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Possibly skirting some regulatory hurdles...
http://www.fiercebiotech.com/biotech/fda-outlines-innovation-initiative-cures-plans-to-speed-up-drug-development
Nice to see you back!
The July corporate presentation is looking mighty good...
http://www.advaxis.com/wp-content/uploads/2017/06/July-2017-Corporate-Presentation.pdf
Thanks for the best laugh of the day!
Blue, I have no doubt they do read this board.
I expect, within the week, for Lombardo to issue some kind of PR and/or CC to introduce himself and state his vision for the company. We don't know how long he'll be in that position but a little communication on his part may help calm troubled waters. I wish him luck!
Whoa...that looks GREAT!
This doesn't change the science or the value of the company. I am a bit shocked at the suddenness of it. Many here were calling for his removal, they now have it. I had no problem with DOC and I thought things were moving along. Let's see how Tony does. They already got rid of Doc's photo from the website. I wonder what the hell happened!
When I spoke with Noelle (IR), she said they were looking at every option so it would not surprise me if it came to pass. These were EXCELLENT results and should be approved quickly.
Who's buying and selling:
https://fintel.io/so/us/cytr
Great reading, thanks James!
Hopefully, Advaxis is going for an AA with the advanced an@l cancer study. At 6 months, 100% of patients who completed RT and received
treatment achieved a CR. At 34 months 89% remained disease free. The historical 3 year recurrence rate is around 45%. 4 of the patients are over the 3 year mark. If that doesn't qualify a treatment for an AA, I don't know what does.
From SA. I believe this biomarker will be of major importance in identifying those patients that can be helped the most:
"Advaxis, Inc (ADXS) is currently in pivotal study with its lead candidate, axalimogene filolisbac, for a variety of tumor types. However, the most advanced data we've seen to date was in advanced, recurrent cervical cancer, from the GOG-0265 study at the Society for Gynecologic Oncology meeting earlier this year.
Recently, ADXS announced that updated findings from this same study were selected for presentation at the European Society for Gynecologic Oncology meeting in November. Specifically, these findings will relate to the identification of a potential biomarker gene expression signature that points to patients having better outcomes overall while being treated with axalimogene filolisbac.
Lower levels of these 4 genes segregated a group of patients with 56% 12-month overall survival rate, while patients with higher levels saw 12-month OS rates of only 15%. One protein in particular, unidentified in the press release, is apparently a useful indicator of outcomes for patients.
Looking forward: While it's not the most groundbreaking finding, potential biomarkers of immunotherapy success are very important to find, and they remain elusive across the board. If ADXS has a way to delineate which patients will benefit from their therapy, it provides a major inroad toward demonstrating the value of their therapy. The 56% 12-month OS rate is substantially better than that seen among the entire patient population (38%), which was already favorable in comparison with historical controls."
Great read! Thanks, James.
I wondered the same thing. I believe Aratana finished the safety trial so it would make sense to use (if they can) the new trial as the confirmatory one.
Search for CYTR on the page and it will come up. Direct link doesn't work for some reason.
Accelerated approval with a confirmatory trial. At least, that's my take on it.
https://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm313768.htm
Anything of additional interest you can add? Obviously, she's limited by what she can say but, like you, she was generous with her time and she LISTENED!
If the stock was BLCM, market not reacting well to the news at all right now.
Blue, I talked with Noelle yesterday, also. I specifically asked about moving to PII registration style studies in lieu of PIII. She couldn't give specific details but did say they were looking at all the options available to them. She believes strongly in the science and DOC which are two of the reasons she came to Advaxis. She called me from her cell while driving home so I did not want to take up too much of her time. She comes across as very credible and sincere and did mention the company was well aware of the stock price and they are focused on driving shareholder value.
Over 1 mil traded so far. Lots of volume. The old saying is "volume precedes price". Let's hope it means a greater rise in PPS.
Is this the post you were referring to? "...Our trial with Astra is still running as well,but we prefer the BMY combo with Opdivo..."
I've always felt they should go for a registration style PII for pediatric osteosarcoma. I have no doubt there would be a huge amount of support for this indication. Maybe the company is already working on it but I don't think questions about it have come up in presentations or conference calls. I did leave another VM for Noelle as we're playing phone tag. I will bring it up.
Ig, Hans works at LifeSci Advisors and works with Advaxis IR. I've talked to him myself. He's very approachable if you reach out to him.
Raja, it's hard to argue with your logic. I will say trials do take time and this certainly does come into play. The FDA, though, seems to be showing a more flexible attitude and this, coupled with our safety and efficacy data, I hope will result in a speedier path to approval. I do think Dan made missteps in regards to the AZN/BMY debacle but we've got to move on from there. I do believe he has hired some very good people. though.
I believe this is the trial where 9 evaluable patients out of 11 had 100% CR at 6 months.
All Dan had to do was state it like that (or similarly) and some of this could have been avoided.
Very good read! Thanks!
I checked the Yahoo finance chart expecting to see all red but it appears the biggest spikes are green. Accumulation? Someone please correct me if I'm wrong. I'm not a chart guy so go easy on me!
I was just responding to someone's question.
From Dafreaks earlier post, "For a registrational study that we plan to use for filing in the future, we chose to go with a different partner. So I believe what Hans meant is that we chose not to move the combination with durvalumab into a registrational, ‘phase 3-style’ study." "We evaluated several options who were interested in partnering with us for the registrational trial with a checkpoint in metastatic and we selected Opdivo." This is a response from Noelle Heber in IR.
As for the reasons to the above, your guesses are probably better than mine but I believe the company thinks Opdivo will give better results. There hasn't been any dual trial yet so no links for that.
And a thanks to Dafreaks for sharing that information. Much appreciated.
If the trial was failing (this is all my own opinion), I would imagine they would just stop it. No sense throwing good money after bad. Or, if they just wanted to let the trial play out, they could show "active, not recruiting" on the clinical trials page and just follow the current patients in the trial. The fact that it WILL go to a PIII and there will be a data readout on the PII tells me something is probably working. Again, I could be very wrong as I usually am.
I don't think I've ever criticized the management here before but this was not well-payed by the company. I think a properly worded PR could have done a lot to control the sell-off. Stating the advantages of partnering with BMY may have dome some damage control. I still believe in the science and the value of the products but this was not handled well.
So, when James S. talked to IR and was told that nothing negative should be inferred by leaving AZN off a slide(s), was that an outright lie?
"Astra Combo trial is continuing as planned, and nothing negative should be reflected from them not being included on slide 4.
Advaxis plan has always been to partner with multiple players and Advaxis feels that they have done this in the PD1 space."
Not sure if this was posted but a study manager job opened 6/6.
It may not move the stock much when it gets approved but it will be an approved construct and there's a certain pride in that.