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Is the combo prostate results are good, it's off to the races. Hopefully, many companies will want to combine their treatments with ours. This is why I feel this year is our year. I know that's been said for the past several years but I think Advaxis' true potential is finally being seen and recognized.
Perhaps not particularly needle moving now BUT, this may help show that Listeria-based immunotherapy can, will and should be combined with many other treatments.
"Rachelle E. Kosoff, Ph.D., Senior Scientist, Advaxis, Inc.". New hire? I think I saw a Senior Scientist job opening a while ago.
Blue, thanks for expressing our concerns to Noelle. I've talked and emailed her many times and, though she's limited to what she can say by the nature of her job, I always felt she truly to listened to what I had to say. I know if I asked her to pass something along to Big T., she would do so. Whether or not he would act on it I don't know but your postings indicate he very well may. Thanks again and glad to see your positive outlook!
Thought I'd throw my theory in the ring. The company could have early data from the prostate trial by the end of last year. They could be confident enough to want to have extra shares available for a deal. Just a theory.
Agree!
Apparently not since you wrote, "The idea of combining an extremely toxic substance to the human body with a new biotech compound just doesn’t seem right..."
This statement does not indicate that you got it.
Zach, I appreciate your cautious tone. You're correct, this alone is not "undeniable out of the park proof" but I look at this as validation of the PII GOG trial and the canine trial. I think we have a winner here. Just how soon the market comes to realize that is anybody's guess.
Blue, I think you're probably very close to the truth of what is transpiring with the company. I, like you, say give him till ASCO to produce concrete results. I believe he can and will do it. A lot also hinges on his meeting the timeline of 1st quarter for the EU filing.
He said objective, not objectionable.
Absolutely.
One of the reasons it could be important is CI's have not shown a lot of activity in prostate cancer. If there is synergy with AXAL, it could be a game-changer.
mfs, I believe they do. I suppose anybody, including a company employee, could be on this board. I hope, if they are, they realize the mindset of a lot of people here and keep in mind interests of the shareholders.
I think so. I'm sure the BOD is not oblivious to the feelings of the shareholders and some in management do read this board. What I expect (and reasonably so) by then is, the EU filing done, a partnership cemented, an announcement of the CMO and CEO, start of trial updates and enrollment updates on current trials. I consider myself a very reasonable person and, barring unforeseen disasters, I can't think of any excuse why these items should have happened by then.
Down to one job opening, Senior Associate, Manufacturing/Technical Lead. Still waiting to hear about CEO and CMO. That would help calm the waters, IMHO.
One reason it is not shared with Noelle could be, if they give a definite date and that date is missed, it could wreck havoc with the stock price. Their thinking could be just give guidance that it will be done first quarter, allowing more of a cushion for filing. This is all conjecture on my part. More of a concern to me is getting a new CMO or CEO on board. Perhaps there'll be some announcement at the annual meeting. I think some of constructs are good enough for AA and I'd LOVE to see them go for that.
Noelle said the people managing the submission know the dates but it is not filtered down to her. I have no reason to doubt her veracity.
Ig, see post #49546. It has not been filed. I received the same info. It is on track to be filed this quarter. Perhaps more will be shared at the annual meeting.
Best ever GOG trial results? I would say yes.
I know people here have talked to both Noelle and Hans (who may have moved on). I don't know why any shareholder would be ignored by IR. I would try Noelle and let her know you've not gotten any response. All my interactions with her have been positive and she's responded in a timely manner. We've talked about shareholder value so it's a safe subject.
If the prostate data is good, I think we'd apply for breakthrough therapy status. FDA has given it to Keytruda with other combos.
Noelle had told me also that the submission portal (EMA) was only open one day a month. I would think they would know the day, though.
Thanks, Blue. 2018 may shape up to be our breakout year.
Blue, did you get the impression from Noelle (I did) that both Advaxis and Merck were enthusiastic about the upcoming combo results? Preliminary data should have been available by the end of year, though I think there won't be any disclosure of it except at a major conference or like venue. I know there is only so much Noelle can disclose and I understand that but I wanted to know if you came away with the same thought. Thanks!
