Replies to post #118214 on PharmaCyte Biotech Inc (PMCB)

[1234jklm]

Done in 2018

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

[rayla1961]

Here is what I received from IR back February 11.

With the successful completion of the 10 “release tests,” the work directly related to the manufacturing process was complete. The pyrogenicity test was not one of those tests. The actual pyrogenicity test itself is not complex, nor is it time-consuming, but the preparations for the test are. Accordingly, at this time, the entire test is in progress.

The conclusion that you had that once the 10 release tests were complete, the IND would be immediately filed is incorrect because the IND consists of other items in addition to information on the manufacturing process. For example, on the medical side of things, very important major documents such as the clinical trial protocol and the Investigators’ Brochure, to name just two, are also a very major part of the IND.

So, as you can glean from the above, the IND for a late-phase clinical trial like PharmaCyte’s Phase 2b trial in LAPC is far more complex to prepare than would be an IND for a Phase 1 trial.

The time that it will take to complete all of the outstanding matters for inclusion in the IND is uncertain at this time and thus the time that it will take to submit the IND to the FDA is uncertain as well.

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[$Pistol Pete$]

Then if one process change, the whole process will start all over again and multiple tests required. They kept dancing forever and ever until 2030. Maybe dilute another 5B shares more and still no IND file.