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Obviously TIAB doesn't agree but a lot of others have said very much the same thing as you. I worry that DF hurts us by not allowing a proper explanation of this reopening of the Phase 1 etc., Anyway it looks most interesting and awoke quite a few investors Friday afternoon.
My simple view is CTIX can only be agreeing to this as there will be absolutely no risk to the Phase 1 and that the "experimental work" can only be to the advantage of the terminally sick. I view it as an extraordinary event that DF should explain for the benefit of CTIX and the world.
That would put the cat among the pigeons.
Kevetrin may actually have two mechanisms that induce apoptosis. Is our wondrous drug about to become even more wondrous?
Faites vos jeux the returns could be astronomical.
He'll show his hand on his own terms but I would say with all the positives we should know soon. It's not desperation time and who knows we may be in for a major surprise. Don't sell him short!
It's the TTR mantra.
Will it be Dana-Farber plus another blue chip cancer hospital involved with Kevetrin. Sounds really intriguing and adds credibility to Dr Menon and his compounds. Will definitely bring more eyes on us.
In the general scheme of things it's a drop in the bucket isn't it?. This company just put out a fantastic update opening a few eyes, no doubt, on the very large scale of possibilities here. Don't knock it you should be happy.
Thanks for posting. Excellent read and provides for a lot more information to be given to the public. Looking forward to the start of a continuous news flow.
"I do not know how often the start of phase 2 trials involves working to find the best dosing(obv not a topic I know anything about without starting to read/ask)"
To think I thought you were on top of this!
Why don't you wait and see.
Copied from PR January 19th 2016:
"In the planned Phase 2 ovarian cancer trial, Cellceutix intends to leverage the short half-life and strong pharmacokinetic profile of Kevetrin to change Kevetrin dosing from a single dose weekly to multiple doses weekly. The company expects that this will further increase p53 activity." - See more at: http://cellceutix.com/cellceutix-submits-briefing-book-for-phase-2-trial-of-p53-targeting-drug-for-ovarian-cancer/#sthash.Uq1OMn00.dpuf
I agree with you and Kelt. There seem to be a lot on here who are the type to get in a car and before it's moved ask "are we there yet?"
I don't know how you can be an investor unless you trust the people doing our trials.
Drug trials are all about "what if" that's why CTIX have a team to figure it all out.
Things are good. We are close to more value adding news and creating more interest for CTIX.
Sometimes there are attacks on stocks because of the potential for bad news. Perhaps all of this was perceived as a bad deal but it could be "the last bad deal" which if it is the stock may make a very hurried recovery from here. Much ado about nothing?
Good. The shorts have got it all wrong then.
I don't think you or any of us know when this starts back up but it will happen. And soon. I think the PR signaled more PRs to follow with ever increasing good news. You shorts had better watch out.
Thank you. I think we have every reason to speculate that the news horizon is looking really good and like you I expect CTIX to make some sharp gains.
It's all in the eye of the beholder. I like being kept up to date and see each pr as a step forward as the company progresses it's science. There is a lot going on now and we are back on the move with all kinds of announcements due.
Sorry I think I started that. My mistake PRURISOL I'll write 20 lines!
One thing I would like to add is, as you know, this stock has been savaged by a crooked hit piece and is selling at a price that is more akin to the hit piece than reality. If you can agree with that you will understand why each one of our drugs is proving the piece wrong and building a very solid foundation for CTIX.
Every one is a building block and adds value. As each become more relevant they will add more value until we get an approval and then we hit the highs. If we add cash it will add value and, of course, if we add a partner we add value. Currently I believe we are very undervalued and in time we will see that corrected. I am well aware that everything takes time but am very happy the science is going so well.
All of it is stock moving.
I like to look at stuff that's staring me in the face such as Plurisol P2, B-OM P2, upcoming B-ABSSSI P3, K end of P1, K Ovarian plans for P2 and now K Pancreatic. Should be enough to get on with for now.
Come on IAB you can do better than that. Did you forget yesterday's PR already? This is new and exciting stuff and when buyers of "anything pancreatic" get hold of it we will have a mini lift off.
IMO this story will only get bigger and bigger.
Anything pancreatic is big news.
Yup and with today's surprise will give the bears something else to look over their shoulders for. Boot maybe be about to be on other foot.
In these markets you get it done when you can.
We need the money so does it really matter if it's down here. I don't believe so and it will take a hell of a lot of pressure off the stock when it's done.
That in itself would be very bullish for CTIX.
