is...still alive.
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Agreed they are still working. Just my opinion that releasing this video would not have occurred unless the "tech" work was complete.
There is still an unknown period of time before IND is completed and submmitted.
Simply I am encouraged that they have completed what they need to document and submit.
Nothing new, but I do believe it's confirmation that all the prep and testing is complete. Otherwise, the video would not have been released.
Implied Msg: Hidalgo confirms trial will occur.
...and coupled with SH meeting means to me, soon.
Shouldn't be a problem.
After 4-5 years of accumulation that will be fewer than 398 people.
Ignoring discussion of ethics, professionalism, etc. Austrianova will not necessarily know how their customer is using the encapsulated cells for "testing" or "research".
Austrianova is open for business and provides many services including putting "Your Cells" in CIAB.
Your Cells, Our Delivery
Cell Encapsulation of Stem Cells service
KU has been placing the patient's own "re-engineered T cells" back into that patient's bloodstream without encapsulation.
KU CAR-T-Cell Therapy
PMCB staff do not tweak any cells. Anyone can contact Austrianova directly.
Austrianova - Your cells, OUR delivery
Austrianova Stem Cell webpage; no indication to contact PMCB
Only mention of PMCB: Partnering webpage
Austrianova upcoming events from Facebook
Austrianova FB posting
Another encapsulation competitor.
It falls significantly short of CIAB capability, but it highlights belief others have in this delivery platform category.
While reading the paragraph beginning
Right! I'm not seeing Level2 CDEL wall at this time
Great summary. Your point #9 is reason I've held for all these years.
"An open IND also signals that many of the major hurdles PharmaCyte faced to get the FDA to approve the initiation of a clinical trial using its unique encapsulation material will not have to be replicated again—meaning that the FDA’s list of extensive requirements related to the capsules that contain live cells for the treatment of diseases will have been met—paving the way for the development of treatments for diabetes and a host of solid tumors."
Many on this board must think that KW is actually doing the work and/or that he is fully in control of the people assembling the documents needed.
At this stage he is more like the mouthpiece reporting the status.
Of course all scientists meet all deadlines they have promised (not).
It's not like he can fire them. They are not all sitting in the PMCB project room (I don't think PMCB office even has a project room) and KW is ordering out for pizza and keeping them there until they are done. They are spread around the world, literally.
There's a lot of i's to dot and t's to cross and KW is not the guy doing that.
Because the document prep and review is taking too long, maybe he should just replace the team and get some scientists who will meet the deadlines.
Therapies for Diabetes Sept Boston
Prices:
Conference Only: USD 2599.0,
Conference + 2 Workshops: USD 3599.0
the positive I saw is drawn from a page in the political handbook:
"I don't care what you print. Just spell my name correctly!"
Anyone that has Amgen in their regular search list will see the PMCB name. They may say WTF is PMCB, but they saw the name.
PharmaCyte Biotech and UTS Creating Advanced Version of Melligen Cells to Treat Diabetes
PMCB IR webpage
KW Interview at GMP Facility
You-Tube video published 7/19
An interview with Kenneth L. Waggoner, Chief Executive Officer at PharmaCyte Biotech, from Austrianova's GMP-manufacturing facility in Bangkok, Thailand. It is at this GMP facility where PharmaCyte's clinical trial product is produced. PharmaCyte will use the product made here in its planned clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).
"more enzimatic activity"
"reproducibility"
[we don't need the data from both of the staggered runs for IND] (my paraphrasing)
Judd appointed to Medical and Scientific Advisory Board
Judd "volunteered to work with us"
"Mr. Morell is prepared to place PharmaCyte in front of a host of media outlets. These outlets are the real story tellers. Also, Mr. Morell’s professional relationships can lead to unique opportunities for PharmaCyte to raise capital from sources that have expressed a keen interest in seeing that the outcome for pancreatic cancer is dramatically improved using PharmaCyte’s therapy. In addition, because Mr. Morell represents numerous celebrities in Hollywood and New York, he can potentially expand the audience that PharmaCyte reaches far beyond what a traditional investor relations or public relations firm could offer."
Alan Morell Strategic Advisor
Whatever happened to Alan Morell, Creative Mgmt Partners?
PMCB IR News Sep 13 2017
Isn't he in place to plan and execute this PR strategy?
Did he 'bail' on us?
Is he about to come out of the dark?
What was the purpose of a "Strategic Advisor to the CEO and BOD"?
"Through Dr. Leonard Makowka, our Senior Strategic Advisor, we were introduced to Alan Morell of Creative Management Partners."
