is...still alive.
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Is Austrianova encapsulating and testing while Eurofins tests the MCB?
Graphic on this PMCB webpage provides a 'fuzzy' time line:
it shows 12 to 28 days (couple weeks?). Don't know about testing timeline.
live-cell-encapsulation
see 1234's post #80053.
he provides a link to a 2 page article summarizing testing of types of cell banks. Page 1 has a table listing tests and their duration (Longest is 7 weeks) and page 2 shows a 2nd table with test to be performed by cell bank type.
this link: mastering-cell-bank-production
The announcement that the MCB was fully populated was Jan 10. Would the testing (and 6-7 weeks) have begun before that?
It is possible that the trial may stop before 6 months. I recall (can't find the quote at the moment) that if success is realized early the trial will stop then. The hard stop is that at 6 months the trial will stop regardless. My thought is that the closer to 6 months the more drop off in pps we would see.
Me too. At first I was picturing myself on sunny beaches for my last years; now I will be happy to leave enough that my children's families will have it a little easier. Oh well, excited to still be here to watch CIAB succeed.
Here is some informative research by iHub member 'plusorminus' message #73571.
msg 73571
Approximately six weeks; I tried to find a published reference that documents that time frame.
I am not in the medical field; the timeframe of six weeks is what I read on this msg board from others.
...or can they grow at one time twice the cells needed for MCB and split the batch, requiring only one timeline of six weeks plus testing?
MCB, test, then WCB, test? or MCB, test, begin encapsulation?
"We have authorized Eurofins to begin production of the MCB. Once that is completed, the MCB will be shipped to Austrianova for encapsulation into what will ultimately become our clinical trial product.”
Just a reminder: Austrianova at Stem Cell Symposium Singapore.
Austrianova COO, John Dangerfield, has been invited as a guest speaker at the Stem Cell Society Singapore 2017 Symposium to be held 16-17 November at SGH, Singapore
Stem Cell Symposium Singapore
What happened to our new Canadian coworkers?
We were going to be surrounded by Canadians soon.
I had expected that we might have heard about potential agreement/support.
What is the possibility that changing CRO is a prerequisite to moving forward with the unmentioned partner?
"The Road to the Biologic IND" reminder
Tuesday, 19 September 2017
12:00 PM to 05:00 PM
Where: JLABS Toronto, ON
perhaps yet another speculative fact will be firmed up here
The drawback occurs when the cannabis related ETF slides due to negative cannabis sentiment, sales of PMCB will be forced in spite of the status of PMCB's non-cannabis activity. Hopefully PMCB value due to diabetes, ascites, etc. will overshadow the ETF's effect. IMO, corrections welcome.
Now June 15 - See Post #69566 from BioInvestor4
BioInvestor4 Wednesday, 06/07/17 03:04:24 PM
Re: None
Post # 69566 of 69760
Emerging Agrosphere ETF pushed out again until June 15
https://www.sec.gov/Archives/edgar/data/1467831/000161577417003002/s106484_485bxt.htm
On or before Mar 13th was promised for the Qtrly.
I have learned to not expect more, but a news item always has the possibility of extra sentences.
Is it possible that since PMCB had already submitted their PreIND package and it was suggested that they alter their objective, that it might take less time to alter their document for a Pivotal IND study than the normal length of time to prepare a full, new IND document?
No, but regarding dates, the next 10Q was confirmed for March 13 or sooner.
No not avail tonight; that access info will not be known until after today.
"The shareholder call is scheduled for:
Date: February 7, 2017
Time: 4:30 p.m. EST
Telephone Number: (515) 739-1030
Access Code: 915-603-449
An audio replay will be available.
PharmaCyte will provide a telephone number and access code to listen to the recorded call the next day."
Best I can recall was the implication of sufficient positive results (reduction of ascites fluid) to confirm that outcome and better document those results in a followup study [indicating to me that reduction of ascites fluid was a fortuitous benefit in the pilot study]
https://globenewswire.com/news-release/2015/01/26/699897/10116902/en/PharmaCyte-Biotech-s-Expanded-Follow-up-Study-on-Malignant-Ascites-Fluid-Accumulation-in-Final-Stages-of-Preparation.html
SILVER SPRING, Md., Jan. 26, 2015 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live cell encapsulation technology, Cell-in-a-Box®, today reported that preparations for an expanded, follow-up study of the effectiveness of its pancreatic cancer treatment (a combination of low doses of the cancer prodrug ifosfamide and Cell-in-a- Box® capsules containing live cells capable of converting ifosfamide into its cancer-killing form) on the accumulation of malignant ascites fluid are in their final stages. This preclinical study will be conducted by Translational Drug Development (TD2) in the United States. Pancreatic cancer expert Dr. Daniel D. Von Hoff is the Chief Development Officer of TD2 and a principal architect of the study. It is expected that the study will begin in approximately two weeks.
