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PMCB hasn't started any tests..... IND has been rejected by the FDA.........PMCB isn't doing anything
Pretty sure that expire
PMCB has nothing never have never will
Thats right the CC where kenny told the world PMCB has failed on all fronts.....and continues to fail on all front today
PMCB can not cure anything let alone diabetes PMCB IND has been rejected by the FDA.......total failure
PharmaCyte Biotech’s live-cell encapsulation technology, called Cell-in-a-Box, can't be use for anything thing because the FDA rejected PMCBs IND
can you believe all this great doctors that kenny paid didn't know what the FDA wanted.......
PMCBs IND reject by the FDA because the top doctors didn't know what to do
yeah kenny is going to market OraPhyte
nothing happening there PMCB is all smoke and mirrors
and the past 4 year PMCB had no idea what the FDA wanted.......The FDA rejected PMCBs IND and thats a fact
not that Im counting but FDA reject PMCBs IND 6 months ago
PMCBs ind has been rejected by the FDA
in the last couple of months I made 300 grand shorting this dead horse......hoping to make more on the next move up on fake news from PMCB.......
Im sure some think your a joke too. Just saying you shouldn't talk bad about others. First grade lessons
Hidalgo is a Joke.......paid article by Uncle Kenny ,,,,,if you pay Hidalgo enough he will say anything no integrity
no proof Ciab works ...pmcb is a company with a failed technology and a IND that has been rejected by the FDA
PMCBs IND has been rejected by the FDA
just for laughs.......did kenny not know he had to file the IND.......PMCB web site is full of all Kennys lies
Q: What other milestones do you hope to accomplish in 2015?
The major milestones for the remainder of 2015 are:
1. Complete the population of our Board of Directors with individuals who have extensive experience in life sciences and who have associated business expertise.
Fully populate our Scientific Advisory Board with world-class physicians and scientists experienced in the fields of cancer and diabetes.
Initiation of the Phase 2b clinical trial in Australia in patients with advanced pancreatic cancer. This is expected to begin in late 3Q2015.
2. Initiation of the Phase 1/2 clinical trial on the effectiveness of PharmaCyte’s pancreatic cancer treatment dealing with pain associated with advanced pancreatic cancer. This trial, to be conducted in the U.S., is expected to begin in late 3Q2015.
3. Initiation of the Phase 1/2 clinical trial on the effectiveness of PharmaCyte’s pancreatic cancer treatment in slowing the accumulation of malignant ascites fluid. This trial, to also be conducted in the U.S., is expected to occur in late 3Q2015 or early 4Q2015.
4. The initiation of these three clinical trials is dependent on the approval for use of the Cell-in-a-Box® live cell encapsulation facility that has been constructed in Bangkok, Thailand, by our partner, Austrianova. This facility must be approved as being compliant with current Good Manufacturing Practices (cGMP) standards by Thailand’s and Australia’s drug regulatory authorities as well as by the U.S. FDA.
5. Completion of our laboratory and small animal studies with the Melligen cells that are necessary to develop our treatment for insulin-dependent diabetes. These studies are designed to obtain data that will be required by regulatory authorities before any human clinical trials can occur.
post a link to peer reviews.......there are none
post a link to the date of those trials.......there are none
who know kenny could be a board member
I think if you where able to dig into Austria Nova finances the some of the money would do a 360 back to kenny.....
but they are foreign private company.......JMO
the cowardly Uncle Kenny instead of having a cc he hide behind the 10Q where he can't lie
In order to address the clinical hold, the FDA has requested that we:
· Provide additional sequencing data and genetic stability studies;
· Conduct a stability study on the final formulated drug product as well as the cells from the Master Cell Bank;
· Evaluate the compatibility of the delivery devices (i.e., the prefilled syringe and microcatheter) with our drug product;
· Provide additional detailed description of the manufacturing process;
· Provide additional product release specifications for the encapsulated cells;
· Demonstrate comparability between the 1st and 2nd generation products and ensure adequate and consistent product performance and safety between the two generations of product;
· Conduct a biocompatibility assessment using the final finished capsules after the entire drug product manufacturing process (but without cells);
· Address insufficiencies in Chemistry, Manufacturing and Controls information in the cross-referenced Drug Master File;
· Conduct an additional nonclinical study to assess the safety, activity and distribution of the drug product;
· Revise the Investigators Brochure to include any additional preclinical studies conducted in response to the clinical hold and remove any statements not supported by the data; and
· Provide data from a new and extensive pig study.
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The FDA also requested that we address several issues not related to the clinical hold in an amendment to the IND, including:
· Providing a Certificate of Analysis for pc3/2B1 plasmid that includes tests for assessing purity, safety, and potency;
· Performing qualification studies for the drug substance filling step to ensure that the product remains sterile and stable during the filling process;
· Submitting an updated batch analysis for the drug product for the specific lot that will be used for manufacturing all future drug product;
· Providing additional details for the methodology for the Resorufin (CYP2B1) potency and the PrestoBlue cell metabolic assays;
· Providing a few examples of common microcatheters that fit the specifications in the Angiography Procedure Manual;
· Clarifying the language in the Pharmacy Manual regarding proper use of the syringe fill with the drug product; and
· Providing a discussion with data for the potential for cellular and humoral immune reactivity against the heterologous rat CYP2B1 protein and potential for induction of autoimmune-mediated toxicities in the Company’s study population.
Since October 31, 2020, there has been no further communication with the FDA regarding the clinical hold.
post the data to the 2 failed clinicals.......there is none
I hear there is going to be a big update 0n 3/18 at 6:22 pm
Hidalgo is a joke.....did even know how to file the ind......where is this hack
no peer reviews if there was you would post a link
so you agree pmcb has done nothing in 6 months
PMCB is basically out of business now they are sell share only to pay salaries......kenny used covid to pump the stock with the test kits and now using covid as an excuse with pmcb has failed
and now we know who was selling all the shares
All such securities were issued without registration under the Securities Act in reliance upon the exemption afforded by Section 4(a)(2) of that Act based on the limited number of investors,
without a doubt ind was rejected and pmcb can not answer fda questions
looks like PMCB will be out of business soon
Proof please...that Ciab works
when was pmcbs last board meeting? who is the recording secretary? why are the minute not made public to shareholders? answer there has never been a board meeting they get paid for there name and there names are not worth much
waggy has done nothing for pmcb of shareholders value......kenny is a one man dog and pony show......he is worthless
almost a year ago kenny preyed on people with covid......PMCB was going to have the best test kits......
just as he preys on people with cancer.......disgusting
where is kenny not a word in months only recycled prs
and when will that be there are no trials no data no studies PMCB is a failure and IND was rejected
its right there kenny knew it wouldn't be accepted,,,,,,,and that why there was a sell off