PharmaCyte Biotech Inc (PMCB)

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PMCB Accomplishments

KW officially takes over as President of NVLX

NVLX immediately acquires 14.5% equity interest in Austrianova. First vision

NVLX contracts with Austrianova to encapsulate cells for clinical trials.

NVLX selects TD2 to conduct preclinical and clinical studies. i.e. the mice studies-

NVLX and PMCB begin preclinical studies

NVLX begins studies for treatment of Ascites Fluid

TD2 joins NVLX to begin studies showing that CiaB can slow the accumulation of Ascites Fluid.

NVLX submits application for ODD to EMA.

NVLX submits application for ODD to FDA.

NVLX secures world-wide license for Insulin producing cells for Diabetes.

NVLX forms Diabetes Consortium with Professor Ann Simpson

NVLX announces opening of Austrianova's cGMP Live Cell Encapsulation Facility.

First live cell encapsulation at new facility just 14 days after it opens.

FDA grants ODD to NVLX for Pancreatic Cancer with marketing exclusivity.

This is the end of 2014 and KW has done a ton including setting the base for everything PMCB is doing today. At this time clinical trials have not been scheduled yet.

NVLX changes name to PharmaCyte Biotech.

PMCB initiates first preclinical study of encapsulation of cells for Diabetes.

PMCB finds in addition to everything else CiaB can do it can also consistently shrink tumors.

PMCB begins talking clinical trial dates.

Research shows that PMCB's Melligen Cell Line can reverse Diabetes.

PMCB completes formation of International Diabetes Consortium to cure Diabetes.

Melligen Cells prove safe in first preclinical test in Vienna.

PMCB appoints Dr. Manuel Hidalgo to Scientific Advisory Board off of his work with CiaB in the preclinical studies at TD2.

Interim Audit of cGMP facility is successful.

PMCB brings Imagining Endpoints on-board to assist in Radiological Imaging for Phase IIB trials

PMCB and TD2 begin to redesign trial design.

PMCB obtains ODD from EMA and additional marketing exclusivity.

PMCB and TD2 meet to re-design of the trial design.

PMCB announces that trial still on target for late 2016.

PMCB and TD2 finalize trial design and is completely re-written.

cGMP finally granted by Thai Government with full go-ahead. Obviously PMCB has no control over how long it takes a country's government to approve a facility like this.

PMCB receives patent protection of melligen cells to treat Diabetes.

Submission of an Investigational New Drug application (IND) to the U.S. FDA requesting authorization to administer its investigational therapy to humans in a proposed Phase 2b clinical trial.

PharmaCyte Biotech Begins DNA Sequence and Stability Studies in Response to FDA Requests for its Clinical Trial Product

PharmaCyte Biotech Begins Physical Testing of CypCaps in Response to FDA Recommendations for its Clinical Trial Product

PharmaCyte Biotech Successfully Completes 9-Month Stability Study

Completed a medical manual pivotal to the completion of its Investigational New Drug application

Pharmacyte completes 6 month stability study
Pharmacyte completes second container closure integrity study
Pharmacyte successfully develops “change history” for its clinical trial product.
Pharmacyte completes medical manual IND filing
Pharmacyte successfully completes all release testing on clinical trial record.