And maybe, just maybe...ADXS is heading north like CPXX and become a $30+ stock by the year end 2018. Mark my post.
Seems like they anticipate being busy with biological manufacturing.
New job opening:
Senior Associate, Manufacturing - Technical Lead
Job Locations
US-Princeton
Posted Date
1 day ago(1/10/2018 7:38 AM)
ID 2018-1113
Overview
The Senior Associate, Manufacturing/Technical Lead will perform various biological manufacturing unit operations which includes media/buffer preparation, fermentation, clarification and purification in a cGMP clinical manufacturing facility. Initial job responsibilities will include working with a group of manufacturing personnel responsible for a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation.
Responsibilities
Biologics Manufacturing:
Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities.
Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
Identifies, escalates and documents events and subtle variances that deviate from normal operation; participate as needed in investigations.
Maintains cleanliness and orderliness of process area.
Maintains production area with supplies.
Prepares and operates bioreactor systems and TFF operations, and/or media/buffer preparation operations.
Performs batch record review, procedure revisions, and work order generation.
May be responsible for training less experienced or new operators.
Utilizes manufacturing knowledge to improve process operations and affect positive change.
Demonstrates ability to troubleshoot basic mechanical operations.
Technical Lead:
Leads, practices and promotes safe work habits and adheres to all safety procedures and guidelines
Ensuring execution of manufacturing material activities in strict accordance with standard operating procedures and cGMP
Manages cross functional teams to drive complex change controls and investigation close outs by determining root cause(s) and implementing appropriate Corrective and Preventative Action(s).
Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change.
Conducts complex document revisions and/or document management including standard operating procedures (SOPs), batch production records, manufacturing procedures, and cross functional procedures.
Performs training with staff on the floor, as needed.
Leads cross-functional continuous improvement teams with various departmental and outside representatives (Process Development, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services).
Works independently with minimal supervision and direction.
Qualifications
EXPERIENCE:
Bachelor's Degree with 5 years of experience, or Master’s Degree with 3 years of experience.
1 year in a lead or supervisor role.
Excellent communication and coordination skills.
Demonstrated ability to effectively coach and train employees.
Subject matter expertise in biologics manufacturing.
Knowledge and demonstrated understanding of GXP and how it applies to specific responsibilities and manufacturing operations.
Ability to influence in a cross-functional environment.
Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.
EDUCATION:
Minimum Bachelor’s degree in Biology, Chemistry, Biochemistry, or Chemical Engineering.
SPECIALIZED KNOWLEDGE, LICENSES, CERTIFICATIONS:
Effectively uses process automation systems to operate production processes
Experience in reviewing and creating controlled documents.
Familiarity with Deviation Management Systems
Thorough knowledge of the cGMP regulations.
Demonstrated abilities for problem solving, working as a key member of a team, and motivation to complete company objectives.
Wow, can't believe the venom I get when I mention Noelle's name. Really, do you really think she is deliberately deceiving you? She is limited by what she can disclose. I can only speak for my own interactions with her which have always been professional and cordial. All companies need an IR person. Just because she doesn't say what you want does not make her worthy of scorn. I think many people here do her an injustice.
Agreed.
She does her job. Why would the cut her?
I've gotten a phone call from her when she's in her car driving home.
So they're at $68 (there about) with three times the outstanding shares of Advaxis. Maybe we should run every trial with a CI. I don't begrudge them success but I feel we are so undervalued...
Thanks!
raja, do you recall the name of the company?
Well, he already made significant changes. He prioritized the focus of the company to push those products most likely to be commercialized and step back from the rest. This is serious cost-saving. He seems to be an under-promise kind of guy. Now, let's hope he's an over-deliver kind of guy, too. That would be a change from DOC.
fbg, I remember hearing something very similar.
Based on all I've read, the SPA PIII trial should indeed be worthy of AA.