Replies to post #118428 on PharmaCyte Biotech Inc (PMCB)

[efood125]

I dont think Facet...cgmp Validation...and Medpace could all be so stupid! Unless big pharma is pulling strings at the FDA...

[$Pistol Pete$]

Very good excuses and also big boys don’t want it to get approve, etc.....lots of excuses from all angles and all possible to cover for this scam company. Next week will be very interesting to see the true value of the PPS. They will be crash hard

[A2Z]

Otto thst certainly is feasible ..., could very well been submitted and this was the feedback. I don’t see any CL saying that’s not what’s going on.

[1234jklm]

No , they knew about this in 2018

Regulatory agencies, including the U.S. Food and Drug Administration (FDA), require that studies be conducted to determine an initial shelf life for a medicinal product before an advanced phase clinical trial can begin. This shelf life can then be extended with further testing as the product is being used in the clinical trial. Austrianova Singapore already has data demonstrating storage life of frozen encapsulated cells for over six years; however, these studies were done with a slightly different cell line than the cell line that will be used for PharmaCyte’s planned clinical trial. The current completed study uses the Research Bank of cells that will be used in the final product for PharmaCyte’s trial and from which Eurofins has already generated PharmaCyte’s Master Cell Bank.
The stability test results show that there are no significant changes in the viability or the enzymatic activity of the cells upon thawing after a 6-month storage period at -80oC. These results will allow an initial shelf life of six months to be set for the product; this will be extended as the product is tested further.

https://pharmacyte.com/pharmacyte-announces-successful-completion-6-month-stability-study-encapsulated-cells-clinical-trial/