Excellent news. It's all building and maybe this time we get a bit of press coverage.
And a game changer.
Right now CTIX can only defend itself with continuing good solid scientific news. Can't do that everyday but the continuous good news is making CTIX a compelling buy in the high risk high reward biotech sector.
CTIX has an incredible drug pipeline and a real possibility of bringing the first new antibiotic drug platform to market in 20 years. Big deal no mistake about it and it will be a major talking point in the industry and world news.
It validates a value for K. Even at a paltry $50 million it puts B and P together at $86 million. Doesn't seem right does it. As I was saying our golden nugget is waiting to be discovered.
We and the world are waiting for Kevetrin Phase1 data. We know it's good and it could be mind blowingly good. It will definitely add value and turn more eyes on how fantastic our pipeline is. Our golden nugget ready for discovery.
Keep it positive this has been a great weekend of posting and nobody is suggesting Leo look the other way.
For Edward Walters I copied a Farrell90 post. Hope this helps.
Dr. Trust has more than four decades of pharmaceutical research and development experience, including senior positions in R&D at Pfizer, Enzon, Wyeth/Lederle, and most recently, Allergan plc affiliate Durata Therapeutics. He has made significant contributions leading to the FDA approval of 11 drugs and supplements, including five antibacterial agents, most notably the blockbuster ZITHROMAX® (azithromycin) and most recently DALVANCE® (dalbavancin) for ABSSSI. An organic chemist by training, Dr. Trust received his PhD in chemistry from the California Institute of Technology and his MBA in pharmaceutical studies from Fairleigh Dickinson University. Dr. Trust has recently formed a regulatory, quality and medical writing consultation firm, PharmExpertise, LLC, with Cellceutix becoming one of its first clients. - See more at: http://cellceutix.com/cellceutix-retains-former-durata-executive-ronald-trust-as-regulatory-affairs-consultant/#sthash.nCeextjG.dpuf
Edward Walters MPH central operations Cellceutix
Past Director of Clinical Operations at PolyMedix, IncDirector of Clinical Operations
Director of Clinical Operations at PolyMedix, Inc
September 2010 – Present (4 years 5 months)
Manage day to day clinical development programs across various therapeutic areas and clinical indications. Overall project management of multiple vendors (domestic and international) for efficiency and cost effectiveness.
Edward J. Walters, MPH
Senior Director, Clinical Development Operations, Epidemiology at Allergan
Allentown, New JerseyPharmaceuticals
Current
Allergan, Director of Clinical Operations at PolyMedix, Inc
Previous
EDON Consultants, LLC, Pharmos, Axonyx
Education
University of Southern Mississippi
178
connectionsSend Edward J. InMailMore options
www.linkedin.com/pub/edward-j-walters-mph/14/a07/a55
Background
Summary
My experience of 25 years of leadership in Clinical Operational and Project Management in the bio/pharmaceutical industry, covering all phases of clinical trials, has been one of increasing responsibilities and challenges, in designing, implementing, and successfully completing clinical programs, across various therapeutic areas. My attention to detail and proven track record of managing internal project teams and external contract personnel, has allowed me to be a part of the success of some of the leading compounds in the market today. I have a successful record of building high performing, cross-functional clinical project teams (internally and externally). I have over 25 years of direct reporting staff management experience as well as direct management of CRO/ vendor partnering. At the same time, I have always been “hands on” with every project. I have both domestic and international project management experience and extensive experience in leading clinical NDA teams on 6 Phase-III NDA Submissions to date and 5 NDA approvals.
Experience
AllerganSenior Director, Clinical Development Operations
Allergan
January 2013 – Present (2 years 1 month)Bridgewater, NJ
Leads and drives all operational and administrative functions in therapeutic area clinical programs by ensuring the execution of epidemiology clinical studies to successfully meet post-approval study requirements. Exercises a high degree of quality, productivity and communication to the department and therapeutic area for the timely completion of all clinical studies. Hires, develops and motivates staff to ensure scientifically valid studies conducted according to Good Clinical Practices, appropriate to the type of study. Leads assigned clinical sub-teams to rapidly deliver studies, which meet minimum and desired requirements in an efficient manner using high quality scientific rationale. Provides project and resource management across therapeutic area portfolio. Serve as a member of therapeutic area management team
Director of Clinical Operations at PolyMedix, IncDirector of Clinical Operations
Director of Clinical Operations at PolyMedix, Inc
September 2010 – Present (4 years 5 months)
Manage day to day clinical development programs across various therapeutic areas and clinical indications. Overall project management of multiple vendors (domestic and international) for efficiency and cost effectiveness.