"Mr. Morell also has experience in developing growth strategy and market positioning for clients within the healthcare industry. This includes identifying associations for media campaigns using video news releases, social media, print publications and online publications. He also works regularly with hundreds of news affiliates, including major networks such as FOX, MSNBC and CNBC, for live appearances and taped interviews."
I thought today's board would just be the same.
Way to wake up and get things going, Thanks.
I was supporting JODI1's comment.
Similar words, same thought.
Post #95835
“Many of life's failures are people who did not realize how close
they were to success when they gave up.” -Thomas Edison
As a proud American, I would have made firm plans to have wrapped up whatever I was doing in order to be back in the good Ol' USA for the 4th of July Independence week.
[Just sayin']
I am not so sure that KW should be the focus of blame.
It seems that someone is always having to drag Austrianova toward success and had someone not believed there was potential then Austrianova would still be struggling with a product that no one was interested in. Each step of the way 3d party organizations have been enlisted by PMCB (and all its previous corporate names) to move CIAB forward to where we are today.
Yes KW is ready for deserved retirement and with a successful IND and trial other stronger organizations will take over 'making Austrianova great' when they couldn't do it themselves.
Apparently we haven't started the two mfg runs.
When the PrimeGen website went 'dark' last year it was PrimegenBiotech.com.
Somewhere between the fall and early 2019 a name change was established.
The original URL now redirects to https://primegenglobal.com/ .
Plans to restructure their company in prep for future growth must have been established.
Installation of new PrimeGen website on hold since late summer 2018.
https://primegenglobal.com/
I only use cheap version otcmarkets but as of 10:30 Chgo time it still shows 0 volume today for PMCB.
https://www.otcmarkets.com/stock/PMCB/quote
I will admit optimism, but today's PR was not just prepared this morning or over this last weekend.
[here comes the optimism...]
The next batch could have already started while the 'suits' spent last week preparing today's PR for release.
We may already be one week into the 22 days.
Austrianova received Chinese patent certificate for freeze-drying encapsulated cells
https://m.facebook.com/story.php?story_fbid=2445117265520133&id=747212361977307
Staggered runs doesn't mean "serial" runs to me.
This doesn't change the message today, but I don't think the two add'l runs will require 7-8 months.
Executing two staggered runs can indicate that Run#1 starts and then Run#2 starts one month later.
This also would provide documentation that multiple manufacturing runs can be conducted independently and that the cGMP is capable of meeting demand for additional product without having to wait for a current run to be completed.
I am disappointed that all the mothers in my life are not getting diamonds on May 12, but I am encouraged that this Christmas is going to be better than it was Dec 2018.
Tiny robots could help drug-delivery nanoparticles reach their targets.
[MIT News Office - April 26, 2019]
Tiny robots powered by magnetic fields could help drug-delivery nanoparticles reach their targets.
"STAY THE COURSE"
When I have been "frustrated" it has usually been due to something that is not in my control, eg., staff incompetency (moving too slowly, making errors, etc), contractor incompetency, gov't regs and/or bureaucracy, etc. If I was in control of the task, I wouldn't be frustrated, I would just fix the problem and move forward.
Point being, it has been something that I know should have been done quicker, better, etc., except now I am in the middle of a project and have to deal with what I have now, unless I fire the incompetent or break the sub-contract or go around the govt reg and deal with the fall-out later.
PMCB doesn't actually do any of what we are waiting on.
If something went wrong PMCB didn't do it, but they must rely on what their sub is telling them, eg. "we are correcting the situation and will be back on track 'soon?".
PMCB can't just publicly bad mouth the sub and since they are in the middle of the project and the sub IS competent and IS rectifying the situation, there is really not much that PMCB can do except wait by the phone. (they can't just go to Austrianova or Eurofins and take over managing their staff).
Yes PMCB could provide a status and expected completion, but first they have to be given that info. They could demand the sub tell them when it will be done, but I think the response would be, "don't bother me now, I know what I'm doing and will finish when I finish."
What would anyone do at this moment? start over with new subs?
It is times like that when I was frustrated.
Whether I chose the right subs or not, often my only choice was to "STAY THE COURSE".
also see the IR/contacts page on PMCB website
https://ir.pharmacytebiotech.com/contacts
Sernova Transplantation of Therapeutic Cells in Cell Pouch
Sernova Announces First Transplantation of Therapeutic Cells in Cell Pouch for the Company’s Phase I/II U.S. Clinical Study for Diabetes - Press Release - April 11, 2019
(note: the link does not go directly to the announcement. Scroll down to the list of 'Press Releases' by date.)
definitely a dangerous combo
Unfortunately, that's all that it was...
April 4th = Nat'l Burrito Day.