatment and exclusion of prior PD-(L)1 (immuno-oncology) therapy," the analysts said in a note."

I didn't see an exclusion of prior PD-(L)1 therapy in the exclusion criteria for Advaxis (I could have missed it) and, for GOG-0265, "More than half the patients had received at least two prior therapies, beyond initial curative-intent treatment."

So, it's not strictly an apples-to-apples comparison.

You nailed it. I did not think it would come down today but you absolutely were correct.

He will be the chair of the Scientific Advisory Board so he will still be around, just in a different capacity.

Cat, in spite of what many say here (i.e. the science doesn't work, the science is outdated, the science is worthless), there is clear evidence that it DOES work. Is it better as part of a combo treatment? I think that's clear, too. I believe MANY existing treatments will be more effective when combined with other agents. The progress has been much slower than anyone likes or anticipated and the missteps by management are legend but I still believe, if management gets its act together, we could have a treatment that will be successful and (maybe) we could make our money back.

"“It is with mixed emotions that I leave my role as the Chief Scientific Officer, however, I am excited to continue providing scientific guidance to Advaxis as we progress toward clinical validation of the platform in furtherance of Advaxis’ mission to improve the lives of people with cancer.”

There will ALWAYS be more promising tech out there. That's the nature of research and progress. A treatment that can be combined with almost any other one should be a viable option for combo therapy. Waiting to see updated results on NEO.

"Presentation: A Phase 1 Dose-Escalation Study of ADXS-NEO Expressing Personalized Tumor Antigens in Subjects with Advanced Solid Tumors: Updated Results Date and Time: June 20-21, 2019 at 12:00pm ET"

I am hoping this will be a golden carrot. I thoroughly depressed myself when I looked at the market cap of INO and realized what our share price would be now if we had the same MC.

Thank you!

I believe she left Advaxis a few months ago.

Interesting read on cancer vaccines, in particular neoantigens:

https://www.genengnews.com/news/taking-a-new-shot-at-tumor-vaccines/

Dr. Mason is a wonderful doctor who's received multiple awards for her great work. As time goes on, she will make more and more advances.

It would appear that the only thing that will move the stock up is a cash-upfront deal or buyout. Or, possibly, some terrific trial results.

I believe this is the trial that got funded. Can't remember who funded it but it was large funding.

I believe felines were also mentioned somewhere along the way.

And, there are the 3 or 4 other constructs (nobody seems to know what they are) that were licensed by Aratana. Maybe we'll see these being pushed forward.

AT-014 would appear to be in competent hands with Elanco. Good-sized company with a global footprint.

Sorry, meant to say second quarter call. Second quarter call 2018 was June 7, so right about that time. I think we may have a better chance for success with AT-014 in Elanco's hands considering their global footprint, also.

Should be due for a 1st quarter update.

Doesn't the company and the FDA each have 30 days to respond to requests? Advaxis submits, 30 days for FDA to respond. FDA wants more info, 30 days for Advaxis to respond, etc. We could be here for a while...

Unless I missed something, the request to the FDA was just to include a secondary interim look. The FDA responded with a partial hold and request for CMC matters. How long should that take?

I'm hoping the reason for the delay in the IST is they are planning a combo trial. I think it makes no sense to run a monotherapy trial at this point.

So, when does our IST H&N cancer trial start? Will it be a monotherapy or combo (best choice, IMO). Will the trial require minimal financial commitment as Oncosec's does?

"The costs of this clinical trial will be shared with others and will require minimal financial commitment from OncoSec."

https://seekingalpha.com/pr/17484130-oncosec-announces-triple-combination-immunotherapy-clinical-trial-tavo-epacadostat-keytruda

Happy Easter and/or Passover to you, girlfriend! Maybe we'll see Advaxis arise from the dead!

I thought so but reading it again gave me pause.

I had always assumed the partial hold for AIM2CERV was due to the request for a second interim look. Reading the PR from 3/12, it appears the hold was due to other causes. If I'm interpreting this wrong, please let me know.

"In January 2019 the Company announced that the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on the Company’s Phase 3 AIM2CERV clinical trial for axalimogene filolisbac (AXAL) in high-risk locally advanced cervical cancer. The partial hold relates to FDA’s request for additional information pertaining to certain AXAL chemistry, manufacturing and controls (CMC) matters. The FDA did not cite any safety issues related to the trial and all currently enrolled patients are continuing to receive treatment. The Company has submitted its initial response to the request for additional CMC information and is currently in discussions with the Agency. In parallel, Advaxis is in discussions with the Agency regarding the Company’s request, made late in 2018, to include a second interim analysis for efficacy. The Company is working diligently to reach a resolution with the Agency on both of these matters."

Hopefully, we hear something before May.