Owner
EDON Consultants, LLC
September 2003 – March 2010 (6 years 7 months)
Provide Project management and day to day clinical operations for Phase I thru IV clinical trials. I have monitored and audited both domestically and internationally. I have created project management and clinical operations at two different companies (Eisai and Andrx). I have over 20 years of successful experience in the industry. Over the past 7 years, I have successfully led project management and clinical operations for two different companies and 4 different compounds. Included was over 200 study sites, across 16 countries, and included over 2000 patients.
Project Management and Clinical Team Leader
Pharmos
January 2007 – October 2009 (2 years 10 months)
• Overseeing project management of national IBS clinical program
• Negotiations of all vendor budgets and responsible for review of all invoices.
• Worked to present quarterly forecasting of budget expenditures and presented to senior management.
• Lead weekly project team meeting with all vendors and company personnel.
(Open)2 recommendations
Jeff Kittrelle
Jeff Kittrelle
Drug Development Consultant
There are few project managers I've worked with who are as experienced, hands-on and knowledgeable as Ed Walters. He is a...View
Harold Doshan, Ph.D.
Harold Doshan, Ph.D.
President at Pharmaconsult Associates
As a consultant to Eisai Pharmaceuticals, and subsequently through other affiliations, I have enjoyed working with Ed...View
Project Management and Clinical Operations Leader
Axonyx
January 2004 – November 2006 (2 years 11 months)
• Responsible for day to day operations of Phase I thru III of multiple clinical programs on multiple continents.
• Overseeing international Alziemers clinical program(s) and the project’s resources and timelines.
• Maintained project budget in access of $20MM, and quarterly forecasting.
• Management of all vendors (CROs, Labs, etc)
VP of Project management and Clinical Operations
Andrx
1998 – 2003 (5 years)
• Created Clinical Operations Department (NJ and FL) and hired personnel
• Responsible for multiple CROs central Laboratories, IRBs, and consultants
• Responsible for multiple department budgets in excess of $30 million dollars.
• Lead project management for multiple projects
• Created Data Management and IT Departments (NJ and FL) and hired personnel (Documented saving in excess of $400 thousand dollars/Yr).
• Created Post Marketing Surveillance Safety Department and hired personnel
. Director of Clinical Operations and Project Mangement
Eisai, Inc
October 1989 – October 1998 (9 years 1 month)
• Negotiation and direct responsibility for multiple contract research organizations and central laboratory services.
• Hiring and direct supervision of clinical monitoring and auditing staff.
• Responsible for project management and coordination of resources for Phase I through IV clinical programs (Aricept™ and Aciphex™).
• Participated in review of clinical data and preparation of final study reports.
• Responsible for implementation of all clinical studies of Aricept™ outside U.S. (Phases I-IV) including new indications program for Aricept™ worldwide.
Schering-Plough PharmaceuticalsSr. Project Manager
Schering-Plough Pharmaceuticals
February 1984 – October 1989 (5 years 9 months)
• Organization and presentation at multicenter investigator meetings.
• Representative at domestic and international symposia/meetings.
• Project management and coordination of numerous protocols for multi-centered NDA program.
• Supervision of field research associates during various clinical programs.
• Assisted in planning for departmental budgets.
• Assisted in organization and implementation of departmental procedures for in-house and on-site clinical monitoring.
• Training of new personnel to industry guidelines and good clinical practices.
• Direct supervision of multiple CROs.
Skills
Top Skills
8CRO
7Clinical Development
7Pharmaceutical Industry
7Clinical Trials
6FDA
5Clinical Research
4Therapeutic Areas
3Regulatory Affairs
3GCP
2Oncology
Edward J. also knows about...
2Infectious Diseases
2Biotechnology
2EDC
2CTMS
1Lifesciences
Education
University of Southern Mississippi
University of Southern Mississippi
Master of Public Health (MPH), Health and Epidemiology
1977 – 1979
Also received degree in Sports Medicine. Did part of training with Dallas Cowboys and New Orleans Saints
Activities and Societies: GRADUATE HONORS Kappa Delta PI – National Honor Society Eta Sigma Gamma – Graduate National Service Honor Society (Vice President) Two Simultaneous Graduate Fellowships
Kean University
Kean University
BS, Physical Education and Biology
1974 – 1977