This expanded study is designed to build upon the successful results of the pilot study that was completed by TD2 late last year. In that study, mice bearing an aggressive human ovarian cancer (ES-2), which produces significant amounts of malignant ascites fluid, were divided into 4 groups with 10 mice in each group. The mice in Group 1 served as a control group. Group 2 was made up of mice treated with PharmaCyte Biotech's pancreatic cancer treatment. Group 3 was treated with cisplatin, a chemotherapy drug often used to treat ovarian cancer. Group 4 was treated with a combination of PharmaCyte Biotech's pancreatic cancer treatment and cisplatin.
"Chardan will be acting as the Company’s placement agent for the resale of shares that will be sold through Nuvilex’s S-3 Registration Statement"
http://content.stockpr.com/pharmacytebiotech/db/Shareholder+Updates/343/pdf/3949f692f38d7bede13809843778532d0a4c25dab366da87305fd7a980a151f5.pdf
I wouldn’t say that Chardan “has the right” to sell. They are a “placement agent”.
I also wonder why PMCB would not hold off until share price is higher, unless there is an immediate need for the cash. And I expect that is a positive indicator for what will be explained to us Feb 7. Based on the last sentence below, I "kinda haveta" trust them; after three years why abandon ship now.
Capitalization and Funding for Future Growth
• Nuvilex’s financial position has become the strongest in the Company’s history. Nuvilex is virtually debt-free and has access to all of the necessary capital it requires to meet both its short-term and long-term monetary commitments. In addition, Nuvilex has established credibility with accredited and institutional investors who have expressed a desire to fund Nuvilex’s expansion plans under reasonable terms.
• Nuvilex has secured a traditional investment banking relationship with Chardan Capital Markets, a multi-national firm with offices located in New York, Los Angeles and Beijing. Chardan will be acting as the Company’s placement agent for the resale of shares that will be sold through Nuvilex’s S-3 Registration Statement to be filed with the Securities and Exchange Commission. The sale or placement of any shares sold following an effective S-3 Registration Statement will be conducted so as to preserve shareholder value as its top priority.
(the above taken from:)
http://content.stockpr.com/pharmacytebiotech/db/Shareholder+Updates/343/pdf/3949f692f38d7bede13809843778532d0a4c25dab366da87305fd7a980a151f5.pdf
I think three weeks is necessary and reasonable.
"... a positive pre-IND meeting with the U.S. FDA. We made excellent progress and received good advice and guidance toward the goal of filing our IND."
PMCB has a team of experts spread out geographically. They are not going to be sequestered in California until they complete the IND application. IMO they each will be providing their input to the finalization of the IND regarding the FDA's "good advice and guidance" from their own home locations. If I was the PI, I would want the time to incorporate everyone's thoughts and for a couple of opportunities for the team to review and agree to the final IND.
Ken Waggoner will want to report the IND was submitted on "mm/dd/2017" and the 30 days has started.
Two weeks to polish up the IND document and then a few days to prepare for the conference call seems quick given what is at stake.
You are correct re: weapons,
but for PMCB stock, load up and lock those shares.
"Lock and Load"
AFAIK, the phrase was born in the early days of WWII, in connection with the M-1 Garand rifle. The M-1 has a safety located in the front of the trigger guard that controls only the trigger. When the operator pulls the safety back into the front of the trigger guard, the trigger is immobilized, rendering the gun "safe". The gun is loaded by pulling the cocking lever back, at which point the action is held open by the follower in the magazine. Then an 8-round clip (yes -- a clip -- this is the proper use of the word) is pushed down into the magazine with the thumb and the cocking lever is released, allowing the bolt to move forward into battery, preferably without mashing the operator's thumb in the process. The gun is now loaded and safety engaged. To fire the gun, the operator just pushes the safety forward, out of the trigger guard. The Garand was a very safe-to-handle gun, mostly because it was possible to load it with the safety engaged. The practise was to carry the gun unloaded with the bolt forward (and it was a real test of one's skill to push down on the follower in the empty magazine and let the bolt move forward into the closed position *without* getting one's thumb caught and mashed ("M-1 Thumb")
When a unit entered a combat situation the order was given to lock and load. These words were heard in a *bunch* of WWII movies, popularizing the phrase...
(borrowed from: roy berkeley, Aug 7, 2004)
The 30 day wait begins after the final IND document which is submitted after addressing all (if any) questions, recommendations raised by the FDA in the pre-IND meeting.
So the next announcement I'm watching for is the date the final IND document was submitted.
http://ir.pharmacytebiotech.com/press-releases/detail/126/pharmacyte-biotech-announces-pre-ind-meeting-date-with-fda
PharmaCyte recently submitted questions to the FDA as part of its pre-IND submission package. With answers to these questions and any additional information provided by CBER during the January 17 meeting, PharmaCyte will address any open issues or requests of CBER before preparing its IND. Once the IND is submitted and found to be acceptable to the FDA, PharmaCyte can proceed with its planned clinical trial in LAPC and enroll patients at the selected trial sites throughout the U.S.
Excerpted from:
http://ir.pharmacytebiotech.com/press-releases/detail/123/pharmacyte-biotech-secures-funding-opportunity-for
December 12, 2016
NEW YORK, NY -- (Marketwired) -- 12/12/16 --
"We will be submitting a very lengthy pre-IND package that provides detailed information and data on our therapy and proposed clinical trial. We will be flying key members of our team from Europe to the U.S. to prepare for and participate in the meeting with the FDA. There will be substantial preparation before the meeting with our team of new regulatory experts. They have extensive experience with the FDA in pre-IND and other meetings. We are in good hands."
"Company Aiming to Produce 6-Month Breakthrough Data
NEW YORK, NY -- (Marketwired) -- 12/01/16 --
PharmaCyte Biotech (OTCQB: PMCB) is now one step closer to enrolling patients in a pivotal clinic trial in advanced, inoperable pancreatic cancer after the FDA granted its request for a pre-IND (Investigational New Drug) meeting. A host of oncologists, clinicians and scientists that represent PharmaCyte will now sit down with the U.S. regulatory agency to gain valuable insight that will assist them in filing an Investigational New Drug application -- the final step before patients can be enrolled in a clinical trial.
With PharmaCyte and a team of world-renowned oncologists that includes leading pancreatic cancer expert Dr. Daniel Von Hoff from Translational Drug Development (TD2), Dr. Manuel Hidalgo from Harvard Medical School, and Dr. Matthias Löhr from the Karolinska Institute in Stockholm, Sweden, set to begin a clinical trial in the U.S. and Europe, the FDA's IND process is vital to getting there.
After the IND process runs its course, shareholders should be prepared for what a planned 6-month "hard stop" in the clinical trial could bring in the way of data to the industry. If past performance in earlier clinical trials is any indication, PharmaCyte may be a short time away from what could be a very powerful story for patients with advanced, inoperable pancreatic cancer."
Taken from: http://ir.pharmacytebiotech.com/press-releases/detail/121/pharmacyte-biotech-moves-closer-to-enrolling-patients-in
Check these out:
"Some popular market makers for these types of transactions include NITE, ATDF, ETRF, and ARCA. "
http://upperdivisioninvesting.com/level-2-tip-know-market-makers/
http://www.otcmarkets.com/stock/PMCB/quote
As of market close today the PMCB website
shows Market Cap of "MKT Cap $76.07M"
http://ir.pharmacytebiotech.com/
Last ten News releases as found on PMCB website:
a three way tie.
3 on Mondays
3 on Tuesdays
3 on Thursdays
1 on a Wednesday
08/02-Tue
09/01-Thu
09/15-Thu
10/10-Mon
10/24-Mon
11/01-Tue
11/14-Mon
11/16-Wed
11/29-Tue
12/01-Thu
I prefer to hold (or buy)... just in case.
Great plan! And after the 6 month trial checkpoint I'm buying a LRover Defender and taking it to my place in the Northwoods where I plan to stay for long periods of time. Good luck to you and GO BREXIT.
Northern Wisconsin & UP Michigan the best fall colors usually occurs (3rd-4th weeks Sept) or (4th week sep-1st week Oct) depending on the moisture & temp.
Mayo Clinic Pancreatic Cancer Conference 2016
11/18-19/2016
Course Directors: Ramesh K. Ramanathan; Mitesh J. Borad, M.D.; Lynn M. Matrisian, Ph.D., the Pancreatic Cancer Action Network, and Daniel D. Von Hoff, M.D., F.A.C.P. (TGEN and Mayo Clinic)
This state-of-the-art conference, offered in cooperation with the Pancreatic Cancer Action Network, the Translational Genomics Research Institute (TGen) and Honor Health Research Institute, is designed to provide a multidisciplinary overview regarding the molecular biology of pancreatic cancer and the importance of early diagnosis and treatment considerations, including surgery, new pharmacological agents and how to incorporate these options into daily clinical practice. The program format will utilize case presentations, open Q&A and an interactive keypad system to generate participant feedback and develop an optimal learning experience between faculty and course participants.
This course is being offered in collaboration with TGEN, The Pancreatic Cancer Action Network and Honor Health.
https://ce.mayo.edu/hematology-and-oncology/content/mayo-clinic-pancreatic-cancer-conference-2016
The IND cannot be far behind.
If I was Hidalgo I would not have accepted the PI position if the IND documents were not already prepared (and I would have had input and approval of same).
future competition? - intels atom processor
http://news.yahoo.com/s/afp/20080402/tc_afp/usitinternetchiptelecomcompanyintel_080402194140;_ylt=AvE6sSoCDYzbMuD2eiitu5YE1vAI
smtx and 1.45 ; nice call, thanks
let's all remember last year's 8K results of Operations was filed on 16 Nov ahead of any CC
That 2nd paragraph tells it all, ie., what the headline leaves out...
]
"...data on mortgage applications may be artificially inflated because prospective borrowers have been filing multiple applications to obtain a single loan ..."
...and those prospective borrowers also includes refinancers trying to get out of their ARM loans before their low fixed rates come to an end.
Therefore I wouldn't trust that statistic as a sign that there is any improvement. Things could improve, but this was not the sign.
I can't provide grounded statistics for this statement, but you have to consider that an increase in mortgage applications (without further qualification as to refinance applications or new home applications) may simply be people in trouble trying to refinance a mortgage going bad. After all, the report you cited does not indicate qty mortgages approved, only applications.
at 10:49am Central Time I could bring up www.citibank.com
apparently its all you